Phase
Condition
Dermatitis, Atopic
Rash
Allergy
Treatment
Placebo
JNJ-95475939
Dupilumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Chronic Atopic Dermatitis (AD), according to American Academy of DermatologyConsensus Criteria with onset of symptoms at least 1 year prior to the screeningvisit
Eczema Area and Severity Index (EASI) score greater than and equal to (>=) 16 at thescreening and baseline visits
Validated investigator global assessment for AD (vIGA-AD) score >= 3 at thescreening and baseline visits
>= 10% body surface area (BSA) of AD involvement at the screening and baselinevisits
Baseline Peak Pruritus Numeric(al) Rating Scale (PP-NRS) average score of >=4
Documented history (within 6 months before screening) of either inadequate responseor inadvisability to topical treatments, or inadequate response to systemictherapies (within 12 months before screening)
Participant has applied a moisturizer at least once daily for at least 7 days beforethe baseline visit
Exclusion
Exclusion criteria:
Experienced primary efficacy failure (no response within 16 weeks) or an adverseevent (AE) requiring discontinuation related to agents (eg, severe ocular surfacedisease, dupilumab-associated facial redness) inhibiting IL-4Rα, IL-4, and/or IL-13signaling (eg, dupilumab, lebrikizumab, or tralokinumab)
Participant is pregnant or breastfeeding, or planning to become pregnant orbreastfeed during the study
Active skin disease other than AD including eczema herpeticum, molluscumcontagiosum, impetigo, psoriasis or has any other ongoing significant skin conditionincluding skin infections, that, according to the investigator, could interfere withefficacy assessments
Current diagnosis or signs or symptoms of severe, progressive, or uncontrolledrenal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,hematologic, rheumatologic, psychiatric, or metabolic disturbances
Recent case of eczema herpeticum, herpes zoster within 8 weeks before screening, orhistory of recurrent eczema herpeticum
History of chronic or recurrent infectious disease, including but not limited tochronic renal infection, chronic chest infection (eg, untreated latenttuberculosis), recurrent urinary tract infection, fungal infection, mycobacterialinfection, or open, draining, or infected skin wounds, or ulcers.
Diagnosed active parasitic infection or at high risk of parasitic infection, unlesstreated with antihelminth therapy prior to randomization
Had major surgery (eg, requiring general anesthesia and hospitalization), within 8weeks before screening, or will not have fully recovered from surgery, or has suchsurgery planned during the time the participant is expected to participate in thestudy
Study Design
Connect with a study center
Derma Internacional S A
Buenos Aires, C1426
ArgentinaActive - Recruiting
INAER - Investigación en Alergias y Enfermedades Respiratorias
Buenos Aires, C1425
ArgentinaSite Not Available
Instituto de Neumonologia y Dermatologia
Buenos Aires, C1425
ArgentinaActive - Recruiting
CIPREC
Buenos Aires 3435910, C1061AAS
ArgentinaActive - Recruiting
Derma Internacional S A
Buenos Aires 3435910, C1426
ArgentinaActive - Recruiting
INAER - Investigación en Alergias y Enfermedades Respiratorias
Buenos Aires 3435910, C1425
ArgentinaActive - Recruiting
Instituto de Neumonologia y Dermatologia
Buenos Aires 3435910, C1425
ArgentinaActive - Recruiting
CIPREC
Ciudad Autonoma de Buenos Aires, C1061AAS
ArgentinaSite Not Available
Ceti - Centro de Estudos Em Terapias Inovadoras
Curitiba, 80.030-110
BrazilSite Not Available
Ceti - Centro de Estudos Em Terapias Inovadoras
Curitiba 3464975, 80.030-110
BrazilActive - Recruiting
Hospital De Clinicas De Porto Alegre
Porto Alegre, 90035 903
BrazilSite Not Available
Hospital De Clinicas De Porto Alegre
Porto Alegre 3452925, 90035 903
BrazilActive - Recruiting
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
Ribeirao Preto, 14048 900
BrazilSite Not Available
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
Ribeirão Preto 3451328, 14048 900
BrazilActive - Recruiting
Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, 20241 180
BrazilSite Not Available
Instituto Brasil de Pesquisa Clinica
Rio de Janeiro 3451190, 20241 180
BrazilActive - Recruiting
Fundacao do ABC Centro Universitario FMABC
Santo Andre, 09060 870
BrazilSite Not Available
Fundacao do ABC Centro Universitario FMABC
Santo André 3449701, 09060 870
BrazilActive - Recruiting
BR TRIALS Ensaios Clinicos e Consultoria Ltda
Sao Paulo, 01236030
BrazilSite Not Available
BR TRIALS Ensaios Clinicos e Consultoria Ltda
São Paulo 3448439, 01236030
BrazilActive - Recruiting
Dermatology Research Institute Inc
Calgary, Alberta T2J 7E1
CanadaSite Not Available
Dermatology Research Institute Inc
Calgary 5913490, Alberta 5883102 T2J 7E1
CanadaActive - Recruiting
Dr. Chih ho Hong Medical
Surrey, British Columbia V3R 6A7
CanadaSite Not Available
Dr. Chih ho Hong Medical
Surrey 6159905, British Columbia 5909050 V3R 6A7
CanadaActive - Recruiting
Karma Clinical Trials Inc.
