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| ID | Type | Description | Link |
|---|---|---|---|
| 95597528ADM2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2025-523464-20-00 | Registry Identifier | EUCT number |
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The purpose of this study is to assess how well JNJ-95597528 works compared to placebo in participants with moderate to severe atopic dermatitis (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: JNJ-95597528 (Dose 1) | Experimental | Participants will receive JNJ-95597528 Dose 1 on Weeks 0, 2, 12, and 24. |
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| Group 2: JNJ-95597528 (Dose 2 and 3) | Experimental | Participants will receive JNJ-95597528 Dose 2 on Week 0 followed by JNJ-95597528 Dose 3 on Weeks 12, and 24. |
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| Group 3: JNJ-95597528 (Dose 4 and 5) | Experimental | Participants will receive JNJ-95597528 Dose 4 on Week 0 followed by JNJ-95597528 Dose 5 on Weeks 12, and 24. |
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| Group 4: Placebo and JNJ-95597528 (Dose 2 and 3) | Placebo Comparator | Participants will receive placebo from Weeks 0 to 12 , then switch to receive JNJ-95597528 Dose 2 administered at Week 12 followed by Dose 3 at Week 24. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-95597528 | Drug | JNJ-95597528 will be administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion 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 from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with EASI 90 Response at Week 12 | EASI-90 response is defined as at least 90% improvement from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First OC Dermatology | Active, not recruiting | Fountain Valley | California | 92708 | United States | |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.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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| Placebo | Drug | Placebo will be administered subcutaneously. |
|
| Week 12 |
| Proportion of Participants with EASI 100 Response at Week 12 | EASI-100 response is defined as at least 100% improvement from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD. | Week 12 |
| Percent Change from Baseline in EASI Total Score at Week 12 | Percent change from baseline in EASI total score will be reported. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD. | Baseline, Week 12 |
| Proportion of Participants with Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 and a Reduction of >= 2 Points from Baseline, at Week 12 | Proportion of participants with vIGA-AD score of 0 or 1 and a reduction of >=2 points from baseline at Week 12 will be reported. 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 (clear) to 4 (severe). The IGA score is selected using the morphological descriptors that best describe the overall appearance of the AD lesions at a given time point. Higher scores are indicative of a more severe AD. | Week 12 |
| Proportion of Participants with vIGA-AD Score of 0 and a Reduction of >= 2 points from Baseline, at Week 12 | Proportion of participants with vIGA-AD score of 0 and a reduction of >=2 points from baseline at Week 12 will be reported. 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 (clear) to 4 (severe). The IGA score is selected using the morphological descriptors that best describe the overall appearance of the AD lesions at a given time point. Higher scores are indicative of a more severe AD. | Week 12 |
| Proportion of Participants with >= 4-Point Improvement in Peak Pruritus Numeric(al) Rating Scale (PP-NRS) from Baseline, at Week 12 | Proportion of participants with >=4-point improvement from baseline in PP-NRS scale at Week 12 will be reported. PP-NRS is a single item asking participants to assess their worst itch over the past 24 hours. There are 11 response categories, ranging from 0 (no itch) to 10 (worst itch imaginable). Higher score indicates greater severity. | Week 12 |
