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

In plain English

What this trial is testing

This study is testing Ozanimod (a drug) as a possible treatment. Condition(s) listed: Colitis, Ulcerative.

Participants are assigned to groups by chance (randomized).

It is blinded: participants and the study team do not know who receives what.

Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.

Who can join

• Ages 2 to 17
• Any sex

Some of the main requirements, copied from the record:

• 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

There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 120 participants are expected to take part.
• The study has 2 groups.
• Start date: 2022-05-30.
• Main results expected around 2032-07-12 (estimate from the record).
• 91 study sites listed (40 marked recruiting) in Australia, Belgium, Canada, France and Germany and 8 more countries.

Groups in this study

• Ozanimod High Dose (listed as: experimental group)
• Ozanimod Low Dose (listed as: experimental group)

Main thing being measured

• Proportion of participants who achieve clinical remission (At Week 52)

In the researchers’ words

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.

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.