2023-509248-86-00RecruitingPhase 2/3
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Jul 2026
Brief summary (registry, in English)
To evaluate the efficacy of ozanimod in pediatric subjects with moderately to severely active UC (3-component Mayo Score: clinical remission, Week 52)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 19 Feb 2024
- Start date
- 11 Mar 2022
- Lead sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Diseases
- Ulcerative colitis
- EU CT number
- 2023-509248-86-00
- EudraCT number
- 2021-002308-11
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 62
- 20 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool
- Apheresis within 2 weeks of randomization
Who the study is looking for
- 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
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Antwerpen | Edegem | Belgium | Recruiting |
| UZ Brussel | Jette | Belgium | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| Centre Hospitalier Regional de la Citadelle | Liège | Belgium | Recruiting |
| Technische Universität Dresden | Dresden | Germany | Recruiting |
| Universitaet Leipzig | Leipzig | Germany | Recruiting |
| Klinikum der Universitaet Muenchen AöR | Munich | Germany | Recruiting |
| Hospital Germans Trias i Pujol | Badalona | Spain | Completed |
| Sant Joan De Deu Barcelona Hospital | Esplugues De Llobregat | Spain | Completed |
| Hospital Infantil Universitario Nino Jesus | Madrid | Spain | Completed |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Completed |
| Hospital Femme Mere Enfant | Bron | France | Recruiting |
| Centre Hospitalier Universitaire De Caen Normandie | Caen Cedex 9 | France | Recruiting |
| Hopital Necker Enfants Malades | Paris | France | Recruiting |
| Hopital Des Enfants | Toulouse Cedex 9 | France | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi | Lodz | Poland | Recruiting |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. | Szczecin | Poland | Recruiting |
| Medical Network Sp z o o | Warsaw | Poland | Recruiting |
| Instytut Pomnik Centrum Zdrowia Dziecka | Warsaw | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.