Actively Recruiting
A Phase 2b Study to Evaluate the Efficacy and Safety of JNJ-95597528 for Adults With Moderate to Severe Atopic Dermatitis
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
180
Participants Needed
62
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how well JNJ-95597528 works compared to a placebo in adults with moderate to severe atopic dermatitis (AD). The study focuses on measuring improvements in skin symptoms and severity to better understand the potential effects of the treatment. It is a Phase 2b randomized, double-blind, placebo-controlled trial designed to assess different doses of JNJ-95597528 in this population. Participants will be randomly assigned to one of four groups receiving various doses of JNJ-95597528 administered by subcutaneous injection at specific weeks throughout the study. One group will receive placebo injections from Weeks 0 to 12 before switching to JNJ-95597528 doses at Weeks 12 and 24. Other groups receive different dosing schedules of JNJ-95597528 at Weeks 0, 2, 12, and 24 depending on the assigned dose group. During the study, participants will have scheduled visits to monitor their condition using tools like the Eczema Area and Severity Index (EASI) and the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). Researchers will track changes in skin symptoms, itching, sleep interference, and skin pain, as well as record any adverse effects. The primary outcome is the proportion of participants achieving a significant improvement in EASI score by Week 12. The study includes ongoing safety assessments and follows participants until approximately Week 24.
CONDITIONS
Brief Title
A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be otherwise healthy based on physical exam, medical history, vital signs, and ECG at screening
- Have chronic atopic dermatitis diagnosed by American Academy of Dermatology criteria with symptoms for at least 1 year
- Have Eczema Area and Severity Index (EASI) score of 16 or higher at screening and Week 0
- Have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 3 or more at screening and Week 0
- Have at least 10% body surface area affected by atopic dermatitis at screening and Week 0
- Have a history within 6 months of poor response or inadvisability for medicated topical treatments or within 12 months for systemic therapies
- Sign informed consent and be willing to comply with study visits, treatment, tests, and procedures
You will not qualify if you...
- History of substance or alcohol abuse within 1 year before screening
- Significant abnormal results in ECG, chemistry, hematology, or urinalysis that could affect safety or data interpretation
- Known or suspected immunodeficiency or history of invasive opportunistic infections
- Previous treatment with JNJ-95597528
- Known allergies or intolerance to JNJ-95597528, its ingredients, or similar biologic medications such as monoclonal antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive subcutaneous injections of JNJ-95597528 or placebo according to their assigned group.
Visits at Weeks 0, 2, 12, and 24 for injections and assessments
Trial Site Locations
Total: 62 locations
1
First OC Dermatology
Fountain Valley, California, United States, 92708
Actively Recruiting
2
University of California Los Angeles - Division of Dermatology
Los Angeles, California, United States, 90024
Actively Recruiting
3
Southern California Dermatology
Santa Ana, California, United States, 92701
Actively Recruiting
4
Driven Research LLC
Miami, Florida, United States, 33126
Actively Recruiting
5
Arlington Dermatology
Rolling Meadows, Illinois, United States, 60008
Actively Recruiting
6
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, United States, 46250
Actively Recruiting
7
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
8
Red River Research Partners LLC
Fargo, North Dakota, United States, 58103
Actively Recruiting
9
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
Actively Recruiting
10
Clinical Research Philadelphia
Philadelphia, Pennsylvania, United States, 19114
Actively Recruiting
11
Center for Clinical Studies
Houston, Texas, United States, 77004
Actively Recruiting
12
Progressive Clinical Research
San Antonio, Texas, United States, 78213
Actively Recruiting
13
