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 | NCT04596293 (ClinicalTrials.gov) | June 11, 2021 | 15/10/2020 | Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis | A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects With Moderate to Severe Ulcerative Colitis, Incorporating a Response-adaptive, Double-blind Extension Phase | Ulcerative Colitis | Drug: BBT-401-1S;Drug: Placebo | Bridge Biotherapeutics, Inc. | Covance | Completed | 18 Years | 60 Years | All | 38 | Phase 2 | United States;Korea, Republic of;New Zealand;Poland;Ukraine |
| 2 | NCT04478825 (ClinicalTrials.gov) | June 1, 2021 | 16/7/2020 | Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis | An Open Label, Proof of Mechanism Study to Explore the Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis | Ulcerative Colitis | Drug: BBT-401-1S | Bridge Biotherapeutics, Inc. | Covance | Terminated | 18 Years | 60 Years | All | 2 | Phase 1 | New Zealand |
| 3 | EUCTR2020-003556-33-PL (EUCTR) | 19/04/2021 | 17/02/2021 | A Placebo-controlled Study of BBT-401-1S in Subjects with Moderate to Severe Ulcerative Colitis | A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects with Moderate to Severe Ulcerative Colitis, Incorporating a Response-Adaptive, Double-blind Extension Phase | Moderate to severe ulcerative colitis. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BBT-401-1S Product Code: BBT-401-1S INN or Proposed INN: None Other descriptive name: Sodium (S)-3-(4-hydroxyphenyl)-2-(2-((S)-1-((S)-1-palmitoylpyrrolidine-2-carbonyl)pyrrolidine-2-carboxamido)acetamido)propanoate | Bridge Biotherapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Poland;Ukraine;New Zealand;Korea, Republic of | ||
| 4 | NCT03800420 (ClinicalTrials.gov) | April 22, 2019 | 7/1/2019 | Efficacy and Safety of BBT-401-1S in Ulcerative Colitis | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of BBT-401-1S in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: BBT-401-1S;Drug: Placebo | Bridge Biotherapeutics, Inc. | KCRN Research, LLC | Terminated | 18 Years | N/A | All | 16 | Phase 2 | United States |
| 5 | NCT03482648 (ClinicalTrials.gov) | March 20, 2018 | 17/3/2018 | First-In-Human Study of BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Volunteers | A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Novel Oral Peptide BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Adult Subjects | Ulcerative Colitis | Drug: BBT-401-1S, Single dose;Drug: BBT-401-1S, Multiple doses;Drug: Placebo | Bridge Biotherapeutics, Inc. | KCRN Research, LLC | Completed | 19 Years | 55 Years | All | 80 | Phase 1 | United States |