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NotableLead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLCStudy sites: 401 to 402 · Eligibility criteria expanded, about 11 words · Secondary endpoints: details revised at 44 of 44 entriesShow 3 more changesShow less
Study sites: 401 to 402
Eligibility criteria expanded, about 11 words
Secondary endpoints: details revised at 44 of 44 entries
MinorStudy sites: 400 to 401v14
MinorStudy sites: 398 to 400v13
MinorTrial sites expanded: 393 → 398 locationsv12
MinorTrial sites expanded: 385 → 393 locationsv11
MinorTrial sites expanded: 367 → 385 locationsv10
MinorTrial sites expanded: 301 → 367 locationsv9
MinorStudy sites: 193 to 301Eligibility criteria expanded, about 5 wordsv8Show 1 more changeShow less
MinorStudy sites: 8 to 10Start date changed from estimate of Oct 23, 2025 to Oct 1, 2025v3Show 1 more changeShow less
Start date changed from estimate of Oct 23, 2025 to Oct 1, 2025
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 4 to 8v2Show 1 more changeShow less
Study sites: 4 to 8
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).