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

RecruitingPhase 3

A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion criteria:

* Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy
* Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\>=) 220 but less than or equal to (\<=) 450
* Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) \>= 4 (for participants with isolated ileal disease) or \>= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores:

  1. a minimum score of 1 for the component of "size of ulcers" AND
  2. a minimum score of 1 for the component of "ulcerated surface"
* In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study
* Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol

Exclusion criteria

* Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab
* Currently has or is suspected to have an abscess
* Has an active fistula during screening or at Week 0 with an anticipated need for surgery
* Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention
* Currently has a malignancy or has a history of malignancy within 5 years before screening

About the study

The purpose of this study is to assess how well guselkumab works when compared to risankizumab 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: 530 · Started: Apr 21, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07499232

Locations in the U.S.

AlabamaDigestive Health Specialists of the Southeast, Dothan
East View Medical Research, Mobile
CaliforniaClinnova Research, Anaheim
Gastro Care Institute, Lancaster
United Gastroenterologists, Los Alamitos
GastroIntestinal Bioscience, Los Angeles
TLC Clinical Research Inc, Los Angeles
Medical Associates Research Group, Inc., San Diego
ColoradoPeak Gastroenterology Associates, Colorado Springs
ConnecticutMedical Research Center of Connecticut, Hamden
FloridaGreen Leaf Clinical Trials, Jacksonville
Biodax Medical Research Trials, Miami
Sanchez Clinical Research, Inc, Miami
GI Pros Research, Naples
GCP Clinical Research, Tampa
GeorgiaMorehouse School of Medicine, Atlanta
Gastroenterology Associates of Central GA, Macon
IowaHeartland Medical Research Inc, Clive
KansasCotton-O'Neil Clinical Research Center, Topeka
LouisianaGastroenterology Clinic of Acadiana, Lafayette
MarylandWoodholme Gastroenterology Associates, Glen Burnie
MassachusettsLucida Clinical Trials, New Bedford
MichiganMichigan Center of Medical Research, Farmington Hills
New YorkWestchester Putnam Gastroenterology, Carmel
New York Gastroenterology Associates, New York
North CarolinaUniversity of North Carolina at Chapel Hill, Chapel Hill
Charlotte Gastroenterology and Hepatology, PLLC, Charlotte
OhioGreat Lakes Gastroenterology Research, LLC, Mentor
OklahomaDigestive Disease Specialists Inc, Oklahoma City
PennsylvaniaFrontier Clinical Research, Uniontown
South CarolinaPalmetto Primary and Specialty Care Physicians, Charleston, Summerville
TexasDFW Clinical Trials, Carrollton
Lubbock Gastroenterology, Lubbock
Gastroenterology Research of America, LLC, San Antonio
Southern Star Research Institute, LLC, San Antonio
The University of Texas Health Science Center at Tyler, Tyler

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.