Phase
Condition
Scalp Disorders
Eczema (Atopic Dermatitis - Pediatric)
Dermatitis, Atopic
Treatment
Dupilumab
JNJ-95475939
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
Jitaikai Tachikawa dermatology clinic
Tachikawa, 190 0023
JapanActive - Recruiting
Shirasaki Dermatology Clinic
Takaoka shi, 933-0871
JapanActive - Recruiting
Queens Square Medical Facilities
Yokohama, 220 6208
JapanActive - Recruiting
First OC Dermatology
Fountain Valley, California 92708
United StatesActive - Recruiting
Dawes Fretzin Clinical Research Group LLC
Indianapolis, Indiana 46250
United StatesActive - Recruiting
Optima Research
Boardman, Ohio 44512
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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