Combination Therapy for Crohn's Disease
(DUET-CD Trial)

Recruiting in Palo Alto (17 mi)

+604 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Janssen Research & Development, LLC

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called JNJ-78934804 to see if it works better than two existing treatments for autoimmune conditions. The study will compare their effectiveness over several months.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for adults with moderate to severe Crohn's Disease who haven't had success with at least one biologic treatment. They must have been diagnosed at least 3 months prior and meet specific disease activity criteria. Women of childbearing age should comply with contraception requirements. Exclusions include a recent history of cancer, certain infections, or recent surgeries.

Inclusion Criteria

I have Crohn's disease and did not respond well to at least one biologic treatment.

I have been diagnosed with Crohn's disease for at least 3 months.

I have a confirmed diagnosis of moderate to severe Crohn's disease.

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Exclusion Criteria

I have or might have an abscess, but if it was drained and treated properly, I can still participate.

I have not had major surgery or bowel resection in the past 6 months.

I have a history of or currently have a chronic infection.

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Treatment Details

Interventions

Golimumab (Monoclonal Antibodies)
Guselkumab (Monoclonal Antibodies)
JNJ-78934804 (Monoclonal Antibodies)
Placebo (Other)

Trial OverviewThe study tests the effectiveness of JNJ-78934804 against guselkumab and golimumab in treating Crohn's Disease by week 48. Participants will receive either the experimental drug (JNJ-78934804) or one of the known drugs along with a placebo to compare results.

Participant Groups

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 6: JNJ-78934804 (Low-dose)Experimental Treatment1 Intervention

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.

Group II: Group 5: JNJ-78934804 (Mid-dose)Experimental Treatment1 Intervention

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.

Group III: Group 4: JNJ-78934804 (High-dose)Experimental Treatment1 Intervention

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.

Group IV: Group 3: GolimumabExperimental Treatment1 Intervention

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.

Group V: Group 2: GuselkumabExperimental Treatment1 Intervention

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.

Group VI: Group 1: PlaceboPlacebo Group1 Intervention

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.

Golimumab is already approved in Canada for the following indications: