Phase
Condition
Dermatitis, Atopic
Treatment
JNJ-95597528
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Be otherwise healthy on the basis of physical examination, medical history, vitalsigns, 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 ofsymptoms 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 >= 3at screening and Week 0; d. >= 10% body surface area (BSA) of AD involvement atscreening and Week 0; e. Documented history (within 6 months before screening) ofeither inadequate response or inadvisability to medicated topical treatments for ADor inadequate response to systemic therapies (within 12 months before screening)
Must sign an informed consent form (ICF) indicating that the participant understandsthe purpose of, and procedures required for, the study and is willing to participatein the study
If willing to participate in the substudy, must sign a separate ICF for thecorresponding substudy (or substudies)
Willing and able to comply with scheduled visits, treatment plan, laboratory tests,lifestyle restrictions, and other study procedures
Exclusion
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-leadECG, chemistry, hematology, or urinalysis laboratory tests obtained at the screeningvisit that would affect interpretation of study data or the participant's safety inthe study
Known or suspected immunodeficiency, including history of invasive opportunisticinfections
Previously received JNJ-95597528
Has known hypersensitivity or intolerance to JNJ-95597528 or its excipients or toany biologic medication or known allergies, or clinically significant reactions tomurine, chimeric, monoclonal antibodies (mAbs), or antibody fragments
Study Design
Connect with a study center
CIPREC
Buenos Aires, C1061AAS
ArgentinaActive - Recruiting
DOM Reumatología
Buenos Aires, C1111
ArgentinaActive - Recruiting
Derma Internacional S A
Buenos Aires, C1426
ArgentinaActive - Recruiting
INAER - Investigación en Alergias y Enfermedades Respiratorias
Buenos Aires, C1425BEN
ArgentinaActive - Recruiting
Instituto Medico De Alta Complejidad (IMAC)
Buenos Aires, B1643CRO
ArgentinaActive - Recruiting
Mautalen Salud e Investigacion
CABA, C1128AAF
ArgentinaActive - Recruiting
Instituto de Investigaciones Clinicas Cordoba
Córdoba, X5000AAW
ArgentinaActive - Recruiting
Centro Respiratorio Infantil
Rosario, 2000
ArgentinaActive - Recruiting
Centro de Investigaciones Clinicas CIC IESR
Rosario, 2000
ArgentinaActive - Recruiting
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, T4000AXL
ArgentinaActive - Recruiting
Ceti - Centro de Estudos Em Terapias Inovadoras
Curitiba, 80030 110
BrazilActive - Recruiting
Hospital De Clinicas De Porto Alegre
Porto Alegre, 90035 903
BrazilActive - Recruiting
Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, 20241 180
BrazilActive - Recruiting
Fundacao do ABC Centro Universitario FMABC
Santo André, 09060 870
BrazilActive - Recruiting
Pesquisare Saude
Santo André, 09080-110
BrazilActive - Recruiting
PSEG trials Centro de Pesquisa Clinica S A
São Paulo, 04038 002
BrazilActive - Recruiting
Dermatology Research Institute Inc
Calgary, Alberta T2J 7E1
CanadaActive - Recruiting
CCA Medical Research Corporation
Ajax, Ontario L1S7K8
CanadaActive - Recruiting
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario L4M 7G1
CanadaActive - Recruiting
Dr Wei Jing Loo Medicine Professional Corporation
London, Ontario N6H 5L5
CanadaActive - Recruiting
DermEdge Research
Mississauga, Ontario L4Y 4C5
CanadaActive - Recruiting
Allergy Research Canada Inc.
