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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-jRCT2021220013
• Date of registration: 18/06/2022
• Prospective Registration: Yes
• Primary sponsor: Liu W. Jerry
• 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: 01/07/2022
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://jrct.niph.go.jp/latest-detail/jRCT2021220013
• Study type: Interventional
• Study design: randomized controlled trial, double blind, dose comparison control, parallel assignment, treatment purpose
• Phase: 2-3

Countries of recruitment

France, Japan, United States

Contacts

• Name: W. Jerry Liu
• Affiliation: Bristol-Myers Squibb

• Name: W. Jerry Liu
• 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

Age minimum: >= 2age old
Age maximum: <= 17age old
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis (UC)

Intervention(s)

Ozanimod High Dose
Ozanimod Low Dose

Primary Outcome(s)

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

Secondary Outcome(s)

Proportion of participants who achieve clinical remission [ Time Frame: At Week 10 ]
Proportion of participants who achieve clinical response [ Time Frame: At Week 52 ]
Proportion of participants who achieve clinical response [ Time Frame: At Week 10 ]
Proportion of participants who achieve symptomatic remission [ Time Frame: At Week 10 and Week 52 ]
Time to achievement of symptomatic remission [ Time Frame: Up to 6 years ]
Proportion of participants who achieve endoscopic improvement [ Time Frame: At Week 10 and Week 52 ]
Proportion of participants who achieve corticosteroid free remission [ Time Frame: At Week 52 ]
Incidence of Adverse Events (AEs) [ Time Frame: Up to 6 years ]
Incidence of Serious Adverse Events [ Time Frame: Up to 6 years ]
Incidence of AEs leading to discontinuation from treatment [ Time Frame: Up to 6 years ]
Incidence of AEs of interest [ Time Frame: Up to 6 years ]
Steady state systemic exposure of ozanimod and CC112273 [ Time Frame: At Week 18 and throughout the study, up to 70 weeks ]
Absolute change from baseline in Absolute Lymphocyte Count (ALC) [ Time Frame: Up to 6 years ]
Percent change from baseline in ALC [ Time Frame: Up to 6 years ]

Secondary ID(s)

NCT05076175