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

95475939ADM2001: 95475939ADM2001 Ph IIB Trial (N=210)

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.

Study Overview

• Status: Terminated
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: Placebo; Drug: Dupilumab; Drug: JNJ-95475939

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1061AAS
    • CIPREC
  • Buenos Aires, Argentina, C1425
    • Instituto de Neumonologia Y Dermatologia
  • Buenos Aires, Argentina, C1426
    • Derma Internacional S A
  • Buenos Aires, Argentina, C1425
    • INAER - Investigacion en Alergias y Enfermedades Respiratorias
• Brazil
  • Curitiba, Brazil, 80.030-110
    • CETI - Centro de Estudos em Terapias Inovadoras
  • Porto Alegre, Brazil, 90035 903
    • Hospital de Clínicas de Porto Alegre
  • Ribeirão Preto, Brazil, 14048 900
    • Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
  • Rio de Janeiro, Brazil, 20241 180
    • Instituto Brasil de Pesquisa Clinica
  • Santo André, Brazil, 09060 870
    • Fundacao do ABC Centro Universitario FMABC
  • São Paulo, Brazil, 01236030
    • BR TRIALS Ensaios Clinicos e Consultoria Ltda
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute Inc
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih ho Hong Medical
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
      • Karma Clinical Trials Inc.
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • SimcoDerm Medical and Surgical Dermatology Centre
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc.
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc.
    • Québec, Quebec, Canada, G1V 4X7
      • Centre De Recherche Dermatologique Du Quebec Metropolitain
• Germany
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim
  • Berlin, Germany, 10789
    • ISA - Interdisciplinary Study Association GmbH
  • Berlin, Germany, 10117
    • Charite - Universitaetsmedizin Berlin (CCM)
  • Bramsche, Germany, 49565
    • Studienzentrum an der Hase GbR
  • Dresden, Germany, 01307
    • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
  • Düsseldorf, Germany, 40225
    • Universitätsklinikum Düsseldorf
  • Frankfurt, Germany, 60596
    • Universitätsklinikum Frankfurt
  • Hamburg, Germany, 20095
    • Eurofins bioskin GmbH
  • Langenau, Germany, 89129
    • Studienzentrum Dr Schwarz Germany
• Japan
  • Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Habikino, Japan, 583 8588
    • Osaka Habikino Medical Center
  • Itabashi Ku, Japan, 173 8606
    • Teikyo University Hospital
  • Sakai, Japan, 593 8324
    • Kume Clinic
  • Sapporo, Japan, 060 0063
    • Sapporo Skin Clinic
  • Tachikawa, Japan, 190 0023
    • Jitaikai Tachikawa dermatology clinic
  • Takaoka Shi, Japan, 933-0871
    • Shirasaki dermatology clinic
  • Tsu, Japan, 514-8507
    • Mie University Hospital
  • Yokohama, Japan, 221 0825
    • Nomura Dermatology Clinic
  • Yokohama, Japan, 220 6208
    • Queens Square Medical Facilities
• Poland
  • Gdansk, Poland, 80 546
    • Centrum Badan Klinicznych PI House sp z o o
  • Katowice, Poland, 40-611
    • Centrum Medyczne Angelius Provita
  • Katowice, Poland, 40 568
    • CaRe Clinic
  • Krakow, Poland, 30 033
    • Centrum Medyczne All Med
  • Krakow, Poland, 30-002
    • Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
  • Lodz, Poland, 90-338
    • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
  • Warsaw, Poland, 02962
    • Royalderm Agnieszka Nawrocka
  • Warsaw, Poland, 02 953
    • Klinika Ambroziak Dermatologia
  • Warsaw, Poland, 01 595
    • Therapia Nova
  • Wroclaw, Poland, 51 685
    • WroMedica I Bielicka A Strzalkowska s c
• Spain
  • Alicante, Spain, 03010
    • Hosp. Gral. Univ. Dr. Balmis
  • Granada, Spain, 18016
    • Hosp. Univ. San Cecilio
  • LHospitalet de Llobregat, Spain, 08907
    • Hosp. Univ. de Bellvitge
  • Madrid, Spain, 28006
    • Hosp. Univ. de La Princesa
  • Madrid, Spain, 28002
    • Grupo Dermatologico Y Estetico Pedro Jaen
  • Manises, Spain, 46940
    • Hosp. de Manises
  • Santiago de Compostela, Spain, 15706
    • Hosp. Clinico Univ. de Santiago
• United Kingdom
  • Kings Lynn, United Kingdom, PE30 4ET
    • The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
  • London, United Kingdom, E1 1BB
    • Royal London Hospital
  • London, United Kingdom, HA13UJ
    • Northwick Park Hospital
  • London, United Kingdom, SE1 9RT
    • Guys and St Thomas NHS Foundation Trust
  • Salford, United Kingdom, M6 8HD
    • Salford Royal Hospital
• United States
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Los Angeles, California, United States, 90024
      • University of California Los Angeles - Division of Dermatology
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Hamilton Research LLC
  • Illinois
    • Chicago, Illinois, United States, 60602
      • DeNova Research
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group LLC
    • Plainfield, Indiana, United States, 46168
      • Indiana Clinical Trial Center
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Red River Research Partners LLC
  • Ohio
    • Boardman, Ohio, United States, 44512
      • Optima Research
  • Oregon
    • Portland, Oregon, United States, 97201
      • Oregon Medical Research Center
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Center for Dermatology
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research
  • Washington
    • Mill Creek, Washington, United States, 98012
      • Frontier Derm Partners CRO, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: Dupilumab; Participants will receive Dupilumab dose regimen 1 subcutaneously through Week 22.	Drug: Dupilumab; Dupilumab will be administered subcutaneously.
Experimental: Group B: JNJ-95475939; Participants will receive JNJ-95475939 dose regimen 1 subcutaneously through Week 22.	Drug: JNJ-95475939; JNJ-95475939 will be administered subcutaneously.
Experimental: Group C: JNJ-95475939; Participants will receive JNJ-95475939 dose regimen 2 subcutaneously through Week 22.	Drug: JNJ-95475939; JNJ-95475939 will be administered subcutaneously.
Experimental: Group D: JNJ-95475939; Participants will receive JNJ-95475939 dose regimen 3 subcutaneously through Week 22.	Drug: JNJ-95475939; JNJ-95475939 will be administered subcutaneously.
Placebo Comparator: Group E: Placebo; 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.	Drug: Placebo; Placebo will be administered subcutaneously.; Drug: JNJ-95475939; JNJ-95475939 will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Eczema Area and Severity Index (EASI) 75 Response at 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.	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With EASI-90 Response at 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.	Baseline, Week 12
Percentage of Participants With EASI-100 Response at 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.	Baseline, Week 12
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	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.	Baseline, Week 12
Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at 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.	Baseline, Week 12
Percent Change From Baseline in the EASI Total Score at 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.	Baseline, Week 12
Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain Numerical Rating Scale (NRS) Score From Baseline to 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.	Baseline, Week 12
Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at 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.	Baseline, Week 12
Percent Change from Baseline in Skin Pain NRS Score at 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.	Baseline, Week 12
Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at 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.	Baseline, Week 12
Percentage of Participants Achieving a >= 4-Point Reduction in PP-NRS Score 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.	From Baseline through Week 12
Percentage of Participants with EASI-75 Response at 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.	Baseline, Week 16
Percentage of Participants with EASI-90 Response at 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.	Baseline, Week 16
Percentage of Participants with EASI-100 Response at 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.	Week 16
Percentage of Participants Achieving vIGA-AD Score of 0 or 1 and a Reduction From Baseline of >= 2 Points at 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.	Baseline, Week 16
Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at 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.	Baseline, Week 16
Percent Change from Baseline in the EASI Total Score at 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.	Baseline, Week 16
Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain Numerical Rating Scale (NRS) Score From Baseline to 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.	Baseline, Week 16
Percent Change from Baseline in PP-NRS Score at 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.	Baseline, Week 16
Percent Change from Baseline in Skin Pain NRS Score at 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.	Baseline, Week 16
Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at 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.	Baseline, Week 16
Percentage of Participants Achieving a >= 4-Point Reduction in PP-NRS Score 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.	From Baseline Through Week 24
Percentage of Participants with EASI-75 Response at 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.	Baseline, Week 24
Percentage of Participants with EASI-90 Response at 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.	Week 24
Percentage of Participants with EASI-100 Response at 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.	Week 24
Percentage of Participants Achieving vIGA-AD Score of 0 or 1 and a Reduction From Baseline of >= 2 Points at 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.	Baseline, Week 24
Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at 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.	Baseline, Week 24
Percent Change from Baseline in the EASI Total Score at Week 24	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.	Baseline, Week 24
Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain NRS Score From Baseline to Week 24	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.	Baseline, Week 24
Percent Change From Baseline in PP-NRS Score at 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.	Baseline, Week 24
Percent Change from Baseline in Skin Pain NRS Score at Week 24	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.	Baseline, Week 24
Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 24	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.	Baseline, Week 24
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	Participants with AEs and SAEs will be reported. An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. TEAEs are AEs with onset during the intervention phase or that are a consequence of a preexisting condition that has worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly.	From Baseline up to Week 36

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Actual): March 26, 2026
• Study Completion (Actual): April 7, 2026

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 18, 2025

Study Record Updates

• Last Update Posted (Actual): July 31, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Substandard Drugs; Pharmaceutical Preparations; dupilumab
• Other Study ID Numbers: 95475939ADM2001 (Other Identifier: Janssen Research & Development, LLC); 2024-517814-13-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No