Last updated 37 days ago
A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD)
240 patients around the world
Available in Argentina, United States
Janssen Research & Development, LLC
3Research sites
240Patients around the world
This study is for people with
Dermatitis
Atopic dermatitis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Chronic Atopic Dermatitis (AD), according to American Academy of Dermatology Consensus Criteria with onset of symptoms at least 1 year prior to the screening visit.Eczema Area and Severity Index (EASI) score greater than and equal to 16 at the screening and baseline visits.Validated investigator global assessment for AD (vIGA-AD) score greater than or equal to 3 at the screening and baseline visits.Greater than or equal to 10% body surface area (BSA) of AD involvement at the screening and baseline visits.Baseline Peak Pruritus Numeric(al) Rating Scale (PP-NRS) average score of greater than or equal to 4.Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, or inadequate response to systemic therapies (within 12 months before screening).Participant has applied a moisturizer at least once daily for at least 7 days before the baseline visit.
- Experienced primary efficacy failure (no response within 16 weeks) or an adverse event (AE) requiring discontinuation related to agents inhibiting IL-4Rα, IL-4, and/or IL-13 signaling.Participant is pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study.Active skin disease other than AD including eczema herpeticum, molluscum contagiosum, impetigo, psoriasis or has any other ongoing significant skin condition including skin infections, that, according to the investigator, could interfere with efficacy assessments.Current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.Recent case of eczema herpeticum, herpes zoster within 8 weeks before screening, or history of recurrent eczema herpeticum.History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection, recurrent urinary tract infection, fungal infection, mycobacterial infection, or open, draining, or infected skin wounds, or ulcers.Diagnosed active parasitic infection or at high risk of parasitic infection, unless treated with antihelminth therapy prior to randomization.Had major surgery within 8 weeks before screening, or will not have fully recovered from surgery, or has such surgery planned during the time the participant is expected to participate in the study.
Sites
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
Recruiting
Instituto de Neumonología y Dermatología Dr. Luna
Recruiting
Derma Internacional S.A.
Recruiting
StudyDUPLEX-AD
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Atopic dermatitis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06881251
