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

ArmDescriptionAssigned 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