Actively Recruiting
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
Led by Bristol-Myers Squibb · Updated on 2026-05-05
120
Participants Needed
90
Research Sites
480 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderately to severely active ulcerative colitis diagnosed before screening
- Ulcerative colitis extending beyond the rectum confirmed by baseline endoscopy
- Inadequate response, loss of response, or intolerance to at least one treatment: oral aminosalicylates, systemic corticosteroids, immunomodulators, or biologic therapy
You will not qualify if you...
- Diagnosis of Crohn's disease or indeterminate colitis
- Positive test for toxin producing Clostridium difficile or positive stool polymerase chain reaction
- Apheresis within 2 weeks before randomization
- History or current primary or secondary immunodeficiency
- Known genetic disorders causing colitis
- Other protocol-defined inclusion/exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 90 locations
1
Local Institution - 0041
Phoenix, Arizona, United States, 85016-7710
Withdrawn
2
University of Arizona
Tucson, Arizona, United States, 85724
Withdrawn
3
Local Institution - 0052
Garden Grove, California, United States, 92845
Completed
4
Loma Linda University Health System
Loma Linda, California, United States, 92354
Actively Recruiting
5
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
6
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
Not Yet Recruiting
7
University of California Davis Health
Sacramento, California, United States, 95817
Actively Recruiting
8
Local Institution - 0007
Hartford, Connecticut, United States, 06106
Completed
9
Local Institution - 0064
Washington D.C., District of Columbia, United States, 20010
Completed
10
Local Institution - 0075
Orlando, Florida, United States, 32803
Completed
11
Local Institution - 0016
Atlanta, Georgia, United States, 30342
Completed
12
Local Institution - 0101
Park Ridge, Illinois, United States, 60068
Not Yet Recruiting
13
Local Institution - 0100
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
14
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
15
Maine Medical Partners
Portland, Maine, United States, 04102
Not Yet Recruiting
16
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
17
Local Institution - 0042
Springfield, Massachusetts, United States, 01199
Completed
18
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01655
Actively Recruiting
19
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
20
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
21
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
22
Local Institution - 0028
New York, New York, United States, 10029
Completed
23
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
24
Local Institution - 0023
New York, New York, United States, 10065
Withdrawn
25
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States, 27599
Withdrawn
26
Local Institution - 0047
Charlotte, North Carolina, United States, 28203
Completed
27
Cleveland Clinic
Cleveland, Ohio, United States, 44124
Actively Recruiting
28
Local Institution - 0062
Oklahoma City, Oklahoma, United States, 73112
Withdrawn
29
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
30
Local Institution - 0099
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
31
Local Institution - 0103
Fort Worth, Texas, United States, 76104
Not Yet Recruiting
32
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
33
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
34
Local Institution - 0091
Seattle, Washington, United States, 98122
Completed
35
MultiCare Health System
Tacoma, Washington, United States, 98405
Actively Recruiting
36
Children's Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
37
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Actively Recruiting
38
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
39
Local Institution - 0086
Murdoch, Western Australia, Australia, 6150
Withdrawn
40
Local Institution - 0076
Brussels, Bruxelles-Capitale, Région de, Belgium, 1090
Withdrawn
41
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
42
Local Institution - 0056
Brussels, Belgium, 1090
Completed
43
Local Institution - 0063
Edegem, Belgium, 2650
Not Yet Recruiting
44
Centre Hospitalier Régional de la Citadelle
Liège, Belgium, 4000
Actively Recruiting
45
Local Institution - 0071
Liège, Belgium, 4000
Withdrawn
46
Local Institution - 0083
Hamilton, Ontario, Canada, L8N 3Z5
Withdrawn
47
Local Institution - 0104
Toronto, Ontario, Canada, M3M 0B2
Not Yet Recruiting
48
Local Institution - 0082
Toronto, Ontario, Canada, M5G 1X8
Not Yet Recruiting
49
CHU de Toulouse - Hôpital des Enfants
Toulouse, Haute-Garonne, France, 31059
Actively Recruiting
50
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, France, 69500
Actively Recruiting
51
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
Caen, France, 14033
Actively Recruiting
52
Hôpital Universitaire Necker Enfants Malades
Paris, France, 75015
Actively Recruiting
53
Local Institution - 0073
Paris, France, 75571
Withdrawn
54
Local Institution - 0032
München, Bavaria, Germany, 80337
Completed
55
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
56
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Actively Recruiting
57
Schneider Children's Medical Center
Petah Tikva, Central District, Israel, 49202
Actively Recruiting
58
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel, 9013102
Actively Recruiting
59
Rambam Health Care Campus
Haifa, Northern District, Israel, 3109601
Actively Recruiting
60
Aichi Children's Health and Medical Center
Ōbu, Aichi-ken, Japan, 474-8710
Actively Recruiting
61
Kurume University Hospital
Kurume-shi, Fukuoka, Japan, 8300011
Actively Recruiting
62
Komatsu Municipal Hospital
Komatsu, Ishikawa-ken, Japan, 923-8560
Actively Recruiting
63
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa, Japan, 2300012
Actively Recruiting
64
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, Japan, 569-8686
Actively Recruiting
65
Institute of Science Tokyo Hospital
Bunkyo-Ku, Tokyo, Japan, 113-8519
Actively Recruiting
66
National Center for Child Health and Development
Setagaya-ku, Tokyo, Japan, 1578535
Actively Recruiting
67
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 160-0023
Actively Recruiting
68
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
Actively Recruiting
69
Juntendo University Hospital
Tokyo, Japan, 113-8431
Actively Recruiting
70
Local Institution - 0084
Krakow, Lesser Poland Voivodeship, Poland, 30-663
Withdrawn
71
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Lower Silesian Voivodeship, Poland, 50-369
Actively Recruiting
72
WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Masovian Voivodeship, Poland, 00-728
Actively Recruiting
73
Centrum Zdrowia Dziecka w Warszawie
Warsaw, Masovian Voivodeship, Poland, 04-746
Actively Recruiting
74
Local Institution - 0015
Rzeszów, Podkarpackie Voivodeship, Poland, 35-302
Withdrawn
75
Local Institution - 0013
Gdansk, Pomeranian Voivodeship, Poland, 80-803
Withdrawn
76
Local Institution - 0079
Gdansk, Pomeranian Voivodeship, Poland, 80-803
Withdrawn
77
Twoja Przychodnia SCM
Szczecin, West Pomeranian Voivodeship, Poland, 71-434
Actively Recruiting
78
Local Institution - 0092
Lodz, Łódź Voivodeship, Poland, 91-738
Completed
79
Clinical Research Puerto Rico
San Juan, Puerto Rico, 00909-1711
Actively Recruiting
80
Local Institution
Moscow, Russia, 119991
Withdrawn
81
Local Institution
Moskva, Russia, 119571
Withdrawn
82
Local Institution - 0048
Badalona, Barcelona [Barcelona], Spain, 08916
Completed
83
Local Institution - 0051
Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
Completed
84
Local Institution - 0044
Madrid, Madrid, Comunidad de, Spain, 28009
Completed
85
Local Institution - 0057
Madrid, Spain, 28007
Completed
86
Local Institution - 0050
Madrid, Spain, 28046
Withdrawn
87
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Actively Recruiting
88
King's College Hospital
London, Greater London, United Kingdom, SE5 9RS
Actively Recruiting
89
Local Institution - 0105
London, Greater London, United Kingdom, SW10 9NH
Not Yet Recruiting
90
Barts Health NHS Trust
London, London, City of, United Kingdom, E1 1BB
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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