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RECRUITING

NCT07196722

PHASE2/PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1092

Start Date

2025-10-03

Completion Date

2032-10-06

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Crohn Disease

Interventions

DRUG

Icotrokinra

Icotrokinra will be administered orally, daily.

DRUG

Placebo

Matching placebo will be administered orally, daily.

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

Locations (395)

AZ Gastro Care

Chandler, Arizona, United States

Research Solutions of Arizona

Litchfield Park, Arizona, United States

Mayo Clinic

Scottsdale, Arizona, United States

Clinnova Research

Anaheim, California, United States

Alliance Research Institute, LLC - Canoga Park

Canoga Park, California, United States

Southern California Research Center

Coronado, California, United States

Om Research, LLC 1

Lancaster, California, United States

TLC Clinical Research Inc

Los Angeles, California, United States

GastroIntestinal Bioscience

Los Angeles, California, United States

Hoag Memorial Hospital

Newport Beach, California, United States

Om Research, LLC 2

Oxnard, California, United States

Clinical Applications Laboratories, Inc

San Diego, California, United States

Medical Associates Research Group, Inc.

San Diego, California, United States

University of California San Francisco

San Francisco, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Nuvance Health Danbury Hospital

Danbury, Connecticut, United States

American Institute of Research

Cutler Bay, Florida, United States

Nature Coast Clinical Research

Inverness, Florida, United States

Green Leaf Clinical Trials

Jacksonville, Florida, United States

Florida Research Center Inc.

Lakewood Rch, Florida, United States

Sanchez Clinical Research, Inc

Miami, Florida, United States

GCP Clinical Research

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Children's Center for Digestive Health Care

Atlanta, Georgia, United States

Gastroenterolgy Associates of Central GA

Macon, Georgia, United States

IU Health University Hospital

Indianapolis, Indiana, United States

Kansas Gastroenterology, LLC

Wichita, Kansas, United States

Tri-State Gastroenterology Assoc

Crestview Hills, Kentucky, United States

University of Louisville - MedCenter One

Louisville, Kentucky, United States

Gastroenterology Clinic of Acadiana

Lafayette, Louisiana, United States

Delta Research Partners, LLC

West Monroe, Louisiana, United States

Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Woodholme Gastroenterology Associates

Glen Burnie, Maryland, United States

Mayo Clinic 1

Rochester, Minnesota, United States

Westchester Putnam Gastroenterology

Carmel, New York, United States

Inflammatory Bowel Disease Center at NYU Langone