NCT07196722From ClinicalTrials.govRecruiting

A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

Crohn Disease

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Janssen Research & Development, LLC
Enrolment target: 1,092
Started: 3 October 2025
Main results due: 19 September 2028
Study sites: 372
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(372)

AZ Gastro Care
Chandler, Arizona, United States
Recruiting
Research Solutions of Arizona
Litchfield Park, Arizona, United States
Recruiting
Mayo Clinic
Scottsdale, Arizona, United States
Recruiting
Clinnova Research
Anaheim, California, United States
Recruiting
Alliance Research Institute, LLC - Canoga Park
Canoga Park, California, United States
Completed
Southern California Research Center
Coronado, California, United States
Recruiting
Om Research, LLC 1
Lancaster, California, United States
Recruiting
TLC Clinical Research Inc
Los Angeles, California, United States
Recruiting
GastroIntestinal Bioscience
Los Angeles, California, United States
Recruiting
Hoag Memorial Hospital
Newport Beach, California, United States
Recruiting
Om Research, LLC 2
Oxnard, California, United States
Recruiting
Clinical Applications Laboratories, Inc
San Diego, California, United States
Completed
Medical Associates Research Group, Inc.
San Diego, California, United States
Recruiting
University of California San Francisco
San Francisco, California, United States
Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Recruiting
Nuvance Health Danbury Hospital
Danbury, Connecticut, United States
Completed
American Institute of Research
Cutler Bay, Florida, United States
Recruiting
Nature Coast Clinical Research
Inverness, Florida, United States
Recruiting
Green Leaf Clinical Trials
Jacksonville, Florida, United States
Completed
Florida Research Center Inc.
Lakewood Rch, Florida, United States
Recruiting
Sanchez Clinical Research, Inc
Miami, Florida, United States
Recruiting
GCP Clinical Research
Tampa, Florida, United States
Recruiting
Emory University
Atlanta, Georgia, United States
Recruiting
Children's Center for Digestive Health Care
Atlanta, Georgia, United States
Recruiting
Gastroenterolgy Associates of Central GA
Macon, Georgia, United States
Recruiting
IU Health University Hospital
Indianapolis, Indiana, United States
Recruiting
Kansas Gastroenterology, LLC
Wichita, Kansas, United States
Recruiting
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, United States
Recruiting
University of Louisville - MedCenter One
Louisville, Kentucky, United States
Recruiting
Gastroenterology Clinic of Acadiana
Lafayette, Louisiana, United States
Recruiting
Delta Research Partners, LLC
West Monroe, Louisiana, United States
Recruiting
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Recruiting
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, United States
Recruiting
Mayo Clinic 1
Rochester, Minnesota, United States
Recruiting
Westchester Putnam Gastroenterology
Carmel, New York, United States
Recruiting
Inflammatory Bowel Disease Center at NYU Langone
New York, New York, United States
Recruiting
Manhattan Clinical Research LLC
New York, New York, United States
Completed
Weill Cornell Medical College
New York, New York, United States
Recruiting
Lenox Hill Hospital
New York, New York, United States
Recruiting
New York Gastroenterology Associates
New York, New York, United States
Recruiting
University of North Carolina
Chapel Hill, North Carolina, United States
Recruiting
Atrium Health
Charlotte, North Carolina, United States
Recruiting
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, United States
Completed
The Oregon Clinic
Portland, Oregon, United States
Recruiting
Susquehanna Research Group
Harrisburg, Pennsylvania, United States
Recruiting
Penn State Milton S Hershey Medical Ctr
Hershey, Pennsylvania, United States
Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Recruiting
Jefferson Digestive Health Institute
Philadelphia, Pennsylvania, United States
Recruiting
University Gastroenterology
Providence, Rhode Island, United States
Recruiting
Digestive Disease Associates
Rock Hill, South Carolina, United States
Completed
The University of Texas at Austin
Austin, Texas, United States
Recruiting
DFW Clinical Trials
Carrollton, Texas, United States
Recruiting
Baylor University Medical Center
Dallas, Texas, United States
Recruiting
UT Southwestern Medical Center
Dallas, Texas, United States
Recruiting
Victorium Clinical Research
Houston, Texas, United States
Recruiting
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Recruiting
GI Alliance Southlake
Southlake, Texas, United States
Recruiting
Tyler Research Institute, LLC
Tyler, Texas, United States
Recruiting
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Recruiting
Blue Ridge Medical Research
Lynchburg, Virginia, United States
Recruiting

Showing 60 of 372 sites — filter to narrow it down. 362 of the 372 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07196722. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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