JNJ-95475939 for Atopic Dermatitis

(DUPLEX-AD Trial)

Recruiting at 12 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Janssen Research & Development, LLC

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate how well JNJ-95475939 works as compared to placebo in participants with moderate to severe atopic dermatitis.

Eligibility Criteria

This trial is for people with moderate to severe atopic dermatitis (AD) who haven't responded well to other treatments. They should have had AD symptoms for at least a year, an EASI score of 16 or more, and affected body surface area of 10% or greater. Participants must not be pregnant, breastfeeding, or planning pregnancy; they can't join if they've failed IL-4Rα inhibitors like Dupilumab before.

Inclusion Criteria

Eczema Area and Severity Index (EASI) score >= 16 at the screening and baseline visits

I have had chronic eczema for at least a year.

My eczema is moderate to severe.

Exclusion Criteria

Participant is pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study

I stopped using certain medications due to no improvement or side effects.

I do not have any significant skin conditions besides AD that could affect treatment assessment.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JNJ-95475939 or placebo subcutaneously through Week 22

22 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

Treatment Details

Interventions

• JNJ-95475939 (Monoclonal Antibodies)

Trial Overview The study tests JNJ-95475939's effectiveness against a placebo in individuals with moderate to severe AD. It will compare the new treatment's results with those from no active medication. Some participants may also receive Dupilumab as part of the study comparison.

Participant Groups

Group I: Group D: JNJ-95475939 Experimental Treatment 1 Intervention

Participants will receive JNJ-95475939 dose regimen 3 subcutaneously through Week 22.

Group II: Group C: JNJ-95475939 Experimental Treatment 1 Intervention

Participants will receive JNJ-95475939 dose regimen 2 subcutaneously through Week 22.

Group III: Group B: JNJ-95475939 Experimental Treatment 1 Intervention

Participants will receive JNJ-95475939 dose regimen 1 subcutaneously through Week 22.

Group IV: Group A: Dupilumab Active Control 1 Intervention

Participants will receive Dupilumab dose regimen 1 subcutaneously through Week 22.

Group V: Group E: Placebo Placebo Group 2 Interventions

Participants will receive matching placebo subcutaneously through Week 10, then switch to receive JNJ-95475939 dose regimen 1 subcutaneously between Week 12 and Week 22.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires