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NCT04613518 · ClinicalTrials.gov registry record · Phase 2
A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT04613518: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT04613518 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04613518, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and tolerability, efficacy, and biomarker response of BMS-986165 administered orally in participants with moderate to severe ulcerative colitis. The study was originally designed to test deucravacitinib at two doses for 12 weeks compared to placebo. After the initial 12-Week period, all subjects receive active therapy (open-label extension). With protocol amendment 2, one of the dose treatment arms is being removed from the 12-week double blind period with no change to the open-label extension.
Primary Outcome
Clinical response is defined as achieving the following changes in the modified Mayo score (excludes the physicians' global assessment) * A decrease from baseline in the modified Mayo score of ≥ 2 points, and * A decrease from baseline in the modified Mayo score ≥ 30%, and * A decrease in rectal bleeding (RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1 Note: The modified Mayo score calculated to determine eligibility will also be used as the baseline disease activity score. The modified
Interventions
- DRUG BMS-986165
- OTHER Placebo Comparator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2023-11-29 |
| Phase | Phase 2 |
What the finished NCT04613518 record still lists
NCT04613518 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which BMS-986165 is the first listed.
NCT04613518 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04613518 about?
NCT04613518 is a clinical study titled "A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis". The purpose of this study is to assess the safety and tolerability, efficacy, and biomarker response of BMS-986165 administered orally in participants with moderate to severe ulcerative colitis. The study was originally designed to test deucravacitinib at two doses for 12 weeks compared to placebo. ...
What is the current status of trial NCT04613518?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2021-03-15. Estimated completion is 2023-11-29.
What interventions are being tested in trial NCT04613518?
The interventions under investigation include: BMS-986165 (DRUG), Placebo Comparator (OTHER).
Who is sponsoring clinical trial NCT04613518?
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 NCT04613518's enrollment target sits among peer trials
38 1467th of 2000 higher than 517 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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