Переход к исследованию дозирования и введения монопрепарата KPL-387
Фаза 2 исследования дозирования с долгосрочным продолжением у пациентов с хорошо контролируемым рецидивирующим перикардитом для оценки эффективности и безопасности переходных схем к монотерапии KPL-387 со стандартных методов лечения
The primary objective of this study is to characterize the efficacy and safety of dosing regimens used to transition from prior pericarditis therapies to KPL-387 monotherapy in participants with well-controlled recurrent pericarditis on standard therapies.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
During the Posology (Dosing and Administration) Study, participants on oral pericarditis therapies alone (i.e., non-steroidal anti-inflammatory drugs [NSAIDs], colchicine, and/or glucocorticoids) and participants on Interleukin-1 (IL-1) pathway inhibition drugs will transition to KPL-387 per protocol guidelines. Participants will receive KPL-387 for up to 16 weeks in the Posology Study.
At study visits throughout the Posology Study, participants will be queried for symptoms of chest pain (and participants will fill out pericarditis pain numerical rating scale [NRS] scores) and will be assessed for physical signs (e.g., pericardial friction rub) and laboratory evidence of pericarditis activity (e.g., C-reactive protein [CRP]) as well as treatment tolerability and pharmacokinetics (PK). Participants experiencing new or worsening symptoms consistent with pericarditis will be managed per study protocol.
All active, enrolled participants in the Posology Study who have not completed an End of Treatment (EOT) Visit may be eligible to transition into the Long-Term Extension (LTE) following completion of the Week 16 Visit. The Week 16 Visit will serve as both a Posology Study End of Study Visit and a Baseline Visit for the LTE. Participants who choose not to participate in the LTE will complete an EOT Visit followed by a Safety Follow-Up until 8 weeks after the last KPL-387 dose administration.
The open-label LTE is designed to evaluate the long-term efficacy and safety of KPL-387 in recurrent pericarditis (RP). Treatment in the LTE may continue until the participant has received up to 24 months of treatment in the LTE or until KPL-387 is approved for commercial use in that region to treat pericarditis, whichever occurs first.
At study visits throughout the LTE, participants will be queried for symptoms of chest pain (and participants will fill out pericarditis pain NRS scores) and will be assessed for physical signs (e.g., pericardial friction rub) and laboratory evidence of pericarditis activity (e.g., CRP) as well as treatment tolerability and PK. Participants experiencing new or worsening symptoms consistent with pericarditis will be managed as described in the protocol.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 2
Контакты и местонахождение
Контакты исследования
- Имя: Clinical Project Manager
- Номер телефона: 781-431-9100
- Электронная почта: clinicaltrials@kiniksa.com
Места учебы
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Dresden, Германия, 01307
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- Investigational Site 041
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Athens, Греция, 115 28
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- Investigational Site 035
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Nea Ionia, Греция, 142 33
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- Investigational Site 023
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Voula, Греция, 166 73
- Рекрутинг
- Investigational Site 024
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Barcelona, Испания, 08017
- Рекрутинг
- Investigational Site 019
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Barcelona, Испания, 08035
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- Investigational Site 015
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Madrid, Испания, 28034
- Рекрутинг
- Investigational Site 017
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Madrid, Испания, 28850
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- Investigational Site 016
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Valencia, Испания, 46015
- Рекрутинг
- Investigational Site 018
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Florence, Италия, 50134
- Рекрутинг
- Investigational Site 044
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Genoa, Италия, 16147
- Рекрутинг
- Investigational Site 034
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Milan, Италия, 20157
- Рекрутинг
- Investigational Site 021
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Padua, Италия, 35143
- Рекрутинг
- Investigational Site 036
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Udine, Италия, 33100
- Рекрутинг
- Investigational Site 033
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Varese, Италия, 21100
- Рекрутинг
- Investigational Site 037
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Ontario
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Ottawa, Ontario, Канада, K1N 6N5
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- Investigational Site 010
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Warsaw, Польша, 02-507
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- Investigational Site 020
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Warsaw, Польша, 02-097
- Рекрутинг
- Investigational Site 048
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Belgrade, Сербия, 1100
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- Investigational Site 030
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Belgrade, Сербия, 11040
