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NCT05076175RecruitingPhase 2/3

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

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: ClinicalTrials.gov · Last updated 20 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
120 (estimated)
First submitted
4 Oct 2021
Start date
30 May 2022
Primary completion date
12 Jul 2032
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT05076175
EudraCT number
2023-509248-86

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 120
  • From 30 May 2022 to the primary completion date, 12 Jul 2032
  • 91 sites in 13 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov 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
  • Other protocol-defined inclusion/exclusion criteria apply

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: 2 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (91)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Monash Health
Coordinator of this site? Confirm its status
ClaytonAustraliaRecruiting
Local Institution - 0086
Coordinator of this site? Confirm its status
MurdochAustraliaWithdrawn
Local Institution - 0106
Coordinator of this site? Confirm its status
NedlandsAustraliaNot yet recruiting
The Children's Hospital at Westmead
Coordinator of this site? Confirm its status
WestmeadAustraliaRecruiting
Local Institution - 0056
Coordinator of this site? Confirm its status
BrusselsBelgiumCompleted
Local Institution - 0076
Coordinator of this site? Confirm its status
BrusselsBelgiumWithdrawn
Local Institution - 0063
Coordinator of this site? Confirm its status
EdegemBelgiumNot yet recruiting
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumRecruiting
Local Institution - 0071
Coordinator of this site? Confirm its status
LiègeBelgiumWithdrawn
Centre Hospitalier Regional de la Citadelle
Coordinator of this site? Confirm its status
LiègeBelgiumRecruiting
Local Institution - 0083
Coordinator of this site? Confirm its status
HamiltonCanadaWithdrawn
The Hospital for Sick Children
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Local Institution - 0104
Coordinator of this site? Confirm its status
TorontoCanadaWithdrawn
Local Institution - 0031
Coordinator of this site? Confirm its status
DresdenGermanyCompleted
Universitatsklinikum Leipzig
Coordinator of this site? Confirm its status
LeipzigGermanyRecruiting
Local Institution - 0032
Coordinator of this site? Confirm its status
MünchenGermanyCompleted
Local Institution - 0048
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BadalonaSpainCompleted
Local Institution - 0051
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Esplugues de LlobregatSpainCompleted
Local Institution - 0057
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MadridSpainCompleted
Local Institution - 0050
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MadridSpainWithdrawn
Local Institution - 0044
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MadridSpainCompleted
Local Institution - 0022
Coordinator of this site? Confirm its status
BronFranceCompleted
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
Coordinator of this site? Confirm its status
CaenFranceRecruiting
Local Institution - 0073
Coordinator of this site? Confirm its status
ParisFranceWithdrawn
Local Institution - 0017
Coordinator of this site? Confirm its status
ParisFranceCompleted
CHU de Toulouse - Hôpital des Enfants
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
Birmingham Children's Hospital
Coordinator of this site? Confirm its status
BirminghamUnited KingdomRecruiting
Barts Health NHS Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Local Institution - 0105
Coordinator of this site? Confirm its status
LondonUnited KingdomNot yet recruiting
King's College Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Rambam Health Care Campus
Coordinator of this site? Confirm its status
HaifaIsraelRecruiting
Shaare Zedek Medical Center
Coordinator of this site? Confirm its status
JerusalemIsraelRecruiting
Schneider Children's Medical Center
Coordinator of this site? Confirm its status
Petah TikvaIsraelRecruiting
Institute of Science Tokyo Hospital
Coordinator of this site? Confirm its status
Bunkyo-kuJapanRecruiting
Hiroshima University Hospital
Coordinator of this site? Confirm its status
HiroshimaJapanRecruiting
Komatsu Municipal Hospital
Coordinator of this site? Confirm its status
KomatsuJapanRecruiting
Kurume University Hospital
Coordinator of this site? Confirm its status
Kurume-shiJapanRecruiting
Aichi Children's Health and Medical Center
Coordinator of this site? Confirm its status
ŌbuJapanRecruiting
National Center for Child Health and Development
Coordinator of this site? Confirm its status
Setagaya-KuJapanRecruiting
Tokyo Medical University Hospital
Coordinator of this site? Confirm its status
Shinjuku-kuJapanRecruiting
Osaka Medical and Pharmaceutical University Hospital
Coordinator of this site? Confirm its status
TakatsukiJapanRecruiting
Juntendo University Hospital
Coordinator of this site? Confirm its status
TokyoJapanRecruiting
Saiseikai Yokohamashi Tobu Hospital
