53. シェーグレン症候群 Sjogren syndrome Clinical trials / Disease details
臨床試験数 : 283 / 薬物数 : 320 - (DrugBank : 101) / 標的遺伝子数 : 56 - 標的パスウェイ数 : 181
| 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-jRCT2031210484 | 28/02/2022 | 14/12/2021 | A Study of Nipocalimab in Adults with Primary Sjogren'sSyndrome (pSS) | A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome(pSS) | Sjogren's Syndrome | Placebo Placebo infusion will be administered intravenously. Nipocalimab Nipocalimab dose 1 and dose 2 infusions will be administered intravenously. Standard of Care Treatment Standard of care treatment including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues, and/or one immunomodulator with or without low-dose glucocorticosteroids will be administered topically/orally. | Numaguchi Hirotaka | NULL | Pending | >= 18age old | <= 65age old | Both | 150 | Phase 2 | Germany;Spain;Italy;Netherlands;Poland;Portugal;United States Of America;France;Taiwan;Japan |
| 2 | EUCTR2021-000665-32-NL (EUCTR) | 16/02/2022 | 21/10/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Spain;Poland;Germany;Netherlands;Italy;Japan | ||
| 3 | EUCTR2021-000665-32-DE (EUCTR) | 12/11/2021 | 27/07/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Spain;Poland;Netherlands;Germany;Italy;Japan | ||
| 4 | EUCTR2021-000665-32-IT (EUCTR) | 10/11/2021 | 08/09/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) - NA | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: nipocalimab Product Code: [M281] INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Spain;Poland;Netherlands;Germany;Japan;Italy | ||
| 5 | EUCTR2021-000665-32-PT (EUCTR) | 09/11/2021 | 16/09/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | France;United States;Portugal;Taiwan;Spain;Poland;Netherlands;Germany;Italy;Japan | ||
| 6 | EUCTR2021-000665-32-ES (EUCTR) | 26/10/2021 | 27/08/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS). | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Poland;Spain;Netherlands;Germany;Italy;Japan | ||
| 7 | NCT04968912 (ClinicalTrials.gov) | September 21, 2021 | 9/7/2021 | A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS) | A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS) | Sjogren's Syndrome | Other: Placebo;Drug: Nipocalimab;Drug: Standard of Care Treatment | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 75 Years | All | 150 | Phase 2 | United States;France;Germany;Italy;Japan;Netherlands;Poland;Portugal;Spain;Taiwan |