Recruiting
Phase 3

Guselkumab vs. Risankizumab

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07499232

Conditions

Crohn Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Guselkumab

Risankizumab

Study Details

Brief 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).

Conditions

Crohn Disease

Study ID

NCT07499232

Start date

Apr 21, 2026

Status verified date

Aug, 2026

Completion date

Dec 11, 2030

Anticipated

Primary completion date

Nov 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

530 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Guselkumab

Participants will receive guselkumab induction dose subcutaneously (SC) at Weeks 0, 4, and 8 followed by guselkumab maintenance dose SC once every 4 weeks (q4w) from Week 12 through Week 52.

experimental: Risankizumab

Participants will receive risankizumab induction dose intravenously (IV) at Weeks 0, 4, and 8 followed by risankizumab maintenance dose SC once every 8 weeks (q8w) from Week 12 through Week 52.

Interventions

Guselkumab

Guselkumab will be administered.

Risankizumab

Risankizumab will be administered.

Primary outcome measure

  • Number of Participants with Deep Remission at Week 52 [ Time Frame: At Week 52 ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

Digestive Health Specialists of the Southeast

Recruiting

Dothan, Alabama, United States, 36305

East View Medical Research

Recruiting

Mobile, Alabama, United States, 36608

Clinnova Research

Recruiting

Anaheim, California, United States, 92805

Gastro Care Institute

Recruiting

Lancaster, California, United States, 93534

United Gastroenterologists

Recruiting

Los Alamitos, California, United States, 90720

TLC Clinical Research Inc

Recruiting

Los Angeles, California, United States, 90048

GastroIntestinal Bioscience

Recruiting

Los Angeles, California, United States, 90067

Medical Associates Research Group, Inc.

Recruiting

San Diego, California, United States, 92123

Peak Gastroenterology Associates

Recruiting

Colorado Springs, Colorado, United States, 80907

Medical Research Center of Connecticut

Recruiting

Hamden, Connecticut, United States, 06518

Green Leaf Clinical Trials

Recruiting

Jacksonville, Florida, United States, 32258

Sanchez Clinical Research, Inc

Recruiting

Miami, Florida, United States, 33157-6575

Biodax Medical Research Trials

Recruiting

Miami, Florida, United States, 33186

GI Pros Research

Recruiting

Naples, Florida, United States, 34102

GCP Clinical Research

Recruiting

Tampa, Florida, United States, 33609

Morehouse School of Medicine

Recruiting

Atlanta, Georgia, United States, 30310

Gastroenterology Associates of Central GA

Recruiting

Macon, Georgia, United States, 31201

Cotton-O'Neil Clinical Research Center

Recruiting

Topeka, Kansas, United States, 66606

Gastroenterology Clinic of Acadiana

Recruiting

Lafayette, Louisiana, United States, 70503

Woodholme Gastroenterology Associates

Recruiting

Glen Burnie, Maryland, United States, 21061

Lucida Clinical Trials

Recruiting

New Bedford, Massachusetts, United States, 02740

Michigan Center of Medical Research

Recruiting

Farmington Hills, Michigan, United States, 48334

Westchester Putnam Gastroenterology

Recruiting

Carmel, New York, United States, 10512

New York Gastroenterology Associates

Recruiting

New York, New York, United States, 10075

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599 7080

Charlotte Gastroenterology and Hepatology, PLLC

Recruiting

Charlotte, North Carolina, United States, 28207

Great Lakes Gastroenterology Research, LLC

Recruiting

Mentor, Ohio, United States, 44060

Digestive Disease Specialists Inc

Recruiting

Oklahoma City, Oklahoma, United States, 73114

Frontier Clinical Research

Recruiting

Uniontown, Pennsylvania, United States, 15401

Palmetto Primary and Specialty Care Physicians, Charleston

Recruiting

Summerville, South Carolina, United States, 29486

DFW Clinical Trials

Recruiting

Carrollton, Texas, United States, 75010

Lubbock Gastroenterology

Recruiting

Lubbock, Texas, United States, 79424

Gastroenterology Research of America, LLC

Recruiting

San Antonio, Texas, United States, 78229

Southern Star Research Institute, LLC

Recruiting

San Antonio, Texas, United States, 78229

The University of Texas Health Science Center at Tyler

Recruiting

Tyler, Texas, United States, 75708

Gastroenterology and Internal Medicine Research Institute (GIRI)

Recruiting

Edmonton, Alberta, Canada, T5R 1W2

GIRI Gastrointestinal Research Institute

Recruiting

Vancouver, British Columbia, Canada, V6Z 2K5

Charlton Digestive Disease Centre

Recruiting

Hamilton, Ontario, Canada, L8N1Y2

London Digestive Disease Institute

Recruiting

London, Ontario, Canada, N6K 1M6

Taunton Surgical Centre

Recruiting

Oshawa, Ontario, Canada, L1J 0C7

Toronto Immune and Digestive Health Institute Inc

Recruiting

Toronto, Ontario, Canada, M6A 3B4

Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Clinique IMD

Recruiting

Montreal, Quebec, Canada, H3H1E3

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.