This study is in progress, not accepting new patients

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

a study on Crohn's Disease Inflammatory Bowel Disease

Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at UC Irvine UCLA UCSF
Dates
study started
completion around
Principal Investigator
by Jenny S. Sauk, MD (ucla)
Headshot of Jenny S. Sauk
Jenny S. Sauk

Description

Summary

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

Official Title

A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

Keywords

Crohn's Disease, Crohn Disease, Golimumab, Guselkumab, JNJ-78934804

Eligibility

For people ages 18-65

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'

Locations

  • UCLA
    Los Angeles California 90095 United States
  • UCI Irvine Medical Center
    Orange California 92868 United States
  • University of California San Francisco
    San Francisco California 94115 United States
  • Hoag Memorial Hospital
    Newport Beach California 92658 United States
  • Cedars Sinai Medical Center
    Los Angeles California 90048 United States
  • Medical Associates Research Group, Inc.
    San Diego California 92123 United States
  • Southern California Research Center
    Coronado California 92118 United States
  • Valley Gastroenterology Medical Group
    Arcadia California 91006 United States

Lead Scientist at University of California Health

  • Jenny S. Sauk, MD (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 64 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT05242471
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 703 people participating
Last Updated