A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis
READY-AD
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-95597528 for the Treatment of Adult Participants With Moderate to Severe Atopic Dermatitis
2 other identifiers
interventional
189
9 countries
62
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2026
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2025
CompletedFirst Posted
Study publicly available on registry
November 17, 2025
CompletedStudy Start
First participant enrolled
January 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 10, 2028
July 31, 2026
July 1, 2026
10 months
November 14, 2025
July 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12
EASI-75 response is defined as at least 75 percent (%) improvement from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD.
Week 12
Secondary Outcomes (11)
Proportion of Participants with EASI 90 Response at Week 12
Week 12
Proportion of Participants with EASI 100 Response at Week 12
Week 12
Percent Change from Baseline in EASI Total Score at Week 12
Baseline, Week 12
Proportion of Participants with Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 and a Reduction of >= 2 Points from Baseline, at Week 12
Week 12
Proportion of Participants with vIGA-AD Score of 0 and a Reduction of >= 2 points from Baseline, at Week 12
Week 12
- +6 more secondary outcomes
Study Arms (4)
Group 1: JNJ-95597528 (Dose 1)
EXPERIMENTALParticipants will receive JNJ-95597528 Dose 1 on Weeks 0, 2, 12, and 24.
Group 2: JNJ-95597528 (Dose 2 and 3)
EXPERIMENTALParticipants will receive JNJ-95597528 Dose 2 on Week 0 followed by JNJ-95597528 Dose 3 on Weeks 12, and 24.
Group 3: JNJ-95597528 (Dose 4 and 5)
EXPERIMENTALParticipants will receive JNJ-95597528 Dose 4 on Week 0 followed by JNJ-95597528 Dose 5 on Weeks 12, and 24.
Group 4: Placebo and JNJ-95597528 (Dose 2 and 3)
PLACEBO COMPARATORParticipants 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.
Interventions
JNJ-95597528 will be administered subcutaneously.
Placebo will be administered subcutaneously.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
First OC Dermatology
Fountain Valley, California, 92708, United States
University of California Los Angeles - Division of Dermatology
Los Angeles, California, 90024, United States
Southern California Dermatology
Santa Ana, California, 92701, United States
Driven Research LLC
Miami, Florida, 33126, United States
Arlington Dermatology
Rolling Meadows, Illinois, 60008, United States
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46250, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Red River Research Partners LLC
Fargo, North Dakota, 58103, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Clinical Research Philadelphia
Philadelphia, Pennsylvania, 19114, United States
Center for Clinical Studies
Houston, Texas, 77004, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
Instituto Medico De Alta Complejidad (IMAC)
Buenos Aires, B1643CRO, Argentina
CIPREC
Buenos Aires, C1061AAS, Argentina
DOM Reumatologia
Buenos Aires, C1111, Argentina
INAER - Investigacion en Alergias y Enfermedades Respiratorias
Buenos Aires, C1425BEN, Argentina
Derma Internacional S A
Buenos Aires, C1426, Argentina
Mautalen Salud e Investigacion
CABA, C1128AAF, Argentina
Instituto de Investigaciones Clinicas Cordoba
Córdoba, X5000AAW, Argentina
Centro de Investigaciones Clinicas CIC IESR
Rosario, 2000, Argentina
Centro Respiratorio Infantil
Rosario, 2000, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, T4000AXL, Argentina
Ceti - Centro de Estudos Em Terapias Inovadoras
Curitiba, 80030 110, Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, 90035 903, Brazil
Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, 20241 180, Brazil
Fundacao do ABC Centro Universitario FMABC
Santo André, 09060 870, Brazil
Pesquisare Saude
Santo André, 09080-110, Brazil
PSEG trials Centro de Pesquisa Clinica S A
São Paulo, 04038 002, Brazil
Dermatology Research Institute Inc
Calgary, Alberta, T2J 7E1, Canada
CCA Medical Research Corporation
Ajax, Ontario, L1S7K8, Canada
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1, Canada
Dr Wei Jing Loo Medicine Professional Corporation
London, Ontario, N6H 5L5, Canada
DermEdge Research
Mississauga, Ontario, L4Y 4C5, Canada
Allergy Research Canada Inc.
Niagara Falls, Ontario, L2H 1H5, Canada
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, L4B1L1, Canada
XLR8 Medical Research
Windsor, Ontario, N8T 1E6, Canada
China Japan Friendship Hospital
Beijing, 100029, China
Xiangya Hospital Central South University
Changsha, 410008, China
Hosp. of Chengde Medical University
Chengde, 067030, China
West China Hospital of Sichuan University
Chengdu, 610041, China
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, 510080, China
Sanmenxia Central Hospital
Sanmenxia, 472000, China
Wuxi People s Hospital
Wuxi, 214100, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710004, China
ISA - Interdisciplinary Study Association GmbH
Berlin, 10789, Germany
Studienzentrum an der Hase GbR
Bramsche, 49565, Germany
Klinikum rechts der Isar an der Technischen Universitat Munchen
München, 80802, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
Miyata Dermatology Clinic
Matsudo, 271-0092, Japan
Kume Clinic
Nishiku, 593-8324, Japan
Kindai University Hospital
Sakai, 590 0197, Japan
Teikyo University Hospital
tabashi City, 173-8606, Japan
Jitaikai Tachikawa dermatology clinic
Tachikawa, 190 0023, Japan
Nomura Dermatology Clinic
Yokohama, 221 0825, Japan
SOLUMED Centrum Medyczne
Poznan, 60 529, Poland
Kaohsiung Veterans General Hospital
Kaohsiung City, 813, Taiwan
Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Tri-Service General Hospital
Taipei, 114202, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, 333, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2025
First Posted
November 17, 2025
Study Start
January 20, 2026
Primary Completion (Estimated)
November 19, 2026
Study Completion (Estimated)
February 10, 2028
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.