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NCT05076175 · ClinicalTrials.gov registry record · Phase 2
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
A Phase 2 study of Colitis, Ulcerative, sponsored by Bristol-Myers Squibb.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT05076175 is a Phase 2 study of Colitis, Ulcerative that is actively recruiting participants, run by Bristol-Myers Squibb. The registered enrollment target is 120 participants, below the 401-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT05076175, a Phase 2 study of Colitis, Ulcerative, is actively recruiting participants, sponsored by Bristol-Myers Squibb.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.
Conditions Studied
Interventions
- DRUG Ozanimod
Study Locations (20)
California
- Local Institution - 0052 - Garden Grove
- Loma Linda University Health System - Loma Linda
- Cedars-Sinai Medical Center - Los Angeles
- Lucile Packard Children's Hospital - Palo Alto
- Local Institution - 0096 - Sacramento
Massachusetts
- Boston Children's Hospital - Boston
- Local Institution - 0042 - Springfield
- University of Massachusetts Chan Medical School - Worcester
Arizona
- Local Institution - 0041 - Phoenix
- University of Arizona - Tucson
Connecticut
- Local Institution - 0007 - Hartford
District of Columbia
- Local Institution - 0064 - Washington D.C.
Florida
- Local Institution - 0075 - Orlando
Georgia
- Local Institution - 0016 - Atlanta
Illinois
- Local Institution - 0101 - Park Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-05-30 |
| Est. Completion | 2031-08-14 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05076175
The ClinicalTrials.gov registry entry for NCT05076175 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 401-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (70% lower). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Colitis, Ulcerative appearing as the primary indexed condition, and to 1 intervention - of which Ozanimod is the first listed.
NCT05076175 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Massachusetts, Arizona.
Frequently Asked Questions
What is clinical trial NCT05076175 about?
NCT05076175 is a clinical study titled "A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis". The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to co...
What is the current status of trial NCT05076175?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2022-05-30. Estimated completion is 2031-08-14.
What conditions does trial NCT05076175 study?
This clinical trial studies the following conditions: Colitis, Ulcerative.
What interventions are being tested in trial NCT05076175?
The interventions under investigation include: Ozanimod (DRUG).
Who is sponsoring clinical trial NCT05076175?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05076175 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.