Recruiting
Phase 3

JNJ-78934804 vs. Guselkumab

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07577856

Conditions

Colitis, Ulcerative

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JNJ-78934804

Guselkumab

Study Details

Brief summary:

The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).

Conditions

Colitis, Ulcerative

Study ID

NCT07577856

Start date

May 23, 2026

Status verified date

Aug, 2026

Completion date

Oct 16, 2030

Anticipated

Primary completion date

Aug 11, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.
  • Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy
  • An endoscopy subscore >=2 as obtained during central review of the screening video endoscopy
  • Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies

Exclusion criteria:

  • Isolated proctitis (UC limited to the rectum only or to less than \[<\] 20 centimeter \[cm\] from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis
  • Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD
  • Has a history of or ongoing chronic or recurrent infectious disease
  • Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab
  • Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention

Study Design

Enrollment

644 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: JNJ-78934804

Participants will receive JNJ-78934804 induction dose at Weeks 0, 4, and 8 followed by JNJ-78934804 maintenance dose, once every 4 weeks (q4w) starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind (DB) treatment phase (Week 48) and benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.

active comparator: Guselkumab

Participants with moderately to severely active UC will receive guselkumab induction dose at Weeks 0, 4, and 8 followed by guselkumab maintenance dose q4w starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete DB treatment phase (Week 48) and benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the LTE phase.

Interventions

JNJ-78934804

JNJ-78934804 will be administered subcutaneously.

Guselkumab

Guselkumab will be administered subcutaneously.

Primary outcome measure

  • Percentage of Participants in Clinical Remission at Week 48 [ Time Frame: At Week 48 ]

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

Clinnova Research

Recruiting

Anaheim, California, United States, 92805

Gastro SB Clinic

Recruiting

Chula Vista, California, United States, 91910

United Medical Doctors

Recruiting

Los Alamitos, California, United States, 90720

Medical Associates Research Group, Inc.

Recruiting

San Diego, California, United States, 92123

Peak Gastroenterology Associates

Recruiting

Colorado Springs, Colorado, United States, 80907

Florida Research Center Inc.

Recruiting

Lakewood Rch, Florida, United States, 34211

Sanchez Clinical Research, Inc

Recruiting

Miami, Florida, United States, 33157-6575

GCP Clinical Research

Recruiting

Tampa, Florida, United States, 33609

Atlanta Gastroenterology Specialists

Recruiting

Suwanee, Georgia, United States, 30024

Tri-State Gastroenterology Assoc

Recruiting

Crestview Hills, Kentucky, United States, 41017

Gastroenterology Clinic of Acadiana

Recruiting

Lafayette, Louisiana, United States, 70503

Michigan Center of Medical Research

Recruiting

Farmington Hills, Michigan, United States, 48334

New York Gastroenterology Associates

Recruiting

New York, New York, United States, 10075

Great Lakes Gastroenterology Research, LLC

Recruiting

Mentor, Ohio, United States, 44060

Digestive Disease Specialists Inc

Recruiting

Oklahoma City, Oklahoma, United States, 73114

The Oregon Clinic

Recruiting

Portland, Oregon, United States, 97220

Gastro One

Recruiting

Cordova, Tennessee, United States, 38018

Southern Star Research Institute, LLC

Recruiting

San Antonio, Texas, United States, 78229

Tyler Research Institute, LLC

Recruiting

Tyler, Texas, United States, 75701

GI Alliance Tacoma

Recruiting

Tacoma, Washington, United States, 98405

South Edmonton Gastroenterology Research Clinic

Recruiting

Edmonton, Alberta, Canada, Code: T6K 4B2

Gastroenterology and Internal Medicine Research Institute (GIRI)

Recruiting

Edmonton, Alberta, Canada, T5R 1W2

GI Research Institute (G.I.R.I.)

Recruiting

Vancouver, British Columbia, Canada, V6Z 2K5

Viable Clinical Research

Recruiting

Kentville, Nova Scotia, Canada, B4N 0A3

Barrie GI Associates

Recruiting

Barrie, Ontario, Canada, L4M 7G1

Charlton Digestive Disease Centre

Recruiting

Hamilton, Ontario, Canada, L8N1Y2

London Digestive Disease Institute

Recruiting

London, Ontario, Canada, N6K 1M6

Toronto Immune and Digestive Health Institute Inc

Recruiting

Toronto, Ontario, Canada, M6A 3B4

CHUM - Centre hospitalier universitaire 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.