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A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

  • Clinicaltrials.gov identifier

    NCT05076175

  • Recruitment Status

    Recruiting

  • First Posted

    October 13, 2021

  • Last update posted

    September 15, 2022

Study Description

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.

  • Condition or Disease:Colitis, Ulcerative
  • Intervention/Treatment: Drug: Ozanimod
  • Phase: Phase 2/Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 120 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
  • Actual Study Start Date: May 2022
  • Estimated Primary Completion Date: May 2026
  • Estimated Study Completion Date: August 2031

Arms and interventions

Arm Intervention/treatment
Experimental: Ozanimod High Dose
Drug: Ozanimod
Specified dose on specified days
Experimental: Ozanimod Low Dose
Drug: Ozanimod
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Proportion of participants who achieve clinical remission [ Time Frame: At Week 52 ]
  • Secondary Outcome Measures: 1. Proportion of participants who achieve clinical remission [ Time Frame: At Week 10 ]
  • 2. Proportion of participants who achieve clinical response [ Time Frame: At Week 52 ]
  • 3. Proportion of participants who achieve clinical response [ Time Frame: At Week 10 ]
  • 4. Proportion of participants who achieve symptomatic remission [ Time Frame: At Week 10 and Week 52 ]
  • 5. Time to achievement of symptomatic remission [ Time Frame: Up to 6 years ]
  • 6. Proportion of participants who achieve endoscopic improvement [ Time Frame: At Week 10 and Week 52 ]
  • 7. Proportion of participants who achieve corticosteroid free remission [ Time Frame: At Week 52 ]
  • 8. Incidence of Adverse Events (AEs) [ Time Frame: Up to 6 years ]
  • 9. Incidence of Serious Adverse Events [ Time Frame: Up to 6 years ]
  • 10. Incidence of AEs leading to discontinuation from treatment [ Time Frame: Up to 6 years ]
  • 11. Incidence of AEs of special interest (AESIs) [ Time Frame: Up to 6 years ]
  • 12. Steady state systemic exposure of ozanimod and CC112273 [ Time Frame: At Week 18 and throughout the study, up to 70 weeks ]
  • 13. Absolute change from baseline in Absolute Lymphocyte Count (ALC) [ Time Frame: Up to 6 years ]
  • 14. Percent change from baseline in ALC [ Time Frame: Up to 6 years ]

Eligibility Criteria

  • Ages Eligible for Study: 2 to 17 Years (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

Locations

United States, Arizona
Local Institution
Phoenix

United States, California
Local Institution
Los Angeles

United States, Connecticut
Local Institution
Hartford

United States, Georgia
Local Institution
Atlanta

United States, Massachusetts
Local Institution
Boston

United States, Massachusetts
Local Institution
Springfield

United States, Minnesota
Mayo Clinic in Rochester, Minnesota
Rochester

United States, Missouri
Washington University
Saint Louis

United States, New York
Local Institution
New York

United States, New York
Local Institution
New York

United States, New York
Local Institution
New York

United States, Ohio
Local Institution
Cleveland

United States, Pennsylvania
Local Institution
Philadelphia

United States, Texas
Texas Children's Hospital
Houston

United States, Wisconsin
Local Institution
Wauwatosa

Belgium, Vlaams-Brabant
Local Institution - 0059
Leuven

Belgium
Local Institution - 0056
Brussels

Belgium
Local Institution - 0061
Liège

Belgium
Local Institution - 0071
Liège

France
Local Institution
Bron

France
Local Institution - 0030
Caen

France
Local Institution - 0017
Paris

France
Local Institution - 0073
Paris

Israel
Local Institution
Haifa

Israel
Local Institution
Jerusalem

Israel
Local Institution
Petah Tikva

Japan, Aichi
Local Institution
Obu-shi

Japan, Fukuoka
Local Institution
Kurume-shi

Japan, Ishikawa
Local Institution - 0068
Komatsu

Japan, Kanagawa
Local Institution
Yokohama

Japan, Osaka
Local Institution
Takatsuki

Japan, Tokyo
Local Institution
Bunkyo-ku

Japan, Tokyo
Local Institution
Setagaya-ku

Japan, Tokyo
Local Institution
Shinjuku-ku

Japan
Local Institution - 0069
Hiroshima

Japan
Local Institution
Tokyo

Poland
Local Institution
Gdansk

Poland
Local Institution
Rzeszow

Poland
Local Institution
Warszawa

Poland
Local Institution
Wroclaw

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Moskva

Spain, Madrid, Comunidad De
Local Institution - 0044
Madrid

United Kingdom
Local Institution - 0066
London

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT05076175 History of Changes
  • Other Study ID Numbers: IM047-001, 2021-002308-11
  • First Posted: October 13, 2021 Key Record Dates
  • Last Update Posted: September 15, 2022
  • Last Verified: September 2022
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)
  • Time Frame: See Plan Description
  • Access Criteria: See Plan Description
  • URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Ulcerative Colitis
    Ozanimod
    Pediatric
  • Additional relevant MeSH terms: Colitis
    Colitis, Ulcerative
    Ulcer
    Gastroenteritis
    Gastrointestinal Diseases
    Digestive System Diseases
    Colonic Diseases
    Intestinal Diseases
    Pathologic Processes
    Inflammatory Bowel Diseases