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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 February 2025
• Main ID: NCT05076175
• Date of registration: 04/10/2021
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
• Scientific 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
• Date of first enrolment: May 30, 2022
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05076175
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Australia, Belgium, Canada, France, Germany, Israel, Japan, Poland, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: BMS Study Connect Contact Center www.BMSStudyConnect.com

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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


Age minimum: 2 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: Ozanimod

Primary Outcome(s)

Proportion of participants who achieve clinical remission [Time Frame: At Week 52]

Secondary Outcome(s)

Proportion of participants who achieve endoscopic improvement [Time Frame: At Week 10 and Week 52]

Proportion of participants who achieve symptomatic remission [Time Frame: At Week 10 and Week 52]

Absolute change from baseline in Absolute Lymphocyte Count (ALC) [Time Frame: Up to 6 years]

Proportion of participants who achieve clinical remission [Time Frame: At Week 10]

Proportion of participants who achieve clinical response [Time Frame: At Week 52]

Steady state systemic exposure of ozanimod and CC112273 [Time Frame: At Week 18 and throughout the study, up to 70 weeks]

Incidence of Adverse Events (AEs) [Time Frame: Up to 6 years]

Incidence of AEs leading to discontinuation from treatment [Time Frame: Up to 6 years]

Percent change from baseline in ALC [Time Frame: Up to 6 years]

Time to achievement of symptomatic remission [Time Frame: Up to 6 years]

Incidence of Serious Adverse Events [Time Frame: Up to 6 years]

Proportion of participants who achieve corticosteroid free remission [Time Frame: At Week 52]

Incidence of AEs of special interest (AESIs) [Time Frame: Up to 6 years]

Proportion of participants who achieve clinical response [Time Frame: At Week 10]

Secondary ID(s)

IM047-001

2021-002308-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors