A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

NCT05242471 · tracked via the Priya Life Science India tracker

Sponsor

Janssen Research & Development, LLC

Phase

Phase 2

Started

2022-07-22

Last updated

2026-08-28

Condition(s) studied

Crohn's Disease

Investigational drug(s) / intervention(s)

GuselkumabGolimumabJNJ-78934804Placebo

Guselkumab: Guselkumab will be administered as subcutaneous injection.

Golimumab: Golimumab will be administered as subcutaneous injection.

JNJ-78934804: JNJ-78934804 will be administered subcutaneously as per defined regimen.

Placebo: Placebo will be administered as subcutaneous injection.

Study summary

The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline * Confirmed diagnosis of moderate to severe CD as assessed by Crohn'

Primary outcome measure(s)

Percentage of Participants with Clinical Remission at Week 48 — Week 48
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).
Percentage of Participants with Endoscopic Response at Week 48 — Week 48
Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the simple endoscopic score for Crohn's disease (SES-CD), as assessed by central endoscopy reading.

Trial sites (456)

Facility	City	Region
University of Alabama Liver Center	Birmingham	Alabama
Del Sol Research Management, LLC	Tucson	Arizona
Moore Clinical Trials, LLC	Little Rock	Arkansas
Om Research LLC	Apple Valley	California
Valley Gastroenterology Medical Group	Arcadia	California
Southern California Research Center	Coronado	California
Desert Gastroenterology Associates	Lancaster	California
Cedars Sinai Medical Center	Los Angeles	California
UCLA	Los Angeles	California
Hoag Memorial Hospital	Newport Beach	California
UCI Irvine Medical Center	Orange	California
Medical Associates Research Group, Inc.	San Diego	California
University of California San Francisco	San Francisco	California
University of Colorado	Aurora	Colorado
Medical Research Center of Connecticut	Hamden	Connecticut
Yale University School Of Medicine	New Haven	Connecticut
MedStar Georgetown University Hospital	Washington D.C.	District of Columbia
Pioneer Research Solutions Inc.	Coconut Creek	Florida
Homestead Associates in Research Inc	Homestead	Florida
Osceola Mental Health D/B/A Park Place Behavioral Health Care	Kissimmee	Florida
Florida Research Center Inc.	Lakewood Rch	Florida
University of Miami Hospital	Miami	Florida
Gastroenterology Group Of Naples	Naples	Florida
Omega Research Consultants	Orlando	Florida
Synergy Clinical Research	St. Petersburg	Florida
GCP Clinical Research	Tampa	Florida
Atlanta Gastroenterology Associates	Atlanta	Georgia
University of Mississippi Medical Center	Atlanta	Georgia
Gastroenterolgy Associates of Central GA	Macon	Georgia
Gastrointestinal Specialists of Georgia	Marietta	Georgia
Northwestern University	Chicago	Illinois
IU Health University Hospital	Indianapolis	Indiana
Gastroenterology of Southern Indiana	New Albany	Indiana
Cotton O'Neil Digestive Health Center	Topeka	Kansas
Ascension via Christi Research	Wichita	Kansas
Univ. of KS School of Med	Wichita	Kansas
Tri-State Gastroenterology Assoc	Crestview Hills	Kentucky
University of Kentucky	Lexington	Kentucky
Jewish Hospital	Louisville	Kentucky
Gastroenterology Clinic of Acadiana	Lafayette	Louisiana

+ 416 more sites — see the full list on the official registry below.

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 NCT05242471 on ClinicalTrials.gov ↗ ← All trials in India