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Clinical Trials in Spain / NCT05242471
Active, not recruiting Phase 2

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 Spain tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 2
Started
2022-07-22
Last updated
2026-09-28

Condition(s) studied

Crohn's Disease

Investigational drug(s) / intervention(s)

Guselkumab →Golimumab →JNJ-78934804 →Placebo

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
No
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)

FacilityCityRegionStatus
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.

On this site

📄 Tremfya (guselkumab) drug profile → 📄 Simponi (golimumab) drug profile →

More Janssen Research & Development, LLC trials in Spain

A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer Recruiting
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease Recruiting
A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Recruiting
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease Recruiting
A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC) Recruiting

Other trials for the same condition

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease Recruiting
Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis Recruiting
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease Recruiting
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD) Recruiting
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease Recruiting
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 Spain