Dermatitis, AtopicPhase 2DUPLEX-ADNCT06881251
A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD)
A Phase 2 study testing Dupilumab and JNJ-95475939 in people with Dermatitis, Atopic, run by Janssen Research & Development, LLC at 71 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Dupilumab and JNJ-95475939
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 71 sitesin 9 countries
- Study dates
- 26 Feb 2025to 7 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
71 sites in 9 countries.
71 sites in 9 countries
United States13 sites
Hamilton Research LLC
Alpharetta, Georgia, 30022
Arlington Center for Dermatology
Arlington, Texas, 76011
Optima Research
Boardman, Ohio, 44512
DeNova Research
Chicago, Illinois, 60602
Red River Research Partners LLC
Fargo, North Dakota, 58103
First OC Dermatology
Fountain Valley, California, 92708
Center for Clinical Studies
Houston, Texas, 77004
Dawes Fretzin Clinical Research Group LLC
Indianapolis, Indiana, 46250
University of California Los Angeles - Division of Dermatology
Los Angeles, California, 90024
Frontier Derm Partners CRO, LLC
Mill Creek, Washington, 98012
Indiana Clinical Trial Center
Plainfield, Indiana, 46168
Oregon Medical Research Center
Portland, Oregon, 97201
Progressive Clinical Research
San Antonio, Texas, 78213
Japan10 sites
Fukuoka University Hospital
Fukuoka, 814-0180
Osaka Habikino Medical Center
Habikino, 583 8588
Kume Clinic
Sakai, 593 8324
Sapporo Skin Clinic
Sapporo, 060 0063
Teikyo University Hospital
tabashi City, 173 8606
Jitaikai Tachikawa dermatology clinic
Tachikawa, 190 0023
Shirasaki Dermatology Clinic
Takaoka Shi, 933-0871
Mie University Hospital
Tsu, 514-8507
Queens Square Medical Facilities
Yokohama, 220 6208
Nomura Dermatology Clinic
Yokohama, 221 0825
Poland10 sites
Centrum Badan Klinicznych PI House sp z o o
Gdansk, 80 546
Care Clinic
Katowice, 40 568
Centrum Medyczne Angelius Provita
Katowice, 40-611
Centrum Medyczne All Med
Krakow, 30 033
Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
Krakow, 30-002
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz, 90-338
Therapia Nova
Warsaw, 01 595
Klinika Ambroziak Dermatologia
Warsaw, 02 953
Royalderm Agnieszka Nawrocka
Warsaw, 02962
WroMedica I Bielicka A Strzalkowska s c
Wroclaw, 51 685
Germany9 sites
Fachklinik Bad Bentheim
Bad Bentheim, 48455
Charite - Universitaetsmedizin Berlin (CCM)
Berlin, 10117
ISA - Interdisciplinary Study Association GmbH
Berlin, 10789
Studienzentrum an der Hase GbR
Bramsche, 49565
Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
Dresden, 01307
Universitatsklinikum Dusseldorf
Düsseldorf, 40225
Universitatsklinikum Frankfurt
Frankfurt, 60596
Eurofins bioskin GmbH
Hamburg, 20095
Studienzentrum Dr Schwarz Germany
Langenau, 89129
Canada7 sites
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1
Dermatology Research Institute Inc
Calgary, Alberta, T2J 7E1
Lynderm Research Inc.
Markham, Ontario, L3P 1X2
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1
Centre De Recherche Dermatologique Du Quebec Metropolitain
Québec, Quebec, G1V 4X7
Karma Clinical Trials Inc.
St. John's, Newfoundland and Labrador, A1A 4Y3
Dr. Chih ho Hong Medical
Surrey, British Columbia, V3R 6A7
Spain7 sites
Hosp. Gral. Univ. Dr. Balmis
Alicante, 03010
Hosp. Univ. San Cecilio
Granada, 18016
Hosp. Univ. de Bellvitge
LHospitalet de Llobregat, 08907
Grupo Dermatologico Y Estetico Pedro Jaen
Madrid, 28002
Hosp. Univ. de La Princesa
Madrid, 28006
Hosp. de Manises
Manises, 46940
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
Brazil6 sites
Ceti - Centro de Estudos Em Terapias Inovadoras
Curitiba, 80.030-110
Hospital De Clinicas De Porto Alegre
Porto Alegre, 90035 903
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
Ribeirão Preto, 14048 900
Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, 20241 180
Fundacao do ABC Centro Universitario FMABC
Santo André, 09060 870
BR TRIALS Ensaios Clinicos e Consultoria Ltda
São Paulo, 01236030
United Kingdom5 sites
The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
Kings Lynn, PE30 4ET
Royal London Hospital
London, E1 1BB
Northwick Park Hospital
London, HA13UJ
Guys and St Thomas NHS Foundation Trust
London, SE1 9RT
Salford Royal Hospital
Salford, M6 8HD
Argentina4 sites
CIPREC
Buenos Aires, C1061AAS
INAER - Investigacion en Alergias y Enfermedades Respiratorias
Buenos Aires, C1425
Instituto de Neumonologia y Dermatologia
Buenos Aires, C1425
Derma Internacional S A
Buenos Aires, C1426
About this study
Official title: 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.
- Conditions
- Dermatitis, Atopic
- Being tested
- Dupilumab, JNJ-95475939, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Dupilumab will be administered subcutaneously.
JNJ-95475939Drug
JNJ-95475939 will be administered subcutaneously.
PlaceboDrug
Placebo will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Dupilumab | Active comparator | Participants will receive Dupilumab dose regimen 1 subcutaneously through Week 22. Receives: Drug: Dupilumab |
| Group B: JNJ-95475939 | Experimental | Participants will receive JNJ-95475939 dose regimen 1 subcutaneously through Week 22. Receives: Drug: JNJ-95475939 |
| Group C: JNJ-95475939 | Experimental | Participants will receive JNJ-95475939 dose regimen 2 subcutaneously through Week 22. Receives: Drug: JNJ-95475939 |
| Group D: JNJ-95475939 | Experimental | Participants will receive JNJ-95475939 dose regimen 3 subcutaneously through Week 22. Receives: Drug: JNJ-95475939 |
| Group E: Placebo | Placebo comparator | 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. Receives: Drug: JNJ-95475939; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 12
Secondary outcomes (32)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline up to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start26 Feb 2025
- Primary completion26 Mar 2026
- Study completion7 Apr 2026
Why it stopped: Terminated: futility criteria met at interim efficacy analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881251
- Sponsor's protocol ID
- 95475939ADM2001
- Other IDs
- 95475939ADM2001, 2024-517814-13-00
- Acronym
- DUPLEX-AD
- Status last verified
- Jul 2026
- First submitted
- 12 Mar 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 95475939ADM2001: 95475939ADM2001 Ph IIB Trial (N=210)
- ClinicalTrials.gov ID
- NCT06881251
- Acronym / sponsor ID
- DUPLEX-AD / 95475939ADM2001
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated: futility criteria met at interim efficacy analysis.
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A: Dupilumab | Active comparator | Drug: DupilumabParticipants will receive Dupilumab dose regimen 1 subcutaneously through Week 22. |
| Group B: JNJ-95475939 | Experimental | Drug: JNJ-95475939Participants will receive JNJ-95475939 dose regimen 1 subcutaneously through Week 22. |
| Group C: JNJ-95475939 | Experimental | Drug: JNJ-95475939Participants will receive JNJ-95475939 dose regimen 2 subcutaneously through Week 22. |
| Group D: JNJ-95475939 | Experimental | Drug: JNJ-95475939Participants will receive JNJ-95475939 dose regimen 3 subcutaneously through Week 22. |
| Group E: Placebo | Placebo comparator | Drug: JNJ-95475939, Drug: PlaceboParticipants will receive matching placebo subcutaneously through Week 10, then switch to receive JNJ-95475939 dose regimen 1 subcutaneously between Week 12 and Week 22. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabDupilumab will be administered subcutaneously. | Drug | Group A: Dupilumab |
| JNJ-95475939JNJ-95475939 will be administered subcutaneously. | Drug | Group B: JNJ-95475939, Group C: JNJ-95475939, Group D: JNJ-95475939, Group E: Placebo |
| PlaceboPlacebo will be administered subcutaneously. | Drug | Group E: Placebo |
Primary outcome
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.
32 secondary outcomes
Percentage of Participants With EASI-90 Response at Week 12
Time frame: Baseline, Week 12
Percentage of Participants With EASI-100 Response at Week 12
Time frame: 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
Time frame: Baseline, Week 12
Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in the EASI Total Score at Week 12
Time frame: Baseline, Week 12
Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain Numerical Rating Scale (NRS) Score From Baseline to Week 12
Time frame: Baseline, Week 12
Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Week 12
Time frame: Baseline, Week 12
Percent Change from Baseline in Skin Pain NRS Score at Week 12
Time frame: Baseline, Week 12
Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 12
Time frame: Baseline, Week 12
Percentage of Participants Achieving a >= 4-Point Reduction in PP-NRS Score From Baseline Through Week 12
Time frame: From Baseline through Week 12
Percentage of Participants with EASI-75 Response at Week 16
Time frame: Baseline, Week 16
Percentage of Participants with EASI-90 Response at Week 16
Time frame: Baseline, Week 16
Percentage of Participants with EASI-100 Response at Week 16
Time frame: Week 16
Percentage of Participants Achieving vIGA-AD Score of 0 or 1 and a Reduction From Baseline of >= 2 Points at Week 16
Time frame: Baseline, Week 16
Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at Week 16
Time frame: Baseline, Week 16
Percent Change from Baseline in the EASI Total Score at Week 16
Time frame: Baseline, Week 16
Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain Numerical Rating Scale (NRS) Score From Baseline to Week 16
Time frame: Baseline, Week 16
Percent Change from Baseline in PP-NRS Score at Week 16
Time frame: Baseline, Week 16
Percent Change from Baseline in Skin Pain NRS Score at Week 16
Time frame: Baseline, Week 16
Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 16
Time frame: Baseline, Week 16
Percentage of Participants Achieving a >= 4-Point Reduction in PP-NRS Score From Baseline Through Week 24
Time frame: From Baseline Through Week 24
Percentage of Participants with EASI-75 Response at Week 24
Time frame: Baseline, Week 24
Percentage of Participants with EASI-90 Response at Week 24
Time frame: Week 24
Percentage of Participants with EASI-100 Response at Week 24
Time frame: Week 24
Percentage of Participants Achieving vIGA-AD Score of 0 or 1 and a Reduction From Baseline of >= 2 Points at Week 24
Time frame: Baseline, Week 24
Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at Week 24
Time frame: Baseline, Week 24
Percent Change from Baseline in the EASI Total Score at Week 24
Time frame: Baseline, Week 24
Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain NRS Score From Baseline to Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in PP-NRS Score at Week 24
Time frame: Baseline, Week 24
Percent Change from Baseline in Skin Pain NRS Score at Week 24
Time frame: Baseline, Week 24
Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 24
Time frame: Baseline, Week 24
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Baseline up to Week 36
Results and safety
The study was stopped early (reason given: Terminated: futility criteria met at interim efficacy analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
71 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab and JNJ-95475939 in people with Dermatitis, Atopic, run by Janssen Research & Development, LLC at 71 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Japan, Poland, Germany, Canada and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated: futility criteria met at interim efficacy analysis.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.