An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

In plain English

What this trial is testing

This study is testing Duvakitug (a drug) as a possible treatment. Condition(s) listed: Crohn's 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:

• Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to <18 years of age who meet the definition of Tanner Stage 5 for development
• Confirmed diagnosis of moderately to severely active Crohn's Disease (CD) for at least 3 months prior to baseline
• Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)

There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 980 participants are expected to take part.
• Start date: 2025-10-01.
• Main results expected around 2029-05-14 (estimate from the record).
• 432 study sites listed (432 marked recruiting) in Argentina, Australia, Austria, Belgium and Brazil and 31 more countries.

Main thing being measured

• Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12 (Week 12)

In the researchers’ words

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week Screening Period. * 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study…

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.