Instituto Medico De Alta Complejidad (IMAC)
Buenos Aires, Argentina, B1643CRO
Actively Recruiting
14
CIPREC
Buenos Aires, Argentina, C1061AAS
Actively Recruiting
15
DOM Reumatología
Buenos Aires, Argentina, C1111
Actively Recruiting
16
INAER - Investigación en Alergias y Enfermedades Respiratorias
Buenos Aires, Argentina, C1425BEN
Actively Recruiting
17
Derma Internacional S A
Buenos Aires, Argentina, C1426
Actively Recruiting
18
Mautalen Salud e Investigacion
CABA, Argentina, C1128AAF
Actively Recruiting
19
Instituto de Investigaciones Clinicas Cordoba
Córdoba, Argentina, X5000AAW
Actively Recruiting
20
Centro de Investigaciones Clinicas CIC IESR
Rosario, Argentina, 2000
Actively Recruiting
21
Centro Respiratorio Infantil
Rosario, Argentina, 2000
Actively Recruiting
22
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Argentina, T4000AXL
Actively Recruiting
23
Ceti - Centro de Estudos Em Terapias Inovadoras
Curitiba, Brazil, 80030 110
Actively Recruiting
24
Hospital De Clinicas De Porto Alegre
Porto Alegre, Brazil, 90035 903
Actively Recruiting
25
Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, Brazil, 20241 180
Actively Recruiting
26
Fundacao do ABC Centro Universitario FMABC
Santo André, Brazil, 09060 870
Actively Recruiting
27
Pesquisare Saude
Santo André, Brazil, 09080-110
Actively Recruiting
28
PSEG trials Centro de Pesquisa Clinica S A
São Paulo, Brazil, 04038 002
Actively Recruiting
29
Dermatology Research Institute Inc
Calgary, Alberta, Canada, T2J 7E1
Actively Recruiting
30
CCA Medical Research Corporation
Ajax, Ontario, Canada, L1S7K8
Active, Not Recruiting
31
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, Canada, L4M 7G1
Active, Not Recruiting
32
Dr Wei Jing Loo Medicine Professional Corporation
London, Ontario, Canada, N6H 5L5
Active, Not Recruiting
33
DermEdge Research
Mississauga, Ontario, Canada, L4Y 4C5
Active, Not Recruiting
34
Allergy Research Canada Inc.
Niagara Falls, Ontario, Canada, L2H 1H5
Active, Not Recruiting
35
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, Canada, L4B1L1
Active, Not Recruiting
36
XLR8 Medical Research
Windsor, Ontario, Canada, N8T 1E6
Active, Not Recruiting
37
China Japan Friendship Hospital
Beijing, China, 100029
Actively Recruiting
38
Xiangya Hospital Central South University
Changsha, China, 410008
Actively Recruiting
39
Hosp. of Chengde Medical University
Chengde, China, 067030
Actively Recruiting
40
West China Hospital of Sichuan University
Chengdu, China, 610041
Actively Recruiting
41
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, China, 510080
Actively Recruiting
42
Sanmenxia Central Hospital
Sanmenxia, China, 472000
Actively Recruiting
43
Wuxi People s Hospital
Wuxi, China, 214100
Actively Recruiting
44
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China, 710004
Actively Recruiting
45
ISA - Interdisciplinary Study Association GmbH
Berlin, Germany, 10789
Actively Recruiting
46
Studienzentrum an der Hase GbR
Bramsche, Germany, 49565
Actively Recruiting
47
Klinikum rechts der Isar an der Technischen Universitat Munchen
München, Germany, 80802
Actively Recruiting
48
Universitaetsklinikum Muenster
Münster, Germany, 48149
Actively Recruiting
49
Miyata Dermatology Clinic
Matsudo, Japan, 271-0092
Actively Recruiting
50
Kume Clinic
Nishiku, Japan, 593-8324
Actively Recruiting
51
Kindai University Hospital
Sakai, Japan, 590 0197
Actively Recruiting
52
Teikyo University Hospital
tabashi City, Japan, 173-8606
Actively Recruiting
53
Jitaikai Tachikawa dermatology clinic
Tachikawa, Japan, 190 0023
Actively Recruiting
54
Nomura Dermatology Clinic
Yokohama, Japan, 221 0825
Actively Recruiting
55
SOLUMED Centrum Medyczne
Poznan, Poland, 60 529
Actively Recruiting
56
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, 813
Actively Recruiting
57
Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 833
Actively Recruiting
58
Taipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan, 235
Actively Recruiting
59
Chung Shan Medical University Hospital
Taichung, Taiwan, 40201
Actively Recruiting
60
National Taiwan University Hospital
Taipei, Taiwan, 10048
Actively Recruiting
61
Tri-Service General Hospital
Taipei, Taiwan, 114202
Actively Recruiting
62
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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