A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

NCT07577843 · tracked via the Priya Life Science USA tracker

Sponsor

Janssen Research & Development, LLC

Phase

Phase 3

Started

2026-05-22

Last updated

2026-08-28

Condition(s) studied

Crohn Disease

Investigational drug(s) / intervention(s)

JNJ-78934804Guselkumab

JNJ-78934804: JNJ-78934804 will be administered subcutaneously.

Guselkumab: Guselkumab will be administered subcutaneously.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Co-Primary: Percentage of Participants with Clinical Remission at Week 48 — At Week 48
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than (\<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Co-Primary: Percentage of Participants with Endoscopic Remission at Week 48 — At Week 48
Endoscopic remission is defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of less than or equal to (\<=) 4 with at least a 2-point reduction from baseline and no subscore greater than (\>) 1 in any individual component. The SES-CD is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

Trial sites (142)

Facility	City	Region	Status
Clinnova Research	Anaheim	California	Recruiting
Gastro SB Clinic	Chula Vista	California	Recruiting
United Medical Doctors	Los Alamitos	California	Recruiting
Medical Associates Research Group, Inc.	San Diego	California	Recruiting
Peak Gastroenterology Associates	Colorado Springs	Colorado	Recruiting
Florida Research Center Inc.	Lakewood Rch	Florida	Recruiting
Sanchez Clinical Research, Inc	Miami	Florida	Recruiting
GCP Clinical Research	Tampa	Florida	Recruiting
Atlanta Gastroenterology Specialists	Suwanee	Georgia	Recruiting
Tri-State Gastroenterology Assoc	Crestview Hills	Kentucky	Recruiting
Gastroenterology Clinic of Acadiana	Lafayette	Louisiana	Recruiting
Michigan Center of Medical Research	Farmington Hills	Michigan	Recruiting
New York Gastroenterology Associates	New York	New York	Recruiting
University of North Carolina Hospital	Chapel Hill	North Carolina	Recruiting
Great Lakes Gastroenterology Research, LLC	Mentor	Ohio	Recruiting
Digestive Disease Specialists Inc	Oklahoma City	Oklahoma	Recruiting
The Oregon Clinic	Portland	Oregon	Recruiting
Gastro One	Cordova	Tennessee	Recruiting
Tyler Research Institute, LLC	Tyler	Texas	Recruiting
GI Alliance Tacoma	Tacoma	Washington	Recruiting
GEDYT	AAI	Argentina	Recruiting
Globalpsy	La Plata	Argentina	Recruiting
HIGEA	Mendoza	Argentina	Recruiting
Cer Instituto Medico	Quilmes	Argentina	Recruiting
Banksia Trials SA	Adelaide	Australia	Recruiting
Royal Prince Alfred Hospital	Camperdown	Australia	Recruiting
Monash Medical Centre	Clayton	Australia	Recruiting
The Melbourne Gut Clinic Epworth Hospital	East Melbourne	Australia	Recruiting
IBD SA	Kurralta Park	Australia	Recruiting
John Hunter Hospital	New Lambton Heights	Australia	Recruiting
Mater Misericordiae Hospital	South Brisbane	Australia	Recruiting
Universitair Ziekenhuis Antwerpen	Edegem	Belgium	Recruiting
Ghent University Hospital	Ghent	Belgium	Recruiting
Universitair Ziekenhuis Leuven	Leuven	Belgium	Recruiting
Algemeen Ziekenhuis Delta	Roeselare	Belgium	Recruiting
CDC - Centro Digestivo de Curitiba	Curitiba	Brazil	Recruiting
Cliged	Macaé	Brazil	Recruiting
Hospital De Clinicas De Porto Alegre	Porto Alegre	Brazil	Recruiting
Hospital Ernesto Dornelles	Porto Alegre	Brazil	Recruiting
Pesquisare Saude	Santo André	Brazil	Recruiting

+ 102 more sites — see the full list on the official registry below.

On this site

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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 NCT07577843 on ClinicalTrials.gov ↗ ← All trials in the USA