49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 946 / 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05278663 (ClinicalTrials.gov) | April 30, 2022 | 4/3/2022 | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus Participants | A Randomized, Double-Blind, Placebo-Controlled, Multi-center, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus Patients | Lupus Erythematosus, Systemic | Drug: E6742;Other: Placebo | Eisai Co., Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 24 | Phase 1/Phase 2 | Japan |
| 2 | EUCTR2019-003406-27-DK (EUCTR) | 09/03/2022 | 04/03/2021 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 3 | EUCTR2019-003407-35-ES (EUCTR) | 09/03/2022 | 17/01/2022 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS FLY | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: dapirolizumab pegol Other descriptive name: DZP | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Czechia;Taiwan;Hong Kong;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Bulgaria;Germany;Japan;China | ||
| 4 | EUCTR2020-004047-86-HU (EUCTR) | 28/02/2022 | 23/12/2021 | A Study of ALPN-101 in Active Lupus | A Randomised, Double-Blind, Placebo-controlled study of ALPN-101 in Systemic Lupus Erythematosus | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042946;Term: Systemic lupus erythematosus rash;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857 MedDRA version: 20.1;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations MedDRA version: 20.0;Classification code 10067658;Term: Systemic lupus erythematosus disease activity index decreased;System Organ Class: 10022891 - Investigations MedDRA version: 20.1;Classification code 10067659;Term: Systemic lupus erythematosus disease activity index abnormal;System Organ Class: 10022891 - Investigations MedDRA version: 21.0;Classification code 10080670;Term: Systemic lupus erythematosus reactivation;Classification code 10073694;Term: Lupus pleurisy;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10040968;Term: SLE arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ALPN-101 INN or Proposed INN: Acazicolcept Other descriptive name: ALPN-101 | Alpine Immune Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 2 | France;United States;Taiwan;Hungary;Spain;Poland;Russian Federation;Germany;Korea, Republic of | ||
| 5 | NCT05123586 (ClinicalTrials.gov) | February 28, 2022 | 16/11/2021 | A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Two-Arm, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LY3361237 as a Treatment for Adults With At Least Moderately Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: LY3361237;Drug: Placebo | Eli Lilly and Company | NULL | Not yet recruiting | 18 Years | 65 Years | All | 90 | Phase 2 | United States;Argentina;Czechia;Mexico;Poland;Puerto Rico;Russian Federation;Ukraine |
| 6 | NCT05203419 (ClinicalTrials.gov) | February 15, 2022 | 10/1/2022 | Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE) | A Two-part, Randomized, Investigator- and Participant- Blinded, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MHS552 in Adult Participants With Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus, Systemic | Drug: MHS552;Drug: Placebo | Novartis Pharmaceuticals | NULL | Not yet recruiting | 18 Years | 65 Years | All | 28 | Phase 1 | NULL |
| 7 | JPRN-jRCT2011210069 | 15/02/2022 | 05/02/2022 | A Study Evaluating the Efficacy and Safety of BMS-986256 Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | ArmA:BMS-986256 30mg QD ArmB:BMS-986256 10mg QD ArmC:BMS-986256 2.5mg QD ArmD:Placebo QD | Ranganathan Usha | NULL | Recruiting | >= 20age old | <= 70age old | Both | 20 | Phase 2 | Argentina;Australia;Brazil;Chile;Colombia;France;Germany;Ireland;Mexico;Poland;Romania;Spain;Taiwan;USA;United Kingdom;Japan |
| 8 | JPRN-jRCT2041210058 | 04/02/2022 | 20/08/2021 | A Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Group 1_Placebo:Participants will receive placebo intravenously (IV) every two weeks (q2w) through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and Glucocorticoids [GCs]). Group 2_Nipocalimab Dose 1: Participants will receive nipocalimab dose 1 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs). Group 3_Nipocalimab Dose 2: Participants will receive nipocalimab dose 2 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs). | Numaguchi Hirotaka | NULL | Recruiting | >= 18age old | <= 65age old | Both | 225 | Phase 2 | Bulgaria;Colombia;Germany;Spain;Hungary;Poland;Taiwan, Province Of China;Ukraine;United States OfAmerica;South Africa;Japan |
| 9 | NCT05203692 (ClinicalTrials.gov) | February 2, 2022 | 20/1/2022 | A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects | A Phase 1, Subjects- and Investigator-Blinded, Sponsor-Unblinded, Placebo-Controlled, Randomized, Sequential Cohort Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of DS-7011a in Healthy Subjects | Systemic Lupus Erythematosus | Drug: DS-7011a;Drug: Placebo | Daiichi Sankyo, Inc. | NULL | Recruiting | 18 Years | 45 Years | All | 80 | Phase 1 | United States |
| 10 | NCT05140824 (ClinicalTrials.gov) | December 30, 2021 | 4/11/2021 | A Study to Evaluate the Safety, Tolerability, and PK Profile of Single and Multiple Doses TJ202 in Patient With Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of TJ202 in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Drug: Placebo;Biological: TJ202 injection | I-Mab Biopharma Co. Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 72 | Phase 1 | China |
| 11 | EUCTR2020-005776-35-NL (EUCTR) | 24/12/2021 | 13/09/2021 | A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not applicable Product Code: BIIB059 INN or Proposed INN: Not applicable Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 540 | Phase 3 | Serbia;United States;Czechia;Israel;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Romania;Netherlands;Germany;China;Japan | ||
| 12 | NCT05162586 (ClinicalTrials.gov) | December 17, 2021 | 8/12/2021 | A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in SLE and in CLE (SCLE and/or DLE) Participants Receiving Standard of Care (WILLOW) | A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in SLE and in CLE (SCLE and/or DLE) Participants Receiving Standard of Care (WILLOW) | Systemic Lupus Erythematosus | Drug: M5049 low dose;Drug: M5049 medium dose;Drug: M5049 high dose;Drug: Placebo | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Not yet recruiting | 18 Years | 75 Years | All | 440 | Phase 2 | United States;Germany |
| 13 | EUCTR2019-004021-25-ES (EUCTR) | 14/12/2021 | 25/08/2021 | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus. | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus. | Active Systemic Lupus Erythematosus. MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TLR7/8 Antagonist (2.5mg) Product Code: BMS-986256 INN or Proposed INN: Not available Other descriptive name: BMS-986256-06, TLR7/8 Antagonist Product Name: TLR7/8 Antagonist (10mg) Product Code: BMS-986256 INN or Proposed INN: Not available Other descriptive name: BMS-986256-06, TLR7/8 Antagonist | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 2 | United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Romania;Australia;Germany;Japan | ||
| 14 | NCT00775476 (ClinicalTrials.gov) | December 2021 | 17/10/2008 | Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine | Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine (NAC) (SNAC) | Systemic Lupus Erythematosus | Drug: N-acetylcysteine;Drug: Placebo | State University of New York - Upstate Medical University | NULL | Not yet recruiting | 18 Years | N/A | All | 290 | Phase 2 | United States |
| 15 | EUCTR2020-005569-14-BG (EUCTR) | 12/11/2021 | 29/09/2021 | A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 2 | United States;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Colombia;Hungary;Argentina;Poland;Bulgaria;South Africa;Germany;Japan | ||
| 16 | EUCTR2020-005776-35-HU (EUCTR) | 10/11/2021 | 08/10/2021 | A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not applicable Product Code: BIIB059 INN or Proposed INN: Not applicable Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 540 | Phase 3 | Serbia;United States;Czechia;Israel;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Romania;Germany;Netherlands;China;Japan | ||
| 17 | EUCTR2020-005775-12-GR (EUCTR) | 02/11/2021 | 13/09/2021 | A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not applicable Product Code: BIIB059 INN or Proposed INN: Not applicable Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 540 | Phase 3 | Taiwan;Greece;Spain;Chile;Russian Federation;France;Mexico;Poland;Brazil;Australia;Peru;Bulgaria;Sweden;Korea, Republic of;Philippines;United States | ||
| 18 | EUCTR2020-005776-35-IT (EUCTR) | 02/11/2021 | 27/01/2022 | A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care - . | systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not applicable Product Code: [BIIB059] INN or Proposed INN: HA 1A ANTICORPO MONOCLONALE UMANO CLASSE IGM | BIOGEN IDEC RESEARCH LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 540 | Phase 3 | United States;Czechia;Israel;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Romania;Germany;Netherlands;China;Japan | ||
| 19 | JPRN-jRCT2071210076 | 01/11/2021 | 15/10/2021 | A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus | The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy - Tulip SC | Systemic Lupus Erythematosus | Approximately 360 patients are planned to be randomly assigned in a 1:1 ratio (180 patients per treatment group) to receive either a fixed SC dose of anifrolumab or placebo once weekly (QW). | Hibi Kazushige | NULL | Recruiting | >= 18age old | <= 70age old | Both | 36 | Phase 3 | United States;Argentina;Bulgaria;Chile;Colombia;Hungary;Mexico;Peru;Poland;Russia;Ukraine;United Kingdom;Germany;Spain;Japan |
| 20 | NCT05019950 (ClinicalTrials.gov) | October 28, 2021 | 16/8/2021 | Safety Tolerability and Pharmacokinetics of Oral LABP-104 in Healthy Adult Male and Female Volunteers | A Randomized, Placebo-Controlled, Double-Blind, Single-Center Study to Evaluate Safety Tolerability and Pharmacokinetics of Oral LABP-104 in Healthy Adult Male and Female Volunteers | Systemic Lupus Erythematosus | Drug: LABP-104 250mg;Drug: Placebo | Landos Biopharma Inc. | NULL | Recruiting | 18 Years | 64 Years | All | 56 | Phase 1 | Australia |
| 21 | EUCTR2019-004021-25-PL (EUCTR) | 27/10/2021 | 24/09/2021 | A Study Evaluating the Efficacy and Safety of BMS-986256 Compared With Placebo in Participants With ActiveSystemic Lupus Erythematosus (SLE) | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus. | Active Systemic Lupus Erythematosus. MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TLR7/8 Antagonist (2.5mg) Product Code: BMS-986256 INN or Proposed INN: Not available Other descriptive name: BMS-986256-06, TLR7/8 Antagonist Product Name: TLR7/8 Antagonist (10mg) Product Code: BMS-986256 INN or Proposed INN: Not available Other descriptive name: BMS-986256-06, TLR7/8 Antagonist | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 2 | United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan | ||
| 22 | NCT04963296 (ClinicalTrials.gov) | October 26, 2021 | 7/7/2021 | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Obinutuzumab;Drug: Placebo;Drug: Acetaminophen/Paracetamol;Drug: Diphenhydramine hydrochloride;Drug: Methylprednisolone | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 75 Years | All | 200 | Phase 3 | United States;Argentina;France;Italy;Mexico;New Zealand;Peru;Russian Federation;South Africa;Spain;Brazil;Poland;United Kingdom |
| 23 | EUCTR2020-005760-57-PL (EUCTR) | 25/10/2021 | 21/09/2021 | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus Erythematosus | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Gazyvaro INN or Proposed INN: OBINUTUZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Poland;Brazil;Australia;Peru;South Africa;New Zealand | ||
| 24 | EUCTR2021-001567-25-IT (EUCTR) | 22/10/2021 | 12/10/2021 | Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus | Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study - APATURA | Systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAR441344 Product Code: [SAR441344] INN or Proposed INN: NON APPLICABILE Other descriptive name: SAR441344 | SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 2 | United States;Mexico;Greece;Argentina;Spain;Ukraine;Turkey;Russian Federation;Chile;Germany;Italy | ||
| 25 | JPRN-jRCTs021210042 | 14/10/2021 | 14/10/2021 | Randomized , double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of belimumab for early systemic lupus erythematosus | Randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of belimumab for early systemic lupus erythematosus - BEFORE-S | Systemic Lupus Erythematosus : SLE Systemic Lupus Erythematosus, SLE;D008180 | Group A to which the test drug is administered and Group B to which the placebo is administered will be set. Group A: In addition to the usual treatment, belimumab (GlaxoSmithKline Co., Ltd., trade name Benlysta) will be administered subcutaneously once a week at 200 mg. Administration will be continued for 24 weeks. Group B: Placebo will be administered and standard of care will be performed. Both groups will receive a combination of hydroxychloroquine unless there is a reason not to use hydroxychloroquine as usual treatment. | Ishii Tomonori | NULL | Recruiting | >= 20age old | < 80age old | Both | 30 | N/A | Japan |
| 26 | EUCTR2019-004021-25-FR (EUCTR) | 13/10/2021 | 13/08/2021 | A Study Evaluating the Efficacy and Safety of BMS-986256 Compared With Placebo in Participants With ActiveSystemic Lupus Erythematosus (SLE) | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus. | Active Systemic Lupus Erythematosus. MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TLR7/8 Antagonist (2.5mg) Product Code: BMS-986256 INN or Proposed INN: Not available Other descriptive name: BMS-986256-06, TLR7/8 Antagonist Product Name: TLR7/8 Antagonist (10mg) Product Code: BMS-986256 INN or Proposed INN: Not available Other descriptive name: BMS-986256-06, TLR7/8 Antagonist | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 2 | United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Romania;Australia;Germany;Japan | ||
| 27 | EUCTR2021-001567-25-DE (EUCTR) | 11/10/2021 | 29/07/2021 | Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus | Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study - APATURA | Systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: Not Applicable Other descriptive name: SAR441344 | Sanofi-Aventis Recherche et Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 2 | United States;Mexico;Greece;Argentina;Spain;Ukraine;Turkey;Russian Federation;Chile;Germany;Italy | ||
| 28 | NCT04895696 (ClinicalTrials.gov) | October 11, 2021 | 19/5/2021 | A Study Evaluating the Efficacy and Safety of BMS-986256 Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: BMS-986256 (Oral);Other: Placebo | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | 70 Years | All | 344 | Phase 2 | United States;Argentina;Australia;Brazil;Chile;Colombia;France;Germany;Ireland;Japan;Mexico;Poland;Puerto Rico;Romania;Spain;Taiwan;United Kingdom |
| 29 | EUCTR2020-005775-12-ES (EUCTR) | 05/10/2021 | 08/07/2021 | A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not applicable Product Code: BIIB059 INN or Proposed INN: Not applicable Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 540 | Phase 3 | United States;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;France;Mexico;Poland;Brazil;Australia;Peru;Bulgaria;Sweden;Korea, Republic of | ||
| 30 | NCT05039840 (ClinicalTrials.gov) | October 2021 | 1/9/2021 | Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus | Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus: A Randomized, Double Blind, Placebo-controlled, Phase 2, Proof of Concept Study | Systemic Lupus Erythematosus | Drug: SAR441344 IV;Drug: SAR441344 SC;Drug: Placebo IV;Drug: Placebo SC | Sanofi | NULL | Recruiting | 18 Years | 70 Years | All | 116 | Phase 2 | United States |
| 31 | EUCTR2021-001567-25-ES (EUCTR) | 22/09/2021 | 27/07/2021 | Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus | Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study - APATURA | Systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: Not Applicable Other descriptive name: SAR441344 | Sanofi-Aventis Recherche et Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 2 | United States;Mexico;Greece;Argentina;Spain;Ukraine;Turkey;Russian Federation;Chile;Germany;Italy | ||
| 32 | NCT04931563 (ClinicalTrials.gov) | September 13, 2021 | 29/4/2021 | Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE) | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Anifrolumab in Asian Participants With Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus | Biological: Anifrolumab;Drug: placebo | AstraZeneca | NULL | Recruiting | 18 Years | 70 Years | All | 328 | Phase 3 | China;Hong Kong;Korea, Republic of;Philippines;Taiwan;Thailand |
| 33 | EUCTR2020-004529-22-BG (EUCTR) | 10/09/2021 | 23/07/2021 | Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus - Tulip SC | Moderate-to-severe Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: ANIFROLUMAB Other descriptive name: ANIFROLUMAB | AstraZeneca | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Peru;Bulgaria;Germany;Japan | ||
| 34 | EUCTR2020-005760-57-IT (EUCTR) | 09/09/2021 | 12/10/2021 | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus Erythematosus | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS - ALLEGORY | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Gazyvaro Product Name: Gazyvaro Product Code: [na] INN or Proposed INN: OBINUTUZUMAB | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Australia;Peru;South Africa;New Zealand | ||
| 35 | NCT04736953 (ClinicalTrials.gov) | September 1, 2021 | 4/12/2020 | Sirolimus Treatment Of Patients With SLE | Sirolimus Treatment of Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Sirolimus;Other: Placebo | State University of New York - Upstate Medical University | NULL | Not yet recruiting | 18 Years | N/A | All | 220 | Phase 2 | NULL |
| 36 | EUCTR2020-005569-14-HU (EUCTR) | 24/08/2021 | 09/07/2021 | A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 2 | United States;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Colombia;Hungary;Argentina;Poland;South Africa;Bulgaria;Germany;Japan | ||
| 37 | EUCTR2020-004529-22-HU (EUCTR) | 24/08/2021 | 18/06/2021 | Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus - Tulip SC | Moderate-to-severe Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: ANIFROLUMAB Other descriptive name: ANIFROLUMAB | AstraZeneca | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;United Kingdom;Hungary;Mexico;Japan;Germany;Bulgaria;Peru;Poland;Argentina | ||
| 38 | NCT04882878 (ClinicalTrials.gov) | August 20, 2021 | 7/5/2021 | A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Other: Placebo;Drug: Nipocalimab;Drug: Standard-of-care treatment | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 65 Years | All | 225 | Phase 2 | United States;Argentina;Bulgaria;Colombia;Germany;Hungary;Japan;Poland;Russian Federation;South Africa;Spain;Taiwan;Ukraine;Hong Kong |
| 39 | EUCTR2020-005528-12-ES (EUCTR) | 17/08/2021 | 18/08/2021 | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus - RECAST SLE | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: VIB7734 Product Code: VIB7734 INN or Proposed INN: VIB7734 Other descriptive name: VIB7734, MEDI7734 | Viela Bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Taiwan;Mexico;Greece;Argentina;Poland;Spain;Ukraine;Russian Federation;India | ||
| 40 | EUCTR2020-005569-14-ES (EUCTR) | 13/08/2021 | 13/08/2021 | A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 2 | United States;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Colombia;Hungary;Argentina;Poland;South Africa;Bulgaria;Germany;Japan | ||
| 41 | EUCTR2018-004175-12-IT (EUCTR) | 13/08/2021 | 17/08/2021 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus. | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) - - | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: [PF-06700841 5 mg] INN or Proposed INN: brepocitinib Product Name: PF-06700841 Product Code: [PF-06700841 25mg] INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 | PFIZER INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | United States;Serbia;Portugal;Taiwan;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 42 | EUCTR2020-004047-86-ES (EUCTR) | 11/08/2021 | 23/06/2021 | A Study of ALPN-101 in Active Lupus | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPN-101 IN SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042946;Term: Systemic lupus erythematosus rash;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857 MedDRA version: 20.1;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations MedDRA version: 20.0;Classification code 10067658;Term: Systemic lupus erythematosus disease activity index decreased;System Organ Class: 10022891 - Investigations MedDRA version: 20.1;Classification code 10067659;Term: Systemic lupus erythematosus disease activity index abnormal;System Organ Class: 10022891 - Investigations MedDRA version: 21.0;Classification code 10080670;Term: Systemic lupus erythematosus reactivation;Classification code 10073694;Term: Lupus pleurisy;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10040968;Term: SLE arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ALPN-101 INN or Proposed INN: Acazicolcept Other descriptive name: ALPN-101 | Alpine Immune Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 2 | France;United States;Poland;Spain;Russian Federation;Germany;Korea, Republic of | ||
| 43 | EUCTR2020-005760-57-ES (EUCTR) | 30/07/2021 | 23/06/2021 | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus Erythematosus | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Gazyvaro INN or Proposed INN: OBINUTUZUMAB | Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Australia;Peru;South Africa;New Zealand | ||
| 44 | NCT04961567 (ClinicalTrials.gov) | July 16, 2021 | 5/7/2021 | A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | Lupus Erythematosus, Systemic | Drug: BIIB059;Drug: BIIB059-Matching Placebo | Biogen | NULL | Recruiting | 18 Years | N/A | All | 540 | Phase 3 | United States;Argentina;Bulgaria;Colombia;Czechia;Hungary;Japan |
| 45 | EUCTR2020-004047-86-PL (EUCTR) | 14/07/2021 | 09/06/2021 | A Study of ALPN-101 in Active Lupus | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPN-101 IN SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042946;Term: Systemic lupus erythematosus rash;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857 MedDRA version: 20.1;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations MedDRA version: 20.0;Classification code 10067658;Term: Systemic lupus erythematosus disease activity index decreased;System Organ Class: 10022891 - Investigations MedDRA version: 20.1;Classification code 10067659;Term: Systemic lupus erythematosus disease activity index abnormal;System Organ Class: 10022891 - Investigations MedDRA version: 21.0;Classification code 10080670;Term: Systemic lupus erythematosus reactivation;Classification code 10073694;Term: Lupus pleurisy;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10040968;Term: SLE arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ALPN-101 INN or Proposed INN: Acazicolcept Other descriptive name: ALPN-101 | Alpine Immune Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 2 | United States;France;Taiwan;Hungary;Spain;Poland;Russian Federation;Germany;Korea, Republic of | ||
| 46 | NCT04925934 (ClinicalTrials.gov) | June 24, 2021 | 4/5/2021 | Study of VIB7734 for the Treatment of Moderate to Severely Active SLE | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: VIB7734;Other: Placebo | Viela Bio | NULL | Recruiting | 18 Years | 70 Years | All | 195 | Phase 2 | United States;Argentina;Greece;Mexico;Poland;Spain;Ukraine |
| 47 | NCT04835441 (ClinicalTrials.gov) | June 22, 2021 | 5/4/2021 | ALPN-101 in Systemic Lupus Erythematosus | A Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: ALPN-101;Drug: Placebo | Alpine Immune Sciences, Inc. | NULL | Recruiting | 18 Years | 65 Years | All | 130 | Phase 2 | United States;Korea, Republic of;Poland |
| 48 | EUCTR2019-002205-22-NL (EUCTR) | 15/06/2021 | 11/02/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | France;United States;Mexico;Argentina;Spain;Poland;Belgium;Germany;Netherlands;United Kingdom | ||
| 49 | NCT05260255 (ClinicalTrials.gov) | June 15, 2021 | 12/5/2021 | Effect of Vitamin D Supplement on Disease Activity in SLE | The Effect of Vitamin D Supplementation on Disease Activity of Systemic Lupus Erythematosus Patients: A Randomized Clinical Trial in Rajavithi Hospital | Vitamin D Deficiency;Hypocalcemia;Hyperparathyroidism;Systemic Lupus Erythematosus (Disorder) | Drug: vitamin D2 ( calciferol );Drug: Placebo | Rajavithi Hospital | NULL | Recruiting | 18 Years | N/A | All | 100 | N/A | Thailand |
| 50 | NCT04877691 (ClinicalTrials.gov) | June 8, 2021 | 4/5/2021 | Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Medi-546;Drug: Placebo | AstraZeneca | Iqvia Pty Ltd | Recruiting | 18 Years | 70 Years | All | 360 | Phase 3 | United States;Argentina;Bulgaria;Chile;Colombia;Germany;Hungary;Japan;Mexico;Peru;Poland;Russian Federation;Spain;Ukraine;United Kingdom |
| 51 | NCT04643067 (ClinicalTrials.gov) | June 3, 2021 | 12/11/2020 | A Study to Assess the Safety and Tolerability, PK and Efficacy of KPG-818 in Mild to Moderate SLE Patients | A Phase 1b/2a Multicenter Study to Assess the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of KPG-818 in Patients With Systemic Lupus Erythematosus | SLE; Drug | Drug: 0.15mg KPG-818 dose;Drug: 0.6mg KPG-818 dose;Drug: 2mg KPG-818 dose;Drug: Placebo | Kangpu Biopharmaceuticals, Ltd. | NULL | Recruiting | 18 Years | N/A | All | 64 | Phase 1/Phase 2 | United States |
| 52 | NCT04895241 (ClinicalTrials.gov) | May 25, 2021 | 17/5/2021 | A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | Lupus Erythematosus, Systemic | Drug: BIIB059;Drug: BIIB059 matching placebo | Biogen | NULL | Recruiting | 18 Years | N/A | All | 540 | Phase 3 | United States;Bulgaria;China;Poland;Spain |
| 53 | JPRN-jRCT2041210076 | 06/05/2021 | 01/10/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy | Active Systemic Lupus Erythematosus | Placebo Comparator: Placebo + Standard of Care Interventions: Drug: Placebo Other: Standard of Care Experimental: Efavaleukin Alfa Dose Level One + Standard of Care Interventions: Drug: Efavaleukin Alfa Other: Standard of Care Experimental: Efavaleukin Alfa Dose Level Two + Standard of Care Interventions: Drug: Efavaleukin Alfa Other: Standard of Care Experimental: Efavaleukin Alfa Dose Level Three + Standard of Care Interventions: Drug: Efavaleukin Alfa Other: Standard of Care | Hama Yoriko | NULL | Recruiting | >= 18age old | <= 75age old | Both | 320 | Phase 2 | United States;Korea, Republic of;Poland;Turkey;Greece,;Spain;Japan |
| 54 | NCT04680637 (ClinicalTrials.gov) | May 6, 2021 | 18/12/2020 | Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy | Active Systemic Lupus Erythematosus | Drug: Efavaleukin Alfa;Drug: Placebo;Other: Standard of Care | Amgen | NULL | Recruiting | 18 Years | 75 Years | All | 320 | Phase 2 | United States;Austria;Bulgaria;Greece;Hong Kong;Italy;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Spain;Switzerland;Taiwan;Turkey |
| 55 | NCT04516408 (ClinicalTrials.gov) | April 20, 2021 | 13/8/2020 | Recombinant Zoster Vaccine in Stable SLE Patients | Efficacy and Safety of Recombinant Zoster Vaccine in Stable SLE Patients(Vtrial) | Herpes Zoster;Recombinant Zoster Vaccine;Systemic Lupus Erythematosus | Biological: Recombinant zoster vaccine;Biological: Placebo | RenJi Hospital | NULL | Recruiting | 50 Years | N/A | All | 464 | N/A | China |
| 56 | EUCTR2019-003406-27-CZ (EUCTR) | 23/03/2021 | 23/12/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 57 | NCT04515719 (ClinicalTrials.gov) | March 19, 2021 | 13/8/2020 | Efficacy and Safety of Belimumab in SLE Patients | Efficacy and Safety of Belimumab for Prevention of Disease Flares in SLE Patients With Low Disease Activity | Systemic Lupus Erythematosus | Biological: Belimumab;Biological: Placebo | RenJi Hospital | NULL | Recruiting | 18 Years | 70 Years | All | 334 | Phase 4 | China |
| 58 | EUCTR2019-003323-38-DE (EUCTR) | 21/01/2021 | 03/07/2020 | A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: Not Applicable Other descriptive name: LY3471851 | Eli Lilly & Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 59 | NCT04700267 (ClinicalTrials.gov) | December 28, 2020 | 6/1/2021 | A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus Erythematosus | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: GLPG3970 film-coated tablet;Drug: Placebo film-coated tablet | Galapagos NV | NULL | Terminated | 18 Years | 65 Years | All | 11 | Phase 1 | Bulgaria;Moldova, Republic of;Poland;Spain;Ukraine |
| 60 | NCT04647708 (ClinicalTrials.gov) | December 16, 2020 | 23/11/2020 | Study of M5049 in CLE and SLE Participants | A Phase Ib, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of M5049 Administered Orally in SLE and CLE Participants Treated With Standard of Care | Systemic Lupus Erythematosus;Cutaneous Lupus Erythematosus | Drug: M5049;Drug: Placebo | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Recruiting | 18 Years | 65 Years | All | 44 | Phase 1 | Bulgaria;Germany;Moldova, Republic of;Spain;Ukraine |
| 61 | EUCTR2019-003406-27-PT (EUCTR) | 14/12/2020 | 29/06/2020 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 62 | EUCTR2019-000638-20-BG (EUCTR) | 09/11/2020 | 14/08/2020 | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Elsubrutinib Product Code: ABBV-105 INN or Proposed INN: ELSUBRUTINIB Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | Phase 2 | United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Puerto Rico;Argentina;Poland;Australia;Bulgaria;Netherlands;Germany;China;Japan;New Zealand;Korea, Republic of | ||
| 63 | EUCTR2019-003323-38-GB (EUCTR) | 06/11/2020 | 13/10/2020 | A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: Not applicable Other descriptive name: LY3471851 | Eli Lilly & Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 64 | EUCTR2019-003323-38-HU (EUCTR) | 04/11/2020 | 10/09/2020 | A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: Not applicable Other descriptive name: LY3471851 | Eli Lilly & Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 65 | NCT04582136 (ClinicalTrials.gov) | November 2020 | 3/10/2020 | Efficacy and Safety of Sirolimus in Active Systemic Lupus Erythematosus | Efficacy and Safety of Sirolimus in Patients With Active Systemic Lupus Erythematosus Despite Standard of Care: a Multi-center, Double Blinded, Randomized, Placebo-controlled, Phase 2 Trial | Systemic Lupus Erythematosus | Drug: Sirolimus;Drug: Placebo | Chinese SLE Treatment And Research Group | Beijing Municipal Science & Technology Commission;North China Pharmaceutical Group Corporation | Not yet recruiting | 18 Years | 65 Years | All | 146 | Phase 2 | NULL |
| 66 | EUCTR2019-003323-38-PL (EUCTR) | 09/10/2020 | 07/10/2020 | A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: Not applicable Other descriptive name: LY3471851 | Eli Lilly & Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Israel;Russian Federation;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Poland;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 67 | EUCTR2019-003406-27-IT (EUCTR) | 07/10/2020 | 21/01/2021 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - - | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: [CDP7657] INN or Proposed INN: Dapirolizumab pegol | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Denmark;Peru;Australia;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 68 | EUCTR2019-002205-22-FR (EUCTR) | 01/10/2020 | 13/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | Netherlands;Germany;United Kingdom;Belgium;Poland;Spain;Argentina;Mexico;France;United States | ||
| 69 | EUCTR2019-003406-27-DE (EUCTR) | 17/09/2020 | 15/04/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 70 | EUCTR2019-003406-27-AT (EUCTR) | 11/09/2020 | 29/05/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 71 | EUCTR2019-003406-27-GB (EUCTR) | 09/09/2020 | 15/07/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Australia;Peru;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 72 | NCT04433585 (ClinicalTrials.gov) | August 19, 2020 | 15/6/2020 | A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE) | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: LY3471851;Drug: Placebo | Eli Lilly and Company | Nektar Therapeutics | Recruiting | 18 Years | 65 Years | All | 280 | Phase 2 | United States;Argentina;Australia;Canada;Czechia;Germany;Hungary;India;Israel;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Romania;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom |
| 73 | NCT04294667 (ClinicalTrials.gov) | August 12, 2020 | 27/2/2020 | A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: DZP;Other: Placebo | UCB Biopharma SRL | NULL | Recruiting | 16 Years | N/A | All | 450 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Colombia;Czechia;France;Germany;Greece;Hong Kong;Hungary;Italy;Korea, Republic of;Mexico;Peru;Philippines;Poland;Portugal;Romania;Serbia;Spain;Taiwan |
| 74 | EUCTR2019-002205-22-DE (EUCTR) | 12/08/2020 | 07/07/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 75 | EUCTR2019-003406-27-GR (EUCTR) | 30/07/2020 | 02/06/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 76 | EUCTR2018-001808-11-GR (EUCTR) | 29/07/2020 | 16/07/2020 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus | Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 | Idorsia Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 325 | Phase 2 | United States;Czechia;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China | ||
| 77 | EUCTR2019-003406-27-HU (EUCTR) | 28/07/2020 | 20/05/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Slovakia;Portugal;United States;Serbia;Philippines;Taiwan;Estonia;Czechia;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden;Korea, Republic of;Netherlands;Australia;Peru;France;Italy;Switzerland;Colombia;Chile;Spain;Greece | ||
| 78 | NCT04451772 (ClinicalTrials.gov) | July 27, 2020 | 29/6/2020 | A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State | A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) | Systemic Lupus Erythematosus (SLE) | Drug: Elsubrutinib;Drug: Placebo for Elsubrutinib;Drug: Upadacitinib;Drug: Placebo for Upadacitinib | AbbVie | NULL | Enrolling by invitation | 18 Years | 65 Years | All | 260 | Phase 2 | United States;Argentina;Australia;Bulgaria;China;Colombia;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;New Zealand;Poland;Puerto Rico;Spain;Taiwan;United Kingdom;Canada;Netherlands |
| 79 | JPRN-jRCT2031210119 | 17/07/2020 | 28/05/2021 | [M20-186] A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) | [M20-186] A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) | Systemic Lupus Erythematosus | Drug: Elsubrutinib Oral; Capsule Other Name: ABBV-105 Drug: Placebo for Elsubrutinib Oral; Capsule Drug: Upadacitinib Oral; Tablet Other Names:ABT-494, RINVOQ Drug: Placebo for Upadacitinib Oral; Tablet | Yamazaki Hayato | NULL | Recruiting | >= 18age old | <= 65age old | Both | 260 | Phase 2 | Argentina;Bulgaria;China;Germany;Hungary;Mexico;Netherlands;Poland;Puerto Rico;Spain;Taiwan;United States;Japan |
| 80 | NCT04060888 (ClinicalTrials.gov) | July 14, 2020 | 16/8/2019 | A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Chinese Subjects With Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Ustekinumab (approximately 6 mg/kg);Drug: Ustekinumab 90 milligram (mg);Drug: Placebo | Janssen Research & Development, LLC | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 3 | China |
| 81 | NCT04305197 (ClinicalTrials.gov) | June 29, 2020 | 10/3/2020 | A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE) | A Phase Ib/IIa Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerance, Pharmacokinetics/ Pharmacodynamics(PK/PD) of ICP-022 in Patients With Mild and Moderate Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: ICP-022;Drug: Placebos | Beijing InnoCare Pharma Tech Co., Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 60 | Phase 1/Phase 2 | China |
| 82 | EUCTR2019-003406-27-BG (EUCTR) | 09/06/2020 | 21/04/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 83 | EUCTR2019-003406-27-ES (EUCTR) | 02/06/2020 | 28/05/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Australia;Peru;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 84 | EUCTR2019-002205-22-GB (EUCTR) | 01/05/2020 | 07/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 85 | EUCTR2019-002205-22-ES (EUCTR) | 06/04/2020 | 23/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 86 | EUCTR2019-002205-22-PL (EUCTR) | 29/03/2020 | 07/02/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | France;United States;Mexico;Argentina;Spain;Belgium;Poland;Netherlands;Germany;United Kingdom | ||
| 87 | NCT04058028 (ClinicalTrials.gov) | February 19, 2020 | 30/7/2019 | Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy | Systemic Lupus Erythematosus (SLE) | Drug: Rozibafusp Alfa;Drug: Placebo for Rozibafusp Alfa | Amgen | NULL | Recruiting | 18 Years | 75 Years | All | 320 | Phase 2 | United States;Argentina;Australia;Bulgaria;Canada;Czechia;France;Germany;Greece;Hong Kong;Hungary;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Russian Federation;Spain |
| 88 | EUCTR2019-000638-20-NL (EUCTR) | 07/02/2020 | 09/12/2019 | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: ABBV-105 INN or Proposed INN: N/A Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | Phase 2 | United States;Czechia;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of | ||
| 89 | EUCTR2019-000638-20-DE (EUCTR) | 22/01/2020 | 09/09/2019 | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Elsubrutinib Product Code: ABBV-105 INN or Proposed INN: Elsubrutinib Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | Phase 2 | United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Puerto Rico;Argentina;Poland;Australia;Bulgaria;Netherlands;Germany;China;Japan;New Zealand;Korea, Republic of | ||
| 90 | NCT04186871 (ClinicalTrials.gov) | January 7, 2020 | 28/11/2019 | Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis | Autoimmune Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Primary Sjögren's Syndrome | Drug: branebrutinib;Drug: abatacept;Drug: branebrutinib placebo | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | 75 Years | All | 185 | Phase 2 | United States;Argentina;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom;Australia |
| 91 | EUCTR2018-004175-12-GB (EUCTR) | 30/12/2019 | 23/07/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | Hong Kong;Greece;Spain;Ukraine;Colombia;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of;United States;Serbia;Portugal;Taiwan | ||
| 92 | EUCTR2018-004175-12-PT (EUCTR) | 25/11/2019 | 30/07/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | United States;Serbia;Portugal;Hong Kong;Taiwan;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 93 | EUCTR2018-004175-12-ES (EUCTR) | 12/11/2019 | 11/11/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 94 | EUCTR2017-005026-37-HR (EUCTR) | 24/10/2019 | 20/01/2020 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China | ||
| 95 | EUCTR2019-000638-20-IT (EUCTR) | 22/10/2019 | 17/06/2021 | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus - na | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Elsubrutinib Product Code: [ABBV-105] INN or Proposed INN: Elsubrutinib Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: UPADACITINIB | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | Phase 2 | United States;Czechia;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Puerto Rico;Argentina;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;China;Japan;New Zealand;Korea, Republic of | ||
| 96 | NCT04275193 (ClinicalTrials.gov) | October 22, 2019 | 12/2/2020 | The Safety and Efficacy of Zishenqing in Subjects With Active Systemic Lupus Erythematosus | The Safety and Efficacy of the Traditional Chinese Medicine Zishenqing in Subjects With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Zishenqing;Drug: Placebo | Shanghai University of Traditional Chinese Medicine | RenJi Hospital | Recruiting | 18 Years | 65 Years | All | 118 | Phase 2/Phase 3 | China |
| 97 | NCT04082416 (ClinicalTrials.gov) | October 16, 2019 | 1/9/2019 | Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) | A Phase III, Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-exploring Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE). | Systemic Lupus Erythematosus | Biological: Placebo plus standard therapy;Biological: RC18 160 mg plus standard therapy | RemeGen Co., Ltd. | NULL | Active, not recruiting | 18 Years | 65 Years | All | 335 | Phase 3 | China |
| 98 | EUCTR2018-004175-12-BG (EUCTR) | 11/10/2019 | 30/07/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | United States;Portugal;Serbia;Hong Kong;Taiwan;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 99 | EUCTR2018-004175-12-DE (EUCTR) | 08/10/2019 | 02/08/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | Serbia;United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 100 | EUCTR2018-001808-11-DE (EUCTR) | 04/10/2019 | 18/10/2018 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus | Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod | Idorsia Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 2 | United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China | ||
| 101 | EUCTR2018-004175-12-HU (EUCTR) | 23/09/2019 | 23/07/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 102 | EUCTR2019-000638-20-HU (EUCTR) | 18/09/2019 | 02/10/2019 | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Elsubrutinib Product Code: ABBV-105 INN or Proposed INN: ELSUBRUTINIB Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | Phase 2 | United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of | ||
| 103 | NCT04077684 (ClinicalTrials.gov) | September 10, 2019 | 1/9/2019 | Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial | Efficacy and Safety of Low-dose Interleukin-2 in Patients With Systemic Lupus Erythematosus: a Multicenter, Randomised, Placebo-controlled Trial | Systemic Lupus Erythematosus | Drug: Interleukin-2 | Peking University People's Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 500 | Phase 2 | China |
| 104 | EUCTR2019-000638-20-ES (EUCTR) | 09/09/2019 | 27/09/2019 | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: ABBV-105 INN or Proposed INN: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Spain;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Germany;New Zealand;Japan;China;Korea, Republic of | ||
| 105 | EUCTR2018-004175-12-PL (EUCTR) | 03/09/2019 | 06/08/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | United States;Serbia;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan | ||
| 106 | ChiCTR1900025376 | 2019-09-01 | 2019-08-25 | Lenalidomide in Treatment-Refractory Lupus-Associated Skin Lesions in Systemic Lupus Erythematosus: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial | Lenalidomide in Treatment-Refractory Lupus-Associated Skin Lesions in Systemic Lupus Erythematosus: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial | systemic lupus erythematosus | intervention group:lenalidomide 10mg qd;control group:placebo 10mg qd; | Chinese Academy of Medical Sciences Peking Union Medical College Hospital | NULL | Recruiting | 18 | 70 | Both | intervention group:15;control group:15; | Phase 4 | China |
| 107 | EUCTR2018-004175-12-CZ (EUCTR) | 21/08/2019 | 25/07/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | Portugal;Serbia;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 108 | EUCTR2017-005026-37-NL (EUCTR) | 06/08/2019 | 13/05/2019 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Czechia;Taiwan;Greece;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Brazil;Belgium;Croatia;Australia;Germany;Netherlands;China | ||
| 109 | EUCTR2017-005026-37-GR (EUCTR) | 26/07/2019 | 03/05/2019 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Germany;Netherlands;China | ||
| 110 | NCT03978520 (ClinicalTrials.gov) | July 25, 2019 | 3/6/2019 | A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE) | A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Drug: Elsubrutinib;Drug: Placebo for Elsubrutinib;Drug: Upadacitinib;Drug: Placebo for upadacitinib | AbbVie | NULL | Active, not recruiting | 18 Years | 65 Years | All | 325 | Phase 2 | United States;Argentina;Australia;Bulgaria;Canada;China;Colombia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Puerto Rico;Spain;Taiwan;United Kingdom |
| 111 | NCT03951259 (ClinicalTrials.gov) | July 24, 2019 | 14/5/2019 | Safety and Efficacy of SM934 Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus | A Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of SM934 in Adult Subjects With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: SM934;Drug: Placebos | RenJi Hospital | Jiangsu ZuoYou Medicine Co., Ltd. | Recruiting | 18 Years | 70 Years | All | 48 | Phase 2 | China |
| 112 | EUCTR2017-001203-79-ES (EUCTR) | 11/06/2019 | 30/04/2019 | A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus. | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Spain;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 113 | NCT03804723 (ClinicalTrials.gov) | June 2019 | 11/1/2019 | Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus | Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial | Systemic Lupus Erythematosus;Glucocorticoids;Therapy Withdrawal | Drug: oral Prednisone 5mg | University of Pisa | NULL | Not yet recruiting | 18 Years | 85 Years | All | 321 | N/A | NULL |
| 114 | NCT03933943 (ClinicalTrials.gov) | May 21, 2019 | 30/4/2019 | A Study of LY3361237 in Participants With Systemic Lupus Erythematosus | A Phase 1, Randomized, Placebo-Controlled, Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: LY3361237;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | 70 Years | All | 28 | Phase 1 | United States |
| 115 | EUCTR2018-001808-11-PL (EUCTR) | 17/05/2019 | 15/05/2019 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus | Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod | Idorsia Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | Phase 2 | United States;Czechia;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Poland;Romania;Georgia;Bulgaria;Germany | ||
| 116 | NCT03949426 (ClinicalTrials.gov) | May 1, 2019 | 8/5/2019 | Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy Subjects | A First-in-Human, Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Dose Study in Healthy Participants to Evaluate the Safety, Tolerability and Pharmacokinetics of KPG-818 | Systemic Lupus Erythematosus | Drug: KPG-818 | Kangpu Biopharmaceuticals, Ltd. | NULL | Completed | 18 Years | 55 Years | All | 40 | Phase 1 | United States |
| 117 | NCT03845517 (ClinicalTrials.gov) | April 18, 2019 | 15/2/2019 | A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus | Drug: Placebo;Drug: PF-06700841 15 mg;Drug: PF-06700841 30 mg;Drug: PF-06700841 45 mg | Pfizer | NULL | Recruiting | 18 Years | 75 Years | All | 448 | Phase 2 | United States;Argentina;Australia;Belgium;Bulgaria;Canada;China;Colombia;Czechia;France;Germany;Greece;Hong Kong;Hungary;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Romania;Serbia;Spain;Taiwan;Ukraine;United Kingdom |
| 118 | NCT03917797 (ClinicalTrials.gov) | April 2, 2019 | 2/4/2019 | Mesenchymal Stromal Cells (MSC´s) in Renal Lupus | Dose-response and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Renal Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic;Lupus Glomerulonephritis | Biological: MSC treatment;Drug: Standard of Care;Drug: Placebo | Universidad de los Andes, Chile | NULL | Recruiting | 18 Years | 75 Years | All | 39 | Phase 2 | Chile |
| 119 | EUCTR2017-005026-37-GB (EUCTR) | 27/03/2019 | 19/09/2018 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 825 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China | ||
| 120 | EUCTR2018-001808-11-BG (EUCTR) | 20/03/2019 | 06/12/2018 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus | Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod | Idorsia Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 325 | Phase 2 | United States;Philippines;Czechia;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany | ||
| 121 | NCT03771885 (ClinicalTrials.gov) | March 16, 2019 | 10/12/2018 | BI 705564 in Patients With Systemic Lupus Erythematosus (SLE) | A Phase Ib, Multicentre, Randomised, Double-blind, Placebo Controlled, 8 Week Crossover Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered BI 705564 in Patients With Systemic Lupus Erythematosus. | Lupus Erythematosus, Systemic | Drug: BI 705564;Drug: Placebo | Boehringer Ingelheim | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 1 | NULL |
| 122 | ChiCTR1900020803 | 2019-03-01 | 2019-01-19 | Efficacy of Melatonin in patients with stable systemic lupus erythematosus complicated with insomnia: a single-center, randomized, double-blind, placebo-controlled clinical trial | Efficacy of Melatonin in patients with stable systemic lupus erythematosus complicated with insomnia: a single-center, randomized, double-blind, placebo-controlled clinical trial | systemic lupus erythematosus | intervention group:melatonin 6mg qn;control group:placebo qn; | Chinese Academy of Medical Sciences Peking Union Medical College Hospital | NULL | Pending | 18 | 65 | Both | intervention group:88;control group:88; | Phase 4 | China |
| 123 | EUCTR2018-001808-11-HU (EUCTR) | 08/02/2019 | 22/11/2018 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) | Moderate to severe systemic lupus erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod | Idorsia Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Lithuania;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China | ||
| 124 | EUCTR2018-001808-11-IT (EUCTR) | 07/02/2019 | 28/01/2021 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE:Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus | Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: [ACT-334441] INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: [ACT-334441] INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: [ACT-334441] INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: [ACT-334441] INN or Proposed INN: Cenerimod | IDORSIA PHARMACEUTICALS LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 2 | United States;Czechia;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China | ||
| 125 | EUCTR2018-001508-12-FR (EUCTR) | 05/02/2019 | 13/11/2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Korea, Republic of;Japan;China;Germany;Australia;Poland;Argentina;Hungary;Czech Republic;France;Israel;Russian Federation;Thailand;Spain;Taiwan | ||
| 126 | EUCTR2017-001489-53-PT (EUCTR) | 04/02/2019 | 08/11/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Ecuador;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 127 | EUCTR2018-001808-11-ES (EUCTR) | 24/01/2019 | 16/11/2018 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) | Moderate to severe systemic lupus erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod | Idorsia Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hong Kong;Taiwan;Spain;Thailand;Ukraine;Lithuania;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China | ||
| 128 | EUCTR2018-001808-11-FR (EUCTR) | 14/01/2019 | 31/08/2018 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) | Moderate to severe systemic lupus erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod | Idorsia Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 2 | United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Lithuania;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China | ||
| 129 | NCT03742037 (ClinicalTrials.gov) | December 21, 2018 | 12/11/2018 | Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Cenerimod 0.5 mg;Drug: Cenerimod 1 mg;Drug: Cenerimod 2 mg;Drug: Cenerimod 4 mg;Drug: Placebo | Idorsia Pharmaceuticals Ltd. | NULL | Active, not recruiting | 18 Years | 75 Years | All | 427 | Phase 2 | United States;Bulgaria;Chile;Czechia;France;Georgia;Greece;Hungary;Israel;Italy;Mexico;Philippines;Poland;Romania;Russian Federation;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Germany;Lithuania |
| 130 | EUCTR2017-005027-25-IT (EUCTR) | 20/12/2018 | 22/01/2021 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus - - | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant - EU/1/16/1170/009-016 Product Name: Baricitinib Product Code: [LY3009104] INN or Proposed INN: Baricitinib Trade Name: Olumiant - EU/1/16/1170/001-008 Product Name: Baricitinib Product Code: [LY3009104] INN or Proposed INN: Baricinitib | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 825 | Phase 3 | Serbia;United States;Philippines;Spain;Chile;Colombia;Italy;India;France;Argentina;Poland;Romania;South Africa;Japan;Korea, Republic of | ||
| 131 | NCT03656562 (ClinicalTrials.gov) | December 19, 2018 | 19/7/2018 | Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients | A Placebo-controlled, Patient and Investigator Blinded, Randomized Parallel Cohort Study to Assess Pharmacodynamics, Pharmacokinetics, Safety, Tolerability and Preliminary Clinical Efficacy of VAY736 and CFZ533 in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) | Drug: VAY736;Drug: VAY736 Placebo;Drug: CFZ533;Drug: CFZ533 Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 75 Years | All | 120 | Phase 2 | United States;Argentina;Australia;China;Czechia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan;Thailand |
| 132 | EUCTR2017-005026-37-AT (EUCTR) | 18/12/2018 | 25/09/2018 | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Czechia;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Brazil;Belgium;Croatia;Australia;Netherlands;Germany;China | ||
| 133 | EUCTR2017-005026-37-BE (EUCTR) | 17/12/2018 | 25/09/2018 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China | ||
| 134 | EUCTR2018-001808-11-GB (EUCTR) | 17/12/2018 | 17/09/2018 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus | Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 | Idorsia Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | Phase 2 | United States;Czechia;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Poland;Romania;Georgia;Bulgaria;Germany | ||
| 135 | NCT03817424 (ClinicalTrials.gov) | December 13, 2018 | 22/1/2019 | A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis | A Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis | Systemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;Dermatomyositis | Drug: VIB7734;Drug: Placebo | Viela Bio | NULL | Completed | 18 Years | 75 Years | All | 31 | Phase 1 | United States;Poland;Spain |
| 136 | EUCTR2018-001508-12-ES (EUCTR) | 12/12/2018 | 09/10/2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533 | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of | ||
| 137 | EUCTR2017-001203-79-DE (EUCTR) | 12/12/2018 | 27/02/2018 | A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus. | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 138 | EUCTR2018-001508-12-DE (EUCTR) | 05/12/2018 | 28/08/2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallelcohort study to assess pharmacodynamics, pharmacokinetics, safety,tolerability and preliminary clinical efficacy of VAY736 and CFZ533 inpatients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 135 | Phase 2 | United States;Czechia;Taiwan;Thailand;Spain;Israel;Russian Federation;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of | ||
| 139 | NCT03878303 (ClinicalTrials.gov) | November 28, 2018 | 5/3/2019 | Study of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE) | A Phase 1b Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Pharmacokinetics and Pharmacodynamics of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: AC0058TA;Drug: Placebo AC0058TA | ACEA Therapeutics, Inc. | Hangzhou ACEA Pharmaceutical Research Co., Ltd. | Recruiting | 18 Years | 75 Years | All | 32 | Phase 1 | United States |
