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

Phase 2

Recruiting

• Conditions: Dermatitis, Atopic
• Interventions: Drug: Dupilumab; Drug: JNJ-95475939; Drug: Placebo

• Registration Number: NCT06881251
• Lead Sponsor: Janssen Research & Development, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-26
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Study First Posted: 2025-03-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-07-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Dupilumab	Dupilumab	Participants will receive Dupilumab dose regimen 1 subcutaneously through Week 22.
Group B: JNJ-95475939	JNJ-95475939	Participants will receive JNJ-95475939 dose regimen 1 subcutaneously through Week 22.
Group C: JNJ-95475939	JNJ-95475939	Participants will receive JNJ-95475939 dose regimen 2 subcutaneously through Week 22.
Group D: JNJ-95475939	JNJ-95475939	Participants will receive JNJ-95475939 dose regimen 3 subcutaneously through Week 22.
Group E: Placebo	JNJ-95475939	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.
Group E: Placebo	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12	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 Outcome Measures

Name	Time	Method
Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 24	Baseline, 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.
Percentage of Participants With EASI-90 Response at Week 12	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.
Percentage of Participants With EASI-100 Response at Week 12	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.
Percentage of Participants Achieving a >= 4-Point Reduction in PP-NRS Score From Baseline Through Week 12	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.
Percentage of Participants with EASI-75 Response at Week 16	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.
Percentage of Participants with EASI-90 Response at Week 16	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.
Percentage of Participants with EASI-100 Response at Week 16	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.
Percentage of Participants Achieving vIGA-AD Score of 0 or 1 and a Reduction From Baseline of >= 2 Points at Week 16	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.
Percentage of Participants Achieving a >= 4-Point Reduction in PP-NRS Score From Baseline Through Week 24	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.
Percentage of Participants with EASI-75 Response at Week 24	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.
Percentage of Participants with EASI-90 Response at Week 24	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.
Percentage of Participants with EASI-100 Response at Week 24	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.
Percent Change from Baseline in the EASI Total Score at Week 24	Baseline, 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.
Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain NRS Score From Baseline to Week 24	Baseline, 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.
Percent Change From Baseline in PP-NRS Score at Week 24	Baseline, 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.
Percent Change from Baseline in Skin Pain NRS Score at Week 24	Baseline, 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.
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	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.
Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at Week 12	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.
Percent Change From Baseline in the EASI Total Score at Week 12	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.
Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain Numerical Rating Scale (NRS) Score From Baseline to Week 12	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.
Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Week 12	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.
Percent Change from Baseline in Skin Pain NRS Score at Week 12	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.
Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 12	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.
Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at Week 16	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.
Percent Change from Baseline in the EASI Total Score at Week 16	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.
Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain Numerical Rating Scale (NRS) Score From Baseline to Week 16	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.
Percent Change from Baseline in PP-NRS Score at Week 16	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.
Percent Change from Baseline in Skin Pain NRS Score at Week 16	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.
Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 16	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.
Percentage of Participants Achieving vIGA-AD Score of 0 or 1 and a Reduction From Baseline of >= 2 Points at Week 24	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.
Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at Week 24	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.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	From Baseline up to Week 32	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.

Trial Locations

Locations (49)

First OC Dermatology; 🇺🇸 Fountain Valley, California, United States

Hamilton Research LLC; 🇺🇸 Alpharetta, Georgia, United States

Dawes Fretzin Clinical Research Group LLC; 🇺🇸 Indianapolis, Indiana, United States

Indiana Clinical Trial Center; 🇺🇸 Plainfield, Indiana, United States

Optima Research; 🇺🇸 Boardman, Ohio, United States

Oregon Medical Research Center; 🇺🇸 Portland, Oregon, United States

Shirasaki Dermatology Clinic; 🇯🇵 Takaoka shi, Japan

Arlington Center for Dermatology; 🇺🇸 Arlington, Texas, United States

Center for Clinical Studies; 🇺🇸 Houston, Texas, United States

Progressive Clinical Research; 🇺🇸 San Antonio, Texas, United States

Frontier Derm Partners CRO, LLC; 🇺🇸 Mill Creek, Washington, United States

Instituto de Neumonologia y Dermatologia; 🇦🇷 Buenos Aires, Argentina

Derma Internacional S A; 🇦🇷 Buenos Aires, Argentina

CIPREC; 🇦🇷 Ciudad Autonoma de Buenos Aires, Argentina

Dermatology Research Institute Inc; 🇨🇦 Calgary, Alberta, Canada

Dr. Chih ho Hong Medical; 🇨🇦 Surrey, British Columbia, Canada

Lynderm Research Inc.; 🇨🇦 Markham, Ontario, Canada

Innovaderm Research Inc.; 🇨🇦 Montreal, Quebec, Canada

Centre De Recherche Dermatologique Du Quebec Metropolitain; 🇨🇦 Quebec, Canada

Fachklinik Bad Bentheim; 🇩🇪 Bad Bentheim, Germany

ISA - Interdisciplinary Study Association GmbH; 🇩🇪 Berlin, Germany

Eurofins bioskin GmbH; 🇩🇪 Hamburg, Germany

Studienzentrum Dr Schwarz Germany; 🇩🇪 Langenau, Germany

Fukuoka University Hospital; 🇯🇵 Fukuoka-shi, Japan

Osaka Habikino Medical Center; 🇯🇵 Habikino, Japan

Teikyo University Hospital; 🇯🇵 Itabashi Ku, Japan

Kume Clinic; 🇯🇵 Sakai City, Japan

Sapporo Skin Clinic; 🇯🇵 Sapporo shi, Japan

Jitaikai Tachikawa dermatology clinic; 🇯🇵 Tachikawa, Japan

Mie University Hospital; 🇯🇵 Tsu, Japan

Centrum Medyczne All Med; 🇵🇱 Krakow, Poland

Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna; 🇵🇱 Lodz, Poland

Queens Square Medical Facilities; 🇯🇵 Yokohama, Japan

Nomura Dermatology Clinic; 🇯🇵 Yokohama, Japan

Centrum Badan Klinicznych PI House sp z o o; 🇵🇱 Gdansk, Poland

Care Clinic; 🇵🇱 Katowice, Poland

Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna; 🇵🇱 Krakow, Poland

Klinika Ambroziak Dermatologia; 🇵🇱 Warszawa, Poland

WroMedica I Bielicka A Strzalkowska s c; 🇵🇱 Wroclaw, Poland

Hosp. Gral. Univ. Dr. Balmis; 🇪🇸 Alicante, Spain

Hosp. Univ. San Cecilio; 🇪🇸 Granada, Spain

Grupo Dermatologico Y Estetico Pedro Jaen; 🇪🇸 Madrid, Spain

Hosp. Univ. de La Princesa; 🇪🇸 Madrid, Spain

Hosp. de Manises; 🇪🇸 Manises, Spain

Hosp. Clinico Univ. de Santiago; 🇪🇸 Santiago de Compostela, Spain

Northwick Park Hospital; 🇬🇧 London, United Kingdom

Guys and St Thomas NHS Foundation Trust; 🇬🇧 London, United Kingdom

The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust; 🇬🇧 Norfolk, United Kingdom

Salford Royal Hospital; 🇬🇧 Salford, United Kingdom