- Рекрутинг
- Investigational Site 029
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London, Соединенное Королевство, EC1A 7BE
- Рекрутинг
- Investigational Site 012
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London, Соединенное Королевство, SE1 7EH
- Рекрутинг
- Investigational Site 007
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London, Соединенное Королевство, NW3 2QG
- Рекрутинг
- Investigational Site 022
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Arizona
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Phoenix, Arizona, Соединенные Штаты, 85054
- Рекрутинг
- Investigational Site 031
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California
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La Jolla, California, Соединенные Штаты, 92037
- Рекрутинг
- Investigational Site 045
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Los Angeles, California, Соединенные Штаты, 90048
- Рекрутинг
- Investigational Site 014
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Santa Monica, California, Соединенные Штаты, 90404
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- Investigational Site 002
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District of Columbia
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Washington D.C., District of Columbia, Соединенные Штаты, 20010
- Рекрутинг
- Investigational Site 046
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Florida
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Jacksonville, Florida, Соединенные Штаты, 32224
- Рекрутинг
- Investigational Site 039
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60611
- Рекрутинг
- Investigational Site 013
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Maryland
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Baltimore, Maryland, Соединенные Штаты, 21287
- Рекрутинг
- Investigational Site 025
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02199
- Рекрутинг
- Investigational Site 043
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Minnesota
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Rochester, Minnesota, Соединенные Штаты, 55905
- Рекрутинг
- Investigational Site 028
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Missouri
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St Louis, Missouri, Соединенные Штаты, 63130
- Рекрутинг
- Investigational Site 042
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New York
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New York, New York, Соединенные Штаты, 10016
- Рекрутинг
- Investigational Site 011
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New York, New York, Соединенные Штаты, 10032
- Рекрутинг
- Investigational Site 003
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Ohio
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Cincinnati, Ohio, Соединенные Штаты, 45219
- Рекрутинг
- Investigational Site 009
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Cleveland, Ohio, Соединенные Штаты, 44195
- Рекрутинг
- Investigational Site 040
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Texas
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Austin, Texas, Соединенные Штаты, 78705
- Рекрутинг
- Investigational Site 005
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Dallas, Texas, Соединенные Штаты, 75235
- Рекрутинг
- Investigational Site 047
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Houston, Texas, Соединенные Штаты, 77030
- Рекрутинг
- Investigational Site 006
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Virginia
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Charlottesville, Virginia, Соединенные Штаты, 22903
- Рекрутинг
- Investigational Site 004
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Norfolk, Virginia, Соединенные Штаты, 23507
- Рекрутинг
- Investigational Site 001
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Richmond, Virginia, Соединенные Штаты, 23284
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- Investigational Site 008
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Paris, Франция, 75013
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- Investigational Site 027
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Poitiers, Франция, 86000
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- Investigational Site 026
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Toulouse, Франция, 31400
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- Investigational Site 038
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Toulouse, Франция, 31400
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- Investigational Site 032
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Key Inclusion Criteria:
- Has well-controlled recurrent pericarditis (i.e., including having CRP < 0.5 mg/dL within 14 days of Baseline and a pericarditis pain NRS score ≤ 3 at Baseline)
- Has a documented history of CRP elevation (> 1 mg/dL) associated with at least one prior acute pericarditis episode, whether the incident event or any pericarditis recurrence
- Has received treatment for RP for at least 3 months prior to Baseline with standard therapy(ies) and is currently on a stable dosing regimen including NSAIDs and/or colchicine, and/or glucocorticoids or an IL-1 pathway inhibitor (anakinra or rilonacept).
Key Exclusion Criteria:
- Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies
- Has had a pericarditis recurrence in the last 3 months prior to Baseline
- Has received an investigational drug during the 4 weeks before study drug administration or is planning to receive an investigational drug at any time during the study.
