A phase 2b, multicenter, randomized, double-blind, placebo- and active-controlled, dose-ranging study to evaluate the efficacy and safety of JNJ-95475939 for the treatment of participants with moderate to severe atopic dermatitis
Atopic dermatitis (AD)
The study consists of 3 periods: Screening period (up to 5 weeks): Eligible participants will be screened for participation in study. Treatment period (up to 24 weeks): Participants will be randomly (by chance) assigned in 1 of the 5 treatment groups: Group A: Dupilumab Dose regimen 1 administered subcutaneously (SC; under the skin) for 24 weeks. Group B: JNJ-95475939 Dose regimen 1 SC for 24 weeks. Group C: JNJ-95475939 Dose regimen 2 SC for 24 weeks. Group D: JNJ-95475939 Dose regimen 3 SC for 24 weeks. Group E: Placebo SC for 12 weeks, then switch to JNJ-95475939 Dose regimen 1 SC for another 12 weeks Follow-up period (up to 12 weeks): Participants will be followed up to monitor their health. Safety assessments will include physical examinations, body weight, vital signs, 12-lead ECG, pregnancy testing, clinical laboratory tests, and monitoring of adverse events and serious adverse events. The overall duration of the study is up to 41 weeks.
Ages Eligible for Study: 18 Years and older Sexes Eligible for Study: All Gender Based: No Accepts Healthy Volunteers: No Inclusion criteria: 1. 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 2. Eczema Area and Severity Index (EASI) score greater than and equal to (>=) 16 at the screening and baseline visits 3. Validated investigator global assessment for AD (vIGA-AD) score >= 3 at the screening and baseline visits 4. >= 10% body surface area (BSA) of AD involvement at the screening and baseline visits 5. Baseline Peak Pruritus Numeric(al) Rating Scale (PP-NRS) average score of >=4 6. 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) 7. Participant has applied a moisturizer at least once daily for at least 7 days before the baseline visit
1. 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) 2. Participant is pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study 3. 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 4. Current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances 5. Recent case of eczema herpeticum, herpes zoster within 8 weeks before screening, or history of recurrent eczema herpeticum 6. 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. 7. Diagnosed active parasitic infection or at high risk of parasitic infection, unless treated with antihelminth therapy prior to randomization 8. 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