🔎 Trials Near Me

Home › Ulcerative Colitis › NCT07196748

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

RecruitingPhase 3

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

Who can join

Ages 12 and older · All sexes

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

About the study

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).

What is being tested

Sponsor: Janssen Research & Development, LLC · Participants: 882 · Started: Oct 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07196748

Locations in the U.S.

ArizonaAZ Gastro Care, Chandler
Research Solutions of Arizona, Litchfield Park
Mayo Clinic, Scottsdale
CaliforniaClinnova Research, Anaheim
Southern California Research Center, Coronado
Om Research LLC, Lancaster
GastroIntestinal Bioscience, Los Angeles
TLC Clinical Research Inc, Los Angeles
Hoag Memorial Hospital, Newport Beach
Om Research LLC 2, Oxnard
Stanford Medicine Children's Health, Palo Alto
Medical Associates Research Group, Inc., San Diego
University of California San Francisco, San Francisco
ColoradoPeak Gastroenterology Associates, Colorado Springs
ConnecticutConnecticut Children's Medical Center, Hartford
FloridaAmerican Institute of Research, Cutler Bay
Nature Coast Clinical Research, Inverness
Florida Research Institute, Lakewood Rch
GCP Clinical Research, Tampa
GeorgiaAtlanta Gastroenterology Associates, Atlanta
Children's Center for Digestive Health Care, Atlanta
Gastroenterolgy Associates of Central GA, Macon
IndianaIU Health University Hospital, Indianapolis
KansasCotton O'Neil Digestive Health Center, Topeka
KentuckyTri-State Gastroenterology Assoc, Crestview Hills
LouisianaDelta Research Partners, LLC, West Monroe
MarylandChevy Chase Clinical Research, Chevy Chase
Woodholme Gastroenterology Associates, Glen Burnie
New YorkWestchester Putnam Gastroenterology, Carmel
Icahn School of Medicine at Mount Sinai, New York
Inflammatory Bowel Disease Center at NYU Langone, New York
Lenox Hill Hospital, New York
New York Gastroenterology Associates, New York
Weill Cornell Medical College, New York
North CarolinaUniversity of North Carolina, Chapel Hill
Atrium Health, Charlotte
OregonThe Oregon Clinic, Portland
PennsylvaniaSusquehanna Research Group, Harrisburg
Penn State Milton S Hershey Medical Ctr, Hershey
Jefferson Digestive Health Institute, Philadelphia
University of Pennsylvania, Philadelphia
Rhode IslandUniversity Gastroenterology, Providence
TexasThe University of Texas at Austin, Austin
DFW Clinical Trials, Carrollton
Victorium Clinical Research, Houston
Southern Star Research Institute, LLC, San Antonio
GI Alliance Southlake, Southlake
Tyler Research Institute, LLC, Tyler
VirginiaGastroenterology Associates of Tidewater, Chesapeake
Blue Ridge Medical Research, Lynchburg
WashingtonGI Alliance Tacoma, Tacoma

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.