Trials / Completed
CompletedNCT04596293
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Bridge Biotherapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative colitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BBT-401-1S or Placebo | Administered by 200mg capsules of BBT-401-1S or placebo |
Timeline
- Start date
- 2021-06-11
- Primary completion
- 2022-05-17
- Completion
- 2022-07-12
- First posted
- 2020-10-22
- Last updated
- 2023-09-07
- Results posted
- 2023-09-07
Locations
30 sites across 4 countries: United States, Poland, South Korea, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04596293. Inclusion in this directory is not an endorsement.