Icotrokinra for adults and teens with moderate to severe ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• AZ Gastro Care
  Chandler, Arizona, United States Recruiting
• Research Solutions of Arizona
  Litchfield Park, Arizona, United States Recruiting
• Mayo Clinic
  Scottsdale, Arizona, United States Recruiting
• Clinnova Research
  Anaheim, California, United States Recruiting
• Southern California Research Center
  Coronado, California, United States Recruiting
• Om Research LLC
  Lancaster, California, United States Recruiting

+335 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.