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

Recruiting Phase 3 Interventional Study
Colitis, Ulcerative
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
12 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
882 (estimated)
Sponsor
Janssen Research & Development, LLC · Industry
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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).

Trial Locations
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Eligibility Criteria
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…
Contacts

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

CONTACT