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A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
NCT05076175 · Bristol-Myers Squibb
In plain English
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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
About this study
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.
Eligibility 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
Study design
Enrollment target: 120 participants
Allocation: randomized
Masking: quadruple
Age groups: child
Timeline
Starts: 2022-05-30
Estimated completion: 2031-08-14
Last updated: 2026-04-07
Interventions
Drug: Ozanimod
Primary outcomes
- • Proportion of participants who achieve clinical remission (At Week 52)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (90)
Local Institution - 0041Withdrawn
Phoenix, Arizona, United States
University of ArizonaWithdrawn
Tucson, Arizona, United States
Local Institution - 0052Completed
Garden Grove, California, United States
Loma Linda University Health SystemRecruiting
Loma Linda, California, United States
Cedars-Sinai Medical CenterRecruiting
Los Angeles, California, United States
Lucile Packard Children's HospitalNot Yet Recruiting
Palo Alto, California, United States
Local Institution - 0096Not Yet Recruiting
Sacramento, California, United States
Local Institution - 0007Completed
Hartford, Connecticut, United States
Local Institution - 0064Completed
Washington D.C., District of Columbia, United States
Local Institution - 0075Completed
Orlando, Florida, United States
Local Institution - 0016Completed
Atlanta, Georgia, United States
Local Institution - 0101Not Yet Recruiting
Park Ridge, Illinois, United States
Local Institution - 0100Not Yet Recruiting
Indianapolis, Indiana, United States
University of IowaRecruiting
Iowa City, Iowa, United States
Maine Medical PartnersNot Yet Recruiting
Portland, Maine, United States
Boston Children's HospitalRecruiting
Boston, Massachusetts, United States
Local Institution - 0042Completed
Springfield, Massachusetts, United States
University of Massachusetts Chan Medical SchoolRecruiting
Worcester, Massachusetts, United States
Children's Hospital of MichiganRecruiting
Detroit, Michigan, United States
Mayo Clinic in Rochester, MinnesotaRecruiting
Rochester, Minnesota, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
Local Institution - 0028Completed
New York, New York, United States
Columbia University Medical CenterRecruiting
New York, New York, United States
Local Institution - 0023Withdrawn
New York, New York, United States
University of North Carolina Medical CenterWithdrawn
Chapel Hill, North Carolina, United States
Local Institution - 0047Completed
Charlotte, North Carolina, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Local Institution - 0062Withdrawn
Oklahoma City, Oklahoma, United States
Penn State Milton S. Hershey Medical CenterRecruiting
Hershey, Pennsylvania, United States
Local Institution - 0099Not Yet Recruiting
Charleston, South Carolina, United States
Local Institution - 0103Not Yet Recruiting
Fort Worth, Texas, United States
Texas Children's HospitalRecruiting
Houston, Texas, United States
Seattle Children's HospitalRecruiting
Seattle, Washington, United States
Local Institution - 0091Completed
Seattle, Washington, United States
MultiCare Health SystemRecruiting
Tacoma, Washington, United States
Children's WisconsinRecruiting
Milwaukee, Wisconsin, United States
The Children's Hospital at WestmeadRecruiting
Westmead, New South Wales, Australia
Monash HealthRecruiting
Clayton, Victoria, Australia
Local Institution - 0086Withdrawn
Murdoch, Western Australia, Australia
Local Institution - 0076Withdrawn
Brussels, Bruxelles-Capitale, Région de, Belgium
UZ LeuvenRecruiting
Leuven, Vlaams-Brabant, Belgium
Local Institution - 0056Completed
Brussels, Belgium
Local Institution - 0063Not Yet Recruiting
Edegem, Belgium
Centre Hospitalier Régional de la CitadelleRecruiting
Liège, Belgium
Local Institution - 0071Withdrawn
Liège, Belgium
Local Institution - 0083Withdrawn
Hamilton, Ontario, Canada
Local Institution - 0104Not Yet Recruiting
Toronto, Ontario, Canada
Local Institution - 0082Not Yet Recruiting
Toronto, Ontario, Canada
CHU de Toulouse - Hôpital des EnfantsRecruiting
Toulouse, Haute-Garonne, France
Hospices Civils de Lyon - Hôpital Femme Mère EnfantRecruiting
Bron, France
Centre Hospitalier Universitaire de Caen - Hôpital Côte de NacreRecruiting
Caen, France
Hôpital Universitaire Necker Enfants MaladesRecruiting
Paris, France
Local Institution - 0073Withdrawn
Paris, France
Local Institution - 0032Completed
München, Bavaria, Germany
Universitätsklinikum LeipzigRecruiting
Leipzig, Saxony, Germany
Universitaetsklinikum Carl Gustav Carus DresdenRecruiting
Dresden, Germany
Schneider Children's Medical CenterRecruiting
Petah Tikva, Central District, Israel
Shaare Zedek Medical CenterRecruiting
Jerusalem, Jerusalem, Israel
Rambam Health Care CampusRecruiting
Haifa, Northern District, Israel
Aichi Children's Health and Medical CenterRecruiting
Ōbu, Aichi-ken, Japan
Kurume University HospitalRecruiting
Kurume-shi, Fukuoka, Japan
Komatsu Municipal HospitalRecruiting
Komatsu, Ishikawa-ken, Japan
Saiseikai Yokohamashi Tobu HospitalRecruiting
Yokohama, Kanagawa, Japan
Osaka Medical and Pharmaceutical University HospitalRecruiting
Takatsuki, Osaka, Japan
Institute of Science Tokyo HospitalRecruiting
Bunkyo-Ku, Tokyo, Japan
National Center for Child Health and DevelopmentRecruiting
Setagaya-ku, Tokyo, Japan
Tokyo Medical University HospitalRecruiting
Shinjuku-ku, Tokyo, Japan
Hiroshima University HospitalRecruiting
Hiroshima, Japan
Juntendo University HospitalRecruiting
Tokyo, Japan
Local Institution - 0084Withdrawn
Krakow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WrocławiuRecruiting
Wroclaw, Lower Silesian Voivodeship, Poland
WIP Warsaw IBD Point Profesor KierkuśRecruiting
Warsaw, Masovian Voivodeship, Poland
Centrum Zdrowia Dziecka w WarszawieRecruiting
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0015Withdrawn
Rzeszów, Podkarpackie Voivodeship, Poland
Local Institution - 0013Withdrawn
Gdansk, Pomeranian Voivodeship, Poland
Local Institution - 0079Withdrawn
Gdansk, Pomeranian Voivodeship, Poland
Twoja Przychodnia SCMRecruiting
Szczecin, West Pomeranian Voivodeship, Poland
Local Institution - 0092Withdrawn
Lodz, Łódź Voivodeship, Poland
Clinical Research Puerto RicoRecruiting
San Juan, Puerto Rico
Local InstitutionWithdrawn
Moscow, Russia
Local InstitutionWithdrawn
Moskva, Russia
Local Institution - 0048Completed
Badalona, Barcelona [Barcelona], Spain
Local Institution - 0051Completed
Esplugues de Llobregat, Barcelona [Barcelona], Spain
Local Institution - 0044Completed
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0057Completed
Madrid, Spain
Local Institution - 0050Withdrawn
Madrid, Spain
Birmingham Children's HospitalRecruiting
Birmingham, England, United Kingdom
King's College HospitalRecruiting
London, Greater London, United Kingdom
Local Institution - 0105Not Yet Recruiting
London, Greater London, United Kingdom
Barts Health NHS TrustRecruiting
London, London, City of, United Kingdom