A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease

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 Crohns Disease.

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:

• Body weight >= 10 kilogram (kg)
• Active CD confirmed by endoscopy (ileocolonoscopy)
• Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score >= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) >=6 (or >=4 for isolated ileal disease) confirmed through centrally-read…
• Inadequate response, loss of response, and/or intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and/or immunosuppressants) or advanced therapies (including anti-tumor necrosis factor,…

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: 2026-08-18.
• Main results expected around 2030-05-31 (estimate from the record).
• 17 study sites listed (17 marked recruiting) in Australia, Brazil, Mexico, South Africa and Taiwan and 3 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 per Pediatric Crohn's Disease Activity Index (PCDAI) (At Week 52)
• Percentage of Participants With Endoscopic Response (At Week 52)

In the researchers’ words

This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).

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.