180 Participants Needed

JNJ-95597528 for Atopic Dermatitis

(READY-AD Trial)

Recruiting at 13 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Janssen Research & Development, LLC
Prior Safety DataThis treatment has passed at least one previous human trial

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-95597528, for individuals with moderate to severe atopic dermatitis, a type of eczema that causes itchy, inflamed skin. Participants will receive varying doses of the treatment or a placebo to determine the most effective option. Ideal candidates have experienced ongoing eczema symptoms for at least a year and have not responded well to standard topical or systemic treatments. Those who fit this profile and are otherwise healthy may find this trial a valuable opportunity. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, contributing to important findings.

Will I have to stop taking my current medications?

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

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

Research has shown that JNJ-95597528 is being tested for safety in individuals with moderate to severe atopic dermatitis, a skin condition causing red, itchy patches. Although detailed safety information for this treatment isn't widely available yet, it is currently in a mid-stage clinical trial. Early tests have demonstrated reasonable safety, as treatments must pass initial safety checks before reaching this stage. Additionally, JNJ-95597528 is being developed for other conditions like asthma, indicating broader safety testing.

While the treatment is still under study, reaching this phase suggests that earlier research likely addressed any serious safety concerns. Overall, JNJ-95597528 appears well-tolerated, but ongoing studies will provide more detailed information on potential side effects.12345

Why do researchers think this study treatment might be promising for atopic dermatitis?

Researchers are excited about JNJ-95597528 for atopic dermatitis because it offers a potentially new approach compared to existing treatments like topical corticosteroids and calcineurin inhibitors. While standard therapies often focus on reducing inflammation, JNJ-95597528 might work through a different mechanism, possibly targeting specific pathways involved in the condition more precisely. This could mean fewer side effects and more effective relief for patients, especially those who haven't responded well to current options. Additionally, the structured dosing schedule might provide a more consistent therapeutic effect over time.

What evidence suggests that JNJ-95597528 might be an effective treatment for atopic dermatitis?

Research has shown that JNJ-95597528 targets two main pathways involved in atopic dermatitis, a skin condition that causes itchy and inflamed skin. Previous patients experienced promising results, with a reduction in symptom severity. This trial will evaluate different dosing regimens of JNJ-95597528: some participants will receive Dose 1, others will receive Doses 2 and 3, and another group will receive Doses 4 and 5. Additionally, one group will initially receive a placebo before switching to JNJ-95597528. Studies indicate that this treatment may help reduce inflammation, a major cause of skin problems in atopic dermatitis. Early findings suggest that JNJ-95597528 can effectively relieve symptoms compared to a placebo, offering hope for those with moderate to severe cases. The treatment uses a bispecific antibody, an innovative approach to addressing this skin condition.13467

Who Is on the Research Team?

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for individuals with moderate to severe atopic dermatitis (AD), who have had symptoms for at least a year, and an EASI score of 16 or more. Participants must have a history of inadequate response to topical or systemic AD treatments and be in good health based on physical exams and tests.

Inclusion Criteria

I am generally healthy based on recent medical exams.
I am willing to sign a consent form to participate in the study.
I am willing to join a specific part of the study and will sign an extra consent form for it.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JNJ-95597528 or placebo with dose adjustments at Weeks 0, 2, 12, and 24

24 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • JNJ-95597528

Trial Overview

The study is testing the effectiveness of JNJ-95597528 compared to a placebo in treating AD. It involves participants taking either the investigational drug or placebo to see which one better improves their skin condition.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 3: JNJ-95597528 (Dose 4 and 5)Experimental Treatment1 Intervention
Group II: Group 2: JNJ-95597528 (Dose 2 and 3)Experimental Treatment1 Intervention
Group III: Group 1: JNJ-95597528 (Dose 1)Experimental Treatment1 Intervention
Group IV: Group 4: Placebo and JNJ-95597528 (Dose 2 and 3)Placebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

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 profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

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

Citations

NCT07230860 | A Study of JNJ-95597528 in Participants ...

The purpose of this study is to assess how well JNJ-95597528 works compared to placebo in participants with moderate to severe atopic dermatitis (AD). Official ...

JNJ-95597528 - Drug Targets, Indications, Patents

... Efficacy and Safety of JNJ-95597528 for the Treatment of Adult Participants With Moderate to Severe Atopic Dermatitis. CTIS2024-517644-62-00.

A Study of JNJ-95597528 in Participants With Moderate to ...

The purpose of this study is to assess how well JNJ-95597528 works compared to placebo in participants with moderate to severe atopic dermatitis ...

Johnson & Johnson strengthens pipeline to lead in atopic ...

NM26 is a Phase 2-ready, first-in-class bispecific antibody targeting two clinically proven pathways in atopic dermatitis (AD)

Chinese Clinical Trial Register (ChiCTR)

A Study of JNJ-95597528 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis ... To evaluate the efficacy of JNJ-95597528 ...

ANZCTR - Registration

Intervention Description: JNJ-95597528 will be administered at a dose decided by data safety monitoring board (DSMB) equivalent starting ...

JNJ 95597528 - AdisInsight

JNJ 95597528 is being developed by Janssen Cilag, in collaboration with Janssen Research and Development, for the treatment of asthma, ...