What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease that target specific inflammatory pathways, such as IL-23 inhibitors (e.g., guselkumab) and TNF-alpha inhibitors (e.g., golimumab), often have side effects including increased risk of infections (e.g., upper respiratory tract infections), injection site reactions, and gastrointestinal symptoms like diarrhea. Other potential adverse effects can include fatigue, headache, and in some cases, more serious conditions like liver enzyme abnormalities and hypersensitivity reactions. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Crohn's Disease that target key inflammatory mediators. Anti-TNF agents such as infliximab, adalimumab, and certolizumab pegol are commonly used and have shown efficacy in reducing inflammation and inducing remission. Additionally, ustekinumab, which targets interleukin-12 and interleukin-23, has been approved for moderate to severe Crohn's Disease. These treatments are similar to the ones being studied in the trial JNJ-78934804, which involves guselkumab (an IL-23 inhibitor) and golimumab (an anti-TNF agent).

What other types of research exist?

Promising novel alternatives to JNJ-78934804 for Crohn's Disease patients include: 1) TJ-M2010-6, a MyD88 inhibitor that has shown efficacy in reducing diabetes onset and insulitis in NOD mice, indicating potential anti-inflammatory effects. 2) CBP30, a selective CBP/p300 bromodomain inhibitor, which suppresses Th17 responses and may offer targeted anti-inflammatory benefits with fewer side effects. 3) J114, an inhibitor of NLRP3 and AIM2 inflammasome-dependent pyroptosis, which has demonstrated significant inhibition of inflammatory pathways in human macrophages.

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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

Summary

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.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants with Clinical Remission at Week 48

Percentage of Participants with Endoscopic Response at Week 48

Secondary study objectives

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

~6080

Golimumab

2014

Completed Phase 4

~3610

0 / 2Eligibility criteria met

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.