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Clinical Trials in the UK / NCT07499232
Recruiting Phase 3

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

NCT07499232 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2026-04-21
Last updated
2026-08-28

Condition(s) studied

Crohn Disease

Investigational drug(s) / intervention(s)

GuselkumabRisankizumab

Guselkumab: Guselkumab will be administered.

Risankizumab: Risankizumab will be administered.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (160)

FacilityCityRegionStatus
Digestive Health Specialists of the Southeast Dothan Alabama Recruiting
East View Medical Research Mobile Alabama Recruiting
Clinnova Research Anaheim California Recruiting
Gastro Care Institute Lancaster California Recruiting
United Gastroenterologists Los Alamitos California Recruiting
TLC Clinical Research Inc Los Angeles California Recruiting
GastroIntestinal Bioscience Los Angeles California Recruiting
Hoag Memorial Hospital Newport Beach California Suspended
Medical Associates Research Group, Inc. San Diego California Recruiting
Peak Gastroenterology Associates Colorado Springs Colorado Recruiting
Medical Research Center of Connecticut Hamden Connecticut Recruiting
Green Leaf Clinical Trials Jacksonville Florida Recruiting
Sanchez Clinical Research, Inc Miami Florida Recruiting
Biodax Medical Research Trials Miami Florida Recruiting
GI Pros Research Naples Florida Recruiting
GCP Clinical Research Tampa Florida Recruiting
Morehouse School of Medicine Atlanta Georgia Recruiting
Atlanta Gastroenterology Associates Atlanta Georgia Suspended
Gastroenterology Associates of Central GA Macon Georgia Recruiting
Comprehensive Gastrointestinal Health Libertyville Northbrook Illinois Suspended
Cotton-O'Neil Clinical Research Center Topeka Kansas Recruiting
Gastroenterology Clinic of Acadiana Lafayette Louisiana Recruiting
Woodholme Gastroenterology Associates Glen Burnie Maryland Recruiting
Lucida Clinical Trials New Bedford Massachusetts Recruiting
Michigan Center of Medical Research Farmington Hills Michigan Recruiting
Westchester Putnam Gastroenterology Carmel New York Recruiting
New York Gastroenterology Associates New York New York Recruiting
University of North Carolina at Chapel Hill Chapel Hill North Carolina Recruiting
Charlotte Gastroenterology and Hepatology, PLLC Charlotte North Carolina Recruiting
Great Lakes Gastroenterology Research, LLC Mentor Ohio Recruiting
Digestive Disease Specialists Inc Oklahoma City Oklahoma Recruiting
Frontier Clinical Research Uniontown Pennsylvania Recruiting
Palmetto Primary and Specialty Care Physicians, Charleston Summerville South Carolina Recruiting
DFW Clinical Trials Carrollton Texas Recruiting
UT Southwestern Dallas Texas Suspended
Lubbock Gastroenterology Lubbock Texas Recruiting
Gastroenterology Research of America, LLC San Antonio Texas Recruiting
Southern Star Research Institute, LLC San Antonio Texas Recruiting
The University of Texas Health Science Center at Tyler Tyler Texas Recruiting
LKH-Univ. Klinikum Graz Graz Austria Recruiting

+ 120 more sites — see the full list on the official registry below.

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 NCT07499232 on ClinicalTrials.gov ↗ ← All trials in the UK