A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis (NCT05076175)
A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Local Institution - 0041 โ Phoenix, Arizona
Age range: 2 Years to 17 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (90 Sites)
Showing the first 25 of 90 sites.
- Local Institution - 0041 โ Phoenix, Arizona
- University of Arizona โ Tucson, Arizona
- Local Institution - 0052 โ Garden Grove, California
- Loma Linda University Health System โ Loma Linda, California
- Cedars-Sinai Medical Center โ Los Angeles, California
- Lucile Packard Children's Hospital โ Palo Alto, California
- University of California Davis Health โ Sacramento, California
- Local Institution - 0007 โ Hartford, Connecticut
- Local Institution - 0064 โ Washington D.C., District of Columbia
- Local Institution - 0075 โ Orlando, Florida
- Local Institution - 0016 โ Atlanta, Georgia
- Local Institution - 0101 โ Park Ridge, Illinois
- Local Institution - 0100 โ Indianapolis, Indiana
- Local Institution - 0049 โ Iowa City, Iowa
- Maine Medical Partners โ Portland, Maine
- Boston Children's Hospital โ Boston, Massachusetts
- Local Institution - 0042 โ Springfield, Massachusetts
- University of Massachusetts Chan Medical School โ Worcester, Massachusetts
- Local Institution - 0093 โ Detroit, Michigan
- Mayo Clinic in Rochester, Minnesota โ Rochester, Minnesota
- Washington University โ St Louis, Missouri
- Local Institution - 0028 โ New York, New York
- Columbia University Medical Center โ New York, New York
- Local Institution - 0023 โ New York, New York
- University of North Carolina Medical Center โ Chapel Hill, North Carolina
๐ Contact the Study Coordinator
Phone: (855) 907-3286
Email: Clinical.Trials@bms.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Colitis, Ulcerative
- A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis โ Oakland, California
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis โ Arcadia, California
- A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis โ Litchfield Park, Arizona
- Determination of the Optimal Treatment Target in Ulcerative Colitis โ Ypsilanti, Michigan
- A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis โ Kelowna, British Columbia
- A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis โ San Francisco, California
Explore by condition: All Colitis, Ulcerative clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.