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

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 2

Conditions: Dermatitis, Atopic

Treatments: Drug: Placebo; Drug: JNJ-95475939; Drug: Dupilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06881251

95475939ADM2001 (Other Identifier)

2024-517814-13-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 5 patient groups, including a placebo group

Group A: Dupilumab

Active Comparator group

Description:

Participants will receive Dupilumab dose regimen 1 subcutaneously through Week 22.

Treatment:

Drug: Dupilumab

Group B: JNJ-95475939

Experimental group

Description:

Participants will receive JNJ-95475939 dose regimen 1 subcutaneously through Week 22.

Treatment:

Drug: JNJ-95475939

Group C: JNJ-95475939

Experimental group

Description:

Participants will receive JNJ-95475939 dose regimen 2 subcutaneously through Week 22.

Treatment:

Drug: JNJ-95475939

Group D: JNJ-95475939

Experimental group

Description:

Participants will receive JNJ-95475939 dose regimen 3 subcutaneously through Week 22.

Treatment:

Drug: JNJ-95475939

Group E: Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo subcutaneously through Week 10, then switch to receive JNJ-95475939 dose regimen 1 subcutaneously between Week 12 and Week 22.

Treatment:

Drug: JNJ-95475939

Drug: Placebo