Coordinator of this site? Confirm its status
YokohamaJapanRecruiting
Local Institution - 0079
Coordinator of this site? Confirm its status
GdanskPolandWithdrawn
Local Institution - 0013
Coordinator of this site? Confirm its status
GdanskPolandWithdrawn
Local Institution - 0084
Coordinator of this site? Confirm its status
KrakowPolandWithdrawn
Local Institution - 0092
Coordinator of this site? Confirm its status
LodzPolandCompleted
Local Institution - 0015
Coordinator of this site? Confirm its status
RzeszówPolandWithdrawn
Twoja Przychodnia SCM
Coordinator of this site? Confirm its status
SzczecinPolandRecruiting
WIP Warsaw IBD Point Profesor Kierkus
Coordinator of this site? Confirm its status
WarsawPolandRecruiting
Centrum Zdrowia Dziecka w Warszawie
Coordinator of this site? Confirm its status
WarsawPolandRecruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
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WroclawPolandRecruiting
Clinical Research Puerto Rico
Coordinator of this site? Confirm its status
San JuanPuerto RicoRecruiting
Local Institution
Coordinator of this site? Confirm its status
MoscowRussiaWithdrawn
Local Institution
Coordinator of this site? Confirm its status
MoskvaRussiaWithdrawn
Local Institution - 0016
Coordinator of this site? Confirm its status
AtlantaUnited StatesCompleted
Boston Children's Hospital
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BostonUnited StatesRecruiting
University of North Carolina Medical Center
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Chapel HillUnited StatesWithdrawn
Local Institution - 0099
Coordinator of this site? Confirm its status
CharlestonUnited StatesNot yet recruiting
Local Institution - 0047
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CharlotteUnited StatesCompleted
Cleveland Clinic
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ClevelandUnited StatesRecruiting
Local Institution - 0093
Coordinator of this site? Confirm its status
DetroitUnited StatesCompleted
Local Institution - 0103
Coordinator of this site? Confirm its status
Fort WorthUnited StatesNot yet recruiting
Local Institution - 0052
Coordinator of this site? Confirm its status
Garden GroveUnited StatesCompleted
Local Institution - 0007
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HartfordUnited StatesCompleted
Local Institution - 0045
Coordinator of this site? Confirm its status
HersheyUnited StatesCompleted
Texas Children's Hospital
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HoustonUnited StatesRecruiting
Local Institution - 0100
Coordinator of this site? Confirm its status
IndianapolisUnited StatesNot yet recruiting
Local Institution - 0049
Coordinator of this site? Confirm its status
Iowa CityUnited StatesCompleted
Loma Linda University Health System
Coordinator of this site? Confirm its status
Loma LindaUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
Local Institution - 0037
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesCompleted
Columbia University Medical Center
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New YorkUnited StatesRecruiting
Local Institution - 0028
Coordinator of this site? Confirm its status
New YorkUnited StatesCompleted
Local Institution - 0023
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New YorkUnited StatesWithdrawn
Local Institution - 0062
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesWithdrawn
Local Institution - 0075
Coordinator of this site? Confirm its status
OrlandoUnited StatesCompleted
Lucile Packard Children's Hospital
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Palo AltoUnited StatesNot yet recruiting
Local Institution - 0101
Coordinator of this site? Confirm its status
Park RidgeUnited StatesNot yet recruiting
Local Institution - 0041
Coordinator of this site? Confirm its status
PhoenixUnited StatesWithdrawn
Maine Medical Partners
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PortlandUnited StatesNot yet recruiting
Mayo Clinic in Rochester, Minnesota
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RochesterUnited StatesRecruiting
University of California Davis Health
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SacramentoUnited StatesRecruiting
Local Institution - 0091
Coordinator of this site? Confirm its status
SeattleUnited StatesCompleted
Seattle Children's Hospital
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SeattleUnited StatesRecruiting
Local Institution - 0042
Coordinator of this site? Confirm its status
SpringfieldUnited StatesCompleted
Washington University
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St LouisUnited StatesRecruiting
MultiCare Health System
Coordinator of this site? Confirm its status
TacomaUnited StatesRecruiting
University of Arizona
Coordinator of this site? Confirm its status
TucsonUnited StatesWithdrawn
Local Institution - 0064
Coordinator of this site? Confirm its status
Washington D.C.United StatesCompleted
University of Massachusetts Chan Medical School
Coordinator of this site? Confirm its status
WorcesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.