Actively Recruiting

Phase 2
Phase 3
Age: 2Years - 17Years
All Genders
NCT05076175

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

Age: 2Years - 17Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

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Withdrawn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Withdrawn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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here