Клинические исследование Arthritis, Psoriatic: Guselkumab, Risankizumab - Реестр клинических исследований

Спонсоры	Ведущий спонсор: Janssen Research & Development, LLC
Источник	Janssen Research & Development, LLC
Краткое содержание	The purpose of this study is to assess the tissue distribution of guselkumab and risankizumab in healthy participants (Part 1) and psoriatic arthritis (PsA) participants (Part 2).

Общий статус

Recruiting

Дата начала

2021-11-04

Дата завершения

2023-05-31

Дата первичного завершения

2023-05-05

Фаза

Phase 1

Тип исследования

Interventional

Первичный результат

Мера	Временное ограничение
Skin Tissue versus Serum Concentration Ratio	Up to Week 12
Part 1: Colon Tissue versus Serum Concentration Ratio	Up to Week 8
Part 2: Colon Tissue versus Serum Concentration Ratio	Up to Week 4

Вторичный результат

Мера	Временное ограничение
Maximum Observed Serum Concentration (Cmax) of Guselkumab and Risankizumab	Part 1: Up to Week 16 and Part 2: Up to Week 24
Time to Reach Maximum Observed Serum Concentration (Tmax) of Guselkumab and Risankizumab	Part 1: Up to Week 16 and Part 2: Up to Week 24
Area Under the Serum Concentration Versus Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC[0-last]) of Guselkumab and Risankizumab	Part 1: Up to Week 16 and Part 2: Up to Week 24
Area Under the Plasma Concentration-time Curve from Time 0 to infinity (AUC[0 - Infinity]) of Guselkumab and Risankizumab	Part 1: Up to Week 16 and Part 2: Up to Week 24
Terminal Half-life (T1/2)	Part 1: Up to Week 16 and Part 2: Up to Week 24
Apparent Total Clearance (CL/F) of Guselkumab and Risankizumab	Part 1: Up to Week 16 and Part 2: Up to Week 24
Apparent Volume of Distribution Based on Terminal Phase (Vz/F) of Guselkumab and Risankizumab	Part 1: Up to Week 16 and Part 2: Up to Week 24
Number of Participants with Antibodies to Guselkumab and Risankizumab	Part 1: Up to Week 16 and Part 2: Up to Week 24

Регистрация

Состояние	Arthritis, Psoriatic Healthy
Вмешательство	Тип вмешательства: Drug Название вмешательства: Guselkumab Описание: Guselkumab will be administered subcutaneously. Тип вмешательства: Drug Название вмешательства: Risankizumab Описание: Risankizumab will be administered subcutaneously. Другое имя: Skyrizi
Приемлемость	Критерии: Inclusion Criteria: Part 1: - Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator - Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease 2019 [COVID-19]) reverse transcription polymerase chain reaction (RT-PCR) test within 72 hours prior to study intervention administration - Body weight within 50 kilograms (kg) to 100 kg and body mass index (BMI) within the range 18 kilograms per meter square (kg/m^2) to 30 kg/m^2 (inclusive) Part 2: - Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study agent and meet classification criteria for psoriatic arthritis (CASPAR) at screening - Have active plaque psoriasis Exclusion Criteria: Part 1: - History or current signs and symptoms of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, genitourinary, or metabolic disturbances - Had major illness or surgery (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study or within 21 weeks after the last dose of study intervention administration Part 2: - History or current signs and symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances - A nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) Пол: All Минимальный возраст: 18 Years Максимальный возраст: 70 Years Здоровые волонтеры: Accepts Healthy Volunteers

Состояние

Arthritis, Psoriatic
Healthy

Вмешательство

Тип вмешательства: Drug

Название вмешательства: Guselkumab

Описание: Guselkumab will be administered subcutaneously.

Тип вмешательства: Drug

Название вмешательства: Risankizumab

Описание: Risankizumab will be administered subcutaneously.

Другое имя: Skyrizi

Приемлемость

Критерии:

Inclusion Criteria: Part 1: - Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator - Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease 2019 [COVID-19]) reverse transcription polymerase chain reaction (RT-PCR) test within 72 hours prior to study intervention administration - Body weight within 50 kilograms (kg) to 100 kg and body mass index (BMI) within the range 18 kilograms per meter square (kg/m^2) to 30 kg/m^2 (inclusive) Part 2: - Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study agent and meet classification criteria for psoriatic arthritis (CASPAR) at screening - Have active plaque psoriasis Exclusion Criteria: Part 1: - History or current signs and symptoms of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, genitourinary, or metabolic disturbances - Had major illness or surgery (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study or within 21 weeks after the last dose of study intervention administration Part 2: - History or current signs and symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances - A nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

70 Years

Здоровые волонтеры:

Accepts Healthy Volunteers

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

Расположение

Объект:	Положение дел:
Medical University Graz \| Graz, 8010, Austria	Recruiting
ARENSIA Exploratory Medicine LLC \| Tbilisi, 0112, Georgia	Not yet recruiting
ARENSIA Exploratory Medicine LLC \| Kyiv, '01103, Ukraine	Not yet recruiting
ARENSIA Exploratory Medicine LLC \| Kyiv, 01135, Ukraine	Not yet recruiting

Расположение Страны	Austria Georgia Ukraine
Дата проверки	2022-01-01
Ответственная сторона	Тип: Sponsor
Имеет расширенный доступ	No
Состояние Просмотр	Arthritis Arthritis, Psoriatic
Количество рук	2
Группа вооружений	Метка: Part 1: Healthy Participants Тип: Experimental Описание: Healthy participants will receive risankizumab and guselkumab subcutaneously (SC) on Day 1. Метка: Part 2: Psoriatic Arthritis (PsA) Participants Тип: Experimental Описание: Participants with PsA will receive either risankizumab or guselkumab SC on Day 1 and Day 29.
Данные пациента	Yes
Информация о дизайне исследования	Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Basic Science Маскировка: None (Open Label)

A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis