A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

In plain English

What this trial is testing

This study is testing Icotrokinra (a drug) as a possible treatment. Condition(s) listed: Crohn 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 18 and older
• Any sex

Some of the main requirements, copied from the record:

• Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
• Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score >=220 but <=450 and either mean daily SF count >=4, or mean daily AP score >=2
• Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD >=…
• A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to…
• Demonstrated an inadequate response to, or failure to tolerate conventional therapy but naïve to advanced therapies (advanced drug therapy \[ADT\]-naïve) or inadequate response to (that is, primary or secondary nonresponse) or failure to…

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 1092 participants are expected to take part.
• The study has 8 groups.
• Start date: 2025-10-03.
• Main results expected around 2028-09-19 (estimate from the record).
• 372 study sites listed (362 marked recruiting) in Argentina, Australia, Belgium, Brazil and Canada and 23 more countries.

Groups in this study

• Induction Study 1: Icotrokinra Dose 1 (listed as: experimental group)
• Induction Study 1: Icotrokinra Dose 2 (listed as: experimental group)
• Induction Study 1: Placebo (listed as: placebo group)
• Induction Study 2: Icotrokinra (listed as: experimental group)
• Induction Study 2: Placebo (listed as: placebo group)
• Maintenance Study: Icotrokinra Dose 1 (listed as: experimental group)

Main thing being measured

• Induction Study 1: Number of Participants with Clinical Response at Week 12 (At Week 12)
• Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint) (At Week 12)
• Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint) (At Week 12)

In the researchers’ words

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

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.