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Clinical Trials in South Korea / NCT07577843
Recruiting Phase 3

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

NCT07577843 · tracked via the Priya Life Science South Korea 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-78934804 →Guselkumab →

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
No
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)

FacilityCityRegionStatus
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

📄 Tremfya (guselkumab) drug profile →

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Other trials for the same condition

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A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease Active, not recruiting
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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 South Korea