St. John's, Newfoundland and Labrador A1A 4Y3
CanadaSite Not Available
Karma Clinical Trials Inc.
St. John's 6324733, Newfoundland and Labrador 6354959 A1A 4Y3
CanadaActive - Recruiting
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario L4M 7G1
CanadaSite Not Available
Lynderm Research Inc.
Markham, Ontario L3P 1X2
CanadaSite Not Available
SimcoDerm Medical and Surgical Dermatology Centre
Barrie 5894171, Ontario 6093943 L4M 7G1
CanadaActive - Recruiting
Lynderm Research Inc.
Markham 6066513, Ontario 6093943 L3P 1X2
CanadaActive - Recruiting
Innovaderm Research Inc.
Montreal, Quebec H2X 2V1
CanadaSite Not Available
Innovaderm Research Inc.
Montreal 6077243, Quebec 6115047 H2X 2V1
CanadaActive - Recruiting
Centre De Recherche Dermatologique Du Quebec Metropolitain
Québec 6325494, Quebec 6115047 G1V 4X7
CanadaActive - Recruiting
Centre De Recherche Dermatologique Du Quebec Metropolitain
Quebec, G1V 4X7
CanadaSite Not Available
Fachklinik Bad Bentheim
Bad Bentheim, 48455
GermanySite Not Available
Fachklinik Bad Bentheim
Bad Bentheim 2953552, 48455
GermanyActive - Recruiting
Charite - Universitaetsmedizin Berlin (CCM)
Berlin, 10117
GermanySite Not Available
ISA - Interdisciplinary Study Association GmbH
Berlin, 10789
GermanyActive - Recruiting
Charite - Universitaetsmedizin Berlin (CCM)
Berlin 2950159, 10117
GermanyActive - Recruiting
ISA - Interdisciplinary Study Association GmbH
Berlin 2950159, 10789
GermanyActive - Recruiting
Hautarztpraxis
Bramsche, 49565
GermanySite Not Available
Hautarztpraxis
Bramsche 2945474, 49565
GermanyActive - Recruiting
Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
Dresden, 01307
GermanySite Not Available
Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
Dresden 2935022, 01307
GermanyActive - Recruiting
Universitatsklinikum Dusseldorf
Düsseldorf, 40225
GermanySite Not Available
Universitatsklinikum Dusseldorf
Düsseldorf 2934246, 40225
GermanyActive - Recruiting
Universitatsklinikum Frankfurt
Frankfurt, 60596
GermanySite Not Available
Universitatsklinikum Frankfurt
Frankfurt 2925536, 60596
GermanyActive - Recruiting
Eurofins bioskin GmbH
Hamburg, 20095
GermanySite Not Available
Eurofins bioskin GmbH
Hamburg 2911298, 20095
GermanyActive - Recruiting
Studienzentrum Dr Schwarz Germany
Langenau, 89129
GermanySite Not Available
Studienzentrum Dr Schwarz Germany
Langenau 2881259, 89129
GermanyActive - Recruiting
Fukuoka University Hospital
Fukuoka 1863967, 814-0180
JapanActive - Recruiting
Fukuoka University Hospital
Fukuoka-shi, 814-0180
JapanSite Not Available
Osaka Habikino Medical Center
Habikino, 583 8588
JapanSite Not Available
Osaka Habikino Medical Center
Habikino 6825496, 583 8588
JapanActive - Recruiting
Teikyo University Hospital
Itabashi Ku, 173 8606
JapanActive - Recruiting
Kume Clinic
Sakai 1853195, 593 8324
JapanActive - Recruiting
Kume Clinic
Sakai City, 593 8324
JapanSite Not Available
Sapporo Skin Clinic
Sapporo 2128295, 060 0063
JapanActive - Recruiting
Sapporo Skin Clinic
Sapporo shi, 060 0063
JapanSite Not Available
Jitaikai Tachikawa dermatology clinic
Tachikawa, 190 0023
JapanSite Not Available
Jitaikai Tachikawa dermatology clinic
Tachikawa 11611487, 190 0023
JapanActive - Recruiting
