We Partner 4 Research

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

Purpose

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

Condition

Crohn's Disease

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Criteria

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'

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Placebo Comparator Group 1: Placebo	Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.	Drug: Placebo Placebo will be administered as subcutaneous injection.
Experimental Group 2: Guselkumab	Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.	Biological: Guselkumab Guselkumab will be administered as subcutaneous injection.
Experimental Group 3: Golimumab	Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.	Biological: Golimumab Golimumab will be administered as subcutaneous injection.
Experimental Group 4: JNJ-78934804 (High-dose)	Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.	Biological: JNJ-78934804 JNJ-78934804 will be administered subcutaneously as per defined regimen.
Experimental Group 5: JNJ-78934804 (Mid-dose)	Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.	Biological: JNJ-78934804 JNJ-78934804 will be administered subcutaneously as per defined regimen.
Experimental Group 6: JNJ-78934804 (Low-dose)	Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.	Biological: JNJ-78934804 JNJ-78934804 will be administered subcutaneously as per defined regimen.

More Details

Status: Active, not recruiting
Sponsor: Janssen Research & Development, LLC

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.