Клинические исследование Dermatitis, Atopic: Bermekimab, Placebo - Реестр клинических исследований

Спонсоры	Ведущий спонсор: Janssen Research & Development, LLC
Источник	Janssen Research & Development, LLC
Краткое содержание	The purpose of this study is to evaluate the efficacy of Bermekimab, compared with placebo, in participants with moderate-to-severe atopic dermatitis (AD).

Общий статус

Recruiting

Дата начала

2021-10-06

Дата завершения

2022-12-06

Дата первичного завершения

2022-10-31

Фаза

Phase 2

Тип исследования

Interventional

Первичный результат

Мера	Временное ограничение
Percentage of Participants with Eczema Area and Severity Index (EASI)-75 (Greater Than or Equal to [>=] 75 Percent [%] Improvement from Baseline) at Week 16	Week 16

Вторичный результат

Мера	Временное ограничение
Serum Concentrations of Bermekimab	Up to week 16
Number of Participants with Antibodies to Bermekimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs])	Up to week 16
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)	Up to week 20
Percentage of Participants with Treatment-emergent Serious Adverse Events (TESAEs)	Up to week 20
Percentage of Participants with Adverse Events (AEs) Leading to Discontinuation of Study Intervention	Up to week 20
Percentage of Participants with AEs Reasonably Related to Study Intervention	Up to week 20
Percentage of Participants with AEs of Infusion-related Reactions.	Up to week 20
Percentage of Participants with AEs of Infections	Up to week 20
Percentage of Participants with Clinically Significant Abnormalities in Vital Signs	Up to week 20
Percentage of Participants with Clinically Significant Abnormalities in Laboratory Parameters	Up to week 20
Percentage of Participants with Both validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 and a Reduction from Baseline of >=2 Points	Up to week 16
Percentage of Participants with Improvement (Reduction) of Eczema-related Itch Numeric Rating Scale (NRS) Score of >=4 from Baseline Among Participants with a Baseline Itch Value >=4	Baseline up to week 16
Percentage of Participants with EASI-90	Up to week 16

Регистрация

Состояние	Dermatitis, Atopic
Вмешательство	Тип вмешательства: Drug Название вмешательства: Bermekimab Описание: Participants will receive bermekimab IV. Другое имя: JNJ-77474462 Тип вмешательства: Drug Название вмешательства: Placebo Описание: Participants will receive placebo IV.
Приемлемость	Критерии: Inclusion Criteria: - Have atopic dermatitis (AD) for at least 1 year (365 days) prior to the first administration of study intervention as determined by the investigator through participant interview and/or review of the medical history - Have a history of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable (example, due to important side effects or safety risks) - Have an Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16 at screening and at baseline - Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study - Must be willing to undergo 4 skin biopsies - Have an Investigator Global Assessment (IGA) score >=3 at screening and at baseline - Have an involved body surface area (BSA) >=10 percent (%) at screening and at baseline Exclusion Criteria: - Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances - Has ever received any Human interleukin-1 (IL-1) antagonist (example, including but not limited to anakinra, rilonacept) Пол: All Минимальный возраст: 18 Years Максимальный возраст: 65 Years Здоровые волонтеры: No

Состояние

Dermatitis, Atopic

Вмешательство

Тип вмешательства: Drug

Название вмешательства: Bermekimab

Описание: Participants will receive bermekimab IV.

Другое имя: JNJ-77474462

Тип вмешательства: Drug

Название вмешательства: Placebo

Описание: Participants will receive placebo IV.

Приемлемость

Критерии:

Inclusion Criteria: - Have atopic dermatitis (AD) for at least 1 year (365 days) prior to the first administration of study intervention as determined by the investigator through participant interview and/or review of the medical history - Have a history of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable (example, due to important side effects or safety risks) - Have an Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16 at screening and at baseline - Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study - Must be willing to undergo 4 skin biopsies - Have an Investigator Global Assessment (IGA) score >=3 at screening and at baseline - Have an involved body surface area (BSA) >=10 percent (%) at screening and at baseline Exclusion Criteria: - Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances - Has ever received any Human interleukin-1 (IL-1) antagonist (example, including but not limited to anakinra, rilonacept)

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

65 Years

Здоровые волонтеры:

Общий Официальный

Фамилия	Роль	Присоединение
Janssen Research & Development, LLC Clinical Trial	Study Director	Janssen Research & Development, LLC

Общий контакт

Фамилия: Study Contact

Телефон: 844-434-4210

Эл. адрес: [email protected]

