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

RecruitingPhase 2/3

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

Who can join

Ages 18 and older · All sexes

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

About the study

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).

What is being tested

Sponsor: Janssen Research & Development, LLC · Participants: 1,092 · Started: Oct 3, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07196722

Locations in the U.S.

ArizonaAZ Gastro Care, Chandler
Research Solutions of Arizona, Litchfield Park
Mayo Clinic, Scottsdale
CaliforniaClinnova Research, Anaheim
Southern California Research Center, Coronado
Om Research, LLC 1, Lancaster
GastroIntestinal Bioscience, Los Angeles
TLC Clinical Research Inc, Los Angeles
Hoag Memorial Hospital, Newport Beach
Om Research, LLC 2, Oxnard
Medical Associates Research Group, Inc., San Diego
University of California San Francisco, San Francisco
ColoradoPeak Gastroenterology Associates, Colorado Springs
FloridaAmerican Institute of Research, Cutler Bay
Nature Coast Clinical Research, Inverness
Florida Research Center Inc., Lakewood Rch
Sanchez Clinical Research, Inc, Miami
GCP Clinical Research, Tampa
GeorgiaChildren's Center for Digestive Health Care, Atlanta
Emory University, Atlanta
Gastroenterolgy Associates of Central GA, Macon
IndianaIU Health University Hospital, Indianapolis
KansasKansas Gastroenterology, LLC, Wichita
KentuckyTri-State Gastroenterology Assoc, Crestview Hills
University of Louisville - MedCenter One, Louisville
LouisianaGastroenterology Clinic of Acadiana, Lafayette
Delta Research Partners, LLC, West Monroe
MarylandChevy Chase Clinical Research, Chevy Chase
Woodholme Gastroenterology Associates, Glen Burnie
MinnesotaMayo Clinic 1, Rochester
New YorkWestchester Putnam Gastroenterology, Carmel
Inflammatory Bowel Disease Center at NYU Langone, New York
Lenox Hill Hospital, New York
New York Gastroenterology Associates, New York
Weill Cornell Medical College, New York
North CarolinaUniversity of North Carolina, Chapel Hill
Atrium Health, Charlotte
OregonThe Oregon Clinic, Portland
PennsylvaniaSusquehanna Research Group, Harrisburg
Penn State Milton S Hershey Medical Ctr, Hershey
Jefferson Digestive Health Institute, Philadelphia
University of Pennsylvania, Philadelphia
Rhode IslandUniversity Gastroenterology, Providence
TexasThe University of Texas at Austin, Austin
DFW Clinical Trials, Carrollton
Baylor University Medical Center, Dallas
UT Southwestern Medical Center, Dallas
Victorium Clinical Research, Houston
Southern Star Research Institute, LLC, San Antonio
GI Alliance Southlake, Southlake
Tyler Research Institute, LLC, Tyler
VirginiaGastroenterology Associates of Tidewater, Chesapeake
Blue Ridge Medical Research, Lynchburg
WashingtonGI Alliance Tacoma, Tacoma

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.