Suspended

DUPLEX-ADJNJ-95475939 for Moderate to Severe Atopic Dermatitis

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What is being tested

Dupilumab

+ JNJ-95475939

+ Placebo

Drug
Who is being recruted

Dermatitis+8

+ Dermatitis, Atopic

+ Hypersensitivity

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: February 2025
See protocol details

Summary

Principal SponsorJanssen Research & Development, LLC
Last updated: March 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 26, 2025

Actual date on which the first participant was enrolled.

This study is focused on assessing the effectiveness and safety of a new treatment called JNJ-95475939 for people suffering from moderate to severe atopic dermatitis, a chronic skin condition causing itchy and inflamed patches. The study aims to compare the effects of this new treatment with a placebo, which is a substance with no active medication. Understanding whether JNJ-95475939 can offer better relief for patients is crucial, as it may lead to improved treatment options for those struggling with this uncomfortable and often distressing skin condition. Participants in this study are randomly assigned to receive either the JNJ-95475939 treatment or a placebo. This approach helps ensure that the results are reliable. The treatment is administered under controlled conditions, though the text does not specify the method of administration. Researchers then monitor the participants to evaluate the treatment's effectiveness and observe any side effects. The aim is to gather comprehensive safety and effectiveness data to determine if JNJ-95475939 is a viable treatment option for atopic dermatitis.

Official TitleA Phase 2b, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of JNJ-95475939 for the Treatment of Participants With Moderate to Severe AD
NCT06881251
Principal SponsorJanssen Research & Development, LLC
Last updated: March 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

256 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DermatitisDermatitis, AtopicHypersensitivityHypersensitivity, ImmediateImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin Diseases, GeneticSkin and Connective Tissue DiseasesSkin Diseases, EczematousGenetic Diseases, Inborn

Criteria

2 inclusion criteria required to participate
Eczema Area and Severity Index (EASI) score greater than and equal to ( >= ) 16 at the screening and baseline visits
Baseline Peak Pruritus Numeric(al) Rating Scale (PP-NRS) average score of >= 4
1 exclusion criteria prevent from participating
History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, untreated latent tuberculosis), recurrent urinary tract infection, fungal infection, mycobacterial infection, or open, draining, or infected skin wounds, or ulcers

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

20% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Group III

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

Group IV

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

Group 5

Placebo
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 71 locations

Suspended

First OC Dermatology

Fountain Valley, United StatesOpen First OC Dermatology in Google Maps
Suspended

University of California Los Angeles - Division of Dermatology

Los Angeles, United States
Suspended

Hamilton Research LLC

Alpharetta, United States
Suspended

DeNova Research

Chicago, United States
Suspended71 Study Centers