Trials / Completed
CompletedNCT03861143
Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 198 (actual)
- Sponsor
- NImmune Biopharma · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BT-11 (440 mg) | Oral, once daily tablet |
| DRUG | BT-11 (880 mg) | Oral, once daily tablet |
| DRUG | Placebo | Oral, once daily tablet |
Timeline
- Start date
- 2019-08-14
- Primary completion
- 2020-12-10
- Completion
- 2021-06-17
- First posted
- 2019-03-04
- Last updated
- 2023-06-29
- Results posted
- 2022-11-03
Locations
16 sites across 5 countries: United States, Bosnia and Herzegovina, Croatia, Poland, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03861143. Inclusion in this directory is not an endorsement.