A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
Launched by BRISTOL-MYERS SQUIBB · Oct 4, 2021
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called ozanimod (also known as RPC1063) to see how well it works in children and teenagers who have moderate to severe ulcerative colitis (UC). Ulcerative colitis is a condition that causes inflammation in the intestines, leading to symptoms like stomach pain and diarrhea. The goal of the study is to find out if ozanimod can help these young patients feel better and stay in remission, which means having fewer or no symptoms. To be eligible for this trial, children must have been diagnosed with ulcerative colitis and not responded well to other treatments like medications or biologic therapies.
Participants in the trial will take ozanimod by mouth and will be monitored for its effectiveness and safety. The study is currently recruiting patients aged 2 to 17 years who have specific criteria, such as having a diagnosis of ulcerative colitis that extends beyond the rectum. It's important to note that certain conditions, like having Crohn's disease or certain infections, may make someone ineligible for the trial. If your child is selected to participate, they will be involved in a structured program that includes regular check-ups to track their progress. This study aims to provide valuable information on how to better treat ulcerative colitis in young patients.
Gender
ALL
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
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Iowa City, Iowa, United States
London, , United Kingdom
Detroit, Michigan, United States
Los Angeles, California, United States
Houston, Texas, United States
Orlando, Florida, United States
Cleveland, Ohio, United States
Washington, District Of Columbia, United States
Saint Louis, Missouri, United States
Tucson, Arizona, United States
Seattle, Washington, United States
Badalona, , Spain
Seattle, Washington, United States
Hershey, Pennsylvania, United States
Boston, Massachusetts, United States
Tacoma, Washington, United States
Hartford, Connecticut, United States
Cleveland, Ohio, United States
Phoenix, Arizona, United States
Palo Alto, California, United States
Shinjuku Ku, Tokyo, Japan
Saint Louis, Missouri, United States
Los Angeles, California, United States
Madrid, , Spain
Gdansk, , Poland
Hiroshima, , Japan
Moscow, , Russian Federation
New York, New York, United States
Chapel Hill, North Carolina, United States
Portland, Maine, United States
Tokyo, , Japan
Boston, Massachusetts, United States
Brussels, , Belgium
London, , United Kingdom
Leuven, Vlaams Brabant, Belgium
Liège, , Belgium
Loma Linda, California, United States
Madrid, , Spain
Bunkyo Ku, Tokyo, Japan
Charlotte, North Carolina, United States
Clayton, Victoria, Australia
Tokyo, , Japan
Toulouse, Haute Garonne, France
Bron, , France
Atlanta, Georgia, United States
Shinjuku Ku, Tokyo, Japan
Obu, Aichi, Japan
Haifa, , Israel
Rochester, Minnesota, United States
Milwaukee, Wisconsin, United States
Esplugues De Llobregat, , Spain
Takatsuki, Osaka, Japan
Madrid, Madrid, Comunidad De, Spain
Esplugues De Llobregat, Barcelona [Barcelona], Spain
Komatsu, Ishikawa, Japan
Dresden, , Germany
Szczecin, Zachodniopomorskie, Poland
Badalona, Barcelona [Barcelona], Spain
Warsaw, Mazowieckie, Poland
Haifa, Hatsafon, Israel
Jerusalem, Yerushalayim, Israel
Bron, , France
Warszawa, , Poland
Worcester, Massachusetts, United States
München, Bayern, Germany
Jerusalem, , Israel
Paris, , France
Springfield, Massachusetts, United States
Philadelphia, Pennsylvania, United States
Wauwatosa, Wisconsin, United States
Leuven, Vlaams Brabant, Belgium
Caen, , France
Paris, , France
Petah Tikva, , Israel
Obu Shi, Aichi, Japan
Kurume Shi, Fukuoka, Japan
Komatsu, Ishikawa, Japan
Yokohama, Kanagawa, Japan
Takatsuki, Osaka, Japan
Setagaya Ku, Tokyo, Japan
Hiroshima, , Japan
Rzeszow, , Poland
Wroclaw, , Poland
Moskva, , Russian Federation
London, , United Kingdom
Dresden, Sachsen, Germany
Brussels, , Belgium
Liège, , Belgium
Liège, , Belgium
Oklahoma City, Oklahoma, United States
Paris, , France
Madrid, Madrid, Comunidad De, Spain
Oklahoma City, Oklahoma, United States
Garden Grove, California, United States
Toulouse, Haute Garonne, France
New York, New York, United States
Clayton, Victoria, Australia
Edegem, , Belgium
Dresden, Sachsen, Germany
Gdansk, Pomorskie, Poland
Esplugues De Llobregat, Barcelona [Barcelona], Spain
London, London, City Of, United Kingdom
Caen, , France
Garden Grove, California, United States
Krakow, Małopolskie, Poland
Madrid, , Spain
Petah Tikva, Hamerkaz, Israel
Warsaw, Mazowieckie, Poland
Murdoch, Western Australia, Australia
Szczecin, Zachodniopomorskie, Poland
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Madrid, , Spain
Phoenix, Arizona, United States
Hartford, Connecticut, United States
Atlanta, Georgia, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
New York, New York, United States
New York, New York, United States
Cleveland, Ohio, United States
Milwaukee, Wisconsin, United States
Brussels, Bruxelles Capitale, Région De, Belgium
Petah Tikva, Hamerkaz, Israel
Haifa, Hatsafon, Israel
Jerusalem, Yerushalayim, Israel
Obu, Aichi, Japan
Kurume Shi, Fukuoka, Japan
Yokohama Shi, Kanagawa, Japan
Takatsuki, Osaka, Japan
Bunkyō, Tokyo, Japan
Setagaya Ku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Tokyo, , Japan
Wrocław, Dolnośląskie, Poland
Warsaw, Mazowieckie, Poland
Warsaw, Mazowieckie, Poland
Rzeszów, Podkarpackie, Poland
Gdansk, Pomorskie, Poland
Badalona, Barcelona [Barcelona], Spain
Birmingham, England, United Kingdom
London, London, City Of, United Kingdom
Lodz, łódzkie, Poland
Oklahoma City, Oklahoma, United States
Detroit, Michigan, United States
Westmead, New South Wales, Australia
Szczecin, , Poland
Bunkyo Ku, Tokyo, Japan
Setagaya Ku, Tokyo, Japan
Sacramento, California, United States
Orlando, Florida, United States
Worcester, Massachusetts, United States
Wrocław, Dolnośląskie, Poland
Charlotte, North Carolina, United States
Bunkyo Ku, Tokyo, Japan
Leipzig, Sachsen, Germany
Loma Linda, California, United States
Indianapolis, Indiana, United States
Charleston, South Carolina, United States
Kurume Shi, Fukuoka, Japan
Yokohama Shi, Kanagawa, Japan
San Juan, , Puerto Rico
London, London, City Of, United Kingdom
Seattle, Washington, United States
Brussels, , Belgium
Wrocław, , Poland
Krakow, , Poland
Lodz, , Poland
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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