JNJ-95475939 for Atopic Dermatitis

(DUPLEX-AD Trial)

Recruiting at 82 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Must not be taking: IL-4 inhibitors

Disqualifiers: Pregnancy, Active skin disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 22 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new treatment, JNJ-95475939, for individuals with moderate to severe atopic dermatitis, a skin condition causing red, itchy patches. Participants will receive either this experimental drug, a placebo (a substance with no active medicine), or an existing treatment called Dupilumab. The trial aims to determine if JNJ-95475939 is more effective than the placebo and how it compares to Dupilumab. It suits those who have struggled with atopic dermatitis for at least a year and have not found success with other treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in atopic dermatitis care.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that JNJ-95475939 is currently being tested for safety and effectiveness in treating moderate to severe atopic dermatitis. Although specific safety information is not yet available, its progression to Phase 2 indicates prior safety testing in a smaller group. Phase 2 trials primarily focus on further assessing safety and determining the appropriate dose.

It is important to note that JNJ-95475939 has not been approved for any condition, and its safety in humans remains under study. Prospective participants should remember that the treatment is experimental. For more questions about its safety, consulting a healthcare provider could be beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about JNJ-95475939 for atopic dermatitis because it offers a fresh approach compared to current treatments like Dupilumab. While most treatments focus on alleviating inflammation, JNJ-95475939 is designed to work at a deeper level by targeting specific pathways related to immune response. This targeted action could mean more effective results with potentially fewer side effects. Additionally, the flexibility in dosing regimens allows for personalized treatment plans, which is promising for patients seeking tailored solutions for their skin condition.

What evidence suggests that this trial's treatments could be effective for atopic dermatitis?

Research has shown that JNJ-95475939 is being tested in this trial to determine its effectiveness for moderate to severe atopic dermatitis, a condition that causes itchy and inflamed skin. This treatment targets specific parts of the immune system responsible for inflammation in atopic dermatitis. Early results suggest that this approach might ease symptoms by calming the skin's immune response. Although data from human studies remains limited, the findings so far are promising and suggest a potential new way to manage this challenging condition. Participants in this trial may receive one of several dose regimens of JNJ-95475939 or a placebo, while others will receive Dupilumab as an active comparator. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-95475939

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.

How Is the Trial Designed?

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+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06881251

A Study of JNJ-95475939 in the Treatment of Participants ... 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.

2. isrctn.com isrctn.com/ISRCTN16314965

A study of JNJ-95475939 in the treatment of participants ... To evaluate how well the treatment with JNJ-95475939 works (efficacy) as compared to placebo in participants with moderate to severe Atopic Dermatitis (AD).

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/582739

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

4. uclahealth.org uclahealth.org/clinical-trials/study-jnj-95475939-treatment-participants-with-moderate

A Study of JNJ-95475939 in the Treatment of Participants ... 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.

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-jnj-95475939-and-dupilumab-for-treating-moderate-to-severe-atopic-dermatitis-in-adults/

Study on the Effectiveness and Safety of JNJ-95475939 ... This clinical trial is focused on studying the effectiveness and safety of a new treatment for people with moderate to severe atopic dermatitis.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06881251

A Study of JNJ-95475939 in the Treatment of Participants ... 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.

7. isrctn.com isrctn.com/pdf/16314965

A study of JNJ-95475939 in the treatment of participants ... ... JNJ-95475939 works (efficacy) as compared to placebo in participants with moderate to severe Atopic Dermatitis (AD). Secondary objectives.