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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 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 38 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04613518
The ClinicalTrials.gov registry entry for NCT04613518 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which BMS-986165 is the first listed.
NCT04613518 reports 0 study locations.
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.
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