Ose-127 (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 53 | シェーグレン症候群 | 3 |
| 97 | 潰瘍性大腸炎 | 3 |
| 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 | EUCTR2020-001526-59-DE (EUCTR) | 19/11/2020 | 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 | United States;France;Hungary;Canada;Spain;Australia;Germany;United Kingdom | ||
| 2 | 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 | ||
| 3 | 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 | United States;France;Hungary;Canada;Spain;Australia;Germany;United Kingdom |
| 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 | EUCTR2020-001398-59-HR (EUCTR) | 02/12/2020 | 07/12/2020 | Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s) | Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: AS INN Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127 | OSE Immunotherapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia | ||
| 2 | EUCTR2020-001398-59-BG (EUCTR) | 13/10/2020 | 18/09/2020 | Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s) | Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: OSE-127 Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127 | OSE Immunotherapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia | ||
| 3 | EUCTR2020-001398-59-LV (EUCTR) | 21/09/2020 | 28/07/2020 | Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s) | Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OSE-127 Product Code: OSE-127 Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127 | OSE Immunotherapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia |