A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
- Registration Number
- NCT05076175
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ozanimod High Dose Ozanimod - Ozanimod Low Dose Ozanimod -
- Primary Outcome Measures
Name Time Method Proportion of participants who achieve clinical remission At Week 52
- Secondary Outcome Measures
Name Time Method Percent change from baseline in ALC Up to 6 years Proportion of participants who achieve symptomatic remission At Week 10 and Week 52 Incidence of Serious Adverse Events Up to 6 years Incidence of AEs leading to discontinuation from treatment Up to 6 years Absolute change from baseline in Absolute Lymphocyte Count (ALC) Up to 6 years Proportion of participants who achieve clinical remission At Week 10 Incidence of AEs of special interest (AESIs) Up to 6 years Time to achievement of symptomatic remission Up to 6 years Proportion of participants who achieve corticosteroid free remission At Week 52 Steady state systemic exposure of ozanimod and CC112273 At Week 18 and throughout the study, up to 70 weeks Proportion of participants who achieve clinical response At Week 10 Proportion of participants who achieve endoscopic improvement At Week 10 and Week 52 Incidence of Adverse Events (AEs) Up to 6 years
Trial Locations
- Locations (82)
Local Institution - 0056
🇧🇪Brussels, Belgium
Local Institution - 0063
🇧🇪Edegem, Belgium
Local Institution - 0061
🇧🇪Liège, Belgium
Local Institution - 0071
🇧🇪Liège, Belgium
Local Institution - 0083
🇨🇦Hamilton, Ontario, Canada
Local Institution
🇷🇺Moskva, Russian Federation
University of Massachusetts Chan Medical School
🇺🇸Worcester, Massachusetts, United States
Local Institution - 0041
🇺🇸Phoenix, Arizona, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Local Institution - 0052
🇺🇸Garden Grove, California, United States
Loma Linda University Health System
🇺🇸Loma Linda, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Lucile Packard Children's Hospital
🇺🇸Palo Alto, California, United States
Local Institution - 0096
🇺🇸Sacramento, California, United States
Local Institution - 0007
🇺🇸Hartford, Connecticut, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Local Institution - 0075
🇺🇸Orlando, Florida, United States
Local Institution - 0016
🇺🇸Atlanta, Georgia, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Maine Medical Partners
🇺🇸Portland, Maine, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Local Institution - 0042
🇺🇸Springfield, Massachusetts, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Mayo Clinic in Rochester, Minnesota
🇺🇸Rochester, Minnesota, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0028
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Local Institution - 0023
🇺🇸New York, New York, United States
University of North Carolina Medical Center
🇺🇸Chapel Hill, North Carolina, United States
Local Institution - 0047
🇺🇸Charlotte, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Local Institution - 0062
🇺🇸Oklahoma City, Oklahoma, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
MultiCare Health System
🇺🇸Tacoma, Washington, United States
Children's Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Local Institution - 0094
🇦🇺Westmead, New South Wales, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
Local Institution - 0086
🇦🇺Murdoch, Western Australia, Australia
Local Institution - 0076
🇧🇪Brussels, Bruxelles-Capitale, Région De, Belgium
Local Institution - 0059
🇧🇪Leuven, Vlaams-Brabant, Belgium
Local Institution - 0082
🇨🇦Toronto, Ontario, Canada
CHU de Toulouse - Hôpital des Enfants
🇫🇷Toulouse, Haute-Garonne, France
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
🇫🇷Bron, France
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
🇫🇷Caen, France
Hôpital Universitaire Necker Enfants Malades
🇫🇷Paris, France
Local Institution - 0073
🇫🇷Paris, France
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
🇩🇪München, Bayern, Germany
Local Institution - 0097
🇩🇪Leipzig, Sachsen, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
Schneider Children's Medical Center
🇮🇱Petah-Tikva, HaMerkaz, Israel
Rambam Health Care Campus
🇮🇱Haifa, HaTsafon, Israel
Local Institution - 0019
🇮🇱Jerusalem, Yerushalayim, Israel
Local Institution - 0025
🇯🇵Obu, Aichi, Japan
Local Institution - 0011
🇯🇵Kurume-shi, Fukuoka, Japan
Local Institution - 0068
🇯🇵Komatsu, Ishikawa, Japan
Local Institution - 0038
🇯🇵Yokohama-shi, Kanagawa, Japan
Osaka Medical and Pharmaceutical University Hospital
🇯🇵Takatsuki, Osaka, Japan
Tokyo Medical and Dental University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
National Center for Child Health and Development
🇯🇵Setagaya-ku, Tokyo, Japan
Local Institution - 0033
🇯🇵Shinjuku-ku, Tokyo, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Local Institution - 0010
🇯🇵Tokyo, Japan
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
🇵🇱Wrocław, Dolnośląskie, Poland
Local Institution - 0043
🇵🇱Warsaw, Mazowieckie, Poland
Centrum Zdrowia Dziecka w Warszawie
🇵🇱Warsaw, Mazowieckie, Poland
Local Institution - 0084
🇵🇱Krakow, Małopolskie, Poland
Local Institution - 0015
🇵🇱Rzeszów, Podkarpackie, Poland
Local Institution - 0013
🇵🇱Gdansk, Pomorskie, Poland
Local Institution - 0079
🇵🇱Gdansk, Pomorskie, Poland
Twoja Przychodnia SCM
🇵🇱Szczecin, Zachodniopomorskie, Poland
Local Institution - 0092
🇵🇱Lodz, Łódzkie, Poland
Local Institution - 0048
🇪🇸Badalona, Barcelona [Barcelona], Spain
Local Institution - 0051
🇪🇸Esplugues de Llobregat, Barcelona [Barcelona], Spain
Local Institution - 0044
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Local Institution - 0050
🇪🇸Madrid, Spain
Local Institution - 0054
🇬🇧Birmingham, England, United Kingdom
King's College Hospital
🇬🇧London, Greater London, United Kingdom
Local Institution - 0066
🇬🇧London, London, City Of, United Kingdom