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ACTIVE NOT RECRUITING

NCT07196748

PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

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).

Official title: 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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

896

Start Date

2025-10-01

Completion Date

2032-01-13

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Colitis, Ulcerative

Interventions

DRUG

Icotrokinra

Icotrokinra tablet will be administered orally.

DRUG

Placebo

Placebo tablet will be administered orally.

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

Locations (402)

AZ Gastro Care

Chandler, Arizona, United States

Research Solutions of Arizona

Litchfield Park, Arizona, United States

Mayo Clinic

Scottsdale, Arizona, United States

Clinnova Research

Anaheim, California, United States

Southern California Research Center

Coronado, California, United States

Om Research LLC

Lancaster, California, United States

TLC Clinical Research Inc

Los Angeles, California, United States

GastroIntestinal Bioscience

Los Angeles, California, United States

Hoag Memorial Hospital

Newport Beach, California, United States

Om Research LLC 2

Oxnard, California, United States

Stanford Medicine Children's Health

Palo Alto, California, United States

Clinical Applications Laboratories, Inc

San Diego, California, United States

Medical Associates Research Group, Inc.

San Diego, California, United States

University of California San Francisco

San Francisco, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Nuvance Health Danbury Hospital

Danbury, Connecticut, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

American Institute of Research

Cutler Bay, Florida, United States

Nature Coast Clinical Research

Inverness, Florida, United States

Florida Research Institute

Lakewood Rch, Florida, United States

GCP Clinical Research

Tampa, Florida, United States

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Children's Center for Digestive Health Care

Atlanta, Georgia, United States

Gastroenterolgy Associates of Central GA

Macon, Georgia, United States

IU Health University Hospital

Indianapolis, Indiana, United States

Cotton O'Neil Digestive Health Center

Topeka, Kansas, United States

Tri-State Gastroenterology Assoc

Crestview Hills, Kentucky, United States

Delta Research Partners, LLC

West Monroe, Louisiana, United States

Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Woodholme Gastroenterology Associates

Glen Burnie, Maryland, United States

Westchester Putnam Gastroenterology

Carmel, New York, United States

Inflammatory Bowel Disease Center at NYU Langone