53. シェーグレン症候群 Sjogren syndrome Clinical trials / Disease details
臨床試験数 : 305 / 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188
| 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 | NCT04605978 (ClinicalTrials.gov) | August 3, 2021 | 19/10/2020 | Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients | A Phase IIa Efficacy and Safety Trial With Intravenous S95011 in Primary Sjögren's Syndrome Patients: An International, Multicentre, Randomised, Double-blind, Placebo-controlled Study | Primary Sjögren's Syndrome | Drug: S95011 concentrate for solution for infusion;Drug: Placebo concentrate for solution for infusion | Institut de Recherches Internationales Servier | ADIR, a Servier Group company | Active, not recruiting | 18 Years | 75 Years | All | 48 | Phase 2 | United States;Australia;France;Germany;Hungary;Spain;United Kingdom;Canada |
| 2 | EUCTR2020-001526-59-DE (EUCTR) | 21/01/2021 | 03/08/2020 | Efficacy and safety of S95011 in primary Sjögren’s Syndrome patients | A phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study | Primary Sjögren’s Syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: S95011 Product Code: S95011 INN or Proposed INN: S95011 Other descriptive name: OSE-127 | Institut de Recherches Internationales Servier | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | France;United States;Hungary;Canada;Spain;Australia;Germany;United Kingdom | ||
| 3 | EUCTR2020-001526-59-GB (EUCTR) | 20/10/2020 | 14/07/2020 | Efficacy and safety of S95011 in primary Sjögren’s Syndrome patients | A phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study | Primary Sjögren’s Syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: S95011 Product Code: S95011 INN or Proposed INN: S95011 Other descriptive name: OSE-127 | Institut de Recherches Internationales Servier | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | United States;France;Hungary;Canada;Spain;Australia;Germany;United Kingdom | ||
| 4 | EUCTR2020-001526-59-HU (EUCTR) | 06/10/2020 | 28/07/2020 | Efficacy and safety of S95011 in primary Sjögren’s Syndrome patients | A phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study | Primary Sjögren’s Syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: S95011 Product Code: S95011 INN or Proposed INN: S95011 Other descriptive name: OSE-127 | Institut de Recherches Internationales Servier | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | France;United States;Hungary;Canada;Spain;Australia;Germany;United Kingdom |