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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05076175
Recruitment Status : Recruiting
First Posted : October 13, 2021
Last Update Posted : August 15, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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 Intervention/treatment Phase
Colitis, Ulcerative Drug: Ozanimod Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 30, 2022
Estimated Primary Completion Date : May 22, 2026
Estimated Study Completion Date : August 14, 2031

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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Ages Eligible for Study:   2 Years 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05076175


Contacts
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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
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05076175    
Other Study ID Numbers: IM047-001
2021-002308-11 ( EudraCT Number )
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: August 15, 2022
Last Verified: August 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

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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:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
 Pathologic Processes
Inflammatory Bowel Diseases
Ozanimod
Sphingosine 1 Phosphate Receptor Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs