97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| 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 | EUCTR2022-002593-89-CZ (EUCTR) | 23/01/2023 | 28/12/2022 | A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease | A 24-Week, Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy Safety, and Tolerability ofTEV-48574 in Adult Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease who completed the treatment phase of the Dose-Ranging Study - RELIEVE UCCD LTE | Moderate to severe Ulcerative colitis or moderate to severe Crohn'sdisease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TEV-48574 Product Code: TEV-48574 INN or Proposed INN: TEV-48574 Other descriptive name: Fully human IgG1 monoclonal antibody specific for TL1A | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 128 | Phase 2 | United States;Czechia;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Norway;Germany | ||
| 2 | NCT05668013 (ClinicalTrials.gov) | January 11, 2023 | 12/12/2022 | A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease | A 24-Week Phase 2b Long-Term Extension, RandomizEd, Double-BLind, Study to Determine the Long-Term PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Completed the Main Phase of the Dose-Ranging Study (RELIEVE UCCD LTE) | Crohn Disease;Colitis, Ulcerative | Drug: TEV-48574 Dose Regimen A;Drug: TEV-48574 Dose Regiment B | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 128 | Phase 2 | United States |
| 3 | EUCTR2021-006881-19-CZ (EUCTR) | 06/01/2023 | 06/01/2023 | A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn’s Disease | A 14-Week Phase 2b, RandomizEd, Double-BLind, Dose-Ranging Study to Determine the PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (RELIEVE UCCD) - RELIEVE UCCD | Moderate to severe Ulcerative colitis or moderate to severe Crohn's disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TEV-48574 Product Code: TEV-48574 INN or Proposed INN: TEV-48574 Other descriptive name: Fully human IgG1 monoclonal antibody specific for TL1A | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | United States;Czechia;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Bulgaria;Norway;Germany;Japan | ||
| 4 | NCT05499130 (ClinicalTrials.gov) | August 29, 2022 | 11/8/2022 | A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease | A 14 Week Phase 2b, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Efficacy, Safety and Tolerability of TEV-48574 in Adult Patients With Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD) | Crohn Disease;Colitis, Ulcerative | Drug: TEV-48574;Drug: Placebo | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 280 | Phase 2 | United States |