| 140 | NCT03724916 (ClinicalTrials.gov) | November 26, 2018 | 18/10/2018 | A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE) | A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus | Systemic Lupus Erythematosus;Lupus Erythematosus, Systemic | Drug: TAK-079;Drug: TAK-079 Placebo | Millennium Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 75 Years | All | 58 | Phase 1 | United States |
| 141 | EUCTR2017-005026-37-HU (EUCTR) | 19/11/2018 | 25/09/2018 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China | ||
| 142 | EUCTR2017-005026-37-CZ (EUCTR) | 12/11/2018 | 26/10/2018 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China | ||
| 143 | EUCTR2018-001508-12-CZ (EUCTR) | 02/11/2018 | 28/08/2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 135 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of | ||
| 144 | NCT02633163 (ClinicalTrials.gov) | October 26, 2018 | 15/12/2015 | Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE) | A Phase II Controlled Trial of Allogeneic Mesenchymal Stem Cells for the Treatment of Refractory Lupus | Systemic Lupus Erythematosus | Drug: Low Dose Mesenchymal Stem Cells (MSCs);Drug: High Dose Mesenchymal Stem Cells (MSCs);Drug: Placebo Infusion | Medical University of South Carolina | NULL | Recruiting | 18 Years | 65 Years | All | 81 | Phase 2 | United States |
| 145 | NCT03626311 (ClinicalTrials.gov) | October 23, 2018 | 6/6/2018 | Omega-3 Replacement With Krill Oil in Disease Management of SLE | A Double-Blind, Placebo-Controlled Randomized, Multicenter Study to Assess Changes in Omega-3 Index in Erythrocytes and Health Benefit After 24 Weeks of Daily Consumption of AKBM-3031 (Omega-3 Phospholipids From Krill), Followed by a 24 Week Open-Label Extension, in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) | Dietary Supplement: AKBM-3031;Other: Placebo | Aker Biomarine Antarctic AS | Ampel BioSolutions, LLC | Completed | 18 Years | N/A | All | 76 | N/A | United States;Canada |
| 146 | EUCTR2017-001489-53-PL (EUCTR) | 24/09/2018 | 23/07/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 147 | EUCTR2017-005027-25-ES (EUCTR) | 21/09/2018 | 24/09/2018 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Serbia;United States;Philippines;Spain;Chile;Colombia;Argentina;Poland;Romania;South Africa;Japan;Korea, Republic of;Italy;India;France | ||
| 148 | NCT03527472 (ClinicalTrials.gov) | August 23, 2018 | 3/5/2018 | Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus | A Randomized Placebo-controlled, Double Blind Phase 2 Clinical Trial of Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Memantine;Drug: Placebo | Vanderbilt University Medical Center | Kleberg Foundation | Suspended | 18 Years | 70 Years | All | 80 | Phase 2 | United States |
| 149 | JPRN-JapicCTI-183973 | 16/8/2018 | 29/05/2018 | A Study of Ustekinumab in Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Intervention name : Ustekinumab INN of the intervention : Ustekinumab Dosage And administration of the intervention : Participants will receive ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160 Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Participants will receive matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160. | Janssen Pharmaceutical K.K. | NULL | complete | 16 | 75 | BOTH | 500 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Africa |
| 150 | NCT03616964 (ClinicalTrials.gov) | August 2, 2018 | 1/8/2018 | A Study of Baricitinib in Participants With Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | Incyte Corporation | Completed | 18 Years | N/A | All | 777 | Phase 3 | United States;Argentina;Chile;Colombia;France;India;Italy;Japan;Korea, Republic of;Philippines;Poland;Romania;Serbia;South Africa;Spain |
| 151 | NCT03616912 (ClinicalTrials.gov) | August 2, 2018 | 1/8/2018 | A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | Incyte Corporation | Active, not recruiting | 18 Years | N/A | All | 809 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;China;Croatia;Czechia;Germany;Greece;Hungary;Israel;Mexico;Netherlands;Russian Federation;Switzerland;Taiwan;United Kingdom;Ukraine |
| 152 | EUCTR2017-001489-53-BG (EUCTR) | 27/06/2018 | 28/03/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 153 | EUCTR2017-001489-53-HU (EUCTR) | 14/06/2018 | 03/04/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Portugal;United States;Serbia;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Australia;Peru;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 154 | EUCTR2017-001489-53-ES (EUCTR) | 12/06/2018 | 14/03/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Portugal;United States;Serbia;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Australia;Peru;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 155 | NCT03541564 (ClinicalTrials.gov) | May 30, 2018 | 17/5/2018 | An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects | A Randomized, Double-Blind, Positive-Controlled, Placebo-Controlled, 4-Period Crossover Study to Investigate the Electrocardiographic Effects of BMS-986165 in Healthy Subjects | Systemic Lupus Erythematosus;Healthy Participants | Drug: BMS-986165;Drug: Moxifloxacin;Other: Placebo | Bristol-Myers Squibb | NULL | Completed | 18 Years | 50 Years | All | 84 | Phase 1 | United States |
| 156 | EUCTR2016-000488-17-FR (EUCTR) | 16/05/2018 | 19/03/2019 | A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE) | A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) | Systematic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ILT-101 Product Code: ILT-101 INN or Proposed INN: Aldesleukin Other descriptive name: INTERLEUKIN-2 | ILTOO PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Portugal;France;Mexico;Spain;Austria;Bulgaria;Italy | ||
| 157 | EUCTR2017-001489-53-DE (EUCTR) | 08/05/2018 | 23/03/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 158 | EUCTR2017-001489-53-LT (EUCTR) | 07/05/2018 | 19/03/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 159 | NCT03556007 (ClinicalTrials.gov) | April 18, 2018 | 7/5/2018 | A Study of NKTR-358 (LY3471851) in Participants With Systemic Lupus Erythematosus (SLE) | A Phase 1, Double-blind, Randomized, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous NKTR-358 in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: LY3471851;Drug: Placebo | Eli Lilly and Company | Nektar Therapeutics | Completed | 18 Years | 70 Years | All | 48 | Phase 1 | United States |
| 160 | NCT03517722 (ClinicalTrials.gov) | April 16, 2018 | 13/4/2018 | A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Placebo;Drug: Ustekinumab (approximately 6 mg/kg);Drug: Ustekinumab 90 mg | Janssen Research & Development, LLC | NULL | Terminated | 16 Years | 75 Years | All | 516 | Phase 3 | United States;Argentina;Bulgaria;Canada;China;Colombia;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Poland;Portugal;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Ukraine;Australia;Ecuador;France;Peru;Philippines;Romania |
| 161 | NCT03451422 (ClinicalTrials.gov) | April 10, 2018 | 1/2/2018 | Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus | A Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Multiple Ascending Subcutaneous Doses of Efavaleukin Alfa in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Efavaleukin Alfa;Drug: Placebo | Amgen | NULL | Completed | 18 Years | 70 Years | All | 35 | Phase 1 | United States;France;Germany;Poland |
| 162 | NCT03312907 (ClinicalTrials.gov) | March 1, 2018 | 13/10/2017 | A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Belimumab;Drug: Rituximab;Drug: Rituximab-placebo;Drug: Standard therapy (Including Immunosuppressants);Drug: Standard therapy (Excluding Immunosuppressants);Drug: Steroid Taper | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 292 | Phase 3 | United States;Argentina;Brazil;Canada;France;Germany;Korea, Republic of;Mexico;Netherlands;Russian Federation;Spain |
| 163 | NCT03396393 (ClinicalTrials.gov) | March 2018 | 4/1/2018 | Exploratory Study of DHA in Systemic Lupus Erythematosus Patients | A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics and Efficacy of Dihydroartemisinin Tablets in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Dihydroartemisinin tablet;Drug: Placebo tablet | Kunming Pharmaceuticals, Inc. | NULL | Not yet recruiting | 18 Years | 65 Years | All | 120 | Phase 2 | NULL |
| 164 | EUCTR2016-003050-32-NL (EUCTR) | 16/02/2018 | 24/10/2017 | A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) – BLISS-BELIEVE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Germany;Netherlands;Korea, Republic of | ||
| 165 | NCT03371251 (ClinicalTrials.gov) | February 7, 2018 | 8/12/2017 | Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care | A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care | Systemic Lupus Erythematosus | Drug: BOS161721;Drug: Placebo | Boston Pharmaceuticals | NULL | Completed | 18 Years | 70 Years | All | 143 | Phase 1/Phase 2 | United States;Argentina;Bulgaria;Colombia;Georgia;Hungary;Mexico;Peru;Philippines;Poland;Romania;Ukraine |
| 166 | EUCTR2016-003050-32-DE (EUCTR) | 09/01/2018 | 21/06/2017 | A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) – BLISS-BELIEVE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) | Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Netherlands;Germany;Korea, Republic of | ||
| 167 | EUCTR2017-001203-79-PL (EUCTR) | 05/01/2018 | 03/11/2017 | A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus. | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 168 | NCT03030118 (ClinicalTrials.gov) | December 28, 2017 | 15/1/2017 | Study of Anti-Malarials in Incomplete Lupus Erythematosus | Study of Anti-Malarials in Incomplete Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Hydroxychloroquine;Drug: Placebo Oral Capsule | Milton S. Hershey Medical Center | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Recruiting | 15 Years | 49 Years | All | 240 | Phase 2 | United States |
| 169 | NCT03093402 (ClinicalTrials.gov) | December 21, 2017 | 21/2/2017 | JBT-101 in Systemic Lupus Erythematosus (SLE) | A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus;SLE;Lupus | Drug: JBT-101;Drug: Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Corbus Pharmaceuticals Inc.;Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Completed | 18 Years | 70 Years | All | 109 | Phase 2 | United States |
| 170 | EUCTR2016-003050-32-ES (EUCTR) | 05/12/2017 | 01/12/2017 | A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE). | Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Mexico;Canada;Argentina;Brazil;Spain;Russian Federation;South Africa;Netherlands;Korea, Republic of | ||
| 171 | EUCTR2017-001203-79-HU (EUCTR) | 04/12/2017 | 04/10/2017 | A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus. | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000017968;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 | Bristol-Myers Squibb international Corporation | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Argentina;Brazil;Poland;Romania;Peru;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 172 | EUCTR2016-004574-17-FR (EUCTR) | 30/11/2017 | 28/11/2018 | A study to measure how safe CC-220 is and how well CC-220 works in people with lupus. | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 280 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany | ||
| 173 | NCT03334851 (ClinicalTrials.gov) | November 17, 2017 | 3/11/2017 | Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis | A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS | Systemic Lupus Erythematosus;Rheumatoid Arthritis | Drug: PF-06835375;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | 70 Years | All | 75 | Phase 1 | United States;Puerto Rico |
| 174 | EUCTR2016-004574-17-BE (EUCTR) | 14/11/2017 | 07/06/2017 | A study to measure how safe CC-220 is and how well CC-220 works in people with lupus. | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Serbia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany | ||
| 175 | EUCTR2016-004574-17-DE (EUCTR) | 27/09/2017 | 21/04/2017 | A study to measure how safe CC-220 is and how well CC-220 works in people with lupus. | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Serbia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany | ||
| 176 | NCT03252587 (ClinicalTrials.gov) | September 21, 2017 | 15/8/2017 | An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: BMS-986165;Other: Placebo | Bristol-Myers Squibb | NULL | Active, not recruiting | 18 Years | 75 Years | All | 363 | Phase 2 | United States;Argentina;Australia;Brazil;Canada;Colombia;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Spain;Taiwan;Bulgaria;France;Peru;Ukraine |
| 177 | NCT03054259 (ClinicalTrials.gov) | September 21, 2017 | 17/1/2017 | Rituximab Objective Outcome Measures Trial in SLE | A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus | Systemic Lupus Erythematosus Arthritis | Drug: Rituximab;Drug: Methylprednisolone;Drug: Normal Saline | University of Leeds | NULL | Recruiting | 18 Years | 99 Years | All | 30 | Phase 2 | United Kingdom |
| 178 | NCT03161483 (ClinicalTrials.gov) | July 6, 2017 | 18/5/2017 | A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Lupus Erythematosus, Systemic | Drug: CC-220;Other: Placebo | Celgene | NULL | Active, not recruiting | 18 Years | N/A | All | 289 | Phase 2 | United States;Argentina;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;Serbia;Spain |
| 179 | NCT03189017 (ClinicalTrials.gov) | July 3, 2017 | 12/6/2017 | A Phase I Study of ICP-022 in Healthy Subjects | A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-022 Following Single and Multiple Escalating Dose | Systemic Lupus Erythematosus;Rheumatoid Arthritis | Drug: ICP-022;Drug: Placebos | Innocare Pharma Australia Pty Ltd | NULL | Completed | 18 Years | 55 Years | Male | 64 | Phase 1 | Australia |
| 180 | NCT02920424 (ClinicalTrials.gov) | June 30, 2017 | 29/9/2016 | A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: JNJ-56022473;Drug: Placebo | Janssen Research & Development, LLC | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 1 | Germany |
| 181 | EUCTR2016-002950-19-DE (EUCTR) | 19/06/2017 | 12/04/2017 | A Phase II Study of M2951 in SLE | A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A | Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: Evobrutinib Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 468 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 182 | EUCTR2016-004574-17-HU (EUCTR) | 19/06/2017 | 13/04/2017 | A study to measure how safe CC-220 is and how well CC-220 works in people with lupus. | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 21.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | Serbia;United States;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany | ||
| 183 | EUCTR2015-004359-32-PL (EUCTR) | 10/06/2017 | 24/04/2017 | Study to Evaluate BIIB059 in CLE with or without SLE | A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations. | Systemic Lupus Erythematosus (SLE) with Active Skin Manifestations and Active Cutaneous Lupus Erythematosus (CLE) with or without Systemic Manifestations MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIIB059 Product Code: BIIB059 INN or Proposed INN: Not Available Other descriptive name: anti-blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | United States;Serbia;Philippines;Taiwan;Mexico;Argentina;Thailand;Poland;Israel;Bulgaria;Colombia;Korea, Republic of | ||
| 184 | EUCTR2016-004574-17-ES (EUCTR) | 08/06/2017 | 07/04/2017 | A study to measure how safe CC-220 is and how well CC-220 works in people with lupus. | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 19.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 | Celgene Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | Serbia;United States;Spain;Russian Federation;Colombia;Italy;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany | ||
| 185 | EUCTR2016-000625-39-BG (EUCTR) | 17/05/2017 | 08/03/2017 | A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 186 | EUCTR2016-002950-19-BG (EUCTR) | 27/04/2017 | 27/03/2017 | A Phase II Study of M2951 in SLE | A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A | Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: Evobrutinib Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 468 | Phase 2 | United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 187 | JPRN-JapicCTI-173544 | 26/4/2017 | 23/03/2017 | TULIP SLE LTE | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus | Intervention name : Anifrolumab INN of the intervention : anifrolumab Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses | AstraZeneca | NULL | complete | 18 | BOTH | 50 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania | |
| 188 | EUCTR2016-002950-19-PL (EUCTR) | 25/04/2017 | 28/03/2017 | A Phase II Study of M2951 in SLE | A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: Evobrutinib Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 468 | Phase 2 | United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 189 | NCT03355482 (ClinicalTrials.gov) | April 10, 2017 | 22/11/2017 | MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE | MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE | Systemic Lupus Erythematosus Arthritis | Drug: Methylprednisolone;Drug: Placebos | Oklahoma Medical Research Foundation | Bristol-Myers Squibb | Recruiting | 18 Years | 70 Years | All | 40 | Phase 2 | United States |
| 190 | EUCTR2015-001341-86-BG (EUCTR) | 10/04/2017 | 16/02/2017 | Phase IIb study of IFN-K in Systemic Lupus Erythematosus | A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 19.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFN-Kinoid Product Code: IFN-K INN or Proposed INN: Not yet assigned Other descriptive name: IFN-Kinoid Drug Substance | Neovacs S.A. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;Germany | ||
| 191 | EUCTR2016-001039-11-DE (EUCTR) | 03/04/2017 | 22/12/2016 | A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 192 | EUCTR2016-000488-17-BG (EUCTR) | 27/03/2017 | 13/02/2017 | A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE) | A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) | Systematic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ILT-101 Product Code: ILT-101 INN or Proposed INN: Aldesleukin Other descriptive name: INTERLEUKIN-2 | ILTOO PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Portugal;France;Mexico;Spain;Romania;Austria;Bulgaria;Germany;Italy | ||
| 193 | EUCTR2016-000488-17-IT (EUCTR) | 02/03/2017 | 10/05/2019 | A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE) | A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) - A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage o | Systematic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ILT-101 Product Code: ILT-101 INN or Proposed INN: ALDESLEUCHINA Other descriptive name: ALDESLEUCHINA | ILTOO PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;Portugal;Spain;Austria;Bulgaria;Italy | ||
| 194 | NCT03042260 (ClinicalTrials.gov) | March 1, 2017 | 10/1/2017 | Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus Erythematous | Prophylactic Trimethoprim-Sulfamethoxazole for the Prevention of Serious Infections in Patients With Systemic Lupus Erythematosus: a Randomized Placebo Controlled Trial | Lupus Erythematosus, Systemic | Drug: Trimethoprim-Sulfamethoxazole;Drug: Placebo Oral Tablet | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | National Council of Science and Technology, Mexico | Recruiting | 18 Years | N/A | All | 310 | Phase 4 | Mexico |
| 195 | EUCTR2015-001341-86-ES (EUCTR) | 01/03/2017 | 27/12/2016 | Phase IIb study of IFN-K in Systemic Lupus Erythematosus | A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFN-Kinoid Product Code: IFN-K INN or Proposed INN: Not yet assigned Other descriptive name: IFN-Kinoid Drug Substance | Neovacs S.A. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;Germany | ||
| 196 | EUCTR2016-001039-11-BG (EUCTR) | 20/02/2017 | 08/11/2016 | A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITHMODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 197 | NCT02962960 (ClinicalTrials.gov) | February 14, 2017 | 23/9/2016 | A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Following Subcutaneous Administration in Adult Systemic Lupus Erythematosus Subjects With Type I Interferon Test High Result and Active Skin Manifestations. | Systemic Lupus Erythematosus | Drug: Anifrolumab;Drug: Placebo | AstraZeneca | NULL | Completed | 18 Years | 70 Years | All | 36 | Phase 2 | United States;Hungary;Korea, Republic of;Poland |
| 198 | EUCTR2016-001039-11-ES (EUCTR) | 07/02/2017 | 26/10/2016 | A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 199 | EUCTR2015-004359-32-BG (EUCTR) | 01/02/2017 | 03/11/2016 | Study to Evaluate BIIB059 in CLE with or without SLE | A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations. | Systemic Lupus Erythematosus (SLE) with Active Skin Manifestations and Active Cutaneous Lupus Erythematosus (CLE) with or without Systemic Manifestations MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIIB059 Product Code: BIIB059 INN or Proposed INN: Not Available Other descriptive name: anti-blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | United States;Serbia;Philippines;Taiwan;Mexico;Argentina;Thailand;Poland;Israel;Bulgaria;Colombia;Korea, Republic of | ||
| 200 | EUCTR2016-001039-11-PT (EUCTR) | 30/01/2017 | 23/09/2016 | A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 201 | EUCTR2016-003246-93-PL (EUCTR) | 26/01/2017 | 13/12/2016 | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations | Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: ANIFROLUMAB Other descriptive name: Immunoglobulin G1, anti-(human type I interferon receptor) (human monoclonal MEDI-546 heavy chain), disulfide with human monoclonal MEDI-546-chain, dimer | Astrazeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | United States;Hungary;Poland;Korea, Republic of | ||
| 202 | JPRN-JapicCTI-183957 | 20/1/2017 | 14/05/2018 | A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE) | A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Intervention name : M2951 (Other Name: Evobrutinib) INN of the intervention : - Dosage And administration of the intervention : M2951 low dose will be administered for 52 weeks in double-blind treatment period. Intervention name : M2951 (Other Name: Evobrutinib) INN of the intervention : - Dosage And administration of the intervention : M2951 mid dose will be administered for 52 weeks in double-blind treatment period. Intervention name : M2951 (Other Name: Evobrutinib) INN of the intervention : - Dosage And administration of the intervention : M2951 high dose will be administered for 52 weeks in double-blind treatment period. Intervention name : M2951 (Other Name: Evobrutinib) INN of the intervention : - Dosage And administration of the intervention : M2951 will be administered for 104 weeks in open-lable extension period at a dose of 50 milligrams twice a day. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo matched to M2951 will be administered for 52 weeks in double-blind treatment period. | Merck Biopharma Co., Ltd | Merck KGaA | complete | 18 | 75 | BOTH | 480 | Phase 2 | Japan, Asia except Japan, North America, South America, Europe, Africa |
| 203 | NCT02908100 (ClinicalTrials.gov) | January 19, 2017 | 14/9/2016 | A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus | A Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: GDC-0853;Drug: Placebo | Genentech, Inc. | NULL | Completed | 18 Years | 75 Years | All | 260 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Chile;Colombia;Germany;Korea, Republic of;Mexico;Spain;Taiwan;United Kingdom;France;Portugal;Thailand |
| 204 | NCT02955615 (ClinicalTrials.gov) | January 18, 2017 | 17/10/2016 | ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE) | A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: ILT-101;Drug: Placebo | Iltoo Pharma | NULL | Completed | 18 Years | N/A | All | 100 | Phase 2 | Austria;Bulgaria;France;Germany;Italy;Mauritius;Mexico;Portugal;Romania;Spain |
| 205 | NCT02975336 (ClinicalTrials.gov) | January 4, 2017 | 23/11/2016 | A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE) | A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Placebo;Drug: M2951 | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Terminated | 18 Years | 75 Years | All | 480 | Phase 2 | United States;Argentina;Bulgaria;Chile;Colombia;Germany;Italy;Japan;Korea, Republic of;Malaysia;Mauritius;Mexico;Peru;Philippines;Poland;Romania;Russian Federation;South Africa;Taiwan |
| 206 | NCT02953821 (ClinicalTrials.gov) | December 16, 2016 | 1/11/2016 | Acthar Gel for Active Systemic Lupus Erythematosus (SLE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose Corticosteroids | Lupus Erythematosus, Systemic | Drug: Acthar Gel;Drug: Placebo Gel | Mallinckrodt | NULL | Completed | 18 Years | N/A | All | 172 | Phase 4 | United States;Argentina;Chile;Mexico;Peru;Colombia |
| 207 | EUCTR2016-000625-39-DE (EUCTR) | 13/12/2016 | 05/07/2016 | A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 208 | EUCTR2016-003246-93-HU (EUCTR) | 06/12/2016 | 19/10/2016 | The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms. | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations | Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 | Astrazeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 32 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Poland;Korea, Republic of | ||
| 209 | EUCTR2016-000488-17-ES (EUCTR) | 21/11/2016 | 18/11/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE) | A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) | Systematic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ILT-101 Product Code: ILT-101 INN or Proposed INN: Aldesleukin Other descriptive name: INTERLEUKIN-2 | ILTOO PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Italy;Bulgaria;Austria;Spain;Mexico;Portugal;France | ||
| 210 | EUCTR2016-001039-11-GB (EUCTR) | 16/11/2016 | 24/08/2016 | A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 211 | EUCTR2015-004457-40-PL (EUCTR) | 04/11/2016 | 02/09/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently havingsymptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or aninactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctornor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SUBJECTSWITH MODERATELY TO SEVERELY ACTIVE SYSTEMICLUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
| 212 | EUCTR2016-000625-39-LT (EUCTR) | 03/11/2016 | 17/08/2016 | A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 213 | EUCTR2016-000488-17-PT (EUCTR) | 24/10/2016 | 28/07/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE) | A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) | Systematic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ILT-101 Product Code: ILT-101 INN or Proposed INN: Aldesleukin Other descriptive name: INTERLEUKIN-2 | ILTOO PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Portugal;Mexico;Mauritius;Spain;Romania;Austria;Bulgaria;Germany;Italy | ||
| 214 | NCT02847598 (ClinicalTrials.gov) | October 20, 2016 | 6/6/2016 | Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE) | A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations | Systemic Lupus Erythematosus;Active Cutaneous Lupus Erythematosus | Drug: BIIB059;Drug: Placebo | Biogen | NULL | Completed | 18 Years | 75 Years | All | 264 | Phase 2 | United States;Argentina;Bulgaria;Colombia;Israel;Korea, Republic of;Mexico;Philippines;Poland;Serbia;Taiwan;Thailand |
| 215 | EUCTR2015-003341-25-GB (EUCTR) | 17/10/2016 | 22/09/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: IPP-201101 INN or Proposed INN: IPP-201101 | ImmuPharma SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Hungary;Germany;United Kingdom | ||
| 216 | EUCTR2015-004457-40-ES (EUCTR) | 10/10/2016 | 05/08/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently havingsymptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or aninactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctornor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS. | SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS. MedDRA version: 19.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
| 217 | EUCTR2015-004457-40-HU (EUCTR) | 20/09/2016 | 13/07/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 19.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
