NCT07196748From ClinicalTrials.govRecruiting

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

Colitis, Ulcerative

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Janssen Research & Development, LLC
Enrolment target: 882
Started: 1 October 2025
Main results due: 14 January 2028
Study sites: 402
Registry updated: 25 September 2026

Can you take part?

Aged 12 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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 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

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(402)

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
TLC Clinical Research Inc
Los Angeles, California, United States
Recruiting
GastroIntestinal Bioscience
Los Angeles, California, United States
Recruiting
Hoag Memorial Hospital
Newport Beach, California, United States
Recruiting
Om Research LLC 2
Oxnard, California, United States
Recruiting
Stanford Medicine Children's Health
Palo Alto, California, United States
Recruiting
Clinical Applications Laboratories, Inc
San Diego, California, United States
Completed
Medical Associates Research Group, Inc.
San Diego, California, United States
Recruiting
University of California San Francisco
San Francisco, California, United States
Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Recruiting
Nuvance Health Danbury Hospital
Danbury, Connecticut, United States
Completed
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Recruiting
American Institute of Research
Cutler Bay, Florida, United States
Recruiting
Nature Coast Clinical Research
Inverness, Florida, United States
Recruiting
Florida Research Institute
Lakewood Rch, Florida, United States
Recruiting
GCP Clinical Research
Tampa, Florida, United States
Recruiting
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Recruiting
Children's Center for Digestive Health Care
Atlanta, Georgia, United States
Recruiting
Gastroenterolgy Associates of Central GA
Macon, Georgia, United States
Recruiting
IU Health University Hospital
Indianapolis, Indiana, United States
Recruiting
Cotton O'Neil Digestive Health Center
Topeka, Kansas, United States
Recruiting
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, United States
Recruiting
Delta Research Partners, LLC
West Monroe, Louisiana, United States
Recruiting
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Recruiting
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, United States
Recruiting
Westchester Putnam Gastroenterology
Carmel, New York, United States
Recruiting
Inflammatory Bowel Disease Center at NYU Langone
New York, New York, United States
Recruiting
Manhattan Clinical Research LLC
New York, New York, United States
Completed
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Recruiting
Weill Cornell Medical College
New York, New York, United States
Recruiting
Lenox Hill Hospital
New York, New York, United States
Recruiting
New York Gastroenterology Associates
New York, New York, United States
Recruiting
University of North Carolina
Chapel Hill, North Carolina, United States
Recruiting
Atrium Health
Charlotte, North Carolina, United States
Recruiting
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, United States
Completed
The Oregon Clinic
Portland, Oregon, United States
Recruiting
Susquehanna Research Group
Harrisburg, Pennsylvania, United States
Recruiting
Penn State Milton S Hershey Medical Ctr
Hershey, Pennsylvania, United States
Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Recruiting
Jefferson Digestive Health Institute
Philadelphia, Pennsylvania, United States
Recruiting
University Gastroenterology
Providence, Rhode Island, United States
Recruiting
Digestive Disease Associates
Rock Hill, South Carolina, United States
Completed
The University of Texas at Austin
Austin, Texas, United States
Recruiting
DFW Clinical Trials
Carrollton, Texas, United States
Recruiting
Victorium Clinical Research
Houston, Texas, United States
Recruiting
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Recruiting
GI Alliance Southlake
Southlake, Texas, United States
Recruiting
Tyler Research Institute, LLC
Tyler, Texas, United States
Recruiting
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Recruiting
Blue Ridge Medical Research
Lynchburg, Virginia, United States
Recruiting
GI Alliance Tacoma
Tacoma, Washington, United States
Recruiting
GEDYT
AAI, Argentina
Recruiting
Cer Instituto Medico
Buenos Aires, Argentina
Recruiting
Kynet Recoleta
Buenos Aires, Argentina
Recruiting
Hospital Britanico de Buenos Aires
Buenos Aires, Argentina
Recruiting

Showing 60 of 402 sites — filter to narrow it down. 386 of the 402 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07196748. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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