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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07196748

Public ClinicalTrials.gov record NCT07196748. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 20, 2026, 11:53 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID
NCT07196748
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Janssen Research & Development, LLC
Industry
Enrollment
882 participants

Conditions and interventions

Conditions

Not listed

Interventions

Not listed

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2025
Primary completion
Jan 13, 2028
Completion
Jan 12, 2032
Last update posted
May 7, 2026

2025 – 2032

United States locations

U.S. sites
53
U.S. states
21
U.S. cities
44
Facility City State ZIP Site status
AZ Gastro Care Chandler Arizona 85206 Recruiting
Research Solutions of Arizona Litchfield Park Arizona 85340 Recruiting
Mayo Clinic Scottsdale Arizona 85259 Recruiting
Clinnova Research Anaheim California 92805 Recruiting
Southern California Research Center Coronado California 92118 Recruiting
Om Research LLC Lancaster California 93534 Recruiting
TLC Clinical Research Inc Los Angeles California 90048 Recruiting
GastroIntestinal Bioscience Los Angeles California 90067 Recruiting
Om Research LLC 2 Oxnard California 93030 Recruiting
Clinical Applications Laboratories, Inc San Diego California 92103 Recruiting
Medical Associates Research Group, Inc. San Diego California 92123 Recruiting
Peak Gastroenterology Associates Colorado Springs Colorado 80907 Recruiting
Nuvance Health Danbury Hospital Danbury Connecticut 06810 Recruiting
Connecticut Children's Medical Center Hartford Connecticut 06106 Recruiting
American Institute of Research Cutler Bay Florida 33157 Recruiting
Nature Coast Clinical Research Inverness Florida 34452 Recruiting
Florida Research Institute Lakewood Rch Florida 34211 Recruiting
GCP Clinical Research Tampa Florida 33609 Recruiting
Atlanta Gastroenterology Associates Atlanta Georgia 30342 Recruiting
Children's Center for Digestive Health Care Atlanta Georgia 30342 Recruiting
Gastroenterolgy Associates of Central GA Macon Georgia 31201 Recruiting
Cotton O'Neil Digestive Health Center Topeka Kansas 66606 Recruiting
Tri-State Gastroenterology Assoc Crestview Hills Kentucky 41017 Recruiting
Delta Research Partners, LLC West Monroe Louisiana 71291 Recruiting
Chevy Chase Clinical Research Chevy Chase Maryland 20815 Recruiting
Woodholme Gastroenterology Associates Glen Burnie Maryland 21061 Recruiting
Westchester Putnam Gastroenterology Carmel New York 10512 Recruiting
Inflammatory Bowel Disease Center at NYU Langone New York New York 10016 Recruiting
Manhattan Clinical Research LLC New York New York 10016 Recruiting
Icahn School of Medicine at Mount Sinai New York New York 10029 Recruiting
Weill Cornell Medical College New York New York 10065 Recruiting
Lenox Hill Hospital New York New York 10075 Recruiting
New York Gastroenterology Associates New York New York 10075 Recruiting
University of North Carolina Chapel Hill North Carolina 27599 Recruiting
Atrium Health Charlotte North Carolina 28204 Recruiting
Gastro Intestinal Research Institute of Northern Ohio LLC Westlake Ohio 44145 Suspended
Digestive Disease Specialists Inc Oklahoma City Oklahoma 73114 Recruiting
The Oregon Clinic Portland Oregon 97220-9428 Recruiting
Susquehanna Research Group Harrisburg Pennsylvania 17110-3673 Recruiting
Penn State Milton S Hershey Medical Ctr Hershey Pennsylvania 17033 Recruiting
University of Pennsylvania Philadelphia Pennsylvania 19104 Recruiting
Jefferson Digestive Health Institute Philadelphia Pennsylvania 19107 Recruiting
University Gastroenterology Providence Rhode Island 02905 Recruiting
Digestive Disease Associates Rock Hill South Carolina 29732 Recruiting
The University of Texas at Austin Austin Texas 78712 Recruiting
DFW Clinical Trials Carrollton Texas 75010 Recruiting
Victorium Clinical Research Houston Texas 77024 Recruiting
Southern Star Research Institute, LLC San Antonio Texas 78229 Recruiting
GI Alliance Southlake Southlake Texas 76092 Recruiting
Tyler Research Institute, LLC Tyler Texas 75701 Recruiting
Gastroenterology Associates of Tidewater Chesapeake Virginia 23320 Recruiting
Blue Ridge Medical Research Lynchburg Virginia 24502 Recruiting
GI Alliance Tacoma Tacoma Washington 98405 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 73 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07196748, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 7, 2026 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07196748 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →