JNJ-95597528 for Atopic Dermatitis
(READY-AD 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.12345Why 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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive JNJ-95597528 or placebo with dose adjustments at Weeks 0, 2, 12, and 24
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
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Treatment groups
Experimental Treatment
Placebo Group
Participants will receive JNJ-95597528 Dose 4 on Week 0 followed by JNJ-95597528 Dose 5 on Weeks 12, and 24.
Participants will receive JNJ-95597528 Dose 2 on Week 0 followed by JNJ-95597528 Dose 3 on Weeks 12, and 24.
Participants will receive JNJ-95597528 Dose 1 on Weeks 0, 2, 12, and 24.
Participants will receive placebo from Weeks 0 to 12 , then switch to receive JNJ-95597528 Dose 2 administered at Week 12 followed by Dose 3 at Week 24.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
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
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.
3.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-jnj-95597528-in-participants-with-moderate-to-severe-atopic-dermatitisA 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, ...
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