A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis

In plain English

What this trial is testing

This study is testing Icotrokinra (a drug) as a possible treatment. Condition(s) listed: Colitis, Ulcerative.

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 12 and older
• Any sex

Some of the main requirements, copied from the record:

• Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC
• Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy
• An endoscopy subscore greater than or equal to (>=) 2 as obtained during central review of the screening video endoscopy
• Adolescent Participants: body weight must be >= 40 kilograms (kg) at baseline (Week I-0)
• Adult female participants of childbearing potential and all adolescent female participants must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[β-hCG\]) at screening and a negative urine pregnancy…
• Demonstrated an inadequate response to, or failure to tolerate conventional therapy but are naïve to advanced therapies (ADT naïve), or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced…

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 882 participants are expected to take part.
• The study has 6 groups.
• Start date: 2025-10-01.
• Main results expected around 2028-01-14 (estimate from the record).
• 402 study sites listed (386 marked recruiting) in Argentina, Australia, Belgium, Brazil and Canada and 23 more countries.

Groups in this study

• Double-blind (DB) Induction Study: Icotrokinra (listed as: experimental group)
• DB Induction Study: Placebo (listed as: placebo group)
• DB Maintenance Study: Icotrokinra (listed as: experimental group)
• DB Maintenance Study: Placebo (listed as: placebo group)
• Open-label (OL) Induction Phase: Icotrokinra (listed as: experimental group)
• OL Maintenance Phase: Icotrokinra (listed as: experimental group)

Main thing being measured

• Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12 (At Week I-12)
• DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40 (At Week M-40)
• Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40 (At Week M-40)

In the researchers’ words

The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).

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.