Shirasaki Dermatology Clinic
Takaoka Shi, 933-0871
JapanActive - Recruiting
Mie University Hospital
Tsu, 514-8507
JapanSite Not Available
Mie University Hospital
Tsu 1849796, 514-8507
JapanActive - Recruiting
Nomura Dermatology Clinic
Yokohama, 221 0825
JapanSite Not Available
Queens Square Medical Facilities
Yokohama, 220 6208
JapanActive - Recruiting
Nomura Dermatology Clinic
Yokohama 1848354, 221 0825
JapanActive - Recruiting
Queens Square Medical Facilities
Yokohama 1848354, 220 6208
JapanActive - Recruiting
Centrum Badan Klinicznych PI House sp z o o
Gdansk, 80 546
PolandSite Not Available
Centrum Badan Klinicznych PI House sp z o o
Gdansk 3099434, 80 546
PolandActive - Recruiting
Care Clinic
Katowice, 40 568
PolandActive - Recruiting
Centrum Medyczne Angelius Provita
Katowice, 40-611
PolandSite Not Available
Care Clinic
Katowice 3096472, 40 568
PolandActive - Recruiting
Centrum Medyczne Angelius Provita
Katowice 3096472, 40-611
PolandActive - Recruiting
Centrum Medyczne All Med
Krakow, 30 033
PolandActive - Recruiting
Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
Krakow, 30-002
PolandSite Not Available
Centrum Medyczne All Med
Krakow 3094802, 30 033
PolandActive - Recruiting
Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
Krakow 3094802, 30-002
PolandActive - Recruiting
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz, 90-338
PolandSite Not Available
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz 3093133, 90-338
PolandActive - Recruiting
Klinika Ambroziak Dermatologia
Warsaw 756135, 02 953
PolandActive - Recruiting
Royalderm Agnieszka Nawrocka
Warsaw 756135, 02962
PolandActive - Recruiting
Therapia Nova
Warsaw 756135, 01 595
PolandActive - Recruiting
Klinika Ambroziak Dermatologia
Warszawa, 02 953
PolandActive - Recruiting
Royalderm Agnieszka Nawrocka
Warszawa, 02962
PolandSite Not Available
Therapia Nova
Warszawa, 01 595
PolandActive - Recruiting
WroMedica I Bielicka A Strzalkowska s c
Wroclaw, 51 685
PolandSite Not Available
WroMedica I Bielicka A Strzalkowska s c
Wroclaw 3081368, 51 685
PolandActive - Recruiting
Hosp. Gral. Univ. Dr. Balmis
Alicante, 03010
SpainSite Not Available
Hosp. Gral. Univ. Dr. Balmis
Alicante 2521978, 03010
SpainActive - Recruiting
Hosp. Univ. San Cecilio
Granada, 18016
SpainSite Not Available
Hosp. Univ. San Cecilio
Granada 2517117, 18016
SpainActive - Recruiting
Hosp. Univ. de Bellvitge
LHospitalet de Llobregat, 08907
SpainActive - Recruiting
Grupo Dermatologico Y Estetico Pedro Jaen
Madrid, 28006
SpainSite Not Available
Hosp. Univ. de La Princesa
Madrid, 28006
SpainActive - Recruiting
Grupo Dermatologico Y Estetico Pedro Jaen
Madrid 3117735, 28006
SpainActive - Recruiting
Hosp. Univ. de La Princesa
Madrid 3117735, 28006
SpainActive - Recruiting
Hosp. de Manises
Manises, 46940
SpainSite Not Available
Hosp. de Manises
Manises 2514197, 46940
SpainActive - Recruiting
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
SpainSite Not Available
Hosp. Clinico Univ. de Santiago
Santiago de Compostela 3109642, 15706
SpainActive - Recruiting
Guys and St Thomas NHS Foundation Trust
London, SE1 9RT
United KingdomActive - Recruiting
Northwick Park Hospital
London, HA13UJ
