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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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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

    Not yet recruiting

  • First Posted

    October 13, 2021

  • Last update posted

    October 13, 2021

Study Description

Brief summary:

The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in causing 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
  • Estimated Study Start Date: October 2021
  • Estimated Primary Completion Date: October 2025
  • Estimated Study Completion Date: January 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 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 interest [ 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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com 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: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

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

Locations

United States, Georgia
Local Institution
Atlanta

France
Local Institution
Paris

Japan, Tokyo
Local Institution
Bunkyo-ku

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: October 13, 2021
  • Last Verified: September 2021
  • 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