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Monoclonal Antibodies

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

Verified Trial
Phase 2
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)
Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohn's disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights

Summary

This trial is testing whether a new drug is better than existing drugs at treating psoriasis.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, injection site reactions, increased risk of infection, allergic responses, and possibly others not listed here as these are common risks associated with biologic treatments for autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a confirmed diagnosis of moderate to severe Crohn's disease.
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I have Crohn's disease and did not respond well to at least one biologic treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Clinical Remission at Week 48
Percentage of Participants with Endoscopic Response at Week 48
Secondary outcome measures
Percentage of Participants with Adverse Events (AEs)
Percentage of Participants with Antibodies to Golimumab
Percentage of Participants with Antibodies to Guselkumab
+11 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5990
Golimumab
2014
Completed Phase 4
~3480

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Crohn's Disease often involve specific pathway inhibition targeting key inflammatory mediators. Guselkumab, for example, targets interleukin-23 (IL-23), a cytokine involved in inflammatory responses, while golimumab targets tumor necrosis factor-alpha (TNF-alpha), another key cytokine in inflammation. These treatments aim to reduce inflammation by inhibiting specific pathways that drive the immune response in Crohn's Disease. This targeted approach is crucial for effectively managing symptoms and potentially inducing remission in patients.
Mediators of mucosal inflammation: implications for therapy.Functional relevance of soluble TNF-alpha, transmembrane TNF-alpha and TNF-signal transduction in gastrointestinal diseases with special reference to inflammatory bowel diseases.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
980 Previous Clinical Trials
6,383,578 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
749 Previous Clinical Trials
3,960,232 Total Patients Enrolled

Media Library

Golimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05242471 — Phase 2
Crohn's Disease Research Study Groups: Group 6: JNJ-78934804 (Low-dose), Group 2: Guselkumab, Group 3: Golimumab, Group 1: Placebo, Group 4: JNJ-78934804 (High-dose), Group 5: JNJ-78934804 (Mid-dose)
Crohn's Disease Clinical Trial 2023: Golimumab Highlights & Side Effects. Trial Name: NCT05242471 — Phase 2
Golimumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05242471 — Phase 2
Crohn's Disease Patient Testimony for trial: Trial Name: NCT05242471 — Phase 2
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