Taking people in BelgiumPhase 2/3
Tests ozanimod in children with moderately to severely active ulcerative colitis
Tests the oral drug ozanimod in children up to 17 with ulcerative colitis.
Key facts
- Who runs it
- Bristol-Myers Squibb Services Unlimited Company
- Where
- Edegem, Jette, Leuven, and Liège, BelgiumSee the 4 sitesAlso in 4 other countries, 16 sites
- Trial code
- EU 2023-509248-86-00
- EudraCT 2021-002308-11
- U1111-1268-2191
- Registry title
- 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.
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 62 people, planned
- Started
- 11 Mar 2022
- Expected to end
- 30 Aug 2034
- Type of study
- Interventional
- Record updated
- 22 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with moderately to severely active ulcerative colitis. Their disease must have gone beyond the rectum, and earlier treatment must not have worked well enough.
- Age
- Up to 17 years old (children and teenagers).
- Sex
- All sexes can join.
- Disease stage
- Moderately to severely active ulcerative colitis, diagnosed before screening. The disease must reach beyond the rectum, as seen on endoscopy at baseline.
- Earlier treatment
- Must have had an inadequate response, lost response, or not tolerated at least 1 of these: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy.
Main reasons for not taking part
- Crohn's disease or indeterminate colitis
- Positive stool test for toxin-producing Clostridium difficile
- Apheresis within 2 weeks of randomization
- Current or past primary or secondary immunodeficiency
- Known genetic disorder as a cause of colitis
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- Diagnosis of Crohn's disease or indeterminate colitis
- History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for 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
Where in Belgium
Also in 4 other countries, 16 sites
- Universitair Ziekenhuis AntwerpenEdegem, BelgiumTaking people
- UZ BrusselJette, BelgiumTaking people
- UZ LeuvenLeuven, BelgiumTaking people
- Centre Hospitalier Regional de la CitadelleLiège, BelgiumTaking people
About the trial
What the trial wants to find out
To evaluate the efficacy of ozanimod in pediatric subjects with moderately to severely active UC (3-component Mayo Score: clinical remission, Week 52)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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.
- Plain-language title
- Tests ozanimod in children with moderately to severely active ulcerative colitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 22 July 2026