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

JRCT ID: jRCT2021220013

Registered date:18/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative Colitis (UC)
• Date of first enrollment: 01/07/2022
• Target sample size: 120
• Countries of recruitment: France,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Ozanimod High Dose
Ozanimod Low Dose

Outcome(s)

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

Secondary Outcome

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 ]

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

• Primary Sponsor: Liu W. Jerry
• Secondary ID(s): NCT05076175