Atopic dermatitis (AD) Skin and Connective Tissue Diseases
Conditions
Interventions
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
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.
Grou
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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-4Ra, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12 [Time Frame: Baseline, Week 12] EASI-75 response is defined as at least 75 percent (%) improvement in EASI total score. EASI-75 response is defined as at least 75% improvement from baseline in EASI total score. The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting a higher severity of AD. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 15/09/2025: 1. Percentage of Participants With EASI-90 Response at Week 12 [Time Frame: Baseline, Week 12] EASI-90 response is defined as at least 90% improvement in EASI total score. EASI-90 response is defined as at least 90% improvement from baseline in EASI total score. The EASI score is used to measure the severity and extent of AD and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body:head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting a higher severity of AD. 2. Percentage of Participants With EASI-100 Response at Week 12 [Time Frame: Baseline, Week 12] EASI-100 response is defined as at least 100% improvement in EASI total score. EASI-100 response is defined as at least 100% improvement from baseline in EASI total score. The EASI score is used to measure the severity and extent of AD and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body:head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting a higher severity of AD. 3. Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 and a Reduction From Baseline of Greater Than Equal to (>=) 2 Points at Week 12 [Time Frame: Baseline, Week 12] vIGA-AD is an assessment instrument used in clinical studies to rate the severity of AD, based on a 5-point scale ranging from 0, where 0=Clear: No inflammatory signs of AD; 1=almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2=mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3=moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, | — |
Countries
Argentina, Brazil, Canada, Germany, Japan, Poland, Spain, United Kingdom, United States of America
Contacts
Public Contact. Medical Information and Product Information Enquiry
Outcome results
None listed