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 | 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 |
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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;South Africa;Spain;Taiwan;Ukraine;Hong Kong;Russian Federation |
| 5 | 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 |