A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis

In plain English

What this trial is testing

This study is testing Afimkibart (a drug) as a possible treatment. Condition(s) listed: Moderately to Severely Active Ulcerative Colitis.

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:

• Bodyweight >= 10 kilogram (kg)
• Confirmed diagnosis of UC
• Moderately to severely active UC, defined as modified Mayo Score (mMS) or 5 to 9 points, including endoscopic score of 2 or 3, confirmed by centrally read endoscopy (flexible sigmoidoscopy or colonoscopy)
• Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and/or biologic therapies as outlined in the protocol

There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 100 participants are expected to take part.
• The study has 2 groups.
• Start date: 2026-04-15.
• Main results expected around 2030-03-31 (estimate from the record).
• 26 study sites listed (26 marked recruiting) in Australia, Brazil, Canada, China and South Africa and 4 more countries.

Groups in this study

• Afimkibart Dose A (listed as: experimental group)
• Afimkibart Dose B (listed as: experimental group)

Main thing being measured

• Percentage of Participants With Clinical Remission at Week 52 (At Week 52)

In the researchers’ words

This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).

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.