| Percent Change from Baseline in PP-NRS Score at Week 12 | Percent change from baseline in PP-NRS score will be reported. PP-NRS is a single item asking participants to assess their worst itch over the past 24 hours. There are 11 response categories, ranging from 0 (no itch) to 10 (worst itch imaginable). Higher score indicates greater severity. | Baseline, Week 12 |
| Percent Change from Baseline in Score of Item 2 of Atopic Dermatitis Sleep Scale (AD Sleep Scale) at Week 12 | Percent change from baseline in the score of Item 2 of AD Sleep Scale at Week 12 will be reported. The AD Sleep Scale is a validated 3-item participant-reported outcome (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. For Item 2, participants select the number of times they woke up each night, ranging from 0 to 29 times. Higher score indicates more sleep disturbance. | Baseline, Week 12 |
| Proportion of Participants with >= 4 Point Improvement in Skin Pain Numeric Rating Scale (Skin Pain NRS) from Baseline, at Week 12 | Proportion of participants with >= 4 point improvement from baseline in skin pain NRS at Week 12 will be reported. Skin Pain NRS is a single item asking participants to assess their worst skin pain over the past 24 hours. There are 11 response categories, ranging from 0 (no pain) to 10 (worst pain imaginable). Higher score indicates more pain. | Week 12 |
| Percent Change from Baseline in Skin Pain NRS at Week 12 | Percent change from baseline in Skin Pain NRS at Week 12 will be reported. Skin Pain NRS is a single item asking participants to assess their worst skin pain over the past 24 hours. There are 11 response categories, ranging from 0 (no pain) to 10 (worst pain imaginable). Higher score indicates more pain. | Baseline, Week 12 |
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are AEs with onset during the intervention phase or that are a consequence of a preexisting condition that has worsened since baseline. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important. | Up to approximately Week 12 |
| University of California Los Angeles - Division of Dermatology |
| Active, not recruiting |
| Los Angeles |
| California |
| 90024 |
| United States |
| Southern California Dermatology | Active, not recruiting | Santa Ana | California | 92701 | United States |
| Driven Research LLC | Active, not recruiting | Miami | Florida | 33126 | United States |
| Arlington Dermatology | Active, not recruiting | Rolling Meadows | Illinois | 60008 | United States |
| Dawes Fretzin Clinical Research Group | Completed | Indianapolis | Indiana | 46250 | United States |
| Henry Ford Health System | Active, not recruiting | Detroit | Michigan | 48202 | United States |
| Red River Research Partners LLC | Active, not recruiting | Fargo | North Dakota | 58103 | United States |
| Oregon Dermatology and Research Center | Active, not recruiting | Portland | Oregon | 97210 | United States |
| Clinical Research Philadelphia | Active, not recruiting | Philadelphia | Pennsylvania | 19114 | United States |
| Center for Clinical Studies | Completed | Houston | Texas | 77004 | United States |
| Progressive Clinical Research | Active, not recruiting | San Antonio | Texas | 78213 | United States |
| Instituto Medico De Alta Complejidad (IMAC) | Active, not recruiting | Buenos Aires | B1643CRO | Argentina |
| CIPREC | Active, not recruiting | Buenos Aires | C1061AAS | Argentina |
| DOM Reumatologia | Active, not recruiting | Buenos Aires | C1111 | Argentina |
| INAER - Investigacion en Alergias y Enfermedades Respiratorias | Active, not recruiting | Buenos Aires | C1425BEN | Argentina |
| Derma Internacional S A | Active, not recruiting | Buenos Aires | C1426 | Argentina |
| Mautalen Salud e Investigacion | Active, not recruiting | CABA | C1128AAF | Argentina |
| Instituto de Investigaciones Clinicas Cordoba | Active, not recruiting | Córdoba | X5000AAW | Argentina |
| Centro de Investigaciones Clinicas CIC IESR | Active, not recruiting | Rosario | 2000 | Argentina |
