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
Who is this study for? Patients with Ulcerative Colitis
What treatments are being studied? Ozanimod
Status: Recruiting
Location: See all (86) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Local Institution - 0041
WITHDRAWN
Phoenix
University of Arizona
WITHDRAWN
Tucson
California
Local Institution - 0052
COMPLETED
Garden Grove
Local Institution - 0087
NOT_YET_RECRUITING
Loma Linda
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Lucile Packard Children's Hospital
NOT_YET_RECRUITING
Palo Alto
Local Institution - 0096
NOT_YET_RECRUITING
Sacramento
Connecticut
Local Institution - 0007
COMPLETED
Hartford
Washington, D.c.
Children's National Medical Center
RECRUITING
Washington
Florida
Local Institution - 0075
COMPLETED
Orlando
Georgia
Local Institution - 0016
COMPLETED
Atlanta
Iowa
University of Iowa
RECRUITING
Iowa City
Indiana
Local Institution - 0100
NOT_YET_RECRUITING
Indianapolis
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Local Institution - 0042
COMPLETED
Springfield
University of Massachusetts Chan Medical School
RECRUITING
Worcester
Maine
Maine Medical Partners
NOT_YET_RECRUITING
Portland
Michigan
Children's Hospital of Michigan
RECRUITING
Detroit
Minnesota
Mayo Clinic in Rochester, Minnesota
RECRUITING
Rochester
Missouri
Washington University
RECRUITING
Saint Louis
North Carolina
University of North Carolina Medical Center
WITHDRAWN
Chapel Hill
Local Institution - 0047
COMPLETED
Charlotte
New York
Columbia University Medical Center
RECRUITING
New York
Local Institution - 0023
WITHDRAWN
New York
Local Institution - 0028
COMPLETED
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Oklahoma
Local Institution - 0062
WITHDRAWN
Oklahoma City
Pennsylvania
Penn State Milton S. Hershey Medical Center
RECRUITING
Hershey
South Carolina
Local Institution - 0099
NOT_YET_RECRUITING
Charleston
Texas
Texas Children's Hospital
RECRUITING
Houston
Washington
Local Institution - 0091
COMPLETED
Seattle
Seattle Children's Hospital
RECRUITING
Seattle
MultiCare Health System
RECRUITING
Tacoma
Wisconsin
Children's Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
Monash Health
RECRUITING
Clayton
Local Institution - 0086
WITHDRAWN
Murdoch
Local Institution - 0094
NOT_YET_RECRUITING
Westmead
Belgium
Local Institution - 0076
WITHDRAWN
Brussels
UZ Brussel
RECRUITING
Brussels
Local Institution - 0063
NOT_YET_RECRUITING
Edegem
UZ Leuven
RECRUITING
Leuven
Centre Hospitalier Régional de la Citadelle
RECRUITING
Liège
Local Institution - 0071
WITHDRAWN
Liège
Canada
Local Institution - 0083
WITHDRAWN
Hamilton
Local Institution - 0082
NOT_YET_RECRUITING
Toronto
France
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
RECRUITING
Bron
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
RECRUITING
Caen
Hôpital Universitaire Necker Enfants Malades
RECRUITING
Paris
Local Institution - 0073
WITHDRAWN
Paris
CHU de Toulouse - Hôpital des Enfants
RECRUITING
Toulouse
Germany
Universitaetsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Local Institution - 0097
NOT_YET_RECRUITING
Leipzig
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
RECRUITING
München
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Schneider Children's Medical Center
RECRUITING
Petah-tikva
Japan
Institute of Science Tokyo Hospital
RECRUITING
Bunkyo-ku
Hiroshima University Hospital
RECRUITING
Hiroshima
Komatsu Municipal Hospital
RECRUITING
Komatsu
Kurume University Hospital
RECRUITING
Kurume-shi
Aichi Children's Health and Medical Center
RECRUITING
Obu
National Center for Child Health and Development
RECRUITING
Setagaya-ku
Tokyo Medical University Hospital
RECRUITING
Shinjuku-ku
Osaka Medical and Pharmaceutical University Hospital
RECRUITING
Takatsuki
Juntendo University Hospital
RECRUITING
Tokyo
Saiseikai Yokohamashi Tobu Hospital
RECRUITING
Yokohama-shi
Poland
Local Institution - 0013
WITHDRAWN
Gdansk
Local Institution - 0079
WITHDRAWN
Gdansk
Local Institution - 0084
WITHDRAWN
Krakow
Local Institution - 0092
WITHDRAWN
Lodz
Local Institution - 0015
WITHDRAWN
Rzeszów
Twoja Przychodnia SCM
RECRUITING
Szczecin
Centrum Zdrowia Dziecka w Warszawie
RECRUITING
Warsaw
WIP Warsaw IBD Point Profesor Kierkuś
RECRUITING
Warsaw
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
RECRUITING
Wrocław
Puerto Rico
Local Institution - 0098
NOT_YET_RECRUITING
San Juan
Russian Federation
Local Institution
WITHDRAWN
Moscow
Local Institution
WITHDRAWN
Moskva
Spain
Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital Sant Joan de Déu
RECRUITING
Esplugues De Llobregat
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Infantil Universitario Niño Jesús
RECRUITING
Madrid
Local Institution - 0050
WITHDRAWN
Madrid
United Kingdom
Local Institution - 0054
NOT_YET_RECRUITING
Birmingham
Barts Health NHS Trust
RECRUITING
London
King's College Hospital
RECRUITING
London
Contact Information
Primary
BMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.
Time Frame
Start Date: 2022-05-30
Estimated Completion Date: 2031-08-14
Participants
Target number of participants: 120
Treatments
Experimental: Ozanimod High Dose
Experimental: Ozanimod Low Dose
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb