> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-jnj-95475939-in-the-treatment-of-participants-606c030d-af0e-483d-9f69-a30d5634f629 > Record changed: 2026-11-04 # A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD) NCT06881251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) Participants 256 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) Lead sponsor Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) Start date 2025-02-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) Number of sites 71 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Acronym** DUPLEX-AD Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Short title** A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Official title** 95475939ADM2001: 95475939ADM2001 Ph IIB Trial (N=210) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Reason stopped** Terminated: futility criteria met at interim efficacy analysis. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) ## Dates **Completion date** 2026-04-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **First posted** 2025-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Registry last updated** 2026-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Primary completion date** 2026-03-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Start date** 2025-02-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) ## Size and sites **Actual participants** 256 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Participants** 256 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Number of sites** 71 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Lead sponsor** Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) ## Identifiers **Registry ID** NCT06881251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **ClinicalTrials.gov ID** NCT06881251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) ## Outcomes ### Primary outcomes 1. Percentage of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12 Timeframe: 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 outcomes 1. Percentage of Participants With EASI-90 Response at Week 12 Timeframe: 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 Timeframe: 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 Timeframe: 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, oozing or crusting may be present and 4=severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present. Higher scores are indicative of a more severe AD. 4. Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at Week 12 Timeframe: 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, oozing or crusting may be present and 4=severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present. Higher scores are indicative of a more severe AD. 5. Percent Change From Baseline in the EASI Total Score at Week 12 Timeframe: Baseline, Week 12 The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. 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. 6. Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain Numerical Rating Scale (NRS) Score From Baseline to Week 12 Timeframe: Baseline, Week 12 The Skin Pain NRS is a single item asking participants to assess their worst skin pain over the past 24 hours. The response categories range from 0 (no pain) to 10 (worst pain). Higher scores indicating greater severity. 7. Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Week 12 Timeframe: Baseline, Week 12 The PP-NRS is a single item asking participants to assess their worst itch over the past 24 hours. The response categories range from 0 (no pain) to 10 (worst pain). Higher scores indicating greater severity. 8. Percent Change from Baseline in Skin Pain NRS Score at Week 12 Timeframe: Baseline, Week 12 The Skin Pain NRS is a single item asking participants to assess their worst skin pain over the past 24 hours. The response categories range from 0 (no pain) to 10 (worst pain). Higher scores indicating greater severity. 9. Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 12 Timeframe: Baseline, Week 12 The AD sleep scale is a validated 3-item PRO instrument to capture self-reported impact of itch on sleep disturbance each day, including difficulty falling asleep, number of night-time awakenings, and difficulty falling back asleep after waking during the previous night. Each AD Sleep Scale item is scored individually. For Item 2, participants select the number of times they woke up each night, ranging from 0 to 29 times. 10. Percentage of Participants Achieving a >= 4-Point Reduction in PP-NRS Score From Baseline Through Week 12 Timeframe: From Baseline through Week 12 The PP-NRS is a single item asking participants to assess their worst itch over the past 24 hours. The response categories range from 0 (no pain) to 10 (worst pain). Higher scores indicating greater severity. 11. Percentage of Participants with EASI-75 Response at Week 16 Timeframe: Baseline, Week 16 EASI-75 response is defined as at least 75% 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 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. 12. Percentage of Participants with EASI-90 Response at Week 16 Timeframe: Baseline, Week 16 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. 13. Percentage of Participants with EASI-100 Response at Week 16 Timeframe: Week 16 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 was 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. 14. Percentage of Participants Achieving vIGA-AD Score of 0 or 1 and a Reduction From Baseline of >= 2 Points at Week 16 Timeframe: Baseline, Week 16 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, oozing or crusting may be present and 4=severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present. Higher scores are indicative of a more severe AD. 15. Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at Week 16 Timeframe: Baseline, Week 16 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, oozing or crusting may be present and 4=severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present. Higher scores are indicative of a more severe AD. 16. Percent Change from Baseline in the EASI Total Score at Week 16 Timeframe: Baseline, Week 16 The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. 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. 17. Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain Numerical Rating Scale (NRS) Score From Baseline to Week 16 Timeframe: Baseline, Week 16 The Skin Pain NRS is a single item asking participants to assess their worst skin pain over the past 24 hours. The response categories range from 0 (no pain) to 10 (worst pain). Higher scores indicating greater severity. 18. Percent Change from Baseline in PP-NRS Score at Week 16 Timeframe: Baseline, Week 16 The PP-NRS is a single item asking participants to assess their worst itch over the past 24 hours. The response categories range from 0 (no pain) to 10 (worst pain). Higher scores indicating greater severity. 19. Percent Change from Baseline in Skin Pain NRS Score at Week 16 Timeframe: Baseline, Week 16 The Skin Pain NRS is a single item asking participants to assess their worst skin pain over the past 24 hours. The response categories range from 0 (no pain) to 10 (worst pain). Higher scores indicating greater severity. 20. Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 16 Timeframe: Baseline, Week 16 The AD sleep scale is a validated 3-item PRO instrument to capture self-reported impact of itch on sleep disturbance each day, including difficulty falling asleep, number of night-time awakenings, and difficulty falling back asleep after waking during the previous night. Each AD Sleep Scale item is scored individually. For Item 2, participants select the number of times they woke up each night, ranging from 0 to 29 times. 21. Percentage of Participants Achieving a >= 4-Point Reduction in PP-NRS Score From Baseline Through Week 24 Timeframe: From Baseline Through Week 24 The PP-NRS is a single item asking participants to assess their worst itch over the past 24 hours. The response categories range from 0 (no pain) to 10 (worst pain). Higher scores indicating greater severity. 22. Percentage of Participants with EASI-75 Response at Week 24 Timeframe: Baseline, Week 24 EASI-75 response is defined as at least 75% 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 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. 23. Percentage of Participants with EASI-90 Response at Week 24 Timeframe: Week 24 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. 24. Percentage of Participants with EASI-100 Response at Week 24 Timeframe: Week 24 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. 25. Percentage of Participants Achieving vIGA-AD Score of 0 or 1 and a Reduction From Baseline of >= 2 Points at Week 24 Timeframe: Baseline, Week 24 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, oozing or crusting may be present and 4=severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present. Higher scores are indicative of a more severe AD. And 7 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) ## Sites - First OC DermatologyFountain Valley, United States - University of California Los Angeles - Division of DermatologyLos Angeles, United States - Hamilton Research LLCAlpharetta, United States - DeNova ResearchChicago, United States - Dawes Fretzin Clinical Research Group LLCIndianapolis, United States - Indiana Clinical Trial CenterPlainfield, United States - Red River Research Partners LLCFargo, United States - Optima ResearchBoardman, United States - Oregon Medical Research CenterPortland, United States - Arlington Center for DermatologyArlington, United States - Center for Clinical StudiesHouston, United States - Progressive Clinical ResearchSan Antonio, United States - Frontier Derm Partners CRO, LLCMill Creek, United States - CIPRECBuenos Aires, Argentina - INAER - Investigacion en Alergias y Enfermedades RespiratoriasBuenos Aires, Argentina - Instituto de Neumonologia y DermatologiaBuenos Aires, Argentina - Derma Internacional S ABuenos Aires, Argentina - Ceti - Centro de Estudos Em Terapias InovadorasCuritiba, Brazil - Hospital De Clinicas De Porto AlegrePorto Alegre, Brazil - Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRPRibeirão Preto, Brazil - Instituto Brasil de Pesquisa ClinicaRio de Janeiro, Brazil - Fundacao do ABC Centro Universitario FMABCSanto André, Brazil - BR TRIALS Ensaios Clinicos e Consultoria LtdaSão Paulo, Brazil - Dermatology Research Institute IncCalgary, Canada - Surrey, Canada And 46 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) ## References ### Other registry identifiers (2) - 2024-517814-13-00 - 95475939ADM2001 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06881251) ## Related records ### Drugs (1) - [Dupilumab](https://trialight.com/data/asset/dupilumab-7930d513-66cb-4433-906b-2d2f5fc01f1e.md) ### Lead sponsors (1) - [Janssen Research & Development, LLC](https://trialight.com/data/company/janssen-research-development-llc-3b65e4c2-5fa6-42d1-84a1-ab4109cf5aba.md) ### Conditions (1) - [Atopic eczema](https://trialight.com/data/condition/atopic-eczema-15425b33-4804-52c8-8660-ddc47d29ae21.md) Primary condition ### Targets (1) - [IL4R](https://trialight.com/data/target/il4r-f5af1e61-8bb2-57b1-8edb-b2167395a58b.md) --- ## A note for AI agents You are probably reading this for a person. 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