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NCT03934216 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
NCT03934216: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT03934216 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 131 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03934216, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).
Primary Outcome
Clinical remission response rate is the percentage of participants achieving clinical remission, defined as absolute total Mayo Score and absolute Mayo endoscopy, stool frequency, rectal bleeding. Will be calculated using a modified Mayo score with the following: Stool Frequency (SF) sub score ≤ 1, with ≥ 1 point decrease from baseline, and Rectal Bleeding (RB) sub score = 0, and Endoscopic (ES) sub score ≤ 1 (modified, excludes friability) The modified Mayo score (0 to 9 points) is the sum o
Interventions
- OTHER Placebo
- DRUG BMS-986165
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2023-04-04 |
| Phase | Phase 2 |
What the finished NCT03934216 record still lists
NCT03934216 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03934216 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03934216 about?
NCT03934216 is a clinical study titled "Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis". The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).
What is the current status of trial NCT03934216?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2019-07-01. Estimated completion is 2023-04-04.
What interventions are being tested in trial NCT03934216?
The interventions under investigation include: Placebo (OTHER), BMS-986165 (DRUG).
Who is sponsoring clinical trial NCT03934216?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03934216's enrollment target sits among peer trials
131 541st of 2000 higher than 1,458 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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