| Centro Respiratorio Infantil | Active, not recruiting | Rosario | 2000 | Argentina |
| Centro de Investigaciones Medicas Tucuman | Completed | San Miguel de Tucumán | T4000AXL | Argentina |
| Ceti - Centro de Estudos Em Terapias Inovadoras | Active, not recruiting | Curitiba | 80030 110 | Brazil |
| Hospital De Clinicas De Porto Alegre | Active, not recruiting | Porto Alegre | 90035 903 | Brazil |
| Instituto Brasil de Pesquisa Clinica | Active, not recruiting | Rio de Janeiro | 20241 180 | Brazil |
| Fundacao do ABC Centro Universitario FMABC | Active, not recruiting | Santo André | 09060 870 | Brazil |
| Pesquisare Saude | Active, not recruiting | Santo André | 09080-110 | Brazil |
| PSEG trials Centro de Pesquisa Clinica S A | Recruiting | São Paulo | 04038 002 | Brazil |
| Dermatology Research Institute Inc | Completed | Calgary | Alberta | T2J 7E1 | Canada |
| CCA Medical Research Corporation | Active, not recruiting | Ajax | Ontario | L1S7K8 | Canada |
| SimcoDerm Medical and Surgical Dermatology Centre | Active, not recruiting | Barrie | Ontario | L4M 7G1 | Canada |
| Dr Wei Jing Loo Medicine Professional Corporation | Active, not recruiting | London | Ontario | N6H 5L5 | Canada |
| DermEdge Research | Active, not recruiting | Mississauga | Ontario | L4Y 4C5 | Canada |
| Allergy Research Canada Inc. | Active, not recruiting | Niagara Falls | Ontario | L2H 1H5 | Canada |
| York Dermatology Clinic and Research Centre | Active, not recruiting | Richmond Hill | Ontario | L4B1L1 | Canada |
| XLR8 Medical Research | Active, not recruiting | Windsor | Ontario | N8T 1E6 | Canada |
| China Japan Friendship Hospital | Active, not recruiting | Beijing | 100029 | China |
| Xiangya Hospital Central South University | Active, not recruiting | Changsha | 410008 | China |
| Hosp. of Chengde Medical University | Active, not recruiting | Chengde | 067030 | China |
| West China Hospital of Sichuan University | Active, not recruiting | Chengdu | 610041 | China |
| The First Affiliated Hospital of Sun Yat-Sen University | Active, not recruiting | Guangzhou | 510080 | China |
| Sanmenxia Central Hospital | Active, not recruiting | Sanmenxia | 472000 | China |
| Wuxi People s Hospital | Active, not recruiting | Wuxi | 214100 | China |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Active, not recruiting | Xi'an | 710004 | China |
| ISA - Interdisciplinary Study Association GmbH | Active, not recruiting | Berlin | 10789 | Germany |
| Studienzentrum an der Hase GbR | Active, not recruiting | Bramsche | 49565 | Germany |
| Klinikum rechts der Isar an der Technischen Universitat Munchen | Active, not recruiting | München | 80802 | Germany |
| Universitaetsklinikum Muenster | Active, not recruiting | Münster | 48149 | Germany |
| Miyata Dermatology Clinic | Active, not recruiting | Matsudo | 271-0092 | Japan |
| Kume Clinic | Active, not recruiting | Nishiku | 593-8324 | Japan |
| Kindai University Hospital | Active, not recruiting | Sakai | 590 0197 | Japan |
| Teikyo University Hospital | Active, not recruiting | tabashi City | 173-8606 | Japan |
| Jitaikai Tachikawa dermatology clinic | Active, not recruiting | Tachikawa | 190 0023 | Japan |
| Nomura Dermatology Clinic | Active, not recruiting | Yokohama | 221 0825 | Japan |
| SOLUMED Centrum Medyczne | Recruiting | Poznan | 60 529 | Poland |
| Kaohsiung Veterans General Hospital | Active, not recruiting | Kaohsiung City | 813 | Taiwan |
| Chang Gung Memorial Hospital | Active, not recruiting | Kaohsiung City | 833 | Taiwan |
| Taipei Medical University Shuang Ho Hospital | Active, not recruiting | New Taipei City | 235 | Taiwan |
| Chung Shan Medical University Hospital | Active, not recruiting | Taichung | 40201 | Taiwan |
| National Taiwan University Hospital | Active, not recruiting | Taipei | 10048 | Taiwan |
| Tri-Service General Hospital | Active, not recruiting | Taipei | 114202 | Taiwan |
| Linkou Chang Gung Memorial Hospital | Active, not recruiting | Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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