| 218 | EUCTR2015-004457-40-DE (EUCTR) | 19/09/2016 | 22/06/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
| 219 | EUCTR2015-004457-40-BG (EUCTR) | 13/09/2016 | 03/08/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 19.1;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
| 220 | EUCTR2016-000625-39-ES (EUCTR) | 24/08/2016 | 15/07/2016 | A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE | Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 221 | EUCTR2016-000625-39-HU (EUCTR) | 18/08/2016 | 23/06/2016 | A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 222 | EUCTR2016-000488-17-AT (EUCTR) | 08/08/2016 | 21/07/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE) | A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) | Systematic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ILT-101 Product Code: ILT-101 INN or Proposed INN: Aldesleukin Other descriptive name: INTERLEUKIN-2 | ILTOO PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;France;Mexico;Mauritius;Spain;Romania;Austria;Bulgaria;Germany;Italy | ||
| 223 | EUCTR2015-003341-25-DE (EUCTR) | 29/07/2016 | 17/03/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: IPP-201101 INN or Proposed INN: IPP-201101 | ImmuPharma SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Hungary;Germany;United Kingdom | ||
| 224 | EUCTR2015-003341-25-IT (EUCTR) | 06/07/2016 | 19/01/2021 | Uno studio per valutare l'efficacia e la sicurezza del farmaco in studio, quando ai pazienti ¿ dato un dosaggio di 200 mcg di IPP-201101 pi¿ standard di cura, in pazienti con lupus eritematoso sistemico. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: IPP-201101 | IMMUPHARMA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;Hungary;Germany;United Kingdom;Italy | ||
| 225 | NCT02794285 (ClinicalTrials.gov) | June 30, 2016 | 6/6/2016 | Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus. | Active Systemic Lupus Erythematosus | Biological: Anifrolumab;Drug: Placebo | AstraZeneca | PRA Health Sciences | Completed | 18 Years | 70 Years | All | 559 | Phase 3 | United States;Argentina;Australia;Bulgaria;Canada;Chile;Colombia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Lithuania;Mexico;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Belgium;Brazil;Czech Republic;Czechia;Italy;New Zealand;Singapore |
| 226 | NCT03155477 (ClinicalTrials.gov) | June 10, 2016 | 13/5/2017 | Effect Of Curcuma Xanthorrhiza and Vitamin D3 Supplementation in SLE Patients With Hypovitamin D | Effect Of Curcuma Xanthorrhiza Supplementation In Systemic Lupus Erythematosus Patients (SLE) With Hypovitamin D Which Were Given Vitamin D3 Towards Disease Activity (SLEDAI), Interleukin-6 (IL-6) And Tumor Growth Factor-ß1 (TGF-ß1) Serum | SLE | Dietary Supplement: Cholecalciferol and C. Xanthorrhiza;Dietary Supplement: Cholecalciferol and placebo | Saiful Anwar Hospital | NULL | Completed | 18 Years | 45 Years | Female | 39 | N/A | NULL |
| 227 | NCT02804763 (ClinicalTrials.gov) | June 2, 2016 | 14/6/2016 | A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus | A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Drug: Placebo;Drug: Dapirolizumab pegol (DZP) | UCB Biopharma S.P.R.L. | NULL | Completed | 18 Years | N/A | All | 182 | Phase 2 | United States;Bulgaria;Chile;Colombia;Germany;Hungary;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Ukraine |
| 228 | NCT02514967 (ClinicalTrials.gov) | June 2016 | 31/7/2015 | CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without Nephritis | Systemic Lupus Erythematosus | Drug: Blisibimod;Drug: Placebo | Anthera Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 3 | Phase 3 | Georgia |
| 229 | NCT02741960 (ClinicalTrials.gov) | May 24, 2016 | 7/4/2016 | The Effect of Metformin on Reducing Lupus Flares | A Multicenter, Randomised, Double-blind Placebo Controlled Trial on the Efficacy and Safety of add-on Metformin to Conventional Immunosuppressants in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: metformin;Drug: placebo | RenJi Hospital | NULL | Completed | 18 Years | 70 Years | All | 180 | Phase 4 | China |
| 230 | EUCTR2015-003341-25-HU (EUCTR) | 02/05/2016 | 07/03/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic Lupus Erythematosus MedDRA version: 18.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: IPP-201101 INN or Proposed INN: IPP-201101 | ImmuPharma SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Hungary;Germany | ||
| 231 | EUCTR2015-004404-35-ES (EUCTR) | 29/04/2016 | 04/04/2016 | A study in Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Lilly S.A. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;United States;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;Korea, Republic of | ||
| 232 | JPRN-JapicCTI-153064 | 27/4/2016 | 11/11/2015 | TULIP | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus | Intervention name : anifrolumab INN of the intervention : anifrolumab Dosage And administration of the intervention : Intravenous infusion (IV) Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Intravenous infusion (IV) | AstraZeneca | NULL | complete | 18 | 70 | BOTH | 60 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Africa |
| 233 | EUCTR2015-004404-35-FR (EUCTR) | 12/04/2016 | 04/05/2016 | A study in Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;France;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;United Kingdom;Korea, Republic of | ||
| 234 | EUCTR2015-004404-35-PL (EUCTR) | 12/04/2016 | 31/03/2016 | A study in Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;United States;Taiwan;Mexico;Argentina;Spain;Poland;Romania;Austria;Japan;United Kingdom;Korea, Republic of | ||
| 235 | EUCTR2015-004404-35-AT (EUCTR) | 06/04/2016 | 24/03/2016 | A study in Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;United States;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;Korea, Republic of | ||
| 236 | NCT02331810 (ClinicalTrials.gov) | April 2016 | 5/12/2014 | Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female Patients | A Randomized, Double-blind, Placebo-controlled Study Of Safety, Tolerability, And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus Patient | Systemic Lupus Erythematosus | Drug: SAR113244;Drug: placebo | Sanofi | NULL | Withdrawn | 18 Years | 75 Years | Both | 0 | Phase 1 | NULL |
| 237 | NCT02618967 (ClinicalTrials.gov) | March 28, 2016 | 13/10/2015 | Single Ascending Dose Study of AMG 570 in Healthy Subjects | A Randomized, Double Blind Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of AMG 570 in Healthy Subjects | Systemic Lupus Erythematosus | Biological: AMG 570;Biological: AMG 570 Matching Placebo | Amgen | NULL | Completed | 18 Years | 65 Years | All | 56 | Phase 1 | United States |
| 238 | NCT02708095 (ClinicalTrials.gov) | March 24, 2016 | 10/3/2016 | A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE) | A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 314 | Phase 2 | United States;Argentina;Austria;France;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Romania;Spain;Taiwan |
| 239 | JPRN-JapicCTI-163359 | 01/3/2016 | A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHH | A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHH | Systemic Lupus Erythematosus (SLE) | Intervention name : Baricitinib INN of the intervention : Baricitinib Dosage And administration of the intervention : Baricitinib given orally once a day for 24 weeks Control intervention name : Placebo Dosage And administration of the control intervention : Placebo given orally once a day for 24 weeks | Eli Lilly Japan K.K. | NULL | 18 | BOTH | Phase 2 | NULL | ||||
| 240 | NCT02711813 (ClinicalTrials.gov) | March 2016 | 14/3/2016 | TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment | Study to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of TAB08 in Patients With Systemic Lupus Erythematosus, Not Adequately Controlled With Current Concomitant Therapy | Lupus Erythematosus, Systemic | Drug: TAB08;Other: Placebo | Theramab LLC | NULL | Terminated | 18 Years | 60 Years | All | 60 | Phase 2 | Russian Federation |
| 241 | EUCTR2015-003341-25-FR (EUCTR) | 24/02/2016 | 20/04/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: IPP-201101 INN or Proposed INN: IPP-201101 | ImmuPharma SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;France;Hungary;Germany | ||
| 242 | NCT02725515 (ClinicalTrials.gov) | February 16, 2016 | 8/1/2016 | A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus | A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity | Systemic Lupus Erythematosus | Biological: XmAb5871;Biological: Placebo to match XmAb5871 | Xencor, Inc. | PPD;ICON plc | Completed | 18 Years | 65 Years | All | 105 | Phase 2 | United States |
| 243 | NCT02660944 (ClinicalTrials.gov) | January 3, 2016 | 16/1/2016 | A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: RSLV-132;Drug: Placebo | Resolve Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 64 | Phase 2 | United States |
| 244 | NCT02483624 (ClinicalTrials.gov) | January 2016 | 23/6/2015 | 3,3'-Diindolylmethane in Patients With Systemic Lupus Erythematosus | A Single-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of 3,3'-Diindolylmethane (BR-DIM) in Patients With Systemic Lupus Erythematosus (SLE) | SLE | Drug: BR-DIM;Drug: Placebo | North Shore Long Island Jewish Health System | NULL | Terminated | 18 Years | 50 Years | Female | 6 | Phase 1 | NULL |
| 245 | EUCTR2014-002184-14-NL (EUCTR) | 22/12/2015 | 03/09/2015 | Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: lulizumab pegol Product Code: BMS-931699 INN or Proposed INN: lulizumab pegol Other descriptive name: Anti-CD28dAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of | ||
| 246 | EUCTR2014-004632-19-BG (EUCTR) | 11/12/2015 | 27/10/2015 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 247 | NCT02074020 (ClinicalTrials.gov) | December 2015 | 26/2/2014 | CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without Nephritis | Systemic Lupus Erythematosus | Drug: Blisibimod;Drug: Placebo | Anthera Pharmaceuticals | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 3 | NULL |
| 248 | NCT02609789 (ClinicalTrials.gov) | December 2015 | 18/11/2015 | A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus | A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Dose Study of JNJ-55920839 in Subjects With Mild to Moderate Systemic Lupus Erythematosus | Systemic Lupus Erythematosus;Healthy | Drug: JNJ-55920839;Drug: Placebo | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 55 Years | All | 72 | Phase 1 | United States;Belgium;Moldova, Republic of;Poland;Romania;Spain;Taiwan |
| 249 | NCT02885610 (ClinicalTrials.gov) | December 2015 | 26/8/2016 | Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) | A Phase IIb , Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-explorating Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE). | Systemic Lupus Erythematosus | Biological: Placebo plus standard therapy;Biological: RC18 80 mg plus standard therapy;Biological: RC18 160 mg plus standard therapy;Biological: RC18 240 mg plus standard therapy | RemeGen | NULL | Completed | 18 Years | 65 Years | All | 249 | Phase 2 | China |
| 250 | NCT02537028 (ClinicalTrials.gov) | November 30, 2015 | 28/8/2015 | MSC2364447C Phase 1b in Systemic Lupus Erythematosus | A Phase Ib Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biological Effect of MSC2364447C in Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: MSC2364447C;Drug: Placebo | EMD Serono Research & Development Institute, Inc. | Merck KGaA | Completed | 18 Years | 65 Years | All | 24 | Phase 1 | United States;Bulgaria |
| 251 | EUCTR2014-004633-96-RO (EUCTR) | 26/11/2015 | 08/10/2015 | A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Ukraine;Chile;Israel;Colombia;Italy;United Kingdom;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of | ||
| 252 | EUCTR2015-001341-86-DE (EUCTR) | 19/11/2015 | 01/09/2015 | Phase IIb study of IFN-K in Systemic Lupus Erythematosus | A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFN-Kinoid Product Code: IFN-K INN or Proposed INN: Not yet assigned Other descriptive name: IFN-Kinoid Drug Substance | Neovacs S.A. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;Germany | ||
| 253 | EUCTR2014-004633-96-DE (EUCTR) | 12/11/2015 | 28/05/2015 | A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Brazil;Poland;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of | ||
| 254 | EUCTR2014-004632-19-DE (EUCTR) | 12/11/2015 | 06/08/2015 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;South Africa;Germany;Korea, Republic of | ||
| 255 | NCT02477150 (ClinicalTrials.gov) | November 2015 | 17/6/2015 | Safety and Immunogenicity of a Zoster Vaccine in SLE | Immunogenicity and Safety of a Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus: a Randomized Controlled Trial | Systemic Lupus Erythematosus | Biological: Zostavax;Biological: placebo | Tuen Mun Hospital | NULL | Completed | 18 Years | N/A | All | 90 | Phase 4 | China |
| 256 | EUCTR2015-001341-86-HR (EUCTR) | 23/10/2015 | 10/11/2015 | Phase IIb study of IFN-K in Systemic Lupus Erythematosus | A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFN-Kinoid Product Code: IFN-K INN or Proposed INN: Not yet assigned Other descriptive name: IFN-Kinoid Drug Substance | Neovas S.A. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Peru;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Korea, Republic of;United States;Philippines;Taiwan;Spain;Thailand;Russian Federation;Chile;Colombia;Switzerland | ||
| 257 | JPRN-JapicCTI-153077 | 21/10/2015 | 20/11/2015 | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of lulizumab pegol of Subjects with Active Systemic Lupus Erythematosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Intervention name : Lulizumab pegol INN of the intervention : - Dosage And administration of the intervention : Four treatments of lulizumab pegol will be administered along with placebo treatment:12.5 mg weekly, 12.5 mg every other week (EOW), 5 mg EOW and 1.25mg EOW, on a background of limited standard of care medications. The dose levels may be modified based on the interim analysis results. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Bristol-Myers Squibb K.K. | NULL | complete | 18 | 70 | BOTH | 350 | Phase 2 | Japan, Asia except Japan, North America, South America, Europe |
| 258 | NCT02349061 (ClinicalTrials.gov) | October 15, 2015 | 23/1/2015 | A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Ustekinumab IV;Drug: Placebo Infusion;Drug: Placebo SC;Drug: Ustekinumab SC;Other: Concomitant Medication | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 75 Years | All | 102 | Phase 2 | United States;Argentina;Australia;Germany;Hungary;Mexico;Poland;Spain;Taiwan;United Kingdom |
| 259 | EUCTR2014-004633-96-PL (EUCTR) | 14/10/2015 | 05/08/2015 | A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of | ||
| 260 | EUCTR2015-000372-95-DE (EUCTR) | 08/10/2015 | 17/06/2015 | Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus | A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY | Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 150 mg/mL INN or Proposed INN: vobarilizumab Other descriptive name: IL-6R nanobody | Ablynx N.V. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of | ||
| 261 | NCT02429934 (ClinicalTrials.gov) | October 2015 | 24/4/2015 | Abatacept for SLE Arthritis (IM101-330) | Efficacy of Abatacept in Inflammatory Polyarthritis of Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus Arthritis | Biological: abatacept also known as Orencia also known as CTLA4-Ig;Drug: Placebo | University of California, Los Angeles | Bristol-Myers Squibb | Terminated | 18 Years | N/A | All | 28 | Phase 1/Phase 2 | United States |
| 262 | NCT02554019 (ClinicalTrials.gov) | September 28, 2015 | 16/9/2015 | Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus | A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated Dose, Multicentre Phase IIa Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: BT063;Biological: Placebo | Biotest | NULL | Completed | 18 Years | 75 Years | All | 36 | Phase 2 | Belarus;Georgia;Poland;Serbia |
| 263 | EUCTR2015-000372-95-HU (EUCTR) | 24/09/2015 | 30/06/2015 | Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus | A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY | Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 150 mg/mL INN or Proposed INN: vobarilizumab Other descriptive name: IL-6R nanobody | Ablynx N.V. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Hungary;Czech Republic;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of | ||
| 264 | NCT02665364 (ClinicalTrials.gov) | September 23, 2015 | 17/11/2015 | Phase IIb Study of IFN-K in Systemic Lupus Erythematosus | A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: IFNa-Kinoid;Other: Placebo;Other: ISA 51 VG | Neovacs | NULL | Terminated | 18 Years | 65 Years | All | 185 | Phase 2 | United States;Argentina;Belgium;Chile;Colombia;Croatia;France;Georgia;Germany;Italy;Korea, Republic of;Mexico;Moldova, Republic of;Peru;Philippines;Poland;Russian Federation;Switzerland;Taiwan;Thailand;Tunisia |
| 265 | EUCTR2014-004632-19-CZ (EUCTR) | 23/09/2015 | 28/07/2015 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 266 | EUCTR2014-005000-19-PL (EUCTR) | 22/09/2015 | 18/08/2015 | A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Hungary;Taiwan;Mexico;Argentina;Spain;Poland;Australia;Germany | ||
| 267 | EUCTR2014-004632-19-ES (EUCTR) | 21/09/2015 | 24/06/2015 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 268 | EUCTR2015-001341-86-IT (EUCTR) | 19/09/2015 | 10/11/2020 | Phase IIb study of IFN-K in Systemic Lupus Erythematosus | A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Neutralization of the Interferon Gene Signature and theClinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic LupusErythematosus - IFN-K-002 | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFN-Kinoid Product Code: IFN-K | NEOVACS | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Philippines;Taiwan;Spain;Thailand;Korea, Democratic People's Republic of;Russian Federation;Chile;Colombia;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Peru;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Korea, Republic of | ||
| 269 | EUCTR2014-004633-96-IT (EUCTR) | 16/09/2015 | 21/01/2020 | A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - NA | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: NA INN or Proposed INN: Anifrolumab Product Name: Anifrolumab Product Code: NA INN or Proposed INN: Anifrolumab | ASTRAZENECA AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Korea, Republic of;New Zealand;Germany;Australia;Peru;Romania;Brazil;Poland;Argentina;Hungary;United Kingdom;Italy;Colombia;Israel;Chile;Ukraine;Taiwan;United States | ||
| 270 | EUCTR2014-005526-35-PL (EUCTR) | 12/09/2015 | 10/08/2015 | Clinical study to evaluate the safety and tolerability of treatment with BT063 versus Placebo in Subjects with Systemic Lupus Erythematosus (BT063 in SLE) | A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated dose, Multicentre Phase IIa Proof-of-Concept Study with BT063 in Subjects with Systemic Lupus Erythematosus (BT063 in SLE) | Systemic Lupus Erythematosus MedDRA version: 19.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BT063 Product Code: BT063 INN or Proposed INN: BT063 Other descriptive name: BT063 | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Serbia;Belarus;Poland;Georgia | ||
| 271 | EUCTR2015-000372-95-PT (EUCTR) | 11/09/2015 | 26/06/2015 | Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus | A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY | Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 18.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 150 mg/mL INN or Proposed INN: N/A Other descriptive name: IL-6R nanobody | Ablynx N.V. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of | ||
| 272 | EUCTR2014-004632-19-BE (EUCTR) | 07/09/2015 | 23/06/2015 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 273 | EUCTR2015-001341-86-BE (EUCTR) | 07/09/2015 | 03/09/2015 | Phase IIb study of IFN-K in Systemic Lupus Erythematosus | A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFN-Kinoid Product Code: IFN-K INN or Proposed INN: Not yet assigned Other descriptive name: IFN-Kinoid Drug Substance | Neovacs S.A. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | Serbia;United States;Philippines;Taiwan;Spain;Thailand;Ukraine;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Georgia;Bulgaria;Germany | ||
| 274 | EUCTR2014-004633-96-HU (EUCTR) | 02/09/2015 | 29/06/2015 | A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of | ||
| 275 | NCT02535689 (ClinicalTrials.gov) | August 28, 2015 | 28/8/2015 | Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus | Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus; a Phase Ib Clinical Trial and Associated Mechanistic Studies | Systemic Lupus Erythematosus | Drug: Tofacitinib;Drug: Placebo | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NULL | Completed | 18 Years | 100 Years | All | 34 | Phase 1 | United States |
| 276 | EUCTR2014-004632-19-LT (EUCTR) | 20/08/2015 | 19/06/2015 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 277 | EUCTR2015-000372-95-CZ (EUCTR) | 20/08/2015 | 16/06/2015 | Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus | A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY | Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000017968;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 150 mg/mL INN or Proposed INN: vobarilizumab Other descriptive name: IL-6R nanobody | Ablynx N.V. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of | ||
| 278 | EUCTR2015-000372-95-ES (EUCTR) | 07/08/2015 | 10/07/2015 | Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus | A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY | Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 18.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 150 mg/mL INN or Proposed INN: N/A Other descriptive name: IL-6R nanobody | Ablynx N.V. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Germany;Korea, Republic of;Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru | ||
| 279 | EUCTR2014-004633-96-GB (EUCTR) | 16/07/2015 | 08/05/2015 | A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of | ||
| 280 | NCT02446899 (ClinicalTrials.gov) | July 9, 2015 | 14/5/2015 | Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus | Biological: Anifrolumab;Drug: Placebo | AstraZeneca | PRA Health Sciences | Completed | 18 Years | 70 Years | All | 373 | Phase 3 | United States;Argentina;Belgium;Brazil;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Lithuania;Mexico;Russian Federation;South Africa;Spain;Czech Republic;Czechia;Singapore |
| 281 | NCT02533570 (ClinicalTrials.gov) | July 2015 | 9/7/2015 | Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus | A Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Brentuximab vedotin;Drug: Placebo | Seagen Inc. | NULL | Terminated | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 282 | NCT02437890 (ClinicalTrials.gov) | July 2015 | 29/4/2015 | A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus | A Phase II Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX-0061 Administered Subcutaneously in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Biological: ALX-0061;Biological: Placebo | Ablynx | NULL | Completed | 18 Years | 64 Years | All | 312 | Phase 2 | United States;Argentina;Chile;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Peru;Philippines;Poland;Portugal;Russian Federation;Serbia;Spain;Taiwan;Ukraine;Czech Republic |
| 283 | EUCTR2014-005000-19-DE (EUCTR) | 17/06/2015 | 12/02/2015 | A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 18.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 134 | Phase 2 | United States;Hungary;Taiwan;Mexico;Argentina;Poland;Spain;Australia;Germany | ||
| 284 | NCT02446912 (ClinicalTrials.gov) | June 9, 2015 | 14/5/2015 | Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus | Biological: Anifrolumab;Drug: Placebo | AstraZeneca | PRA Health Sciences | Completed | 18 Years | 70 Years | All | 460 | Phase 3 | United States;Argentina;Australia;Brazil;Chile;Colombia;Germany;Hungary;Israel;Italy;Korea, Republic of;New Zealand;Peru;Poland;Romania;Taiwan;Ukraine;United Kingdom |
| 285 | EUCTR2014-002984-14-BG (EUCTR) | 05/06/2015 | 11/05/2015 | International clinical trial to evaluate the biological activity and safety of ACT-334441 in lupus | A multicenter, randomized, double-blind, placebo-controlled, dose-response study to investigate the biological activity, safety, tolerability, and pharmacokinetics of ACT-334441 in subjects with systemic lupus erythematosus. - | Systemic lupus erythematosus ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ACT-334441 Other descriptive name: ACT-334441 | ACTELION Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 2 | Belarus;United States;Ukraine;Russian Federation;Georgia;Bulgaria | ||
| 286 | NCT02472795 (ClinicalTrials.gov) | June 1, 2015 | 14/5/2015 | Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Matching placebo;Drug: Cenerimod | Idorsia Pharmaceuticals Ltd. | NULL | Completed | 18 Years | 65 Years | All | 105 | Phase 1/Phase 2 | United States;Belarus;Bulgaria;Georgia;Russian Federation;Ukraine |
| 287 | NCT02465580 (ClinicalTrials.gov) | June 2015 | 3/6/2015 | A Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus | A Phase II Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: hrIL-2 active;Drug: hrIL-2 placebo | Peking University People's Hospital | Monash University;Beijing SL Pharmaceutical Company Ltd | Recruiting | 18 Years | 65 Years | Both | 60 | Phase 2 | China |
| 288 | EUCTR2014-005000-19-ES (EUCTR) | 11/05/2015 | 03/03/2015 | A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Hungary;Taiwan;Mexico;Argentina;Poland;Spain;Australia;Germany | ||
| 289 | EUCTR2014-005000-19-HU (EUCTR) | 18/03/2015 | 03/02/2015 | A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 18.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 134 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Hungary;Mexico;Argentina;Poland;Spain;Australia;Germany | ||
| 290 | NCT02504645 (ClinicalTrials.gov) | March 2015 | 17/7/2015 | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: IPP-201101;Drug: Placebo;Other: Standard of Care | ImmuPharma | NULL | Completed | 18 Years | 70 Years | All | 202 | Phase 3 | United States;Czechia;France;Germany;Hungary;Mauritius;Poland;Puerto Rico;Czech Republic;Italy |
| 291 | EUCTR2014-002184-14-DE (EUCTR) | 26/02/2015 | 23/12/2014 | Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus ErythematosusPharmacogenetics Blood Sample Amendment 01 - Site Specific- dated-20-Aug-2014 | Active Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: lulizumab pegol Product Code: BMS-931699 INN or Proposed INN: lulizumab pegol Other descriptive name: Anti-CD28dAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of | ||
| 292 | EUCTR2014-002184-14-IT (EUCTR) | 24/02/2015 | 09/01/2015 | Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anti-CD28dab Product Code: BMS-931699 INN or Proposed INN: Lulizumab Pegol Other descriptive name: Lulizumab Pegol | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of | ||
| 293 | EUCTR2014-002184-14-HU (EUCTR) | 16/02/2015 | 29/12/2014 | Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus ErythematosusPharmacogenetics Blood Sample Amendment 1 - Site Specific - dated-20-Aug-2014 | Active Systemic Lupus Erythematosus MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anti-CD28dab Product Code: BMS-931699 INN or Proposed INN: Anti-CD28dAb Other descriptive name: Anti-CD28dAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of | ||
| 294 | EUCTR2014-002184-14-ES (EUCTR) | 26/12/2014 | 22/12/2014 | Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anti-CD28dab Product Code: BMS-931699 INN or Proposed INN: Anti-CD28dAb Other descriptive name: Anti-CD28dAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of;France;United States;Taiwan;Spain;Chile;Colombia;Italy | ||
| 295 | NCT02265744 (ClinicalTrials.gov) | November 13, 2014 | 15/10/2014 | Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus | Lupus | Drug: BMS-931699;Drug: Placebo matching BMS-931699 | Bristol-Myers Squibb | NULL | Completed | 18 Years | 70 Years | All | 730 | Phase 2 | United States;Argentina;Brazil;Canada;Chile;Colombia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Lebanon;Mexico;Netherlands;Peru;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Taiwan;Qatar |
| 296 | NCT02321709 (ClinicalTrials.gov) | November 2014 | 5/12/2014 | Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients | A Randomized, Double-blind, Placebo-controlled Study Of Safety, Tolerability, And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus Patients | Systemic Lupus Erythematosus | Drug: SAR113244;Drug: placebo | Sanofi | NULL | Completed | 18 Years | 75 Years | Both | 21 | Phase 1 | Germany |
| 297 | NCT02185040 (ClinicalTrials.gov) | September 16, 2014 | 7/7/2014 | A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus. | A Pilot, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Study To Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Pharmacogenetics of CC-220 In Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: CC-220;Drug: Placebo | Celgene | NULL | Completed | 18 Years | N/A | All | 42 | Phase 2 | United States |
| 298 | NCT02194400 (ClinicalTrials.gov) | July 2014 | 16/7/2014 | Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus | A Double-Blind, Placebo-Controlled Dose Escalation Study of the Administration of Multiple Intravenous Doses of RSLV-132 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: RSLV-132 | Resolve Therapeutics | NULL | Completed | 18 Years | 70 Years | Both | 32 | Phase 1 | United States |
| 299 | EUCTR2011-005667-25-PL (EUCTR) | 22/05/2014 | 07/06/2013 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 4000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 300 | NCT01956188 (ClinicalTrials.gov) | May 2014 | 25/9/2013 | Omega 3 in LES and APS | Efficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome | Systemic Lupus Erythematosus;Primary Antiphospholipid Syndrome | Dietary Supplement: EPA and DHA supplementation;Dietary Supplement: Placebo | University of Sao Paulo | NULL | Active, not recruiting | 20 Years | 45 Years | Female | 22 | N/A | Brazil |
| 301 | NCT02106897 (ClinicalTrials.gov) | April 30, 2014 | 4/4/2014 | Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 in Healthy Volunteers and Participants With Systemic Lupus Erythematosus | A Single-Ascending-Dose and Multiple-Ascending-Dose Study of BIIB059 in Healthy Volunteers and Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus;Healthy Volunteers | Drug: BIIB059;Drug: Placebo | Biogen | NULL | Completed | 18 Years | N/A | All | 109 | Phase 1 | United States |
| 302 | EUCTR2013-002773-21-IT (EUCTR) | 25/03/2014 | 03/02/2014 | Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II) | A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) - ADDRESS II | Systemic Lupus Erythematosus (SLE) MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 279 | Phase 2 | United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 303 | EUCTR2013-002773-21-GB (EUCTR) | 03/03/2014 | 15/01/2014 | Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II) | A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 279 | Phase 2 | United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 304 | EUCTR2013-002773-21-ES (EUCTR) | 20/02/2014 | 22/01/2014 | Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II) | A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 279 | Phase 2 | United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 305 | EUCTR2013-002773-21-CZ (EUCTR) | 20/02/2014 | 11/12/2013 | Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II) | A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 279 | Phase 2 | United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 306 | EUCTR2013-002773-21-DE (EUCTR) | 17/02/2014 | 07/01/2014 | Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II) | A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 279 | Phase 2 | United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 307 | NCT02270957 (ClinicalTrials.gov) | January 2014 | 13/10/2014 | Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches | Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches (The ABC Study) | Systemic Lupus Erythematosus | Biological: Abatacept;Other: Placebo | Oklahoma Medical Research Foundation | Bristol-Myers Squibb | Completed | 18 Years | 70 Years | All | 66 | Phase 2 | United States |
| 308 | NCT01972568 (ClinicalTrials.gov) | December 2013 | 24/10/2013 | Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus | A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus, Systemic | Drug: Atacicept 75 milligram (mg);Drug: Atacicept 150 mg;Drug: Placebo | EMD Serono | NULL | Completed | 18 Years | N/A | All | 306 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Chile;Czechia;Germany;Italy;Japan;Korea, Republic of;Mexico;Peru;Philippines;Poland;Russian Federation;South Africa;Spain;United Kingdom;Czech Republic;Ukraine |
| 309 | EUCTR2011-005667-25-RO (EUCTR) | 21/06/2013 | 21/07/2014 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 5000 | Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | |||
| 310 | EUCTR2011-005672-42-GB (EUCTR) | 11/06/2013 | 27/03/2013 | Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) (EMBRACE) | A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE) - EMBRACE | Systemic Lupus Erythematosus (SLE) MedDRA version: 19.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3;Phase 4 | United States;France;Martinique;Brazil;South Africa;Colombia;United Kingdom | ||
| 311 | EUCTR2011-005667-25-LT (EUCTR) | 10/05/2013 | 29/11/2012 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | GlaxoSmithKline, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 4000 | Phase 4 | Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Czechia;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 312 | EUCTR2011-005667-25-BG (EUCTR) | 24/04/2013 | 31/01/2013 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | GlaxoSmithKline, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 4000 | Phase 4 | Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Czechia;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 313 | EUCTR2011-005667-25-PT (EUCTR) | 05/04/2013 | 17/01/2013 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | GlaxoSmithKline, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 4000 | Phase 4 | Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Czechia;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 314 | NCT01863641 (ClinicalTrials.gov) | April 2013 | 17/5/2013 | The Effect of Calcitriol on Progress and Activity of Lupus Nephritis | The Effect of Calcitriol on Progress and Activity of Lupus Nephritis | Systemic Lupus Erythematosus | Drug: calcitriol;Drug: placebo | Guilan University of Medical Sciences | NULL | Recruiting | 18 Years | 65 Years | Both | 50 | Phase 2 | Iran, Islamic Republic of |
| 315 | EUCTR2011-005667-25-SK (EUCTR) | 27/03/2013 | 05/02/2013 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 4000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 316 | EUCTR2011-005667-25-IT (EUCTR) | 21/03/2013 | 14/01/2013 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 15.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 15.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion INN or Proposed INN: BELIMUMAB | HUMAN GENOME SCIENCES INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 5000 | Portugal;United States;Philippines;Estonia;Taiwan;Hong Kong;Spain;Thailand;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Korea, Democratic People's Republic of;Lithuania;Turkey;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Croatia;Bulgaria;New Zealand | |||
| 317 | NCT01777256 (ClinicalTrials.gov) | March 1, 2013 | 24/1/2013 | An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184 | An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184 in Patients With Mild to Moderate Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: GSK2586184 50 mg;Drug: GSK2586184 100 mg;Drug: GSK2586184 200 mg;Drug: GSK2586184 400 mg;Drug: Placebo | GlaxoSmithKline | NULL | Terminated | 18 Years | 75 Years | All | 51 | Phase 2 | Argentina;Chile;Czechia;Estonia;France;Germany;Greece;Hong Kong;Hungary;Korea, Republic of;Peru;Poland;Romania;South Africa;Spain;Sweden;Brazil;Czech Republic |
| 318 | NCT01632241 (ClinicalTrials.gov) | February 19, 2013 | 28/6/2012 | Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) | A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Biological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Drug: Standard therapy | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Completed | 18 Years | N/A | All | 503 | Phase 4 | United States;Brazil;Colombia;France;South Africa;United Kingdom |
| 319 | EUCTR2011-005667-25-ES (EUCTR) | 14/02/2013 | 21/12/2012 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 5000 | Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Romania;Bulgaria;Norway;New Zealand | |||
| 320 | EUCTR2011-000368-88-IT (EUCTR) | 04/02/2013 | 11/12/2012 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patient 5 to 17 years of age. | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE). - Belimumab in pediatric patients with SLE | Systemic lupus erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta (belimumab) INN or Proposed INN: BELIMUMAB | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 100 | United States;Mexico;Canada;Argentina;Spain;Brazil;Peru;Netherlands;United Kingdom;Italy | |||
| 321 | NCT01395745 (ClinicalTrials.gov) | February 2013 | 14/7/2011 | CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: blisibimod;Drug: Placebo | Anthera Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 442 | Phase 3 | Belarus;Brazil;Colombia;Georgia;Guatemala;Hong Kong;India;Korea, Republic of;Malaysia;Mexico;Philippines;Russian Federation;Singapore;Sri Lanka;Taiwan;Thailand |
| 322 | EUCTR2011-005667-25-CZ (EUCTR) | 30/01/2013 | 04/12/2012 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | GlaxoSmithKline, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 4000 | Phase 4 | Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Czechia;Lithuania;Turkey;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 323 | EUCTR2011-005667-25-HU (EUCTR) | 22/01/2013 | 22/11/2012 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | GlaxoSmithKline, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 4000 | Phase 4 | Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Czechia;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 324 | EUCTR2011-005667-25-EE (EUCTR) | 08/01/2013 | 12/12/2012 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 4000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 325 | NCT01753401 (ClinicalTrials.gov) | January 2013 | 17/12/2012 | Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active Disease | A Two-part Study Exploring the Efficacy, Safety, and Pharmacodynamics of Acthar in Systemic Lupus Erythematosus Patients With a History of Persistently Active Disease | Systemic Lupus Erythematosus (SLE) | Drug: Acthar;Drug: Placebo;Drug: Steroid Drug | Mallinckrodt | NULL | Completed | 18 Years | N/A | All | 38 | Phase 4 | United States |
| 326 | NCT01764594 (ClinicalTrials.gov) | January 2013 | 2/1/2013 | Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus | A Multicenter, Investigator- and Subject-Blind, Randomized, Placebo-Controlled, Parallel-Group, Repeat-Dose Study to Evaluate the Effect of CDP7657 in Subjects With Active Systemic Lupus Erythematosus | Immune System Diseases;Autoimmune Diseases;Lupus Erythematosus, Systemic;Skin and Connective Tissue Diseases;Connective Tissue Disease | Biological: CDP7657;Other: Placebo | UCB Pharma | Biogen | Completed | 18 Years | 75 Years | Both | 24 | Phase 1 | Belgium;Bulgaria;Germany;Poland;Romania;Russian Federation;Spain |
| 327 | EUCTR2011-000368-88-NL (EUCTR) | 03/12/2012 | 02/07/2012 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE | Systemic Lupus Erythematosus MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Mexico;Canada;Argentina;Poland;Brazil;Spain;Peru;Russian Federation;Netherlands;Italy;United Kingdom | |||
| 328 | NCT01705977 (ClinicalTrials.gov) | November 27, 2012 | 10/10/2012 | Belimumab Assessment of Safety in SLE | A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Systemic Lupus Erythematosus | Biological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Other: Standard therapy | GlaxoSmithKline | NULL | Active, not recruiting | 18 Years | N/A | All | 4019 | Phase 4 | United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Estonia;Hong Kong;Hungary;Indonesia;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Taiwan;Thailand;Ukraine;Czech Republic;Norway |
| 329 | NCT01686555 (ClinicalTrials.gov) | November 2012 | 13/9/2012 | A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE) | Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus | Drug: ABT-199;Other: Placebo | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | 65 Years | Female | 97 | Phase 1 | United States;Germany;Mexico;Puerto Rico |
| 330 | NCT01649765 (ClinicalTrials.gov) | September 7, 2012 | 23/7/2012 | Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy | A Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: belimumab 10mg/kg;Other: placebo | GlaxoSmithKline | Human Genome Sciences Inc., a GSK Company | Active, not recruiting | 5 Years | 17 Years | All | 93 | Phase 2 | United States;Argentina;Canada;Japan;Mexico;Peru;Poland;Russian Federation;Spain;United Kingdom;Brazil;Italy;Netherlands |
| 331 | NCT01689025 (ClinicalTrials.gov) | September 2012 | 14/9/2012 | An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE) | A Randomised, Placebo-controlled, Double-blind, Multiple-dose, Dose-escalation Trial Investigating the Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus | Inflammation;Systemic Lupus Erythematosus | Drug: NNC0114-0006;Drug: placebo | Novo Nordisk A/S | NULL | Terminated | 18 Years | 64 Years | Both | 10 | Phase 1 | United States;Hungary;Poland;Serbia |
| 332 | EUCTR2011-004296-36-CZ (EUCTR) | 29/08/2012 | 28/06/2012 | A study to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with Systemic Lupus Erythematosus | A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: MEDI-546 Product Code: MEDI-546 INN or Proposed INN: MEDI-546 | MedImmune, LLC | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;Taiwan;Hong Kong;Ukraine;Israel;Colombia;India;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Korea, Republic of | ||
| 333 | NCT01597050 (ClinicalTrials.gov) | August 2012 | 9/5/2012 | Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of R333 6% Ointment Administered Topically to Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Patients With Active Cutaneous Discoid Lesions | Lupus Erythematosus, Discoid;Lupus Erythematosus, Systemic | Drug: R932333;Drug: Placebo | Rigel Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 54 | Phase 2 | United States;Canada |
| 334 | EUCTR2011-000368-88-ES (EUCTR) | 27/07/2012 | 21/05/2012 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age. | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE). - Belimumab in pediatric patients with SLE | Systemic Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA? (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Poland;United States;Spain;Mexico;Argentina;Peru;Canada;United Kingdom;Russian Federation;Brazil;Italy;Netherlands;Germany | |||
| 335 | NCT01892748 (ClinicalTrials.gov) | July 2012 | 17/6/2013 | Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus. | Effects of Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Onset Systemic Lupus Erythematosus. | Systemic Lupus Erythematosus | Drug: Cholecalciferol;Drug: Placebo | ROSA MARIA RODRIGUES PEREIRA | NULL | Completed | 10 Years | 25 Years | Female | 60 | N/A | Brazil |
| 336 | EUCTR2011-000420-15-DE (EUCTR) | 21/06/2012 | 06/12/2011 | STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF 04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) - Butterfly | SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Not applicable Product Code: PF-04236921 INN or Proposed INN: Not applicable | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 180 | United States;Taiwan;Lithuania;Chile;Israel;Colombia;India;Hungary;Mexico;Argentina;Poland;Romania;Peru;Germany;Moldova, Republic of;Korea, Republic of | |||
| 337 | EUCTR2011-000368-88-GB (EUCTR) | 13/06/2012 | 18/04/2012 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Mexico;Canada;Argentina;Spain;Poland;Brazil;Peru;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 338 | EUCTR2011-003814-18-PL (EUCTR) | 06/06/2012 | 19/06/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, a wholly owned subsidiary of GlaxoSmithKline, Plc | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 339 | EUCTR2011-003814-18-PT (EUCTR) | 01/06/2012 | 21/02/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, a wholly owned subsidiary of GlaxoSmithKline, Plc | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | Serbia;United States;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 340 | NCT01683695 (ClinicalTrials.gov) | June 2012 | 14/3/2012 | Safety Study of AMG 557 in Subjects With Lupus Arthritis | A Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Systemic Lupus Erythematosus (SLE) Subjects With Active Lupus Arthritis | Lupus Arthritis, Systemic Lupus Erythematosus | Drug: AMG 557;Drug: Matching Placebo | Amgen | NULL | Completed | 18 Years | 65 Years | All | 20 | Phase 1 | United States;Australia;Denmark;France;Germany;Malaysia;Taiwan;United Kingdom;Singapore |
| 341 | EUCTR2010-023396-25-PL (EUCTR) | 30/05/2012 | 23/09/2011 | A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE) | Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis - SMILE | Systemic lupus erythematosus (SLE) MedDRA version: 15.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 INN or Proposed INN: . Other descriptive name: soluble Fc receptor | SuppreMol GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 342 | EUCTR2011-003814-18-BE (EUCTR) | 29/05/2012 | 01/02/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 15.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 343 | EUCTR2011-003814-18-BG (EUCTR) | 22/05/2012 | 21/05/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 17.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 344 | EUCTR2011-003814-18-IT (EUCTR) | 15/05/2012 | 08/06/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab Product Code: NA INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | HUMAN GENOME SCIENCES INC | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | United States;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Bulgaria;Germany;Sweden | ||
| 345 | EUCTR2011-003814-18-ES (EUCTR) | 03/05/2012 | 29/02/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 346 | EUCTR2011-003814-18-DE (EUCTR) | 03/05/2012 | 16/12/2011 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 18.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 347 | NCT01687309 (ClinicalTrials.gov) | April 30, 2012 | 10/5/2012 | A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK2586184 and the Effect of Food and Gender | A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2586184 Following a Single Doseof 800mg and Repeat Oral Tablet Doses of 800mg b.d and the Effect of Food and Gender on the Pharmacokinetics of oralGSK2586184 in Healthy Subjects | Systemic Lupus Erythematosus | Drug: GSK2586184 800mg single and repeat dose;Drug: Placebo-to-match GSK2586184;Other: GSK2586184 single dose taken with food;Other: GSK2586184 single dose taken without food | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | All | 19 | Phase 1 | Belgium |
| 348 | EUCTR2011-003814-18-GB (EUCTR) | 12/04/2012 | 19/04/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholy owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 349 | EUCTR2010-018563-41-EE (EUCTR) | 09/04/2012 | 09/03/2012 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 350 | EUCTR2011-003814-18-SE (EUCTR) | 28/03/2012 | 31/01/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 351 | EUCTR2011-003814-18-CZ (EUCTR) | 27/03/2012 | 25/01/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 352 | EUCTR2010-018563-41-LT (EUCTR) | 14/03/2012 | 14/02/2012 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 353 | EUCTR2011-003814-18-HU (EUCTR) | 08/03/2012 | 18/01/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 18.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 354 | EUCTR2011-003814-18-DK (EUCTR) | 08/03/2012 | 08/03/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 355 | NCT01551069 (ClinicalTrials.gov) | March 2012 | 8/3/2012 | Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion | A Randomized, Double Blind, Baseline Controlled Study Using Placebo as Reference for Assessing the Efficacy and Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus in the Presence of Active Lupus Erythematosus Specific Skin Lesion | Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus | Drug: hydroxychloroquine (Z0188);Drug: Placebo | Sanofi | NULL | Completed | 18 Years | N/A | Both | 103 | Phase 3 | Japan |
| 356 | EUCTR2010-023396-25-NL (EUCTR) | 16/02/2012 | 24/10/2011 | A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE) | Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis - SMILE | Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 INN or Proposed INN: . Other descriptive name: soluble Fc receptor | SuppreMol GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Czech Republic;Belgium;Spain;Poland;Australia;Germany;Netherlands;Italy;United Kingdom | ||
| 357 | EUCTR2011-000420-15-HU (EUCTR) | 08/02/2012 | 15/12/2011 | STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF 04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) - Butterfly | SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) MedDRA version: 15.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Not applicable Product Code: PF-04236921 INN or Proposed INN: Not applicable | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 180 | United States;Taiwan;Lithuania;Chile;Israel;Colombia;India;Hungary;Mexico;Argentina;Poland;Romania;Peru;Germany;Moldova, Republic of;Korea, Republic of | |||
| 358 | EUCTR2011-003814-18-AT (EUCTR) | 01/02/2012 | 23/01/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 359 | NCT01440231 (ClinicalTrials.gov) | February 2012 | 22/9/2011 | Atacicept Demonstrating Dose RESponSe | A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Dose-Response Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Placebo;Drug: Atacicept | EMD Serono | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 2 | United States |
| 360 | NCT01438489 (ClinicalTrials.gov) | January 2012 | 9/9/2011 | A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus | A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Anifrolumab 300 mg;Biological: Anifrolumab 1000 mg;Other: Placebo | MedImmune LLC | NULL | Completed | 18 Years | 65 Years | All | 626 | Phase 2 | United States;Brazil;Bulgaria;Colombia;Czech Republic;Hungary;India;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Hong Kong |
| 361 | NCT01488708 (ClinicalTrials.gov) | January 2012 | 6/12/2011 | On Open-Label Study in Participants With Systemic Lupus Erythematosus | A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE) (Illuminate-X) | Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune Disease | Drug: LY2127399;Drug: Placebo | Eli Lilly and Company | NULL | Terminated | 18 Years | N/A | All | 1518 | Phase 3 | United States |
| 362 | NCT01405196 (ClinicalTrials.gov) | December 2011 | 27/7/2011 | Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus | A Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle) | Lupus Erythematosus, Systemic | Biological: PF-04236921 | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 183 | Phase 2 | United States;Argentina;Chile;Colombia;Germany;Hungary;Korea, Republic of;Moldova, Republic of;Peru;Poland;Puerto Rico;Romania;Taiwan;Mexico |
| 363 | NCT01484496 (ClinicalTrials.gov) | November 16, 2011 | 28/11/2011 | A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Biological: Placebo;Biological: Belimumab 200 mg SC;Drug: Standard therapy | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Completed | 18 Years | N/A | All | 839 | Phase 3 | United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Chile;Colombia;Croatia;Czechia;Denmark;France;Germany;Hungary;Italy;Japan;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic |
| 364 | EUCTR2010-023396-25-DE (EUCTR) | 09/11/2011 | 14/06/2011 | A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE) | Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE | Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 INN or Proposed INN: . Other descriptive name: soluble Fc receptor | SuppreMol GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 365 | EUCTR2010-023396-25-CZ (EUCTR) | 13/10/2011 | 01/08/2011 | A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE) | Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE | Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 INN or Proposed INN: . Other descriptive name: soluble Fc receptor | SuppreMol GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 366 | NCT01449071 (ClinicalTrials.gov) | October 2011 | 3/10/2011 | Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) | A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Pharmacokinetics of One 12 Week Treatment Cycle of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects With Moderate to Severe Disease | Systemic Lupus Erythematosus | Biological: Placebo;Biological: Epratuzumab 400 mg;Biological: Epratuzumab 1200 mg;Biological: Epratuzumab 100 mg;Biological: Epratuzumab 600 mg | UCB Pharma | NULL | Completed | 18 Years | 64 Years | Both | 20 | Phase 1/Phase 2 | Japan |
| 367 | EUCTR2010-023396-25-GB (EUCTR) | 22/09/2011 | 11/04/2011 | A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE) | Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE | Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 INN or Proposed INN: . Other descriptive name: soluble Fc receptor | SuppreMol GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United Kingdom;Italy;Germany;Netherlands;Australia;Poland;Spain;Belgium;Czech Republic;France | ||
| 368 | EUCTR2010-023396-25-ES (EUCTR) | 20/09/2011 | 11/11/2011 | A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE) | Ensayo clínico multicéntrico, de grupos paralelos, controlado por placebo, doble ciego, randomizado 2:2:1, de fase IIa, para investigar la seguridad, eficacia y farmacocinética del receptor Fc-gamma IIb recombinante, humano, soluble (SM101) para su aplicación intravenosa en el tratamiento de pacientes con lupus eritematoso sistémico (LES) con o sin un historial de nefritis lúpica - SMILE | lupus eritematoso sistémico (LES) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 Other descriptive name: soluble Fc receptor | SuppreMol GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Poland;Australia | |||
| 369 | EUCTR2010-018565-26-IT (EUCTR) | 15/09/2011 | 05/01/2012 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF FOUR 12-WEEK TREATMENT CYCLES (48 WEEKS TOTAL) OF EPRATUZUMAB IN SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATE TO SEVERE DISEASE (EMBODY 2) - EMBODY 2 | Systemic Lupus Erythmatosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: EPRATUZUMAB | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Hungary;Mexico;Canada;Spain;Brazil;Ukraine;South Africa;Russian Federation;Germany;United Kingdom;Italy;India | ||
| 370 | EUCTR2010-018563-41-BG (EUCTR) | 02/09/2011 | 25/07/2011 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Taiwan;Spain;Lithuania;Russian Federation;Israel;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 371 | EUCTR2010-023396-25-BE (EUCTR) | 13/07/2011 | 20/04/2011 | A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE) | Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE | Systemic lupus erythematosus (SLE) MedDRA version: 13.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 Other descriptive name: soluble Fc receptor | SuppreMol GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Czech Republic;Spain;Poland;Belgium;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 372 | EUCTR2010-022099-29-DE (EUCTR) | 04/07/2011 | 14/12/2010 | Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE). | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-1) - ILLUMINATE-1 | Systemic Lupus Erythematosus (SLE) MedDRA version: 16.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY2127399 Product Code: LY2127399 Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1140 | Phase 3 | United States;Belarus;Philippines;Thailand;Ukraine;Guatemala;Turkey;Austria;Chile;Colombia;Italy;Egypt;Canada;Macedonia, the former Yugoslav Republic of;Argentina;Poland;Singapore;Croatia;Peru;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 373 | EUCTR2010-018563-41-IT (EUCTR) | 23/06/2011 | 20/03/2012 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF FOUR 12-WEEK TREATMENT CYCLES (48 WEEKS TOTAL) OF EPRATUZUMAB IN SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATE TO SEVERE DISEASE (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: EPRATUZUMAB | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Taiwan;Spain;Lithuania;Russian Federation;Israel;United Kingdom;Italy;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 374 | EUCTR2010-018563-41-DE (EUCTR) | 21/06/2011 | 21/01/2011 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 375 | EUCTR2010-018565-26-DE (EUCTR) | 21/06/2011 | 21/01/2011 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2 | Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Hungary;Mexico;Canada;Spain;Brazil;Ukraine;Russian Federation;South Africa;Germany;Italy;United Kingdom;India | ||
| 376 | EUCTR2010-022099-29-BG (EUCTR) | 16/06/2011 | 24/02/2011 | Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE). | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-1) - ILLUMINATE-1 | Systemic Lupus Erythematosus (SLE) MedDRA version: 17.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY2127399 Product Code: LY2127399 Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1140 | Phase 3 | United States;Belarus;Philippines;Thailand;Guatemala;Ukraine;Turkey;Austria;Chile;Colombia;Italy;Egypt;Macedonia, the former Yugoslav Republic of;Canada;Argentina;Poland;Singapore;Croatia;Peru;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 377 | EUCTR2010-018563-41-BE (EUCTR) | 25/05/2011 | 19/11/2010 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Belgium;Brazil;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 378 | NCT01345253 (ClinicalTrials.gov) | May 23, 2011 | 28/4/2011 | GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia | GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia | Systemic Lupus Erythematosus | Drug: Belimumab;Drug: Placebo | GlaxoSmithKline | Human Genome Sciences Inc. | Completed | 18 Years | N/A | All | 709 | Phase 3 | China;Japan;Korea, Republic of |
| 379 | EUCTR2010-018565-26-GB (EUCTR) | 13/05/2011 | 09/02/2011 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2 | Systemic Lupus Erythmatosus MedDRA version: 16.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Mexico;Canada;Spain;Brazil;Ukraine;South Africa;Russian Federation;Germany;Italy;United Kingdom;India | ||
| 380 | EUCTR2010-018563-41-GB (EUCTR) | 13/05/2011 | 09/02/2011 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 381 | NCT01858792 (ClinicalTrials.gov) | May 2011 | 19/12/2012 | A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies | Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients With Higher Disease Activity (Anti-dsDNA Positive and Low Complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies | Lupus Erythematosus, Discoid | Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg;Other: Placebo | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Completed | 18 Years | N/A | Both | 1 | N/A | NULL |
| 382 | EUCTR2010-022100-42-GB (EUCTR) | 28/04/2011 | 19/01/2011 | Not available | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - (ILLUMINATE-2) | Systemic Lupus Erythematosus (SLE) MedDRA version: 16.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY2127399 Product Code: LY2127399 Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1140 | Phase 3 | United States;Serbia;Taiwan;Ecuador;Spain;Russian Federation;Israel;United Kingdom;India;France;Hungary;Mexico;Canada;Brazil;Malaysia;Romania;Australia;South Africa;Tunisia;Latvia;New Zealand | ||
| 383 | EUCTR2010-022100-42-ES (EUCTR) | 20/04/2011 | 15/02/2011 | Estudio de Fase 3, multicéntrico, aleatorizado, doble ciego y controlado con placebo, para evaluar la eficacia y la seguridad de LY2127399 subcutáneo en pacientes con lupus sistémico eritematoso (LSE)//A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy andSafety of Subcutaneous LY2127399 in Patients withSystemic Lupus Erythematosus (SLE) | Estudio de Fase 3, multicéntrico, aleatorizado, doble ciego y controlado con placebo, para evaluar la eficacia y la seguridad de LY2127399 subcutáneo en pacientes con lupus sistémico eritematoso (LSE)//A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy andSafety of Subcutaneous LY2127399 in Patients withSystemic Lupus Erythematosus (SLE) | Lupus Eritematoso Sistémico (LES) //Systemic Lupus Erythematosus (SLE) MedDRA version: 12.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic | Product Name: LY2127399 Product Code: LY2127399 Other descriptive name: Anti LP40 anticuerpo, subclase IgG4 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1140 | Phase 3 | Hungary;Spain;Latvia;United Kingdom | ||
| 384 | EUCTR2010-022100-42-LV (EUCTR) | 08/04/2011 | 13/01/2011 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2 | Systemic Lupus Erythematosus (SLE) MedDRA version: 16.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY2127399 Product Code: LY2127399 Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1140 | Phase 3 | Serbia;United States;Taiwan;Ecuador;Spain;Israel;Russian Federation;United Kingdom;India;France;Hungary;Mexico;Canada;Malaysia;Brazil;Romania;Australia;South Africa;Latvia;Tunisia;New Zealand | ||
| 385 | NCT01283139 (ClinicalTrials.gov) | March 31, 2011 | 20/1/2011 | A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Sifalimumab 200 mg;Biological: Sifalimumab 600 mg;Biological: Sifalimumab 1,200 mg;Other: Placebo | MedImmune LLC | NULL | Completed | 18 Years | 75 Years | All | 834 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Canada;Chile;France;Germany;Hungary;India;Italy;Jamaica;Mexico;Netherlands;Peru;Philippines;Poland;Romania;South Africa;Spain;Thailand;United Kingdom |
| 386 | EUCTR2010-018563-41-CZ (EUCTR) | 25/02/2011 | 26/01/2011 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 387 | EUCTR2010-022100-42-HU (EUCTR) | 23/02/2011 | 13/01/2011 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2 | Systemic Lupus Erythematosus (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY2127399 Product Code: LY2127399 Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1140 | Phase 3 | Serbia;United States;Taiwan;Ecuador;Spain;Israel;Russian Federation;United Kingdom;India;France;Hungary;Mexico;Canada;Malaysia;Brazil;Romania;Australia;South Africa;Latvia;Tunisia;New Zealand | ||
| 388 | EUCTR2010-018565-26-ES (EUCTR) | 22/02/2011 | 23/12/2010 | Estudio en fase III, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY2). - EMBODY 2 | Estudio en fase III, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY2). - EMBODY 2 | Lupus Sistémico Eritematoso MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Hungary;Spain;Germany;Italy;United Kingdom | |||
| 389 | EUCTR2010-018563-41-ES (EUCTR) | 21/02/2011 | 22/12/2010 | Estudio en fase 3, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY 1). //A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1). - EMBODY 1 | Estudio en fase 3, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY 1). //A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1). - EMBODY 1 | Lupus eritematoso sistémico MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom | ||
| 390 | EUCTR2010-022099-29-AT (EUCTR) | 27/01/2011 | 28/12/2010 | Study investigating a new medicine, LY2127399, in patients diagnosedwith Systemic Lupus Erythematosus (SLE). | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-1) - ILLUMINATE-1 | Systemic Lupus Erythematosus (SLE) MedDRA version: 17.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY2127399 Product Code: LY2127399 Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1140 | Phase 3 | United States;Belarus;Philippines;Thailand;Ukraine;Guatemala;Turkey;Austria;Chile;Colombia;Italy;Egypt;Macedonia, the former Yugoslav Republic of;Canada;Argentina;Poland;Singapore;Croatia;Peru;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 391 | EUCTR2010-018565-26-HU (EUCTR) | 16/01/2011 | 22/11/2010 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2 | Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Hungary;Mexico;Canada;Spain;Brazil;Ukraine;Russian Federation;South Africa;Germany;Italy;United Kingdom;India | ||
| 392 | NCT01205438 (ClinicalTrials.gov) | January 2011 | 17/9/2010 | A Study of LY2127399 in Participants With Systemic Lupus Erythematosus | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune Disease | Drug: LY2127399;Drug: Placebo every 2 weeks;Drug: Placebo every 4 weeks | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 1124 | Phase 3 | United States;Australia;Brazil;Canada;Ecuador;France;Hungary;India;Israel;Latvia;Malaysia;Mexico;New Zealand;Romania;Russian Federation;Serbia;South Africa;Spain;Taiwan;Tunisia;United Kingdom |
| 393 | NCT01276782 (ClinicalTrials.gov) | January 2011 | 12/1/2011 | Levothyroxine in Pregnant SLE Patients | Pilot Double-Blind Placebo Controlled Trial of Levothyroxine in Pregnant Systemic Lupus Erythematosus (SLE) Patients With Autoimmune Thyroid Disease | Systemic Lupus Erythematosus | Drug: Levothyroxine | Johns Hopkins University | New York University School of Medicine;Duke University;University of Chicago;Stanford University | Withdrawn | 18 Years | 45 Years | Female | 0 | Phase 4 | United States |
| 394 | NCT01217320 (ClinicalTrials.gov) | January 2011 | 6/10/2010 | Creatine Supplementation in Pediatric Rheumatology | Efficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis | Juvenile Systemic Lupus Erythematosus;Juvenile Dermatomyositis | Dietary Supplement: creatine;Dietary Supplement: placebo (dextrose) | University of Sao Paulo | NULL | Recruiting | 6 Years | 18 Years | Both | 40 | N/A | Brazil |
| 395 | NCT01261793 (ClinicalTrials.gov) | December 2010 | 14/12/2010 | Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE) | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease | Systemic Lupus Erythematosus | Drug: Placebo;Drug: Epratuzumab | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 791 | Phase 3 | United States;Brazil;Canada;France;Germany;Hungary;India;Italy;Mexico;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Netherlands |
| 396 | NCT01196091 (ClinicalTrials.gov) | December 2010 | 3/9/2010 | A Study of LY2127399 in Participants With Systemic Lupus Erythematosus | A Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune Disease | Drug: LY2127399;Drug: Placebo every 2 weeks;Drug: Placebo every 4 weeks;Drug: Standard of Care | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 1164 | Phase 3 | United States;Argentina;Austria;Belarus;Bulgaria;Canada;Chile;Colombia;Croatia;Egypt;Germany;Guatemala;Italy;Japan;Korea, Republic of;Macedonia, The Former Yugoslav Republic of;Peru;Philippines;Poland;Puerto Rico;Singapore;Thailand;Ukraine;Turkey |
| 397 | NCT01262365 (ClinicalTrials.gov) | December 2010 | 14/12/2010 | Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease | Systemic Lupus Erythematosus | Drug: Epratuzumab;Drug: Placebo | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 793 | Phase 3 | United States;Australia;Belgium;Brazil;Bulgaria;Czechia;Estonia;France;Germany;India;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Puerto Rico;Romania;Russian Federation;Spain;Taiwan;United Kingdom;Czech Republic |
| 398 | EUCTR2010-018383-16-BE (EUCTR) | 10/11/2010 | 19/07/2010 | A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus). | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | France;United States;Portugal;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany | ||
| 399 | EUCTR2010-018383-16-PT (EUCTR) | 01/10/2010 | 23/07/2010 | A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus). | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 13.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | France;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany | |||
| 400 | EUCTR2010-018383-16-DE (EUCTR) | 17/09/2010 | 16/07/2010 | A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus). | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Portugal;France;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany | |||
| 401 | NCT01085097 (ClinicalTrials.gov) | September 1, 2010 | 4/3/2010 | A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroids) | Lupus Nephritis | Drug: Laquinimod;Drug: Mycophenolate Mofetil;Drug: Prednisolone/Prednisone;Drug: Placebo;Drug: Methylprednisolone | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | 75 Years | All | 46 | Phase 2 | United States;Canada;France;Russian Federation;United Kingdom |
| 402 | EUCTR2010-018383-16-HU (EUCTR) | 16/08/2010 | 20/07/2010 | A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus). | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Portugal;Hungary;Germany;Czech Republic;Ukraine;Belgium;France;Spain;United States;Poland | |||
| 403 | EUCTR2010-018383-16-CZ (EUCTR) | 13/08/2010 | 22/07/2010 | A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus). | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | France;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany | |||
| 404 | EUCTR2009-012059-47-DE (EUCTR) | 12/08/2010 | 21/01/2010 | A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus | A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 12.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: IFN-a2b Kinoid Product Code: IFN-K INN or Proposed INN: Not assigned yet Other descriptive name: IFN-a 2b Kinoid Drug Substance | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 1;Phase 2 | France;Belgium;Bulgaria;Germany | ||
| 405 | EUCTR2010-018383-16-ES (EUCTR) | 10/08/2010 | 20/07/2010 | Estudio aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de una dosis de 200 µg de CEP-33457 en pacientes con lupus eritematoso sistémico.A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Estudio aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de una dosis de 200 µg de CEP-33457 en pacientes con lupus eritematoso sistémico.A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Pacientes con lupus eritematoso sistémico (LES). Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 13;Level: LLT;Classification code 10042945;Term: Lupus eritematoso sistémico | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: rigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | France;Portugal;Czech Republic;Hungary;Belgium;Spain;Germany | ||
| 406 | EUCTR2010-018383-16-FR (EUCTR) | 05/08/2010 | 29/07/2010 | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: rigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | Portugal;France;Czech Republic;Hungary;Spain;Belgium;Germany | ||
| 407 | NCT01164917 (ClinicalTrials.gov) | August 2010 | 15/7/2010 | Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus | A Randomized, Double-blind, Placebo-controlled, Single Dose, Two-period, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of AMG 811 in Subjects With Discoid Lupus Erythematosus | Cutaneous Lupus;Discoid Lupus;Lupus;Systemic Lupus Erythematosus | Drug: AMG811;Drug: AMG811 Placebo | Amgen | NULL | Terminated | 18 Years | 70 Years | Both | 16 | Phase 1 | United States |
| 408 | NCT01381536 (ClinicalTrials.gov) | July 20, 2010 | 21/4/2011 | Phase I Study of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE) | GSK1550188, A Randomised, Single-blind, Placebo Controlled, Dose Ascending, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: GSK1550188 1mg/kg or 10mg/kg | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 12 | Phase 1 | Japan |
| 409 | NCT01085084 (ClinicalTrials.gov) | July 2010 | 9/3/2010 | Laquinimod Study in Systemic Lupus Erythematosus (SLE) Patients With Active Lupus Arthritis | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Systemic Lupus Erythematosus Patients With Active Lupus Arthritis | Lupus Arthritis | Drug: Laquinimod;Other: Placebo | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 75 Years | Both | 82 | Phase 2 | United States;Canada |
| 410 | NCT01170585 (ClinicalTrials.gov) | July 2010 | 26/7/2010 | A Trial of Rosuvastatin in Systemic Lupus Erythematosus | A Randomised Placebo Controlled Trial of Rosuvastatin in Systemic Lupus Erythematosus | Atherosclerosis;Systemic Lupus Erythematosus | Drug: Rosuvastatin;Drug: Placebo | Imperial College London | NULL | Completed | 18 Years | 80 Years | Both | 33 | Phase 2 | United Kingdom |
| 411 | NCT01162681 (ClinicalTrials.gov) | July 2010 | 13/7/2010 | PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus | A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: A-623;Other: Placebo Comparator | Anthera Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 547 | Phase 2 | United States;Argentina;Brazil;Chile;Colombia;Hong Kong;India;Mexico;Peru;Philippines;Taiwan |
| 412 | NCT01135459 (ClinicalTrials.gov) | June 2010 | 1/6/2010 | A Study to Evaluate the Efficacy and Safety of CEP-33457 in Patients With Systemic Lupus Erythematosus | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Lupuzor;Drug: Placebo | Cephalon | NULL | Completed | 18 Years | 70 Years | Both | 183 | Phase 2 | United States;Belgium;Czech Republic;France;Germany;Hungary;Poland;Portugal;Spain;Ukraine;United Kingdom |
| 413 | EUCTR2009-012059-47-FR (EUCTR) | 07/05/2010 | 02/02/2010 | A phase I-II, randomized, observer-blind, placebo-controlled, dose escalation study to evaluate the safety and immune responses of various doses of Neovacs’ IFNa-Kinoid in adult patients with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus | A phase I-II, randomized, observer-blind, placebo-controlled, dose escalation study to evaluate the safety and immune responses of various doses of Neovacs’ IFNa-Kinoid in adult patients with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 12.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: IFN-a2b Kinoid Product Code: IFN-K INN or Proposed INN: Not assigned yet Other descriptive name: IFN-a 2b Kinoid Drug Substance | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 28 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Bulgaria;Germany | ||
| 414 | NCT01127321 (ClinicalTrials.gov) | May 2010 | 14/4/2010 | A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus | A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE | Lupus Erythematosus, Systemic | Other: Placebo;Biological: MEDI-570 0.03 MG;Biological: MEDI-570 0.1 MG;Biological: MEDI-570 0.3 MG;Biological: MEDI-570 1 MG | MedImmune LLC | AstraZeneca | Terminated | 18 Years | N/A | All | 44 | Phase 1 | United States;Canada;Mexico;Peru;South Africa |
| 415 | EUCTR2009-012059-47-BG (EUCTR) | 23/04/2010 | 15/04/2010 | A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. | A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: IFN-a2b Kinoid Product Code: IFN-K INN or Proposed INN: Not assigned yet Other descriptive name: IFN-a 2b Kinoid Drug Substance | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 1;Phase 2 | France;Belgium;Bulgaria;Germany | ||
| 416 | NCT01425775 (ClinicalTrials.gov) | April 2010 | 18/8/2011 | The Effect of Vitamin D Supplementation on Disease Activity Markers in Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: vitamin D 25(OH)D;Other: Placebo | Faculty of Medicine, University of Alexandria | NULL | Completed | 18 Years | 60 Years | Both | 248 | N/A | Egypt | |
| 417 | NCT01093911 (ClinicalTrials.gov) | March 2010 | 12/3/2010 | Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE) | A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and to Explore the Pharmacodynamics of CDP7657 Administered in Healthy Subjects and in SLE Patients. | Immune System Diseases;Autoimmune Diseases;Lupus Erythematosus, Systemic;Skin and Connective Tissue Diseases;Connective Tissue Disease | Biological: CDP7657;Other: Placebo | UCB Pharma | NULL | Completed | 18 Years | 60 Years | Both | 44 | Phase 1 | Belgium;Bulgaria;Germany |
| 418 | NCT01058343 (ClinicalTrials.gov) | March 2010 | 27/1/2010 | Safety of IFNa Kinoid in Systemic Lupus Erythematosus | A Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNa-Kinoid in Adult Subjects With Systemic Lupus Erythematosus. | Systemic Lupus Erythematosus | Biological: IFN-K | Neovacs | NULL | Completed | 18 Years | 50 Years | All | 28 | Phase 1/Phase 2 | Belgium;Bulgaria;Croatia;France;Germany;Switzerland;Romania;Spain |
| 419 | EUCTR2006-006214-16-GB (EUCTR) | 23/02/2010 | 29/02/2008 | A randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus. - RCT of statin in SLE | A randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus. - RCT of statin in SLE | Systemic lupus erythematosus. MedDRA version: 13.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Crestor Product Name: Crestor INN or Proposed INN: ROSUVASTATIN CALCIUM Other descriptive name: rosuvastatin Trade Name: Crestor Product Name: Crestor INN or Proposed INN: ROSUVASTATIN CALCIUM Other descriptive name: rosuvastatin | Imperial College | NULL | Not Recruiting | Female: yes Male: yes | 64 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 420 | EUCTR2009-012059-47-BE (EUCTR) | 28/01/2010 | 05/01/2010 | A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus | A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: IFN-a2b Kinoid Product Code: IFN-K INN or Proposed INN: Not assigned yet Other descriptive name: IFN-a 2b Kinoid Drug Substance | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 1;Phase 2 | France;Belgium;Bulgaria;Germany | ||
| 421 | NCT01018238 (ClinicalTrials.gov) | November 2009 | 16/11/2009 | An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE) | A Multiple Dose, Randomised, Double-blind, Placebo-controlled, Multiple Site Study of Anti-C5a Receptor Antibody (NNC 0151-0000-0000) in Subjects With Systemic Lupus Erythematosus (SLE) | Inflammation;Systemic Lupus Erythematosus | Drug: NNC 0151-0000-0000;Drug: placebo | Novo Nordisk A/S | NULL | Withdrawn | 18 Years | 65 Years | Both | 0 | Phase 1 | United States |
| 422 | NCT00962832 (ClinicalTrials.gov) | September 2009 | 19/8/2009 | A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus | A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rontalizumab (rhuMAb IFNalpha) in Patients With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Placebo;Drug: Rontalizumab | Genentech, Inc. | NULL | Completed | 18 Years | 65 Years | Both | 238 | Phase 2 | United States;Argentina;Colombia;Mexico;Poland;Russian Federation;United Kingdom |
| 423 | NCT00960362 (ClinicalTrials.gov) | July 2009 | 14/8/2009 | An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE) | A Randomised, Double-blind, Placebo-controlled, and Single Dose-escalation Trial of AGS-009 Administered in Subjects With Systemic Lupus Erythematosus | Inflammation;Systemic Lupus Erythematosus (SLE) | Drug: AGS-009;Drug: placebo | Argos Therapeutics | NULL | Completed | 18 Years | 65 Years | Both | 13 | Phase 1 | United States;Sweden |
| 424 | NCT01914770 (ClinicalTrials.gov) | July 2009 | 3/4/2012 | Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76 | Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76 | Systemic Lupus Erythematosus | Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg;Drug: Placebo | GlaxoSmithKline | Human Genome Sciences Inc. | Completed | 18 Years | N/A | Both | 1016 | N/A | NULL |
| 425 | NCT00976729 (ClinicalTrials.gov) | May 2009 | 11/9/2009 | NOX-E36 First-in-Human (FIH) Study | NOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects | Chronic Inflammatory Diseases;Type 2 Diabetes Mellitus;Systemic Lupus Erythematosus | Drug: NOX-E36;Drug: Placebo | NOXXON Pharma AG | NULL | Completed | 18 Years | 60 Years | Both | 72 | Phase 1 | United Kingdom |
| 426 | EUCTR2007-003621-24-AT (EUCTR) | 30/03/2009 | 23/04/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 427 | NCT00818948 (ClinicalTrials.gov) | March 2009 | 18/12/2008 | Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis | Nephritis;Systemic Lupus Erythematosus | Drug: AMG 811 | Amgen | NULL | Completed | 18 Years | 70 Years | Both | 56 | Phase 1 | United States;France;Hong Kong;Malaysia;Mexico;Singapore |
| 428 | NCT00828178 (ClinicalTrials.gov) | February 2009 | 22/1/2009 | Efficacy of Fish Oil in Lupus Patients | A Randomized, Double-blind, Placebo-controlled, Clinical Trial of Omega-3-polyunsaturated Fatty Acids in Subjects With SLE. | Systemic Lupus Erythematosus | Drug: Omega-3;Device: flow-mediated dilation of the brachial artery;Other: corn starch | Michelle Petri M.D.,MPH | NULL | Completed | 18 Years | N/A | All | 106 | Phase 4 | United States |
| 429 | EUCTR2007-003621-24-GB (EUCTR) | 02/12/2008 | 14/07/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 430 | NCT00774943 (ClinicalTrials.gov) | December 2008 | 16/10/2008 | A Study of AMG 557 in Adults With Systemic Lupus Erythematosus | A Randomized, Double-blind, Placebo-controlled, Ascending, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: AMG 557 | Amgen | NULL | Completed | 18 Years | 70 Years | Both | 58 | Phase 1 | United States;Canada |
| 431 | NCT00752999 (ClinicalTrials.gov) | November 2008 | 15/9/2008 | Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus Erythematosus | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Systemic Lupus Erythematosus Patients With Active Disease | Systemic Lupus Erythematosus | Drug: Fostamatinib Disodium (R935788);Drug: Placebo | Rigel Pharmaceuticals | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 2 | NULL |
| 432 | NCT00710021 (ClinicalTrials.gov) | November 2008 | 1/7/2008 | Vitamin D3 in Systemic Lupus Erythematosus | Effect of Vitamin D3 on the IFN Alpha Signature in Patients With Systemic Lupus Erythematosus (ALE02) | Systemic Lupus Erythematosus;SLE;Lupus | Drug: Vitamin D3;Drug: Vitamin D3 placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Completed | 18 Years | N/A | All | 57 | Phase 2 | United States |
| 433 | EUCTR2007-003698-13-BG (EUCTR) | 29/09/2008 | 07/08/2008 | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus (SLE) MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2/3 | France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom | ||
| 434 | EUCTR2007-003698-13-LV (EUCTR) | 15/09/2008 | 19/06/2008 | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2/3 | Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;France;Spain;Greece;Latvia;Austria;Lithuania | ||
| 435 | EUCTR2007-003698-13-GR (EUCTR) | 09/09/2008 | 29/10/2009 | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2/3 | France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom | ||
| 436 | EUCTR2006-000674-73-BG (EUCTR) | 14/08/2008 | 14/08/2008 | A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease | A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease | Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Abetimus Sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium Other descriptive name: RIQUENT | La Jolla Pharmaceutical Company | NULL | Not Recruiting | Female: yes Male: yes | 730 | Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy | |||
| 437 | EUCTR2007-003621-24-NL (EUCTR) | 23/07/2008 | 13/03/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 438 | EUCTR2007-003621-24-IT (EUCTR) | 15/07/2008 | 17/11/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil | MONDOGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 439 | NCT00657189 (ClinicalTrials.gov) | July 2008 | 9/4/2008 | A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With Lupus | A Phase 2A , Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Dose Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Doses of MEDI-545, A Fully Human Anti-Interferon-Alpha Monoclonal Antibody, In Subjects With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic;Lupus | Drug: MEDI-545;Drug: Placebo | MedImmune LLC | NULL | Completed | 18 Years | N/A | Both | 87 | Phase 2 | United States |
| 440 | EUCTR2007-003621-24-BE (EUCTR) | 20/06/2008 | 08/01/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | |||
| 441 | EUCTR2006-005357-29-BG (EUCTR) | 18/06/2008 | 17/04/2008 | Clinical trial to study a drug in people with kidney disease related to lupus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONG | Patients with ISN/RPS or WHO class III or IV Active Lupus Nephritis MedDRA version: 15.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 369 | Sweden;United Kingdom;Germany;Netherlands;Bulgaria;Spain;Hungary;France;Portugal | |||
| 442 | EUCTR2007-002566-35-HU (EUCTR) | 09/06/2008 | 28/01/2008 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | systemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab Other descriptive name: hLL2 | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Hungary;United Kingdom;Belgium;Spain;Lithuania | ||
| 443 | NCT02151409 (ClinicalTrials.gov) | June 2008 | 28/5/2014 | Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects | A Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Trial of Anti-C5aR Antibody (NNC 0151-0000-0000) Administered by i.v. Infusion or s.c. Injection in Healthy Subjects. | Inflammation;Systemic Lupus Erythematosus;Rheumatoid Arthritis;Healthy | Drug: NNC 0151-0000-0000;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 18 Years | 55 Years | Male | 60 | Phase 1 | Netherlands |
| 444 | EUCTR2007-003621-24-FR (EUCTR) | 29/05/2008 | 27/12/2007 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 445 | EUCTR2007-003698-13-LT (EUCTR) | 14/05/2008 | 13/03/2008 | Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE) | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2/3 | Serbia;United States;Philippines;Taiwan;Greece;Spain;Lebanon;Israel;Chile;Switzerland;India;France;Malaysia;Peru;Australia;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany | ||
| 446 | EUCTR2006-000674-73-IT (EUCTR) | 12/05/2008 | 20/03/2008 | A randomized, double-blind, placebo-controlled, three-arm, parallel-group, multicenter, multinational, safety and efficacy trial of 300 mg and 900 mg of Abetimus sodium in Systemic Lupus Erythematosus (SLE) patients with a history of renal disease - ND | A randomized, double-blind, placebo-controlled, three-arm, parallel-group, multicenter, multinational, safety and efficacy trial of 300 mg and 900 mg of Abetimus sodium in Systemic Lupus Erythematosus (SLE) patients with a history of renal disease - ND | Systemic lupus erithematosus (SLE) patients with a history of renal disease. MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus | LA JOLLA PHARMACEUTICAL COMPANY | NULL | Not Recruiting | Female: yes Male: yes | 730 | Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy | |||
| 447 | EUCTR2007-003698-13-ES (EUCTR) | 09/05/2008 | 12/02/2008 | Estudio randomizado, doble ciego, controlado frente a placebo, prospectivo, multicéntrico, de búsqueda de dosis, en fase II/III, con atacicept subcutáneo en sujetos que recientemente han experimentado un brote de Lupus eritematoso sistémico.A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Estudio randomizado, doble ciego, controlado frente a placebo, prospectivo, multicéntrico, de búsqueda de dosis, en fase II/III, con atacicept subcutáneo en sujetos que recientemente han experimentado un brote de Lupus eritematoso sistémico.A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Lupus Eritematoso Sistémico Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono International SA, An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2;Phase 3 | France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom | ||
| 448 | EUCTR2006-005355-16-GB (EUCTR) | 07/05/2008 | 16/08/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 423 | Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden | |||
| 449 | EUCTR2006-005357-29-GB (EUCTR) | 07/05/2008 | 16/08/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | Lupus Nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 369 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;Hungary;Poland;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden | ||
| 450 | NCT00611663 (ClinicalTrials.gov) | May 2008 | 28/1/2008 | Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus Erythematosus | VACCILUP A Multicenter, Randomized Double-blind Trial Comparing Two Pneumococcal Vaccination Strategies in Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Biological: Prevenar® and Pneumo23®;Biological: Placebo, Pneumo23® | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | 65 Years | Both | 47 | Phase 2/Phase 3 | France |
| 451 | EUCTR2007-003698-13-AT (EUCTR) | 30/04/2008 | 10/03/2008 | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2/3 | France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom | ||
| 452 | EUCTR2007-004892-21-BG (EUCTR) | 16/04/2008 | 15/04/2008 | A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses of Subcutaneous IPP-201101 Plus Standard of Care, Versus Placebo Plus Standard of Care in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses of Subcutaneous IPP-201101 Plus Standard of Care, Versus Placebo Plus Standard of Care in Subjects with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 9.1;Level: HLT;Classification code 10025135;Term: Lupus erythematosus (incl subtypes) | Product Code: IPP-201101 INN or Proposed INN: IPP - 201101 Other descriptive name: P 140 | IMMUPHARMA SA | NULL | Not Recruiting | Female: yes Male: yes | 296 | Phase 2 | Bulgaria;Spain | ||
| 453 | EUCTR2006-005355-16-SE (EUCTR) | 10/04/2008 | 21/12/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 423 | Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden | |||
| 454 | EUCTR2007-003698-13-CZ (EUCTR) | 09/04/2008 | 06/02/2008 | Atacicept phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE) | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2/3 | United States;Philippines;Taiwan;Greece;Spain;Lebanon;Israel;Chile;India;France;Malaysia;Australia;Peru;Netherlands;Latvia;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany | ||
| 455 | EUCTR2006-005355-16-PL (EUCTR) | 04/04/2008 | 03/01/2008 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 423 | Phase 3 | United Kingdom;Sweden;Portugal;France;Hungary;Spain;Poland;Netherlands;Germany | ||
| 456 | EUCTR2007-003698-13-NL (EUCTR) | 01/04/2008 | 08/01/2008 | Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE) | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2/3 | Serbia;United States;Philippines;Taiwan;Greece;Spain;Lebanon;Israel;Chile;Switzerland;India;France;Malaysia;Peru;Australia;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany | ||
| 457 | EUCTR2006-005355-16-DE (EUCTR) | 25/03/2008 | 01/10/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 423 | Portugal;Hungary;United Kingdom;Germany;Netherlands;France;Spain;Poland;Sweden | |||
| 458 | EUCTR2007-003621-24-DE (EUCTR) | 20/03/2008 | 13/02/2009 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 459 | EUCTR2007-002566-35-GB (EUCTR) | 19/03/2008 | 29/11/2007 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | systemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab Other descriptive name: hLL2 | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Hungary;United Kingdom;Belgium;Spain;Lithuania | ||
| 460 | EUCTR2005-004575-37-GB (EUCTR) | 14/03/2008 | 08/10/2008 | A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE). Revised Protocol 03, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Protocol Amendment 07 (V1.0, dated 17-Apr-2008), and Protocol Amendment 11 (V1.0, dated 11-Dec-2008). + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007). | A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE). Revised Protocol 03, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Protocol Amendment 07 (V1.0, dated 17-Apr-2008), and Protocol Amendment 11 (V1.0, dated 11-Dec-2008). + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007). | IMMUNOSUPPRESSION FOR DISEASE, NOS MedDRA version: 9.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: CellCept Product Name: mycophenolate mofetil INN or Proposed INN: mycophenolate mofetil Other descriptive name: CellCept | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 2;Phase 3 | France;Belgium;United Kingdom | ||
| 461 | EUCTR2006-005357-29-PT (EUCTR) | 07/03/2008 | 23/11/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | Lupus Nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 369 | Hungary;Portugal;Germany;United Kingdom;Netherlands;Bulgaria;France;Spain;Sweden | |||
| 462 | EUCTR2006-005355-16-PT (EUCTR) | 07/03/2008 | 23/11/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 423 | Hungary;Portugal;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden | |||
| 463 | EUCTR2007-003698-13-GB (EUCTR) | 06/03/2008 | 13/12/2007 | Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE) | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Philippines;Taiwan;Greece;Spain;Lebanon;Chile;Israel;Switzerland;India;France;Malaysia;Australia;Peru;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany | ||
| 464 | EUCTR2007-003698-13-FR (EUCTR) | 04/03/2008 | 28/01/2008 | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono International SA, An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2;Phase 3 | France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom | ||
| 465 | EUCTR2007-002566-35-BE (EUCTR) | 25/02/2008 | 03/12/2007 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | systemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab Other descriptive name: hLL2 | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Hungary;United Kingdom;Belgium;Spain;Lithuania | ||
| 466 | EUCTR2006-005355-16-NL (EUCTR) | 22/02/2008 | 22/11/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 423 | Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden | |||
| 467 | EUCTR2006-005357-29-NL (EUCTR) | 22/02/2008 | 22/11/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | Lupus Nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 369 | Portugal;Hungary;Germany;United Kingdom;Netherlands;Bulgaria;France;Spain;Sweden | |||
| 468 | EUCTR2006-000674-73-ES (EUCTR) | 21/02/2008 | 03/12/2007 | ESTUDIO ALEATORIZADO, A DOBLE CIEGO, CONTROLADO CON PLACEBO, DE TRES BRAZOS, GRUPOS PARALELOS, MULTICÉNTRICO Y MULTINACIONAL SOBRE LA SEGURIDAD Y EFICACIA DE 300 MG Y 900 MG DE ABETIMUS SÓDICO EN PACIENTES CON LUPUS ERITEMATOSO SISTÉMICO (LES) CON ANTECEDENTES DE NEFROPATÍA | ESTUDIO ALEATORIZADO, A DOBLE CIEGO, CONTROLADO CON PLACEBO, DE TRES BRAZOS, GRUPOS PARALELOS, MULTICÉNTRICO Y MULTINACIONAL SOBRE LA SEGURIDAD Y EFICACIA DE 300 MG Y 900 MG DE ABETIMUS SÓDICO EN PACIENTES CON LUPUS ERITEMATOSO SISTÉMICO (LES) CON ANTECEDENTES DE NEFROPATÍA | Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium | La Jolla Pharmaceutical Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 730 | Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy | |||
| 469 | EUCTR2007-002566-35-ES (EUCTR) | 14/02/2008 | 20/12/2007 | Estudio en fase IIb aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis y pauta posológica, para evaluar la seguridad y eficacia de epratuzumab en pacientes con lupus eritematoso sistémico con serología positiva y enfermedad activa.A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | Estudio en fase IIb aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis y pauta posológica, para evaluar la seguridad y eficacia de epratuzumab en pacientes con lupus eritematoso sistémico con serología positiva y enfermedad activa.A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | Lupus eritematoso sistémicosystemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab Other descriptive name: hLL2 | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Hungary;Belgium;Spain;Lithuania;United Kingdom | ||
| 470 | EUCTR2007-002566-35-LT (EUCTR) | 11/02/2008 | 04/12/2007 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | systemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab Other descriptive name: hLL2 | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Hungary;United Kingdom;Belgium;Spain;Lithuania | ||
| 471 | NCT00626197 (ClinicalTrials.gov) | February 2008 | 20/2/2008 | A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG) | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus Erythematosus | Lupus Nephritis;Systemic Lupus Erythematosus | Drug: corticosteroids;Drug: cyclophosphamide;Drug: mycophenolate mofetil;Drug: ocrelizumab;Drug: placebo | Genentech, Inc. | Roche Pharma AG | Completed | 16 Years | N/A | All | 381 | Phase 3 | United States |
| 472 | EUCTR2006-005357-29-DE (EUCTR) | 31/01/2008 | 01/10/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONG | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONG | Lupus Nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 369 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Bulgaria;France;Spain;Sweden | |||
| 473 | EUCTR2006-005357-29-SE (EUCTR) | 30/01/2008 | 21/12/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | Lupus Nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 369 | Portugal;France;Hungary;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden | |||
| 474 | EUCTR2006-000674-73-DE (EUCTR) | 23/01/2008 | 16/10/2007 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE | Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium | La Jolla Pharmaceutical Company | NULL | Not Recruiting | Female: yes Male: yes | 850 | Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy | |||
| 475 | EUCTR2006-000674-73-PT (EUCTR) | 11/01/2008 | 17/09/2007 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE | Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium | La Jolla Pharmaceutical Company | NULL | Not Recruiting | Female: yes Male: yes | 730 | Portugal;Czech Republic;Hungary;Spain;Bulgaria;Germany;Italy | |||
| 476 | EUCTR2006-000674-73-CZ (EUCTR) | 07/01/2008 | 25/10/2007 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE | Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium | La Jolla Pharmaceutical Company | NULL | Not Recruiting | Female: yes Male: yes | 730 | Portugal;Hungary;Germany;Czech Republic;Bulgaria;Spain;Italy | |||
| 477 | NCT00624338 (ClinicalTrials.gov) | January 2008 | 15/2/2008 | Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE) | A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus, Systemic | Drug: Atacicept 75 mg;Drug: Atacicept 150 mg;Other: Placebo Comparator | EMD Serono | Merck KGaA | Completed | 16 Years | N/A | All | 461 | Phase 2/Phase 3 | United States;Argentina;Australia;Austria;Bulgaria;Croatia;Czech Republic;France;Germany;Greece;India;Israel;Korea, Republic of;Latvia;Lebanon;Lithuania;Malaysia;Mexico;Netherlands;Philippines;Poland;Russian Federation;Serbia;South Africa;Spain;Switzerland;Taiwan;Ukraine;United Kingdom |
| 478 | NCT00624351 (ClinicalTrials.gov) | January 2008 | 15/2/2008 | Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease | Systemic Lupus Erythematosus | Biological: Epratuzumab;Other: Placebo | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 227 | Phase 2 | United States;Belgium;Brazil;Hong Kong;Hungary;India;Lithuania;Poland;Spain;Ukraine;United Kingdom |
| 479 | NCT00539838 (ClinicalTrials.gov) | December 19, 2007 | 3/10/2007 | A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN) | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Prednisone;Drug: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate);Drug: Methylprednisolone;Drug: Ocrelizumab;Drug: Placebo | Genentech, Inc. | Roche Pharma AG | Terminated | 16 Years | N/A | All | 33 | Phase 3 | United States |
| 480 | EUCTR2006-005177-21-AT (EUCTR) | 06/12/2007 | 26/02/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||
| 481 | NCT02291588 (ClinicalTrials.gov) | December 2007 | 3/11/2014 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus | A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: AMG 811;Drug: Placebo | Amgen | NULL | Completed | 18 Years | 65 Years | Both | 26 | Phase 1 | NULL |
| 482 | EUCTR2005-004575-37-BE (EUCTR) | 21/11/2007 | 15/06/2007 | A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).Revised Protocol 05, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Amendment 07 (V1.0, dated 17-Apr-2008), Amendment 11 (V1.0, dated 11-Dec-2008), Amendment 13 (V1.0, dated 30-Apr-2010), Amendment 14 (V1.0, dated 12-Oc t-2010), Administrative Letter 04 (V1.0, dated 15-Oct-2009), Administrative Letter 05 (V1.0, dated 02-Dec-2009), and Administrative Letter 06 (V1.0, dated 12-May-2010) + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007). | A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).Revised Protocol 05, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Amendment 07 (V1.0, dated 17-Apr-2008), Amendment 11 (V1.0, dated 11-Dec-2008), Amendment 13 (V1.0, dated 30-Apr-2010), Amendment 14 (V1.0, dated 12-Oc t-2010), Administrative Letter 04 (V1.0, dated 15-Oct-2009), Administrative Letter 05 (V1.0, dated 02-Dec-2009), and Administrative Letter 06 (V1.0, dated 12-May-2010) + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007). | IMMUNOSUPPRESSION FOR DISEASE, NOS MedDRA version: 9.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: CellCept Product Name: mycophenolate mofetil INN or Proposed INN: mycophenolate mofetil Other descriptive name: CellCept | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 2;Phase 3 | France;Belgium;United Kingdom | ||
| 483 | EUCTR2006-005355-16-HU (EUCTR) | 21/11/2007 | 18/10/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 423 | Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden | |||
| 484 | EUCTR2006-005357-29-HU (EUCTR) | 21/11/2007 | 18/10/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | Lupus Nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 369 | Phase 3 | Portugal;France;Hungary;Poland;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden | ||
| 485 | EUCTR2006-005355-16-FR (EUCTR) | 15/11/2007 | 28/08/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 423 | Phase 3 | Portugal;France;Hungary;Poland;Spain;Netherlands;Germany;United Kingdom;Sweden | ||
| 486 | EUCTR2006-005357-29-FR (EUCTR) | 09/11/2007 | 24/08/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | Patients with ISN/RPS or WHO class III or IV Active Lupus Nephritis MedDRA version: 9.1;Level: LLT;Classification code 10025140;Term: Lupus nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 369 | Phase 3 | Portugal;France;Hungary;Poland;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden | ||
| 487 | EUCTR2007-004635-29-DK (EUCTR) | 09/11/2007 | 02/10/2007 | Randomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301 | Randomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301 | Patients with Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) symptoms of the skin can be included in this study. Those patients who have a diagnosis of Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions of the skin can also be included in the study. | Product Name: ASF-1096 Cream 0.25% INN or Proposed INN: R-salbutamol sulphate Product Name: ASF-1096 Cream 0.5% INN or Proposed INN: R-salbutamol sulphate Product Name: ASF-1096 Cream 1.0% INN or Proposed INN: R-salbutamol sulphate | Astion Pharma A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Denmark;Spain;Sweden | |||
| 488 | EUCTR2007-004635-29-SE (EUCTR) | 07/11/2007 | 12/09/2007 | Randomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301 | Randomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301 | Patients with Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) symptoms of the skin can be included in this study. Those patients who have a diagnosis of Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions of the skin can also be included in the study. | Product Name: ASF-1096 Cream 0.25% INN or Proposed INN: R-salbutamol sulphate Product Name: ASF-1096 Cream 0.5% INN or Proposed INN: R-salbutamol sulphate Product Name: ASF-1096 Cream 1.0% INN or Proposed INN: R-salbutamol sulphate | Astion Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 140 | Denmark;Spain;Sweden | |||
| 489 | EUCTR2006-005177-21-IT (EUCTR) | 20/09/2007 | 13/07/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - HGS1006-C1056 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - HGS1006-C1056 | Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Belimumab Product Code: HGS1006 | HUMAN GENOME SCIENCES INC | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||
| 490 | NCT00739050 (ClinicalTrials.gov) | September 19, 2007 | 19/8/2008 | Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED) | Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: simvastatin;Drug: Comparator: Placebo | Merck Sharp & Dohme Corp. | NULL | Terminated | 18 Years | N/A | Female | 4 | Phase 4 | NULL |
| 491 | EUCTR2006-005177-21-FR (EUCTR) | 11/09/2007 | 23/07/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 492 | EUCTR2006-005177-21-NL (EUCTR) | 03/08/2007 | 04/06/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||
| 493 | EUCTR2006-005177-21-SE (EUCTR) | 08/06/2007 | 07/05/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||
| 494 | NCT00430677 (ClinicalTrials.gov) | June 2007 | 1/2/2007 | Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis | A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Corticosteroids (prednisone or prednisolone);Drug: Abatacept;Drug: Mycophenolate mofetil (MMF) | Bristol-Myers Squibb | NULL | Terminated | 18 Years | N/A | All | 423 | Phase 2/Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;China;France;Hong Kong;India;Korea, Republic of;Mexico;Poland;Russian Federation;South Africa;Taiwan;Turkey;United Kingdom;Japan;Philippines;Puerto Rico |
| 495 | NCT00482989 (ClinicalTrials.gov) | June 2007 | 4/6/2007 | A Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI 545 in Patients With Systemic Lupus Erythematosus | A Phase 1b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI-545, a Fully Human Anti-Interferon-Alpha Monoclonal Antibody, in Patients With Systemic Lupus Erythematosus | Lupus | Biological: MEDI 545;Other: Placebo | MedImmune LLC | NULL | Completed | 18 Years | N/A | Both | 183 | Phase 1 | United States;Argentina;Brazil;Chile;Canada |
| 496 | EUCTR2006-005177-21-GB (EUCTR) | 29/05/2007 | 02/01/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 497 | EUCTR2006-005177-21-SK (EUCTR) | 17/05/2007 | 20/03/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 498 | EUCTR2006-005177-21-ES (EUCTR) | 09/05/2007 | 09/03/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)Un estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 76 semanas para evaluar la eficacia y la seguridad de belimumab (HGS1006, LymphoStat-BTM), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)Un estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 76 semanas para evaluar la eficacia y la seguridad de belimumab (HGS1006, LymphoStat-BTM), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) - BLISS-76 | Systemic Lupus Erythematosus (SLE)Lupus Eritematoso Sistémico MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | France;Czech Republic;Slovakia;Belgium;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 499 | EUCTR2006-005177-21-BE (EUCTR) | 07/05/2007 | 29/01/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||
| 500 | EUCTR2006-005177-21-DE (EUCTR) | 03/05/2007 | 20/02/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||
| 501 | NCT00424476 (ClinicalTrials.gov) | May 2007 | 17/1/2007 | A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg | Human Genome Sciences Inc. | GlaxoSmithKline | Completed | 18 Years | N/A | All | 865 | Phase 3 | Argentina;Australia;Brazil;Chile;Colombia;Hong Kong;India;Korea, Republic of;Peru;Philippines;Romania;Russian Federation;Taiwan;Bulgaria;China |
| 502 | EUCTR2005-004575-37-FR (EUCTR) | 27/04/2007 | 26/03/2007 | A Sequential Adaptive Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).And Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (Version 2.0, Date 19-Jan-07). | A Sequential Adaptive Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).And Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (Version 2.0, Date 19-Jan-07). | IMMUNOSUPPRESSION FOR DISEASE, NOS MedDRA version: 9.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: CellCept Product Name: mycophenolate mofetil INN or Proposed INN: mycophenolate mofetil Other descriptive name: CellCept | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 2;Phase 3 | France;Belgium;United Kingdom | ||
| 503 | EUCTR2006-005177-21-CZ (EUCTR) | 23/04/2007 | 28/02/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | Germany;United Kingdom;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||
| 504 | NCT00668330 (ClinicalTrials.gov) | April 2007 | 25/4/2008 | Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus | Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus-Prevalence,Risk Factors and Treatment | Systemic Lupus Erythematosus | Drug: Ibandronate+alfacalcidol+calcium;Drug: placebo ibandronate+alfacalcidol+calcium | Chinese University of Hong Kong | NULL | Completed | 18 Years | 80 Years | Female | 40 | Phase 4 | China |
| 505 | EUCTR2006-001062-17-SE (EUCTR) | 07/03/2007 | 12/01/2007 | Efficacy and safety of ASF-1096 Cream 0.5% in the treatment of patients with newly developed discoid lupus erythematosus (DLE) lesions. A multi centre clinical phase 2, placebo controlled and double blind proof of concept study. - Lupus study | Efficacy and safety of ASF-1096 Cream 0.5% in the treatment of patients with newly developed discoid lupus erythematosus (DLE) lesions. A multi centre clinical phase 2, placebo controlled and double blind proof of concept study. - Lupus study | Male or female patients with a clinical diagnosis of either Discoid Lupus Erythematosus or Systemic Lupus Erythematosus and at least one newly developed, sharply demarcated DLE lesion. MedDRA version: 8.1;Level: LLT;Classification code 10025138;Term: | Product Name: ASF-1096 Cream 0.5% | Astion Danmark A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | United Kingdom;Sweden | ||
| 506 | JPRN-UMIN000000639 | 2007/03/01 | 16/03/2007 | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus | Systemic lupus erythematosus | IDEC-C2B8 plus oral prednisolone(tapering) 1000 mg of IDEC-C2B8 on days 1 and 15.Repeated at an interval of 6 months (Days 169 and 183). Placebo plus oral prednisolone(tapering) 1000 mg of placebo day 1 and 15.Repeated at an interval of 6 months (Days 169 and 183). | Zenyaku Kogyo Co., Ltd. | NULL | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 150 | Phase 2/3 | Japan | |
| 507 | NCT01322308 (ClinicalTrials.gov) | March 2007 | 23/3/2011 | Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus | Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus, a Randomized, Double-blind, Placebo-controlled Clinical Trial | Systemic Lupus Erythematosus | Drug: pioglitazone;Drug: placebo | National Heart Institute, Mexico | National Council of Science and Technology, Mexico;Universidad Nacional Autonoma de Mexico | Completed | 18 Years | 55 Years | Female | 30 | Phase 4 | NULL |
| 508 | NCT01702740 (ClinicalTrials.gov) | March 2007 | 6/7/2012 | A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus | A Phase 1, Double-blind, Placebo-controlled, Multiple Intravenous, Ascending-Dose Study of CNTO 136 to Evaluate Safety and Pharmacokinetics in Subjects With Cutaneous Lupus Erythematosus and to Evaluate Safety and Pharmacokinetics in a Cohort of Subjects With Systemic Lupus Erythematosus | Lupus Erythematosus, Cutaneous;Lupus Erythematosus, Systemic | Drug: 1 mg/kg CNTO 136;Drug: 4 mg/kg CNTO 136;Drug: 10 mg/kg CNTO 136;Drug: Placebo | Centocor Research & Development, Inc. | NULL | Completed | 18 Years | 70 Years | Both | 49 | Phase 1 | NULL |
| 509 | NCT00541749 (ClinicalTrials.gov) | February 2007 | 7/10/2007 | A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus | A Phase I, Randomized, Double-Blind, Placebo-Controlled, Escalating Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: rhuMAb IFNalpha | Genentech, Inc. | NULL | Completed | 18 Years | 65 Years | Both | 60 | Phase 1 | United States |