- Has a history of active or untreated, latent tuberculosis (TB) prior to screening.
- Has a history of immunodeficiency.
- Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.
- Has chest x-ray at Screening or within 12 weeks before first study drug administration, with evidence of malignancy, abnormality consistent with prior or active TB infection or active infection.
- Has a history of malignancy of any organ system within the past 5 years before Screening (other than a successfully treated non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma and/or localized carcinoma in situ of the cervix).
- Has a known or suspected current active infection or a history of chronic or recurrent infectious disease (> 3 episodes in prior 12 months), including but not limited to, genitourinary infection, chest infection, sinusitis, or skin/soft tissue infection.
- Has had a serious infection, has been admitted to the hospital for an infection, or has been treated for a documented infection requiring antibiotics for a documented infection within 2 weeks prior to first study drug administration.
- Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration).
- In the Investigator's opinion, has any other medical condition that could adversely affect the subject's participation or interfere with study evaluations.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Posology KPL-387
In Posology Study, KPL-387 will be administered by subcutaneous (SC) injection through Week 16. |
administered by subcutaneous injection |
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Экспериментальный: Long-Term Extension
Participants from Posology Study who continue into the Long-Term Extension will receive KPL-387 for up to 24 months or until KPL-387 is approved for commercial use in that region to treat pericarditis, whichever occurs first. |
administered by subcutaneous injection |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Долгосрочное расширение: Годовая частота рецидива перикардита до окончания LTE.
Временное ограничение: До 24 месяцев
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До 24 месяцев
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Posology: Proportion of participants free from Pericarditis Recurrence by Week 16
Временное ограничение: From baseline up to Week 16
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From baseline up to Week 16
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Posology: Time to Pericarditis Recurrence by Week 16
Временное ограничение: From baseline up to Week 16
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From baseline up to Week 16
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Long Term Extension: Change from LTE Baseline in SF-36v2 Physical Component Summary score through the end of the LTE
Временное ограничение: Up to 24 Months
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SF-36 (36-item Short Form Survey) Physical Component determines participants' quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; Scores on each item are summed and averaged (range: 0=worst to 100=best) with higher scores indicating better health. Increases from baseline indicate improvement. |
Up to 24 Months
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Long Term Extension: Change from LTE Baseline in SF-36v2 Mental Component Summary score through the end of the LTE
Временное ограничение: Up to 24 Months
|
SF-36 (36-item Short Form Survey) Mental Component determines participants' quality of life by assessing 1) vitality; 2) limitations in social functioning because of physical or emotional problems; 3) limitations in usual role due to emotional problems; and 4) general mental health. Scores on each item are summed and averaged (range: 0=worst to 100=best) with higher scores indicating better health. Increases from baseline indicate improvement. |
Up to 24 Months
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Long Term Extension: Change from LTE Baseline in EQ-5D-5L individual index scores over time through the end of the LTE
Временное ограничение: Up to 24 months
|
The EQ-5D-5L (EuroQol-5 Dimension 5-level) is a self-reported health status questionnaire that consists of 6 questions used to calculate a health utility score for use in health economic analysis. There are 2 components to the EQ-5D-5L: a 5-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. Individual and index scores range from 0 to 1, with low scores representing a higher level of dysfunction. |
Up to 24 months
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Long Term Extension: Change from LTE Baseline in EQ-5D-5L visual analog scale (VAS) over time through the end of the LTE.
Временное ограничение: Up to 24 months
|
The EQ-5D-5L (EuroQol-5 Dimension 5-level) is a self-reported health status questionnaire that consists of 6 questions used to calculate a health utility score for use in health economic analysis. There are 2 components to the EQ-5D-5L: a 5-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a VAS that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. |
Up to 24 months
|
Соавторы и исследователи
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- KPL-387-C212
- 2025-523234-66 (Номер EudraCT)
- 2025 (Грант/контракт NIH США)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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