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

NCT07196722 · tracked via the Priya Life Science UK tracker

Sponsor

Janssen Research & Development, LLC

Phase

Phase 2/3

Started

2025-10-03

Last updated

2026-08-28

Condition(s) studied

Crohn Disease

Investigational drug(s) / intervention(s)

IcotrokinraPlacebo

Icotrokinra: Icotrokinra will be administered orally, daily.

Placebo: Matching placebo will be administered orally, daily.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Induction Study 1: Number of Participants with Clinical Response at Week 12 — At Week 12
Clinical response is defined as a greater than or equal to (\>=) 100-point reduction from baseline in Crohn's Disease Activity Index (CDAI) score. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint) — At Week 12
Clinical remission is defined as CDAI score less than (\<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint) — At Week 12
Endoscopic response is defined as greater than (\>) 50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
Maintenance Study: Number of Participants with Clinical Remission at Week 40 (Co-Primary Endpoint) — At Week 40
Clinical remission is defined as CDAI score \< 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Maintenance Study: Number of Participants with Endoscopic Response at Week 40 (Co-Primary Endpoint) — At Week 40
Endoscopic response is defined as \> 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

Trial sites (370)

Facility	City	Region	Status
AZ Gastro Care	Chandler	Arizona	Recruiting
Research Solutions of Arizona	Litchfield Park	Arizona	Recruiting
Mayo Clinic	Scottsdale	Arizona	Recruiting
Clinnova Research	Anaheim	California	Recruiting
Alliance Research Institute, LLC - Canoga Park	Canoga Park	California	Completed
Southern California Research Center	Coronado	California	Recruiting
Om Research, LLC 1	Lancaster	California	Recruiting
TLC Clinical Research Inc	Los Angeles	California	Recruiting
GastroIntestinal Bioscience	Los Angeles	California	Recruiting
Hoag Memorial Hospital	Newport Beach	California	Recruiting
Om Research, LLC 2	Oxnard	California	Recruiting
Clinical Applications Laboratories, Inc	San Diego	California	Completed
Medical Associates Research Group, Inc.	San Diego	California	Recruiting
University of California San Francisco	San Francisco	California	Recruiting
Peak Gastroenterology Associates	Colorado Springs	Colorado	Recruiting
Nuvance Health Danbury Hospital	Danbury	Connecticut	Completed
American Institute of Research	Cutler Bay	Florida	Recruiting
Nature Coast Clinical Research	Inverness	Florida	Recruiting
Green Leaf Clinical Trials	Jacksonville	Florida	Completed
Florida Research Center Inc.	Lakewood Rch	Florida	Recruiting
Sanchez Clinical Research, Inc	Miami	Florida	Recruiting
GCP Clinical Research	Tampa	Florida	Recruiting
Emory University	Atlanta	Georgia	Recruiting
Children's Center for Digestive Health Care	Atlanta	Georgia	Recruiting
Gastroenterolgy Associates of Central GA	Macon	Georgia	Recruiting
IU Health University Hospital	Indianapolis	Indiana	Recruiting
Kansas Gastroenterology, LLC	Wichita	Kansas	Recruiting
Tri-State Gastroenterology Assoc	Crestview Hills	Kentucky	Recruiting
Gastroenterology Clinic of Acadiana	Lafayette	Louisiana	Recruiting
Delta Research Partners, LLC	West Monroe	Louisiana	Recruiting
Chevy Chase Clinical Research	Chevy Chase	Maryland	Recruiting
Woodholme Gastroenterology Associates	Glen Burnie	Maryland	Recruiting
Mayo Clinic 1	Rochester	Minnesota	Recruiting
Westchester Putnam Gastroenterology	Carmel	New York	Recruiting
Inflammatory Bowel Disease Center at NYU Langone	New York	New York	Recruiting
Manhattan Clinical Research LLC	New York	New York	Completed
Weill Cornell Medical College	New York	New York	Recruiting
Lenox Hill Hospital	New York	New York	Recruiting
New York Gastroenterology Associates	New York	New York	Recruiting
University of North Carolina	Chapel Hill	North Carolina	Recruiting

+ 330 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in the UK

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Other trials for the same condition

A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Recruiting

A Long-term Extension Study of Ustekinumab in Pediatric Participants Active, not recruiting

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011) Recruiting

A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07196722 on ClinicalTrials.gov ↗ ← All trials in the UK