A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (DUET-CD)

Janssen (J&J Innovative Medicine)

Status and phase: Active, not recruiting; Phase 2

Conditions: Crohn's Disease

Treatments: Biological: JNJ-78934804; Biological: Golimumab; Biological: Guselkumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05242471

2021-003314-39 (EudraCT Number)

2023-504741-32-00 (Registry Identifier)

78934804CRD2001 (Other Identifier)

CR109178

Details and patient eligibility

About

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

Enrollment: 703 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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'

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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703 participants in 6 patient groups, including a placebo group

Group 1: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Group 2: Guselkumab

Experimental group

Description:

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.

Treatment:

Biological: Guselkumab

Group 3: Golimumab

Experimental group

Description:

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.

Treatment:

Biological: Golimumab

Group 4: JNJ-78934804 (High-dose)

Experimental group

Description:

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.

Treatment:

Biological: JNJ-78934804

Group 5: JNJ-78934804 (Mid-dose)

Experimental group

Description:

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.

Treatment:

Biological: JNJ-78934804

Group 6: JNJ-78934804 (Low-dose)

Experimental group

Description:

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.

Treatment:

Biological: JNJ-78934804