Cure8 trial brief
A new Phase 3 trial is testing icotrokinra, an oral investigational drug, for induction and maintenance of remission in moderate–severe ulcerative colitis. Trials like this could expand treatment options if the drug proves safe and effective.
Adult patients with moderately to severely active UC, adolescents meeting eligibility, caregivers, gastroenterologists considering trial referral, and researchers following new drug development.
This is a Phase 3 randomized, double-blind clinical trial record testing oral icotrokinra versus placebo for induction and maintenance of clinical remission in moderately to severely active ulcerative colitis in adults, with an open-label adolescent arm.
The protocol describes induction (12 weeks) and maintenance (up to 40 weeks) phases, criteria for clinical remission based on modified Mayo subscores, eligibility (age ≥12, weight and pregnancy testing requirements), and planned enrollment of about 882 participants, with a long-term extension available.
If you read the registry entry you’ll see who may qualify and how the study is structured (induction responders randomized into maintenance, nonresponders entering maintenance on active drug, and an LTE).
The record lists common exclusion criteria such as recent major abdominal surgery, presence of a stoma or fistula, and severe complications like toxic megacolon. Locations and contact information are provided on the ClinicalTrials.gov page for people or clinicians considering referral.
This note is grounded in the study protocol posted on ClinicalTrials.gov and does not represent review of trial results or safety data beyond what the registry lists.
This is a trial registry entry (Phase 3, recruiting) describing planned study design and outcomes; it does not report trial results. Eligibility and study procedures are specified in the protocol; contacting listed sites or the sponsor is needed for enrollment details.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
A new IL-23–targeting therapy (JNJ-78934804) is being tested against an approved IL-23 inhibitor (guselkumab) in a large Phase 3 trial for moderate–severe ulcerative colitis, which could affect future treatment options...
This trial tests whether raising the upadacitinib dose to 45 mg can recapture clinical response in people with ulcerative colitis who lost response on the 30 mg maintenance dose. If effective and safe, the approach could...
This study reports real-world data on mirikizumab in adults with ulcerative colitis, focusing on clinical and endoscopic remission and inflammatory markers — outcomes patients and clinicians use to judge treatment...