| 510 | NCT01845740 (ClinicalTrials.gov) | January 2007 | 17/4/2013 | Phase Ib Study of SC Milatuzumab in SLE | A Phase Ib Study of Milatuzumab Administered Subcutaneously in Patients With Active Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus, Cutaneous;Lupus Erythematosus, Discoid;Lupus Erythematosus, Systemic;Lupus Vasculitis, Central Nervous System;Lupus Nephritis | Drug: milatuzumab;Drug: Placebo | Gilead Sciences | United States Department of Defense | Completed | 18 Years | N/A | All | 22 | Phase 1 | United States |
| 511 | NCT00410384 (ClinicalTrials.gov) | December 2006 | 8/12/2006 | A Study of Belimumab in Subjects With Systemic Lupus Erythematosus | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg | Human Genome Sciences Inc. | GlaxoSmithKline | Completed | 18 Years | N/A | All | 819 | Phase 3 | United States;Austria;Belgium;Canada;Costa Rica;Czech Republic;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Sweden;United Kingdom |
| 512 | NCT02391259 (ClinicalTrials.gov) | November 2006 | 6/1/2015 | A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus | Randomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: AMG 557;Drug: Placebo | Amgen | NULL | Completed | 18 Years | 70 Years | Both | 57 | Phase 1 | United States;United Kingdom |
| 513 | NCT00594932 (ClinicalTrials.gov) | November 2006 | 4/1/2008 | Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis | Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis | Systemic Lupus Erythematosus;Arthritis | Drug: mycophenolate mofetil;Other: placebo | Oklahoma Medical Research Foundation | NYU Langone Health | Completed | 14 Years | 70 Years | All | 27 | Phase 1/Phase 2 | United States |
| 514 | EUCTR2006-000674-73-SK (EUCTR) | 09/10/2006 | 09/08/2006 | A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 100 mg, 300 mg, and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease | A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 100 mg, 300 mg, and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease | Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Abetimus Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium | La Jolla Pharmaceutical Company | NULL | Not Recruiting | Female: yes Male: yes | 588 | Phase 3 | Portugal;Czech Republic;Hungary;Slovakia;Spain;Bulgaria;Germany;Italy | ||
| 515 | EUCTR2005-004067-30-DE (EUCTR) | 05/10/2006 | 11/05/2006 | A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis | A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis | Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Azathioprine Other descriptive name: Azathioprine | Department of Rheumatology, Internal Medicine III, Medical University of Vienna | NULL | Not Recruiting | Female: yes Male: yes | 44 | Germany;Netherlands;Austria | |||
| 516 | NCT00368264 (ClinicalTrials.gov) | September 2006 | 23/8/2006 | TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL ) | A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNF-alpha Chimeric Monoclonal Antibody (Infliximab) and Azathioprine in Patients Suffering From Systemic Lupus Erythematosus (SLE) With WHO Class V Glomerulonephritis | Lupus Erythematosus, Systemic;Lupus Nephritis | Drug: infliximab;Drug: placebo | Medical University of Vienna | Hospital Hietzing;Medical University of Graz;Charite University, Berlin, Germany;University of Erlangen-Nürnberg;Heinrich-Heine University, Duesseldorf;University Medical Centre Groningen;Leiden University Medical Center;Radboud University | Terminated | 18 Years | N/A | Both | 1 | Phase 2/Phase 3 | Austria;Germany;Netherlands |
| 517 | EUCTR2006-000674-73-HU (EUCTR) | 11/08/2006 | 15/06/2006 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE | Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium | La Jolla Pharmaceutical Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 730 | Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy | |||
| 518 | EUCTR2005-004067-30-NL (EUCTR) | 08/08/2006 | 20/04/2006 | A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis | A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis | Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Azathioprine Other descriptive name: Azathioprine | Department of Rheumatology, Internal Medicine III, Medical University of Vienna | NULL | Not Recruiting | Female: yes Male: yes | 44 | Germany;Netherlands;Austria | |||
| 519 | NCT00383513 (ClinicalTrials.gov) | June 2006 | 29/9/2006 | Study of Epratuzumab in Systemic Lupus Erythematosus | An Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Epratuzumab | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 29 | Phase 2 | United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Italy;Netherlands;Spain;United Kingdom |
| 520 | NCT00371501 (ClinicalTrials.gov) | June 2006 | 1/9/2006 | Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus | Low Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled Trial | Atherosclerosis;Thromboembolism;Systemic Lupus Erythematosus | Drug: Rosuvastatin;Drug: placebo;Drug: aspirin | Tuen Mun Hospital | AstraZeneca | Completed | 18 Years | N/A | Both | 72 | Phase 4 | Hong Kong |
| 521 | EUCTR2004-004051-19-IT (EUCTR) | 26/05/2006 | 30/08/2006 | Phase IIb, multi 8722;center, randomized, double 8722;blind, placebo 8722;controlled study to evaluate the efficacy and safety of abatacept vs placebo on a background of oral glucocorticosteroids in the tratment of subjects with systemic lupus erythematosus and the prevention of subsequent lupus flares - ND | Phase IIb, multi 8722;center, randomized, double 8722;blind, placebo 8722;controlled study to evaluate the efficacy and safety of abatacept vs placebo on a background of oral glucocorticosteroids in the tratment of subjects with systemic lupus erythematosus and the prevention of subsequent lupus flares - ND | Systemic Lupus Erythematosus MedDRA version: 6.1;Level: HLT;Classification code 10025136 | Product Name: abatacept | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United Kingdom;Germany;Italy;Sweden | ||
| 522 | EUCTR2005-004067-30-AT (EUCTR) | 08/05/2006 | 31/03/2006 | A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis | A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis | Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Azathioprine Other descriptive name: Azathioprine | Department of Rheumatology, Internal Medicine III, Medical University of Vienna | NULL | Not Recruiting | Female: yes Male: yes | 44 | Germany;Netherlands;Austria | |||
| 523 | EUCTR2005-000705-59-DE (EUCTR) | 11/04/2006 | 07/06/2005 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE Flares | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE Flares | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 Other descriptive name: hLL2 (trivial name or chemical description) | UCB Pharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Hungary;United Kingdom;Germany;Spain;Italy | ||
| 524 | NCT00299819 (ClinicalTrials.gov) | March 2006 | 6/3/2006 | Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE) | A Phase I, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study to Evaluate Safety and Tolerability of a Single IV Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Patients With Systemic Lupus Erythematosus (SLE) | Lupus | Biological: MEDI-545;Biological: MEDI 545 | MedImmune LLC | NULL | Completed | 18 Years | 80 Years | Both | 45 | Phase 1 | United States;Canada |
| 525 | NCT00181298 (ClinicalTrials.gov) | March 2006 | 13/9/2005 | Memantine in Systemic Lupus Erythematosus | Memantine in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Memantine;Drug: Placebo | Johns Hopkins University | Forest Laboratories | Completed | 18 Years | N/A | Both | 61 | N/A | United States |
| 526 | NCT01101802 (ClinicalTrials.gov) | March 2006 | 9/4/2010 | Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE) | A Prospective, Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Mycophenolate Mofetil on 'Surrogate Markers' for Atherosclerosis in Female Patients With SLE. | Systemic Lupus Erythematosus;Atherosclerosis | Drug: Mycophenolate mofetil;Drug: sugar pill | Guy's and St Thomas' NHS Foundation Trust | Institute of Child Health, University College London, London, UK. | Completed | 18 Years | 60 Years | Female | 71 | Phase 4 | United Kingdom |
| 527 | EUCTR2005-000705-59-HU (EUCTR) | 09/01/2006 | 12/10/2005 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 Other descriptive name: hLL2 (trivial name or chemical description) | Immunomedics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Hungary;Slovakia;Spain;Germany;Italy;United Kingdom | ||
| 528 | EUCTR2005-000706-31-DE (EUCTR) | 05/01/2006 | 28/06/2005 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 Other descriptive name: hLL2 (trivial name or chemical description) | UCB Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United Kingdom;Germany;Spain;Italy | ||
| 529 | EUCTR2005-000705-59-SK (EUCTR) | 14/10/2005 | 29/07/2005 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 Other descriptive name: hLL2 (trivial name or chemical description) | Immunomedics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Hungary;Slovakia;Spain;Germany;Italy;United Kingdom | ||
| 530 | EUCTR2005-001391-12-GB (EUCTR) | 12/10/2005 | 15/06/2005 | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | Systemic lupus erythematosus (SLE) MedDRA version: 7.1;Level: PT;Classification code 10042945 | Product Name: edratide Product Code: TV-4710 INN or Proposed INN: edratide | TEVA Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Spain;Germany;Italy;United Kingdom | ||
| 531 | EUCTR2005-001391-12-DE (EUCTR) | 23/09/2005 | 15/07/2005 | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | Systemic lupus erythematosus (SLE) MedDRA version: 7.1;Level: PT;Classification code 10042945 | Product Name: edratide Product Code: TV-4710 INN or Proposed INN: edratide | TEVA Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Hungary;United Kingdom;Germany;Spain;Italy | |||
| 532 | EUCTR2005-001688-74-GB (EUCTR) | 22/09/2005 | 16/08/2005 | A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile) | A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile) | Atherosclerosis in patients with Systemic Lupus Erythematosis | Trade Name: CellCept Product Name: Mycophenolate mofetil Product Code: Ro 106-1443 INN or Proposed INN: Mycophenolate motetil | Guy's & St Thomas' NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: no | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 533 | EUCTR2005-000706-31-IT (EUCTR) | 15/09/2005 | 30/09/2005 | A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients with Active Systemic LupusErythematosus | A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients with Active Systemic LupusErythematosus | improvement of signs and symptoms of Active Systemic Lupus Erythematosus MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Epatuzumab Product Code: hLL2,IMMU-103 | IMMUNOMEDICS | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany;United Kingdom;Spain;Italy | |||
| 534 | EUCTR2005-001391-12-ES (EUCTR) | 01/09/2005 | 07/07/2005 | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | Systemic lupus erythematosus (SLE) MedDRA version: 7.1;Level: PT;Classification code 10042945 | Product Name: edratide Product Code: TV-4710 INN or Proposed INN: edratide Product Name: edratide Product Code: TV-4710 INN or Proposed INN: edratide Product Name: edratide Product Code: TV-4710 INN or Proposed INN: edratide | TEVA Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Hungary;Spain;Germany;Italy;United Kingdom | ||
| 535 | NCT00119678 (ClinicalTrials.gov) | September 2005 | 30/6/2005 | Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone | A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares | Systemic Lupus Erythematosus | Drug: Abatacept;Drug: Placebo;Drug: Prednisone | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 183 | Phase 2 | United States;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Italy;Korea, Republic of;Mexico;Puerto Rico;South Africa;Taiwan;United Kingdom;Sweden |
| 536 | EUCTR2004-004051-19-AT (EUCTR) | 30/08/2005 | 26/07/2005 | A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol 1.0 (incorporating Amendment 2) dated 03-June-2005 + Amendment 1 dated 08-Feb-2005 | A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol 1.0 (incorporating Amendment 2) dated 03-June-2005 + Amendment 1 dated 08-Feb-2005 | SYSTEMIC LUPUS ERYTHEMATOSUS, NOS | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Austria;Germany;Italy;United Kingdom;Sweden | ||
| 537 | EUCTR2004-004051-19-BE (EUCTR) | 29/08/2005 | 29/06/2005 | A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006). | A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006). | SYSTEMIC LUPUS ERYTHEMATOSUS, NOS | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Belgium;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 538 | EUCTR2005-001391-12-IT (EUCTR) | 28/07/2005 | 23/03/2006 | A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Three Doses of Edratide TV-4710 for Injection Administered Subcutaneously to Systemic Lupus Erythematosus SLE patients | A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Three Doses of Edratide TV-4710 for Injection Administered Subcutaneously to Systemic Lupus Erythematosus SLE patients | Treatment of active SLE patients who are concurrently undergoing a regimented program of decreased steroid use. MedDRA version: 6.1;Level: PT;Classification code 10042945 | Product Name: Edratide Acetate Product Code: TV-4710 Product Name: Edratide Acetate Product Code: TV-4710 Product Name: Edratide Acetate Product Code: TV-4710 | TEVA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Germany;United Kingdom;Spain;Italy | |||
| 539 | EUCTR2005-001391-12-HU (EUCTR) | 27/07/2005 | 15/06/2005 | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | Systemic lupus erythematosus (SLE) MedDRA version: 7.1;Level: PT;Classification code 10042945 | Product Name: edratide Product Code: TV-4710 INN or Proposed INN: edratide | TEVA Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Germany;United Kingdom;Spain;Italy | |||
| 540 | EUCTR2005-000706-31-ES (EUCTR) | 25/07/2005 | 23/05/2006 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 INN or Proposed INN: Epratuzumab Other descriptive name: hLL2 (trivial name or chemical description) | Immunomedics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Belgium;Spain;Germany;Italy;United Kingdom | ||
| 541 | NCT00203151 (ClinicalTrials.gov) | July 2005 | 13/9/2005 | A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus | A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Edratide for Subcutaneous Injection in Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: edratide | Teva Pharmaceutical Industries | NULL | Terminated | 18 Years | 65 Years | Both | 340 | Phase 2 | United States |
| 542 | EUCTR2005-000706-31-BE (EUCTR) | 29/06/2005 | 26/07/2005 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 Other descriptive name: hLL2 (trivial name or chemical description) | UCB Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Spain;Belgium;Germany;Italy;United Kingdom | ||
| 543 | EUCTR2005-000705-59-GB (EUCTR) | 07/06/2005 | 19/04/2005 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE Flares | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE Flares | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 Other descriptive name: hLL2 (trivial name or chemical description) | Immunomedics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Hungary;Germany;United Kingdom;Spain;Italy | ||
| 544 | EUCTR2004-004051-19-SE (EUCTR) | 01/06/2005 | 29/03/2005 | A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol Number 02: Incorporates Amendments 2 & 3 - Protocol Amendment 1 - Site Specific. | A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol Number 02: Incorporates Amendments 2 & 3 - Protocol Amendment 1 - Site Specific. | SYSTEMIC LUPUS ERYTHEMATOSUS, NOS | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United Kingdom;Germany;Italy;Sweden | ||
| 545 | NCT00111306 (ClinicalTrials.gov) | June 2005 | 19/5/2005 | Study of Epratuzumab in Systemic Lupus Erythematosus | A Phase III, Randomized, Double-Blind. Placebo-Controlled, Multi-Center Study of Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological Systems | Systemic Lupus Erythematosus | Drug: epratuzumab | UCB Pharma | NULL | Terminated | 18 Years | N/A | Both | 510 | Phase 3 | United States;Belgium;Hungary;Netherlands;Spain;United Kingdom |
| 546 | EUCTR2004-004051-19-DE (EUCTR) | 13/05/2005 | 22/03/2005 | A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006). | A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006). | SYSTEMIC LUPUS ERYTHEMATOSUS, NOS | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United Kingdom;Germany;Italy;Sweden | ||
| 547 | EUCTR2005-000706-31-GB (EUCTR) | 13/05/2005 | 19/04/2005 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 Other descriptive name: hLL2 (trivial name or chemical description) | Immunomedics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Germany;United Kingdom;Spain;Italy | ||
| 548 | NCT00137969 (ClinicalTrials.gov) | May 10, 2005 | 26/8/2005 | A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus | Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Rituximab;Drug: Placebo;Drug: Prednisone;Drug: Acetaminophen;Drug: Diphenhydramine | Genentech, Inc. | NULL | Completed | 16 Years | 75 Years | All | 262 | Phase 2/Phase 3 | United States;Canada |
| 549 | NCT02411136 (ClinicalTrials.gov) | May 2005 | 3/4/2015 | A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Multi-dose Administration in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: AMG 623;Drug: Placebo | Amgen | NULL | Completed | 18 Years | 65 Years | Both | 64 | Phase 1 | NULL |
| 550 | NCT00383214 (ClinicalTrials.gov) | May 2005 | 29/9/2006 | Study of Epratuzumab in Systemic Lupus Erythematosus (SLE) | A Phase III, Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients With Active Systemic Lupus Erythematosus. | Systemic Lupus Erythematosus | Drug: Epratuzumab;Other: Placebo | UCB Pharma | NULL | Terminated | 18 Years | N/A | Both | 54 | Phase 3 | United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Italy;Netherlands;Spain;United Kingdom |
| 551 | EUCTR2004-004051-19-GB (EUCTR) | 18/04/2005 | 24/03/2005 | A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol 1.0 dated 03-June-2005 + Amendment 1 dated 08-Feb-2005 | A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol 1.0 dated 03-June-2005 + Amendment 1 dated 08-Feb-2005 | SYSTEMIC LUPUS ERYTHEMATOSUS, NOS | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Germany;United Kingdom;Italy;Sweden | ||
| 552 | NCT02443506 (ClinicalTrials.gov) | October 2004 | 11/5/2015 | A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus | A Randomized Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Single Dose Administration in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: AMG 623;Drug: Placebo | Amgen | NULL | Completed | 18 Years | 55 Years | Both | 56 | Phase 1 | NULL |
| 553 | NCT00089804 (ClinicalTrials.gov) | October 2004 | 13/8/2004 | Study of LJP 394 in Lupus Patients With History of Renal Disease | A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease | Lupus Erythematosus, Systemic;Lupus Nephritis | Drug: abetimus sodium (LJP 394) and/or placebo solution;Drug: abetimus sodium (LJP 394);Drug: Phosphate-buffered saline | La Jolla Pharmaceutical Company | NULL | Terminated | 12 Years | 70 Years | Both | 943 | Phase 3 | United States;Argentina;Australia;Belarus;Brazil;Bulgaria;Czech Republic;Georgia;Germany;Hong Kong;Hungary;India;Indonesia;Italy;Korea, Republic of;Lebanon;Malaysia;Mexico;Philippines;Poland;Portugal;Puerto Rico;Romania;Serbia;Slovakia;Spain;Sri Lanka;Taiwan;Thailand;Ukraine;Former Serbia and Montenegro |
| 554 | NCT00071487 (ClinicalTrials.gov) | October 2003 | 24/10/2003 | Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus, Systemic | Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 4 mg/kg;Drug: Belimumab 10 mg/kg | Human Genome Sciences Inc. | NULL | Completed | 18 Years | 65 Years | All | 449 | Phase 2 | United States;Canada |
| 555 | NCT00637819 (ClinicalTrials.gov) | January 2003 | 11/3/2008 | Leflunomide in Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo Controlled Clinical Trial of Leflunomide in Systemic Lupus Erythematosus (SLE) | Systemic Lupus Eythematosus (SLE) | Drug: Leflunomide | Sanofi | NULL | Completed | 18 Years | N/A | Both | 27 | Phase 2 | Hong Kong |
| 556 | NCT00053560 (ClinicalTrials.gov) | December 2002 | 30/1/2003 | To Assess Prevention of Bone Loss in Women With Lupus Receiving Treatment With Glucocorticoids | A Randomized, Double-Blind, Multi-Center, Placebo- Controlled Study to Assess Prevention of Bone Loss by Treatment With GL701 (Prestara) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids | Lupus | Drug: Prasterone (GL701) | Genelabs Technologies | NULL | Active, not recruiting | 18 Years | N/A | Female | 155 | Phase 3 | United States;Mexico |
| 557 | NCT00412841 (ClinicalTrials.gov) | November 2002 | 18/12/2006 | Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus | AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial | Avascular Necrosis | Drug: Atorvastatin;Procedure: MRI, Venipuncture;Drug: Placebo | NYU Langone Health | NULL | Terminated | 18 Years | 75 Years | Female | 43 | Phase 2 | United States |
| 558 | NCT00657007 (ClinicalTrials.gov) | February 2002 | 8/4/2008 | Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 1, Multi-Center, Double-Blind, Single and Double Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: belimumab;Biological: Placebo | Human Genome Sciences Inc. | NULL | Completed | 18 Years | N/A | Both | 70 | Phase 1 | United States |
| 559 | NCT00035308 (ClinicalTrials.gov) | November 2001 | 2/5/2002 | Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Safety and Efficacy Trial of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease | Immunologic Diseases;Autoimmune Diseases;Systemic Lupus Erythematosus;Lupus Nephritis;Lupus Glomerulonephritis | Drug: Abetimus sodium (LJP 394) | La Jolla Pharmaceutical Company | NULL | Completed | 12 Years | 70 Years | Both | 330 | Phase 3 | United States;Austria;Canada;France;Germany;Italy;Mexico;Spain;Sweden;United Kingdom |
| 560 | NCT00000421 (ClinicalTrials.gov) | September 1997 | 3/11/1999 | Serologically Active, Clinically Stable Systemic Lupus Erythematosus | Serologically Active, Clinically Stable Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Prednisone;Drug: Placebo | New York University School of Medicine | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | 13 Years | 65 Years | Female | 154 | Phase 2 | United States |
| 561 | NCT00004662 (ClinicalTrials.gov) | March 1996 | 24/2/2000 | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: dehydroepiandrosterone | National Center for Research Resources (NCRR) | Northwestern University | Completed | 18 Years | N/A | Female | 300 | Phase 3 | NULL | |
| 562 | NCT00470522 (ClinicalTrials.gov) | June 1995 | 2/5/2007 | Study of Methotrexate in Lupus Erythematosus | A Canadian Multicenter, Randomized, Double-Blind Placebo-Controlled Study of Methotrexate and Folic Acid in Systemic Lupus Erythematosus: A Phase III Trial. | Systemic Lupus Erythematosus | Drug: Methotrexate and folic acid | University Health Network, Toronto | McGill University Health Center | Completed | 18 Years | N/A | Both | 86 | Phase 3 | Canada |
| 563 | NCT00004795 (ClinicalTrials.gov) | August 1994 | 24/2/2000 | Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Mild to Moderate Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: dehydroepiandrosterone | National Center for Research Resources (NCRR) | Northwestern University | Completed | 18 Years | N/A | Female | 190 | Phase 2/Phase 3 | NULL | |
| 564 | EUCTR2007-003698-13-DE (EUCTR) | 09/05/2008 | Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE) | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2/3 | United States;Serbia;Philippines;Taiwan;Greece;Spain;Lebanon;Chile;Israel;Switzerland;India;France;Malaysia;Australia;Peru;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany | |||
| 565 | EUCTR2019-003406-27-PL (EUCTR) | 14/04/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | NA | Female: yes Male: yes | 450 | Phase 3 | Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Germany;Norway;Sweden;Czech Republic;United Kingdom;Austria;Lithuania;Czechia;Korea, Republic of;Netherlands;Denmark;Australia;Peru;France;Italy;Switzerland;Colombia;Chile;Spain;Greece;Slovakia;Estonia;Taiwan;Philippines;Serbia;United States;Portugal | |||
| 566 | JPRN-JapicCTI-184095 | 03/09/2018 | A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (I4V-MC-JAIA) | A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (I4V-MC-JAIA) | Systemic Lupus Erythematosus | Intervention name : LY3009104 INN of the intervention : Baricitinib Dosage And administration of the intervention : High Dose or Low Dose. Baricitinib administered orally. Placebo administered orally to maintain the blind. Control intervention name : Placebo Dosage And administration of the control intervention : Placebo administered orally. | Eli Lilly Japan K.K. | NULL | recruiting | 18 | BOTH | Phase 3 | NULL | |||
| 567 | EUCTR2011-000368-88-PL (EUCTR) | 04/06/2012 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with SLE - Belimumab in pediatric patients with SLE | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Mexico;Canada;Argentina;Brazil;Spain;Poland;Peru;Russian Federation;Netherlands;Italy;United Kingdom | |||
| 568 | EUCTR2020-004047-86-FR (EUCTR) | 04/06/2021 | A Study of ALPN-101 in Active Lupus | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPN-101 IN SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042946;Term: Systemic lupus erythematosus rash;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857 MedDRA version: 20.1;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations MedDRA version: 20.0;Classification code 10067658;Term: Systemic lupus erythematosus disease activity index decreased;System Organ Class: 10022891 - Investigations MedDRA version: 20.1;Classification code 10067659;Term: Systemic lupus erythematosus disease activity index abnormal;System Organ Class: 10022891 - Investigations MedDRA version: 21.0;Classification code 10080670;Term: Systemic lupus erythematosus reactivation;Classification code 10073694;Term: Lupus pleurisy;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10040968;Term: SLE arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ALPN-101 INN or Proposed INN: Acazicolcept Other descriptive name: ALPN-101 | Alpine Immune Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 2 | United States;France;Spain;Poland;Russian Federation;Germany;Korea, Republic of | |||
| 569 | EUCTR2011-000368-88-Outside-EU/EEA (EUCTR) | 17/02/2014 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE | Systemic Lupus Erythematosus MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline Research & Development Ltd | NULL | NA | Female: yes Male: yes | 100 | Argentina;Brazil;Netherlands;Mexico;Peru;Poland;Russian Federation;Germany;Canada;Italy;Spain;United Kingdom;United States | ||||
| 570 | EUCTR2019-003406-27-FR (EUCTR) | 22/12/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | NA | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany | |||
| 571 | EUCTR2006-005357-29-PL (EUCTR) | 10/01/2008 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | Lupus Nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 369 | Phase 3 | Portugal;France;Hungary;Spain;Poland;Bulgaria;Netherlands;Germany;United Kingdom;Sweden | |||
| 572 | EUCTR2019-003406-27-BE (EUCTR) | 28/02/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | NA | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany | |||
| 573 | EUCTR2019-003407-35-BE (EUCTR) | 24/01/2022 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS FLY | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: dapirolizumab pegol Other descriptive name: DZP | UCB Biopharma SRL | NULL | NA | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Czechia;Taiwan;Hong Kong;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Bulgaria;Germany;China;Japan |