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Icotrokinra for adults and teens with moderate to severe ulcerative colitis

A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults With an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis

Phase 3 Interventional Janssen Research & Development, LLC · NCT07196748

This trial tests oral icotrokinra versus placebo to see if it helps adults and adolescents with moderately to severely active ulcerative colitis.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment882 (estimated)
Ages12 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Locations385 sites (Chandler, Arizona and 384 other locations)
Trial IDNCT07196748 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized interventional protocol compares oral icotrokinra to placebo for people with moderately to severely active ulcerative colitis. Participants must have endoscopy- and histology-confirmed UC with a modified Mayo score of 5–9 and an endoscopy subscore ≥2 at screening. The trial will track symptom improvement, endoscopic findings, safety, and tolerability over the treatment period. Sites include clinical centers in Arizona, with a lead sponsor of a large pharmaceutical company.

Who should consider this trial

Good fit: Ideal candidates are adolescents (≥40 kg) and adults with endoscopy- and histology-confirmed moderately to severely active UC (modified Mayo score 5–9 and endoscopy subscore ≥2) who can comply with study visits and required pregnancy testing if applicable.

Not a fit: Patients with mild UC, those who are pregnant or breastfeeding, those without the required endoscopic/histologic confirmation, or those with contraindications to oral therapy are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, icotrokinra could reduce inflammation and symptoms and provide an additional oral treatment option for patients with moderate to severe UC.

How similar studies have performed: Other oral small-molecule and targeted therapies for UC have shown benefit in prior trials, and icotrokinra has advanced to Phase 3 following earlier-phase studies.

Eligibility criteria

Show full inclusion / exclusion 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 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 test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests
* 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 therapy defined as biologics and/or advanced oral agents for the treatment of UC (ADT-inadequate responder \[IR\]) as defined in the protocol

Exclusion Criteria:

* Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study
* Presence of a stoma
* Presence or history of a fistula
* Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline
* History of extensive colonic resection (that is, less than \[\<\] 30 centimeter \[cm\] of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study intervention

Where this trial is running

Chandler, Arizona and 384 other locations

+335 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colitis, Ulcerative
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.