Расположение

Объект:	Положение дел:
University of Colorado \| Aurora, Colorado, 80045, United States	Withdrawn
Dawes Fretzin Clinical Research Group \| Indianapolis, Indiana, 46256, United States	Recruiting
Clinical Research Institute of Michigan, LLC \| Chesterfield, Michigan, 48047, United States	Recruiting
Vital Prospects Clinical Research Institute, PC \| Tulsa, Oklahoma, 74136, United States	Recruiting
Modern Research Associates \| Dallas, Texas, 75231, United States	Recruiting
Progressive Clinical Research \| San Antonio, Texas, 78213, United States	Withdrawn
Progressive Clinical Research \| San Antonio, Texas, 78213, United States	Recruiting
Texas Dermatology and Laser Specialists \| San Antonio, Texas, 78218, United States	Recruiting
Conexa Investigacion Clinica S.A. \| Caba, 1012, Argentina	Recruiting
STAT Research S.A. \| Caba, C1023AAB, Argentina	Recruiting
Clínica Adventista Belgrano \| Caba, C1430EGF, Argentina	Recruiting
CARE - Centro de Alergia y Enfermedades Respiratorias \| Ciudad Autonoma de Buenos Aires, 1414, Argentina	Recruiting
CINME - Centro de Investigaciones Metabolicas \| Ciudad de Buenos Aires, C1056ABJ, Argentina	Recruiting
Fundación CIDEA \| Ciudad de Buenos Aires, C1121ABE, Argentina	Withdrawn
Charite - Universitatsmedizin Berlin (CCM) \| Berlin, 10117, Germany	Not yet recruiting
University Hospital Dresden \| Dresden, 01307, Germany	Not yet recruiting
Universitaetsklinikum Schleswig-Holstein Campus Kiel \| Kiel, 24105, Germany	Not yet recruiting
Universitätsklinikum Marburg \| Marburg, 35043, Germany	Not yet recruiting
Technische Universitaet Muenchen \| Muenchen, 80802, Germany	Not yet recruiting
Universitaetsklinikum Muenster \| Muenster, 48149, Germany	Not yet recruiting
Universitaetsklinik Tuebingen \| Tuebingen, 72076, Germany	Not yet recruiting
Centrum Medyczne Promed \| Krakow, 31-513, Poland	Withdrawn
Diamond Clinic \| Krakow, 31-559, Poland	Withdrawn
Dermed Centrum Medyczne Sp. z o.o \| Lodz, 90-265, Poland	Withdrawn
Clinical Research Center sp. z o.o MEDIC-R s.k. \| Poznań, 60-848, Poland	Withdrawn
Przychodnia Specjalistyczna High-Med \| Warszawa, 01-817, Poland	Withdrawn
SE Dnipropetrovsk Medical Academy \| Dnipro, 49074, Ukraine	Withdrawn
Limited Liability Company Medical Center Consilium Medical \| Kyiv, 04050, Ukraine	Not yet recruiting
Medical Center of "Euroderm" Limited Liability Company \| Kyiv, 04107, Ukraine	Not yet recruiting
Communal Nonprofit Enterprise Kyiv City Clinical Dermatological and Venerological Hospital \| Kyiv, 04209, Ukraine	Not yet recruiting
Treatment and diagnostic center of the private enterprise Asclepiy \| Lviv, 79000, Ukraine	Not yet recruiting
Limited Liability Company Medcontynent \| Poltava, 36024, Ukraine	Not yet recruiting
Treatment and diagnostic center of the private enterprise Asclepiy \| Uzhgorod, 88002, Ukraine	Not yet recruiting
Military Hospital military unit A3309 of the Military Medical Clinical Center of the Eastern Region \| Zaporizhzhya, 69092, Ukraine	Not yet recruiting

Расположение Страны	Argentina Germany Poland Ukraine United States
Дата проверки	2022-01-01
Ответственная сторона	Тип: Sponsor
Имеет расширенный доступ	No
Состояние Просмотр	Dermatitis, Atopic Dermatitis
Количество рук	3
Группа вооружений	Метка: Part A: Bermekimab Dose 1 Тип: Experimental Описание: Participants will receive bermekimab Dose 1 or placebo as an intravenous (IV) infusion weekly from Week 0 to Week 15. Метка: Part B: Bermekimab Dose 2 Тип: Experimental Описание: Participants will receive bermekimab Dose 2 or placebo as an IV infusion weekly from Week 0 to Week 15. Метка: Part C: Bermekimab Dose 3 Тип: Experimental Описание: Participants will receive bermekimab or placebo at a higher or lower dose (not less than [<] Dose 1) than Part B, but with a maximum dose of Dose 3 IV weekly based on pharmacokinetic (PK), pharmacodynamic (PD), efficacy, and safety analysis.
Данные пациента	Yes
Информация о дизайне исследования	Распределение: Randomized Модель вмешательства: Sequential Assignment Первичное назначение: Treatment Маскировка: Double (Participant, Investigator)

A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis