49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
| 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 | NCT03312335 (ClinicalTrials.gov) | August 8, 2018 | 29/9/2017 | Low-dose Interleukin-2 for Treatment of Systemic Lupus Erythematosus | Open-label, Monocentric, Phase II, Investigator-initiated Clinical Trial on Unbiased Characterization of Immunological Parameters in Interleukin-2-treated Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Low-dose Aldesleukin (Proleukin®) | Onur Boyman, MD | NULL | Completed | 18 Years | N/A | All | 16 | Phase 2 | Switzerland |
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 |
| 6 | 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 | France;Portugal;Mexico;Spain;Austria;Bulgaria;Italy | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | EUCTR2013-001599-40-DE (EUCTR) | 03/01/2014 | 14/11/2013 | Evaluation of the therapeutic potential of a low-dose therapy with the interleukin-2 analogue Aldesleukin (Proleukin®) in the treatment of systemic lupus erythematosus. | Evaluation of the safety, tolerability, efficacy and immunological responses of the interleukin-2 analogue Aldesleukin (Proleukin®) in the treatment of systemic lupus erythematosus as prototypic autoimmune disease (PRO-IMMUN).A COMBINED PHASE I/IIA, PROSPECTIVE, OPEN-LABEL AND UNCONTROLLED SINGLE-CENTER STUDY TO ANALYSE SAFETY, TOLERABILITY, EFFICACY AND IMMUNOLOGICAL RESPONSES OF LOW-DOSE SUBCUTANEOUS INTERLEUKIN-2 (ALDESLEUKIN, PROLEUKIN®) IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS AND INCREASED DISEASE ACTIVITY REFRACTORY TO STANDARD THERAPIES. - PRO-IMMUN | Patients with systemic lupus erythematosus (SLE) and increased disease activity refractory to standard therapies. MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Proleukin Product Name: Proleukin INN or Proposed INN: Aldesleukin Other descriptive name: ALDESLEUKIN | Charité - Universitätsmedizin Berlin | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 1;Phase 2 | Germany |