Phase
Condition
Eczema (Atopic Dermatitis - Pediatric)
Dermatitis, Atopic
Allergy
Treatment
JNJ-95475939
Dupilumab
Placebo
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
Instituto de Neumonologia y Dermatologia
Buenos Aires, C1425
ArgentinaActive - Recruiting
CIPREC
Ciudad Autonoma de Buenos Aires, C1061AAS
ArgentinaActive - Recruiting
Dermatology Research Institute Inc
Calgary, Alberta T2J 7E1
CanadaActive - Recruiting
Dr. Chih ho Hong Medical
Surrey, British Columbia V3R 6A7
CanadaActive - Recruiting
Lynderm Research Inc.
Markham, Ontario L3P 1X2
CanadaActive - Recruiting
Innovaderm Research Inc.
Montreal, Quebec H2X 2V1
CanadaActive - Recruiting
Centre De Recherche Dermatologique Du Quebec Metropolitain
Quebec, G1V 4X7
CanadaActive - Recruiting
Fachklinik Bad Bentheim
Bad Bentheim, 48455
GermanyActive - Recruiting
ISA - Interdisciplinary Study Association GmbH
Berlin, 10789
GermanyActive - Recruiting
Eurofins bioskin GmbH
Hamburg, 20095
GermanyActive - Recruiting
Studienzentrum Dr Schwarz Germany
Langenau, 89129
GermanyActive - Recruiting
Fukuoka University Hospital
Fukuoka-shi, 814-0180
JapanActive - Recruiting
Osaka Habikino Medical Center
Habikino, 583 8588
JapanActive - Recruiting
Teikyo University Hospital
Itabashi Ku, 173 8606
JapanActive - Recruiting
Kume Clinic
Sakai City, 593 8324
JapanActive - Recruiting
Sapporo Skin Clinic
Sapporo shi, 060 0063
JapanActive - Recruiting
Jitaikai Tachikawa dermatology clinic
Tachikawa, 190 0023
JapanActive - Recruiting
Shirasaki Dermatology Clinic
Takaoka shi, 933-0871
JapanActive - Recruiting
Mie University Hospital
Tsu, 514-8507
JapanActive - Recruiting
Nomura Dermatology Clinic
Yokohama, 221 0825
JapanActive - Recruiting
Queens Square Medical Facilities
Yokohama, 220 6208
JapanActive - Recruiting
Centrum Badan Klinicznych PI House sp z o o
Gdansk, 80 546
PolandActive - Recruiting
Care Clinic
Katowice, 40 568
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
PolandActive - Recruiting
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz, 90-338
PolandActive - Recruiting
Klinika Ambroziak Dermatologia
Warszawa, 02 953
PolandActive - Recruiting
WroMedica I Bielicka A Strzalkowska s c
Wroclaw, 51 685
PolandActive - Recruiting
Hosp. Gral. Univ. Dr. Balmis
Alicante, 03010
SpainActive - Recruiting
Hosp. Univ. San Cecilio
Granada, 18016
SpainActive - Recruiting
Grupo Dermatologico Y Estetico Pedro Jaen
Madrid, 28006
SpainActive - Recruiting
Hosp. Univ. de La Princesa
Madrid, 28006
SpainActive - Recruiting
Hosp. de Manises
Manises, 46940
SpainActive - Recruiting
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
SpainActive - Recruiting
Guys and St Thomas NHS Foundation Trust
London, SE1 9RT
United KingdomActive - Recruiting
Northwick Park Hospital
London, HA13UJ
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 KingdomActive - Recruiting
First OC Dermatology
Fountain Valley, California 92708
United StatesActive - Recruiting
Hamilton Research LLC
Alpharetta, Georgia 30022
United StatesActive - Recruiting
Dawes Fretzin Clinical Research Group LLC
Indianapolis, Indiana 46250
United StatesActive - Recruiting
Indiana Clinical Trial Center
Plainfield, Indiana 46168
United StatesActive - Recruiting
Optima Research
Boardman, Ohio 44512
United StatesActive - Recruiting
Oregon Medical Research Center
Portland, Oregon 97201
United StatesActive - Recruiting
Arlington Center for Dermatology
Arlington, Texas 76011
United StatesActive - Recruiting
Center for Clinical Studies
Houston, Texas 77004
United StatesActive - Recruiting
Progressive Clinical Research
San Antonio, Texas 78213
United StatesActive - Recruiting
Frontier Derm Partners CRO, LLC
Mill Creek, Washington 98012
United StatesActive - Recruiting
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