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Clinical Trial ยท PHASE3 ยท Recruiting

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

07 September 2026 NCT07196748 ClinicalTrials.gov โ†—
✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE3
Participants
ALL
Age Range
12 Years+

About This Trial

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).

Who Can Join?

Inclusion Criteria: * 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 [ฮฒ-hCG]) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests * Demonstrated an…

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