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 | 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 | ||
| 2 | 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 |
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | EUCTR2020-003509-72-FR (EUCTR) | 21/10/2021 | 10/03/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosus | 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 MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 7 | 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 |
| 8 | 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 | ||
| 9 | NCT04956484 (ClinicalTrials.gov) | September 1, 2021 | 8/7/2021 | Belimumab In Treatment of Early Systemic Lupus Erythematosus | A Single-center, Randomized, Open Label, 52-week Study of Belimumab In Treatment of Early Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Biological: Belimumab;Drug: Standard of care | Peking Union Medical College Hospital | NULL | Not yet recruiting | 18 Years | 75 Years | All | 84 | Phase 4 | China |
| 10 | EUCTR2020-003509-72-BG (EUCTR) | 31/08/2021 | 01/06/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosus | 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;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 11 | EUCTR2020-003509-72-AT (EUCTR) | 12/08/2021 | 11/05/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosus | 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 MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan;Korea, Republic of | ||
| 12 | EUCTR2020-003509-72-IT (EUCTR) | 27/07/2021 | 17/08/2021 | 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 - NA | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: [AMG 592] INN or Proposed INN: EFAVALEUKIN ALFA Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | AMGEN INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 13 | 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 |
| 14 | EUCTR2020-003509-72-ES (EUCTR) | 17/06/2021 | 11/06/2021 | 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 MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 15 | EUCTR2020-003509-72-GR (EUCTR) | 17/06/2021 | 22/04/2021 | 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 | 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 MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Taiwan;Hong Kong;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 16 | EUCTR2019-000328-16-GR (EUCTR) | 10/06/2021 | 12/05/2021 | Safety and Efficacy 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 - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | Active 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: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Portugal;United States;Czechia;Hong Kong;Greece;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 17 | 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 |
| 18 | EUCTR2020-003509-72-PL (EUCTR) | 21/05/2021 | 11/05/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosus | 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 MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Taiwan;Hong Kong;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 19 | 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 |
| 20 | 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 |
| 21 | ChiCTR2100043138 | 2021-04-01 | 2021-02-05 | Efficacy of belimumab combined with standard of care in patients with untreated systemic lupus erythematosus | Efficacy of belimumab combined with standard of care in patients with untreated systemic lupus erythematosus | Systemic lupus erythematosus | Belimumab+SoC group:Belimumab+SoC;SoC group:SoC; | Affiliated Hospital of Guilin Medical College | NULL | Recruiting | 16 | 65 | Both | Belimumab+SoC group:40;SoC group:40; | Phase 4 | China |
| 22 | NCT04726553 (ClinicalTrials.gov) | January 20, 2021 | 22/1/2021 | Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLE | Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in Patients With Moderately to Severely Active Systemic Lupus Erythematosus: A Multi-Centre Open Label Parallel Group Trial: | Systemic Lupus Erythematosus (SLE) | Drug: Anifrolumab;Drug: Standard of Care | Oklahoma Medical Research Foundation | NYU Langone Health;Yale University;Piedmont Heart Institute, Inc., Atlanta, GA;Columbia University | Recruiting | 18 Years | 70 Years | All | 20 | Early Phase 1 | United States |
| 23 | 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 |
| 24 | 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 |
| 25 | EUCTR2019-000328-16-PT (EUCTR) | 02/03/2020 | 09/08/2019 | A 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 | 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 - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | Active 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: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Portugal;United States;Czechia;Greece;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 26 | 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 |
| 27 | EUCTR2019-000328-16-FR (EUCTR) | 20/12/2019 | 16/07/2019 | A Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy | A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | Active 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 Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | 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 | Korea, Republic of;Japan;Germany;Bulgaria;Australia;Poland;Canada;Mexico;Hungary;Czech Republic;France;Italy;United Kingdom;Switzerland;Russian Federation;Austria;United States;Portugal | ||
| 28 | EUCTR2019-000328-16-IT (EUCTR) | 01/10/2019 | 15/06/2021 | A 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 | 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 - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | Active 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: AMG 570 Product Code: [AMG 570] Other descriptive name: AMG 570 Product Name: AMG 570 Product Code: [AMG 570] Other descriptive name: AMG 570 Product Name: AMG 570 Product Code: [AMG 570] Other descriptive name: AMG 570 | AMGEN INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Portugal;United States;Czechia;Greece;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 29 | EUCTR2019-000328-16-HU (EUCTR) | 23/09/2019 | 16/07/2019 | A Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy | A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | Active 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 Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | 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 | Korea, Republic of;Japan;Germany;Bulgaria;Australia;Poland;Canada;Mexico;Czech Republic;Hungary;France;Italy;United Kingdom;Switzerland;Russian Federation;Austria;United States;Portugal | ||
| 30 | EUCTR2019-000328-16-DE (EUCTR) | 17/09/2019 | 11/07/2019 | A Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy | A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | 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 Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | 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 | Portugal;United States;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 31 | 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 |
| 32 | EUCTR2018-000305-23-BG (EUCTR) | 20/03/2019 | 12/11/2018 | A Phase 1b/2 Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients | 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 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] - Skin and Connective Tissue Diseases [C17] | Product Name: BOS161721 Product Code: BOS161721 INN or Proposed INN: Not known Other descriptive name: IMMUNOGLOBULIN G | Boston Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2 | United States;Philippines;Hungary;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Georgia;Bulgaria;Colombia | ||
| 33 | EUCTR2018-000305-23-HU (EUCTR) | 07/02/2019 | 28/11/2018 | No | 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 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] - Skin and Connective Tissue Diseases [C17] | Product Name: BOS161721 Product Code: BOS161721 INN or Proposed INN: Not known Other descriptive name: IMMUNOGLOBULIN G | Boston Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2 | United States;Philippines;Hungary;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Georgia;Bulgaria;Colombia | ||
| 34 | EUCTR2017-002564-40-DE (EUCTR) | 10/04/2018 | 04/12/2017 | Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus | A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy. | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: AMG592 Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 1;Phase 2 | United States;France;Poland;Germany | ||
| 35 | EUCTR2017-004060-35-HU (EUCTR) | 12/03/2018 | 10/01/2018 | An open-label study to evaluate the safety and tolerability of 200-mcg Dose of IPP-201101 in Patients With SLE | An open-label study of the safety and tolerability of repeated administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With 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: Body processes [G] - Immune system processes [G12] | Product Name: IPP-201101 Product Code: IPP-201101 INN or Proposed INN: IPP-201101 | ImmuPharma | NULL | Not Recruiting | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Mauritius | ||
| 36 | NCT03427151 (ClinicalTrials.gov) | February 27, 2018 | 8/12/2017 | Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | An Open-label Study of the Safety and Tolerability of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: IPP-201101 | ImmuPharma | NULL | Completed | 18 Years | N/A | All | 62 | Phase 3 | United States;Czechia;France;Germany;Hungary;Mauritius;Puerto Rico;Poland |
| 37 | 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 |
| 38 | 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 | ||
| 39 | 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 | ||
| 40 | 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 | ||
| 41 | 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 | ||
| 42 | 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 | ||
| 43 | 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 | ||
| 44 | 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 |
| 45 | 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 |
| 46 | 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 | ||
| 47 | 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 | ||
| 48 | 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 | ||
| 49 | 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 | ||
| 50 | 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 |
| 51 | 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 |
| 52 | 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 |
| 53 | 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 |