Recruiting
Phase 3

JNJ-78934804 vs. Guselkumab

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07577843

Conditions

Crohn Disease

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 Crohn's disease (a long-term, progressive \[worsens with time\] and life-threatening disease of the intestine).

Conditions

Crohn Disease

Study ID

NCT07577843

Start date

May 22, 2026

Status verified date

Aug, 2026

Completion date

Jul 12, 2030

Anticipated

Primary completion date

Jun 12, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
  • Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score >= 220 but less than or equal to (<=) 450 and either: a. Mean daily stool frequency (SF) count >= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score >= 2.0, based on the unweighted CDAI component of abdominal pain (AP)
  • Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria
  • Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies

Exclusion criteria:

  • Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC
  • Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study
  • Presence of draining (that is, functioning) stoma or ostomy
  • Has a history of short bowel syndrome, is missing greater than (>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention
  • Currently has or is suspected of having an abscess

Study Design

Enrollment

460 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 treatment phase (Week 48) and who may 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 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 double-blind treatment phase (Week 48) and who may 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

  • Co-Primary: Percentage of Participants with Clinical Remission at Week 48 [ Time Frame: At Week 48 ]
  • Co-Primary: Percentage of Participants with Endoscopic 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

University of North Carolina Hospital

Recruiting

Chapel Hill, North Carolina, United States, 27599

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

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

London Digestive Disease Institute

Recruiting

London, Ontario, Canada, N6K 1M6

West GTA Research Inc

Recruiting

Mississauga, Ontario, Canada, L5M 2S4

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.