A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants 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).

Some participants receive a placebo or sham for comparison.

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 16 to 80
• Any sex

Some of the main requirements, copied from the record:

• Confirmed diagnosis of CD
• Moderately to severely active CD
• Bodyweight >= 40 kilogram (kg)
• Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
• Males and females of childbearing potential must meet protocol criteria for contraception requirements

There are also 14 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 600 participants are expected to take part.
• The study has 3 groups.
• Start date: 2025-03-17.
• Main results expected around 2028-12-31 (estimate from the record).
• 375 study sites listed (357 marked recruiting) in Argentina, Australia, Austria, Belgium and Brazil and 33 more countries.

Groups in this study

• Arm 1: Afimkibart (listed as: experimental group)
• Arm 2: Afimkibart (listed as: experimental group)
• Arm 3: Placebo (listed as: placebo group)

Main thing being measured

• Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score (At Week 52)
• Percentage of Participants with Endoscopic Response (At Week 52)

In the researchers’ words

This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants 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.