United KingdomActive - Recruiting
Royal London Hospital
London, E1 1BB
United KingdomSite Not Available
Guys and St Thomas NHS Foundation Trust
London 2643743, SE1 9RT
United KingdomActive - Recruiting
Northwick Park Hospital
London 2643743, HA13UJ
United KingdomActive - Recruiting
Royal London Hospital
London 2643743, E1 1BB
United KingdomActive - Recruiting
The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
Norfolk, PE30 4ET
United KingdomActive - Recruiting
Salford Royal Hospital
Salford, M6 8HD
United KingdomSite Not Available
Salford Royal Hospital
Salford 2638671, M6 8HD
United KingdomActive - Recruiting
First OC Dermatology
Fountain Valley, California 92708
United StatesSite Not Available
University of California Los Angeles - Division of Dermatology
Los Angeles, California 90024
United StatesSite Not Available
First OC Dermatology
Fountain Valley 5350207, California 5332921 92708
United StatesActive - Recruiting
University of California Los Angeles - Division of Dermatology
Los Angeles 5368361, California 5332921 90024
United StatesActive - Recruiting
Hamilton Research LLC
Alpharetta, Georgia 30022
United StatesSite Not Available
Hamilton Research LLC
Alpharetta 4179574, Georgia 4197000 30022
United StatesActive - Recruiting
DeNova Research
Chicago, Illinois 60602
United StatesSite Not Available
DeNova Research
Chicago 4887398, Illinois 4896861 60602
United StatesActive - Recruiting
Dawes Fretzin Clinical Research Group LLC
Indianapolis, Indiana 46250
United StatesSite Not Available
Indiana Clinical Trial Center
Plainfield, Indiana 46168
United StatesSite Not Available
Dawes Fretzin Clinical Research Group LLC
Indianapolis 4259418, Indiana 4921868 46250
United StatesActive - Recruiting
Indiana Clinical Trial Center
Plainfield 4263108, Indiana 4921868 46168
United StatesActive - Recruiting
Red River Research Partners LLC
Fargo, North Dakota 58103
United StatesSite Not Available
Red River Research Partners LLC
Fargo 5059163, North Dakota 5690763 58103
United StatesActive - Recruiting
Optima Research
Boardman, Ohio 44512
United StatesSite Not Available
Optima Research
Boardman 5147784, Ohio 5165418 44512
United StatesActive - Recruiting
Oregon Medical Research Center
Portland, Oregon 97201
United StatesSite Not Available
Oregon Medical Research Center
Portland 5746545, Oregon 5744337 97201
United StatesActive - Recruiting
Arlington Center for Dermatology
Arlington, Texas 76011
United StatesSite Not Available
Center for Clinical Studies
Houston, Texas 77004
United StatesSite Not Available
Progressive Clinical Research
San Antonio, Texas 78213
United StatesSite Not Available
Arlington Center for Dermatology
Arlington 4671240, Texas 4736286 76011
United StatesActive - Recruiting
Center for Clinical Studies
Houston 4699066, Texas 4736286 77004
United StatesActive - Recruiting
Progressive Clinical Research
San Antonio 4726206, Texas 4736286 78213
United StatesActive - Recruiting
Frontier Derm Partners CRO, LLC
Mill Creek, Washington 98012
United StatesSite Not Available
Frontier Derm Partners CRO, LLC
Mill Creek 5803457, Washington 5815135 98012
United StatesActive - Recruiting
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