Niagara Falls, Ontario L2H 1H5
CanadaActive - Recruiting
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario L4B1L1
CanadaActive - Recruiting
XLR8 Medical Research
Windsor, Ontario N8T 1E6
CanadaActive - Recruiting
China Japan Friendship Hospital
Beijing, 100029
ChinaActive - Recruiting
China Japan Friendship Hospital
Beijing 1816670, 100029
ChinaSite Not Available
Xiangya Hospital Central South University
Changsha, 410008
ChinaActive - Recruiting
Hosp. of Chengde Medical University
Chengde, 067030
ChinaActive - Recruiting
West China Hospital of Sichuan University
Chengdu, 610041
ChinaActive - Recruiting
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, 510080
ChinaActive - Recruiting
Sanmenxia Central Hospital
Sanmenxia, 472000
ChinaActive - Recruiting
Sanmenxia Central Hospital
Sanmenxia 1796669, 472000
ChinaSite Not Available
Wuxi People s Hospital
Wuxi, 214100
ChinaActive - Recruiting
Wuxi People s Hospital
Wuxi 1790923, 214100
ChinaSite Not Available
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710004
ChinaActive - Recruiting
Miyata Dermatology Clinic
Matsudo, 271-0092
JapanActive - Recruiting
Kume Clinic
Nishiku, 593-8324
JapanActive - Recruiting
Kindai University Hospital
Sakai, 590 0197
JapanActive - Recruiting
Jitaikai Tachikawa dermatology clinic
Tachikawa, 190 0023
JapanActive - Recruiting
Jitaikai Tachikawa dermatology clinic
Tachikawa 11611487, 190 0023
JapanSite Not Available
Nomura Dermatology Clinic
Yokohama, 221 0825
JapanActive - Recruiting
Nomura Dermatology Clinic
Yokohama 1848354, 221 0825
JapanSite Not Available
Teikyo University Hospital
tabashi City, 173-8606
JapanActive - Recruiting
Chang Gung Memorial Hospital
Kaohsiung City, 833
TaiwanActive - Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City, 813
TaiwanActive - Recruiting
Chang Gung Memorial Hospital
Kaohsiung City 1673820, 833
TaiwanSite Not Available
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235
TaiwanActive - Recruiting
Taipei Medical University Shuang Ho Hospital
New Taipei City 12908892, 235
TaiwanSite Not Available
Chung Shan Medical University Hospital
Taichung, 40201
TaiwanActive - Recruiting
Chung Shan Medical University Hospital
Taichung 1668399, 40201
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 10048
TaiwanActive - Recruiting
Tri-Service Genaral Hospital
Taipei, 114202
TaiwanActive - Recruiting
Tri-Service General Hospital
Taipei, 114202
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei 1668341, 10048
TaiwanActive - Recruiting
Tri-Service Genaral Hospital
Taipei 1668341, 114202
TaiwanSite Not Available
Linkou Chang Gung Memorial Hospital
Taoyuan, 333
TaiwanActive - Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan District, 333
TaiwanSite Not Available
Linkou Chang Gung Memorial Hospital
Taoyuan District 1667905, 333
TaiwanSite Not Available
First OC Dermatology
Fountain Valley, California 92708
United StatesActive - Recruiting
Southern California Dermatology
Santa Ana, California 92701
United StatesActive - Recruiting
Driven Research LLC
Coral Gables, Florida 33134
United StatesActive - Recruiting
Arlington Dermatology
Rolling Meadows, Illinois 60008
United StatesActive - Recruiting
Arlington Dermatology
Rolling Meadows 4908052, Illinois 4896861 60008
United StatesSite Not Available
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana 46250
United StatesActive - Recruiting
Henry Ford Health System
Detroit, Michigan 48202
United StatesActive - Recruiting
Red River Research Partners LLC
Fargo, North Dakota 58103
United StatesActive - Recruiting
Red River Research Partners LLC
Fargo 5059163, North Dakota 5690763 58103
United StatesSite Not Available
Oregon Dermatology and Research Center
Portland, Oregon 97210
United StatesActive - Recruiting
Clinical Research Philadelphia
Philadelphia, Pennsylvania 19114
United StatesActive - Recruiting
Clinical Research Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19114
United StatesSite Not Available
Center for Clinical Studies
Houston, Texas 77004
United StatesActive - Recruiting
Progressive Clinical Research
San Antonio, Texas 78213
United StatesActive - Recruiting

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