Recruiting
Phase 2
Phase 3

Icotrokinra

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07196722

Conditions

Crohn Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Icotrokinra

Placebo

Study Details

Brief summary:

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Conditions

Crohn Disease

Study ID

NCT07196722

Start date

Oct 3, 2025

Status verified date

Aug, 2026

Completion date

Oct 10, 2032

Anticipated

Primary completion date

Sep 19, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
  • Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score >=220 but <=450 and either mean daily SF count >=4, or mean daily AP score >=2
  • Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD >= 6 for participants with colonic or ileocolonic disease, and SES-CD >= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments
  • A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-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 naïve to advanced therapies (advanced drug therapy \[ADT\]-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 CD- (ADT-inadequate responder \[IR\]) as defined in the protocol

Exclusion criteria:

  • Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention
  • Presence of a stoma or ostomy
  • Participants with presence of active fistulas may be included if there is no surgery needed
  • Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline
  • Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization

Study Design

Enrollment

1092 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Induction Study 1: Icotrokinra Dose 1

Participants will receive Icotrokinra dose 1 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.

experimental: Induction Study 1: Icotrokinra Dose 2

Participants will receive Icotrokinra dose 2 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.

placebo comparator: Induction Study 1: Placebo

Participants will receive matching placebo in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.

experimental: Induction Study 2: Icotrokinra

Participants will receive Icotrokinra at the dose regimen determined in Induction Study 1 up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.

placebo comparator: Induction Study 2: Placebo

Participants will receive matching placebo for up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.

experimental: Maintenance Study: Icotrokinra Dose 1

Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 1. Participants receiving Icotrokinra Dose 1 and meeting criteria for loss of response during the Maintenance Study will be eligibile for a single blinded dose adjustment to Icotrokinra Dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in long-term extension (LTE).

experimental: Maintenance Study: Icotrokinra Dose 2

Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 2. Participants who were non-responders at Week 12 of the induction studies will also receive icotrokinra maintenance dose 2 but will not be randomized. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE.

placebo comparator: Maintenance Study: Placebo

Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 will be randomized to receive placebo. Participants receiving placebo in induction studies 1 or 2 and in response at Week 12 of the induction study will continue to receive placebo during maintenance on non-randomized basis. Placebo non-responders from induction study will receive icotrokinra maintenance dose 2 on a non-randomized basis and will be assessed for response at Week 12.

Participants receiving placebo and meeting criteria for loss of response during the Maintenance Study will be eligible for a single blinded dose adjustment to icotrokinra dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE.

Interventions

Icotrokinra

Icotrokinra will be administered orally, daily.

Placebo

Matching placebo will be administered orally, daily.

Primary outcome measure

  • Induction Study 1: Number of Participants with Clinical Response at Week 12 [ Time Frame: At Week 12 ]
  • Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint) [ Time Frame: At Week 12 ]
  • Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint) [ Time Frame: At Week 12 ]
  • Maintenance Study: Number of Participants with Clinical Remission at Week 40 (Co-Primary Endpoint) [ Time Frame: At Week 40 ]
  • Maintenance Study: Number of Participants with Endoscopic Response at Week 40 (Co-Primary Endpoint) [ Time Frame: At Week 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 1

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

American Institute of Research

Recruiting

Cutler Bay, Florida, United States, 33157

Nature Coast Clinical Research

Recruiting

Inverness, Florida, United States, 34452

Florida Research Center Inc.

Recruiting

Lakewood Rch, Florida, United States, 34211

Sanchez Clinical Research, Inc

Recruiting

Miami, Florida, United States, 33157-6575

GCP Clinical Research

Recruiting

Tampa, Florida, United States, 33609

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

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

Kansas Gastroenterology, LLC

Recruiting

Wichita, Kansas, United States, 67226

Tri-State Gastroenterology Assoc

Recruiting

Crestview Hills, Kentucky, United States, 41017

Gastroenterology Clinic of Acadiana

Recruiting

Lafayette, Louisiana, United States, 70503

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

Mayo Clinic 1

Recruiting

Rochester, Minnesota, United States, 55905

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

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

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

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

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

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

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.