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Looking for participantsPhase2/Phase3

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

Sponsor: Bristol-Myers Squibb

NCT ID: NCT05076175

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Ozanimod (drug)
How long the study runs
Study runs about 122 months (dates as stated)
About the drug or intervention
Ozanimod — drug: Specified dose on specified days
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
2 Years to 17 Years
Who
All
Number of participants
120
Started
2022-05-30
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for colitis, ulcerative
  • • Phase2/Phase3 - 120 participants
  • • The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission

Who can take part?

  • • Ages 2 Years to 17 Years
  • • Diagnosed with colitis, ulcerative

Where?

  • • Birmingham - Birmingham Children's Hospital
  • • London - King's College Hospital
  • • London - Local Institution - 0105
  • • London - Barts Health NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Colitis, Ulcerative

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 2 Years - 17 Years
  • Who can join: All genders

Biomarkers mentioned

documentation of positive

What the study is looking for

  • ✓Inclusion Criteria
  • ✓Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit
  • ✓Evidence of UC extending beyond the rectum, as determined by baseline endoscopy
  • ✓Exclusion Criteria
  • ✓Diagnosis of Crohn's disease or indeterminate colitis
See the full criteria
Inclusion Criteria * Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit * Evidence of UC extending beyond the rectum, as determined by baseline endoscopy * Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy Exclusion Criteria * Diagnosis of Crohn's disease or indeterminate colitis * Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool * Apheresis within 2 weeks of randomization * History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis * Other protocol-defined inclusion/exclusion criteria apply

Where Is This Study? (4 UK sites)

Birmingham Children's Hospital

Birmingham B4 6NH, United Kingdom

Recruiting
Site contact (verified)
Rafeeq Muhammed, Site 0054+44 121 333 9999

King's College Hospital

London SE5 9RS, United Kingdom

Recruiting
Site contact (verified)
Babu Vadamalayan, Site 0026+44 20 3299 9000

Local Institution - 0105

London SW10 9NH, United Kingdom

NOT_YET_RECRUITING

Barts Health NHS Trust

London E1 1BB, United Kingdom

Recruiting
Site contact (verified)
Protima Deb, Site 006602035941551

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-09