Идёт набор NCT06836232

An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

Фаза II С лечением Recurrent Pericarditis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: VTX2735, VTX2735, VTX2735, VTX2735.
Кому может быть актуально: Состояния в реестре: Recurrent Pericarditis. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 2a, Open-Label Pilot Study to Evaluate the Safety/Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of VTX2735 in Participants With Recurrent Pericarditis

Обзор

This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Recurrent Pericarditis (RP). Cohort A will include approximately 10 participants and will consist of the following: * A 30-day Screening Period (to see if a participant qualifies for the study) * A 6-week Open Label Treatment Period - participant receives VTX2735 Dose A * A 7-week Extension Treatment Period (if a participant meets criteria for extension treatment) - participant receives VTX2735 Dose A * An 11-week Once Daily Treatment Period (if a participant meets criteria for this treatment period) - participant receives VTX2735 Dose B * A 14-day Follow-Up Period Cohort B will include approximately 20 participants and will consist of the following: * A 30-day Screening Period (to see if a participant qualifies for the study) * A 6-week Open Label Treatment Period - participant receives VTX2735 Dose B or C * An 18-week Extension Treatment Period (if a participant meets criteria for extension treatment) - participant receives VTX2735 Dose B or C * A 14-day Follow-Up Period Cohort C will include approximately 20 participants and will consist of the following: * A 30-day Screening Period (to see if a participant qualifies for the study) * A 6-week Open Label Treatment Period - participant receives VTX2735 Dose D or E, and B * An 18-week Extension Treatment Period (if a participant meets criteria for extension treatment) - participant receives VTX2735 Dose B * A 14-day Follow-Up Period

Вмешательства

Препарат VTX2735
Dose A, Daily
Препарат VTX2735
Dose B, Daily
Препарат VTX2735
Dose C, Daily
Препарат VTX2735
Dose D, Daily
Препарат VTX2735
Dose E, Daily

Первичные конечные точки

Safety and tolerability of VTX2735 [Срок оценки: Day 1 of treatment period through study completion, up to 26 weeks]

Вторичные конечные точки (2)

Effect of VTX2735 on pericardial pain [Срок оценки: Day 1 of treatment period to Week 6 of treatment period]
Effect of VTX2735 on inflammation [Срок оценки: Day 1 of treatment period to Week 6 of treatment period]

Критерии участия

Критерии включения

Participants are male or female ≥ 18 years up to ≤ 75 years of age.
Capable of giving signed informed consent and able to comply with the protocol
Previously had an index (first) episode of pericarditis which met the criteria for an acute pericarditis event
Ongoing symptomatic episode of pericarditis, or may have an episode of recurrent pericarditis in the next 4 weeks.
CRP by local laboratory assessment prior to first dose of study treatment (participants with CRP ≤ 10 mg/L must be receiving corticosteroid treatment for RP and have evidence of pericardial inflammation)
Pericarditis pain score ≥ 4 based on the 11-point NRS.
Stable doses of NSAIDs, colchicine, and/or oral corticosteroids (if receiving these treatments)

Критерии исключения

Current or prior diagnosis of pericarditis that is secondary to specific prohibited causes, including but not limited to tuberculosis, blunt trauma, tumor, myocarditis, or systemic autoimmune diseases.
History of clinically significant immunosuppressive disorder, autoimmune/autoinflammatory disorder, or primary or secondary immunodeficiency.
Clinically important history of a medical disorder that would compromise safety or data quality, per the Investigator's judgment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет