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New eczema drug shows promise in Mid-Stage trial

NCT ID NCT07230860

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests an experimental drug called JNJ-95597528 in 180 adults with moderate to severe atopic dermatitis (eczema). Participants will receive either the drug or a placebo to see if it improves skin symptoms by at least 75% after 12 weeks. The goal is to control the disease, not cure it, and ongoing treatment may be needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

189 people

The number who actually took part.

Started

Jan 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening * Meets all the following disease activity criteria: a. Chronic atopic dermatitis (AD), according to American Academy of Dermatology Consensus Criteria with onset of symptoms at least 1 year prior to screening visit; b. Eczema area and severity index (EASI) score greater than or equal to (\>=) 16 at the screening and Week 0; c. validated investigator global assessment for atopic dermatitis (vIGA-AD) score \>= 3 at screening and Week 0; d. \>= 10% body surface area (BSA) of AD involvement at screening and Week 0; e. Documented history (within 6 months before screening) of either inadequate response or inadvisability to medicated topical treatments for AD or inadequate response to systemic therapies (within 12 months before screening) * Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study * If willing to participate in the substudy, must sign a separate ICF for the corresponding substudy (or substudies) * Willing and able to comply with scheduled visits, treatment plan, laboratory tests, lifestyle restrictions, and other study procedures Exclusion criteria: * History of substance abuse or alcohol abuse within 1 year before screening * In the investigator's opinion, any clinically significant results from the 12-lead ECG, chemistry, hematology, or urinalysis laboratory tests obtained at the screening visit that would affect interpretation of study data or the participant's safety in the study * Known or suspected immunodeficiency, including history of invasive opportunistic infections * Previously received JNJ-95597528 * Has known hypersensitivity or intolerance to JNJ-95597528 or its excipients or to any biologic medication or known allergies, or clinically significant reactions to murine, chimeric, monoclonal antibodies (mAbs), or antibody fragments

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dermatitis, atopic

Contacts and locations

Locations

  • Allergy Research Canada Inc.

    Niagara Falls, Ontario, L2H 1H5, Canada

  • Arlington Dermatology

    Rolling Meadows, Illinois, 60008, United States

  • CCA Medical Research Corporation

    Ajax, Ontario, L1S7K8, Canada

  • CIPREC

    Buenos Aires, C1061AAS, Argentina

  • Center for Clinical Studies

    Houston, Texas, 77004, United States

  • Centro Respiratorio Infantil

    Rosario, 2000, Argentina

  • Centro de Investigaciones Clinicas CIC IESR

    Rosario, 2000, Argentina

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, T4000AXL, Argentina

  • Cepes - Fmabc

    São Paulo, 09060-870, Brazil

  • Ceti - Centro de Estudos Em Terapias Inovadoras

    Curitiba, 80030 110, Brazil

  • Chang Gung Memorial Hospital

    Kaohsiung City, 833, Taiwan

  • China Japan Friendship Hospital

    Beijing, 100029, China

  • Chung Shan Medical University Hospital

    Taichung, 40201, Taiwan

  • Clinical Research Philadelphia

    Philadelphia, Pennsylvania, 19114, United States

  • DOM Reumatologia

    Buenos Aires, C1111, Argentina

  • Dawes Fretzin Clinical Research Group

    Indianapolis, Indiana, 46250, United States

  • DermEdge Research

    Mississauga, Ontario, L4Y 4C5, Canada

  • Derma Internacional S A

    Buenos Aires, C1426, Argentina

  • Dermatology Research Institute Inc

    Calgary, Alberta, T2J 7E1, Canada

  • Dr Wei Jing Loo Medicine Professional Corporation

    London, Ontario, N6H 5L5, Canada

  • Driven Research LLC

    Miami, Florida, 33126, United States

  • First OC Dermatology

    Fountain Valley, California, 92708, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hosp. of Chengde Medical University

    Chengde, 067030, China

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035 903, Brazil

  • INAER - Investigacion en Alergias y Enfermedades Respiratorias

    Buenos Aires, C1425BEN, Argentina

  • ISA - Interdisciplinary Study Association GmbH

    Berlin, 10789, Germany

  • Instituto Brasil de Pesquisa Clinica

    Rio de Janeiro, 20241 180, Brazil

  • Instituto Medico De Alta Complejidad (IMAC)

    Buenos Aires, B1643CRO, Argentina

  • Instituto de Investigaciones Clinicas Cordoba

    Córdoba, X5000AAW, Argentina

  • Jitaikai Tachikawa dermatology clinic

    Tachikawa, 190 0023, Japan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813, Taiwan

  • Kindai University Hospital

    Sakai, 590 0197, Japan

  • Klinikum rechts der Isar an der Technischen Universitat Munchen

    München, 80802, Germany

  • Kume Clinic

    Nishiku, 593-8324, Japan

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333, Taiwan

  • Mautalen Salud e Investigacion

    CABA, C1128AAF, Argentina

  • Miyata Dermatology Clinic

    Matsudo, 271-0092, Japan

  • National Taiwan University Hospital

    Taipei, 10048, Taiwan

  • Nomura Dermatology Clinic

    Yokohama, 221 0825, Japan

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210, United States

  • PSEG trials Centro de Pesquisa Clinica S A

    São Paulo, 04038 002, Brazil

  • Pesquisare Saude

    Santo André, 09080-110, Brazil

  • Progressive Clinical Research

    San Antonio, Texas, 78213, United States

  • Red River Research Partners LLC

    Fargo, North Dakota, 58103, United States

  • SOLUMED Centrum Medyczne

    Poznan, 60 529, Poland

  • Sanmenxia Central Hospital

    Sanmenxia, 472000, China

  • SimcoDerm Medical and Surgical Dermatology Centre

    Barrie, Ontario, L4M 7G1, Canada

  • Southern California Dermatology

    Santa Ana, California, 92701, United States

  • Studienzentrum an der Hase GbR

    Bramsche, 49565, Germany

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 235, Taiwan

  • Teikyo University Hospital

    tabashi City, 173-8606, Japan

  • The First Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, 510080, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710004, China

  • Tri-Service General Hospital

    Taipei, 114202, Taiwan

  • Universitaetsklinikum Muenster

    Münster, 48149, Germany

  • University of California Los Angeles - Division of Dermatology

    Los Angeles, California, 90024, United States

  • West China Hospital of Sichuan University

    Chengdu, 610041, China

  • Wuxi People s Hospital

    Wuxi, 214100, China

  • XLR8 Medical Research

    Windsor, Ontario, N8T 1E6, Canada

  • Xiangya Hospital Central South University

    Changsha, 410008, China

  • York Dermatology Clinic and Research Centre

    Richmond Hill, Ontario, L4B1L1, Canada

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