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.
Key facts
- Where
- Lodz, Szczecin, Warsaw és Wroclaw, LengyelországSee the 5 sites
- Phase
- 2/3. fázis
Where in Lengyelország
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W LodziLodz, LengyelországTaking people
- Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.Szczecin, LengyelországTaking people
- Instytut Pomnik Centrum Zdrowia DzieckaWarsaw, LengyelországTaking people
- Medical Network Sp z o oWarsaw, LengyelországTaking people
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we WroclawiuWroclaw, LengyelországTaking people
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?
Trial details
- Who runs it
- Bristol-Myers Squibb Services Unlimited Company
- Trial code
- EU 2023-509248-86-00
- Record updated
- 2026. július 22.
- Original description
To evaluate the efficacy of ozanimod in pediatric subjects with moderately to severely active UC (3-component Mayo Score: clinical remission, Week 52)Read full original descriptionShow less
To evaluate the efficacy of ozanimod in pediatric subjects with moderately to severely active UC (3-component Mayo Score: clinical remission, Week 52)
Inclusion: 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: 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.