A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (

A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD) (DUPLEX-AD)

Last Updated May 14, 2025

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95475939ADM2001

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 2
Sites
23 Sites
Status

Recruiting

SUMMARY

The purpose of this study is to evaluate how well JNJ-95475939 works as compared to placebo in participants with moderate to severe atopic dermatitis.

CONDITIONS

Dermatitis, Atopic

ELIGIBILITY

Inclusion criteria:

* 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 >= 3 at the screening and baseline visits
* >= 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 >=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

Exclusion criteria:

* Experienced primary efficacy failure (no response within 16 weeks) or an adverse event (AE) requiring discontinuation related to agents (eg, severe ocular surface disease, dupilumab-associated facial redness) inhibiting IL-4Rα, IL-4, and/or IL-13 signaling (eg, dupilumab, lebrikizumab, or tralokinumab)
* 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 (eg, untreated latent tuberculosis), 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 (eg, requiring general anesthesia and hospitalization), 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

Inclusion criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, Canada, Japan, United Kingdom

Country (4)	City or Province (23)	Status
United States	Fountain Valley First OC Dermatology	RECRUITING
United States	Indianapolis Dawes Fretzin Clinical Research Group LLC	RECRUITING
United States	Boardman Optima Research	RECRUITING
United States	Portland Oregon Medical Research Center	RECRUITING
United States	Arlington Arlington Center for Dermatology	RECRUITING
United States	Houston Center for Clinical Studies	RECRUITING
United States	San Antonio Progressive Clinical Research	RECRUITING
United States	Mill Creek Frontier Derm Partners CRO, LLC	RECRUITING
Canada	Montreal Innovaderm Research Inc.	RECRUITING
Japan	Tachikawa Jitaikai Tachikawa dermatology clinic	RECRUITING
Japan	Takaoka shi Shirasaki Dermatology Clinic	RECRUITING
Japan	Yokohama Queens Square Medical Facilities	RECRUITING
United Kingdom	London Northwick Park Hospital	RECRUITING
United States	Alpharetta Hamilton Research LLC	RECRUITING
Canada	Surrey Dr. Chih ho Hong Medical	RECRUITING
Canada	Markham Lynderm Research Inc.	RECRUITING
Canada	Quebec Centre De Recherche Dermatologique Du Quebec Metropolitain	RECRUITING
Japan	Fukuoka-shi Fukuoka University Hospital	RECRUITING
Japan	Habikino Osaka Habikino Medical Center	RECRUITING
Japan	Sapporo shi Sapporo Skin Clinic	RECRUITING
Japan	Tsu Mie University Hospital	RECRUITING
Japan	Yokohama Nomura Dermatology Clinic	RECRUITING
United Kingdom	Salford Salford Royal Hospital	RECRUITING

Geo Locations

33.70918, -117.95367

39.76838, -86.15804

41.02423, -80.66285

45.52345, -122.67621

32.73569, -97.10807

29.76328, -95.36327

29.42412, -98.49363

47.8601, -122.2043

45.50884, -73.58781

35.6913016, 139.4072136

36.75, 137.01667

35.43333, 139.65

51.50853, -0.12574

34.07538, -84.29409

49.10635, -122.82509

43.86682, -79.2663

46.81228, -71.21454

33.6, 130.41667

34.55276, 135.59097

43.06667, 141.35

34.73333, 136.51667

35.43333, 139.65

53.48771, -2.29042

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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