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 | JPRN-jRCT2011210019 | 06/11/2021 | 30/06/2021 | Phase 2 double blind study of cenerimod | A randomized, double-blind, parallel-group, multicenter, phase 2 study to investigate the safety and PD of cenerimod in Japanese subjects with moderate to severe systemic lupus erythematosus (SLE) | Systemic lupus erythematosus | Administration of two doses of cenerimod (2 and 4 mg) given orally once daily for 3 months in adult subjects with moderate to severe SLE concurrently receiving SLE background treatment | Yokoyama Yoshinari | NULL | Recruiting | >= 18age old | <= 75age old | Both | 16 | Phase 2 | Japan |
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 |
| 11 | 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 | ||
| 12 | 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 |