Recruiting
Phase 3

Icotrokinra

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07196748

Conditions

Colitis, Ulcerative

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Icotrokinra

Placebo

Study Details

Brief 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).

Conditions

Colitis, Ulcerative

Study ID

NCT07196748

Start date

Oct 1, 2025

Status verified date

Aug, 2026

Completion date

Jan 13, 2032

Anticipated

Primary completion date

Jan 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

882 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Double-blind (DB) Induction Study: Icotrokinra

Adult participants will be randomized to receive icotrokinra daily, orally starting at induction Week 0 (Week I-0). At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study.

placebo comparator: DB Induction Study: Placebo

Adult participants will be randomized to receive placebo daily, orally starting at Week I-0. At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study.

experimental: DB Maintenance Study: Icotrokinra

Adult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive icotrokinra daily, orally starting at maintenance Week 0 (Week M-0) through Week M-40. Participants who are clinical nonresponders to icotrokinra or placebo will also enter the Maintenance study directly and receive icotrokinra daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a long-term extension (LTE).

placebo comparator: DB Maintenance Study: Placebo

Adult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive placebo daily, orally starting at Week M-0 through Week M-40. Participants who are clinical responders to placebo will also enter the Maintenance study directly and continue to receive placebo daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a LTE.

experimental: Open-label (OL) Induction Phase: Icotrokinra

Adolescent participants will enter the Induction phase and receive icotrokinra daily, orally. At Week I-12 all participants will be evaluated for clinical response and will enter the Maintenance phase.

experimental: OL Maintenance Phase: Icotrokinra

Adolescent participants who are in clinical response to icotrokinra will enter the Maintenance phase at Week M-0 and continue to receive icotrokinra daily, orally up to Week M-40. Participants who are nonresponders to icotrokinra will also enter the Maintenance phase to receive icotrokinra daily. After completion of the Maintenance phase through Week M-40, eligible participants can participate in a LTE.

Interventions

Icotrokinra

Icotrokinra tablet will be administered orally.

Placebo

Placebo tablet will be administered orally.

Primary outcome measure

  • Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12 [ Time Frame: At Week I-12 ]
  • DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40 [ Time Frame: At Week M-40 ]
  • Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40 [ Time Frame: At Week M-40 ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

AZ Gastro Care

Recruiting

Chandler, Arizona, United States, 85206

Research Solutions of Arizona

Recruiting

Litchfield Park, Arizona, United States, 85340

Mayo Clinic

Recruiting

Scottsdale, Arizona, United States, 85259

Clinnova Research

Recruiting

Anaheim, California, United States, 92805

Southern California Research Center

Recruiting

Coronado, California, United States, 92118

Om Research LLC

Recruiting

Lancaster, California, United States, 93534

TLC Clinical Research Inc

Recruiting

Los Angeles, California, United States, 90048

GastroIntestinal Bioscience

Recruiting

Los Angeles, California, United States, 90067

Hoag Memorial Hospital

Recruiting

Newport Beach, California, United States, 92658

Om Research LLC 2

Recruiting

Oxnard, California, United States, 93030

Medical Associates Research Group, Inc.

Recruiting

San Diego, California, United States, 92123

University of California San Francisco

Recruiting

San Francisco, California, United States, 94115

Peak Gastroenterology Associates

Recruiting

Colorado Springs, Colorado, United States, 80907

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

American Institute of Research

Recruiting

Cutler Bay, Florida, United States, 33157

Nature Coast Clinical Research

Recruiting

Inverness, Florida, United States, 34452

Florida Research Institute

Recruiting

Lakewood Rch, Florida, United States, 34211

GCP Clinical Research

Recruiting

Tampa, Florida, United States, 33609

Atlanta Gastroenterology Associates

Recruiting

Atlanta, Georgia, United States, 30342

Children's Center for Digestive Health Care

Recruiting

Atlanta, Georgia, United States, 30342

Gastroenterolgy Associates of Central GA

Recruiting

Macon, Georgia, United States, 31201

IU Health University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Cotton O'Neil Digestive Health Center

Recruiting

Topeka, Kansas, United States, 66606

Tri-State Gastroenterology Assoc

Recruiting

Crestview Hills, Kentucky, United States, 41017

Delta Research Partners, LLC

Recruiting

West Monroe, Louisiana, United States, 71291

Chevy Chase Clinical Research

Recruiting

Chevy Chase, Maryland, United States, 20815

Woodholme Gastroenterology Associates

Recruiting

Glen Burnie, Maryland, United States, 21061

Westchester Putnam Gastroenterology

Recruiting

Carmel, New York, United States, 10512

Inflammatory Bowel Disease Center at NYU Langone

Recruiting

New York, New York, United States, 10016

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10065

Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

New York Gastroenterology Associates

Recruiting

New York, New York, United States, 10075

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28204

The Oregon Clinic

Recruiting

Portland, Oregon, United States, 97220-9428

Susquehanna Research Group

Recruiting

Harrisburg, Pennsylvania, United States, 17110-3673

Penn State Milton S Hershey Medical Ctr

Recruiting

Hershey, Pennsylvania, United States, 17033

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Jefferson Digestive Health Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

University Gastroenterology

Recruiting

Providence, Rhode Island, United States, 02905

The University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

DFW Clinical Trials

Recruiting

Carrollton, Texas, United States, 75010

Victorium Clinical Research

Recruiting

Houston, Texas, United States, 77024

Southern Star Research Institute, LLC

Recruiting

San Antonio, Texas, United States, 78229

GI Alliance Southlake

Recruiting

Southlake, Texas, United States, 76092

Tyler Research Institute, LLC

Recruiting

Tyler, Texas, United States, 75701

Gastroenterology Associates of Tidewater

Recruiting

Chesapeake, Virginia, United States, 23320

Blue Ridge Medical Research

Recruiting

Lynchburg, Virginia, United States, 24502

GI Alliance Tacoma

Recruiting

Tacoma, Washington, United States, 98405

South Edmonton Gastroenterology Research Clinic

Recruiting

Edmonton, Alberta, Canada, Code: T6K 4B2

Gastroenterology and Internal Medicine Research Institute (GIRI)

Recruiting

Edmonton, Alberta, Canada, T5R 1W2

GIRI Gastrointestinal Research Institute

Recruiting

Vancouver, British Columbia, Canada, V6Z 2K5

Viable Clinical Research

Recruiting

Kentville, Nova Scotia, Canada, B4N 0A3

Barrie GI Associates

Recruiting

Barrie, Ontario, Canada, L4M 7G1

London Digestive Disease Institute

Recruiting

London, Ontario, Canada, N6K 1M6

West GTA Research Inc

Recruiting

Mississauga, Ontario, Canada, L5M 2S4

ABP Research Services Corp.

Recruiting

Oakville, Ontario, Canada, L6L 5L7

Toronto Immune and Digestive Health Institute Inc

Recruiting

Toronto, Ontario, Canada, M6A 3B4

CHUM - Centre hospitalier universitaire de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Clinique IMD

Recruiting

Montreal, Quebec, Canada, H3H1E8

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.