Phase 2/3 Study of KPL-387 in Recurrent Pericarditis

Официальное название

A Phase 2/3 Efficacy and Safety Study of KPL-387 Treatment in Participants With Recurrent Pericarditis

Обзор

This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.

Подробное описание

This clinical trial is comprised of 3 separate study parts: Phase 2, Phase 3, and Long-Term Extension. The primary objective of Phase 2 is to evaluate how well different dose regimens of KPL-387 control the pain and inflammation of pericarditis in a group of participants experiencing an acute episode of recurrent pericarditis. This part of the study will confirm the KPL-387 dose regimen to be further tested in Phase 3 and the Long-Term Extension. The primary objective of Phase 3 is to confirm the efficacy of KPL-387 for the treatment of recurrent pericarditis and reduction in risk of recurrence in an additional group of participants experiencing an acute episode of recurrent pericarditis. Participants who complete Phase 2 or Phase 3 may be eligible to participate in the Long-Term Extension. The primary objective of the Long-Term Extension is to assess the long-term efficacy of KPL-387 while maintaining long-term disease control. All of the study parts also have other objectives to learn about the safety, tolerability, concentration of KPL-387 in blood, and effects of KPL-387 on blood test markers of immune activity in recurrent pericarditis.

Вмешательства

• Препарат KPL-387
  administered by subcutaneous injection
• Препарат Placebo
  administered by subcutaneous injection

Первичные конечные точки

• Phase 2: Time to Treatment Response by Week 24 [Срок оценки: From Randomization up to Week 24]
• Phase 3: Time to Pericarditis Recurrence [Срок оценки: From first administration of study drug in the RW Period]
• Long-Term Extension: Annualized rate of Pericarditis Recurrence [Срок оценки: Up to 24 Months]

Вторичные конечные точки (12)

• Phase 2: Time to CRP Normalization (CRP ≤ 0.5 mg/dL) by Week 24 [Срок оценки: From Randomization up to Week 24]
• Phase 2: Time to Pain Response by Week 24 [Срок оценки: From Randomization up to Week 24]
• Phase 2: Percentage of Days With No or Minimal Pain (Numerical Rating Scale (NRS) ≤ 2) While on KPL-387 Treatment Over Time by Week 24 [Срок оценки: From Randomization up to Week 24]
• Phase 2: Proportion of Participants With Normalization of CRP (CRP ≤ 0.5 mg/dL) Over Time by Week 24 [Срок оценки: From Randomization up to Week 24]
• Phase 2: Time to resolution of pericarditis manifestations (i.e. echocardiogram [ECHO] abnormalities, electrocardiogram [ECG] abnormalities, and pericardial rub), when present at Baseline, by Week 16. [Срок оценки: From Randomization up to Week 16]
• Phase 2: Change from Baseline in SF-36v2® Physical Component Summary score through Week 24. [Срок оценки: From Randomization up to Week 24]
• Phase 2: Change from Baseline in SF-36v2® Mental Component Summary score through Week 24. [Срок оценки: From Randomization to Week 24]
• Phase 2: Proportion of participants with Protocol-Defined Pericarditis Recurrence by Week 24. [Срок оценки: From Randomization to Week 24]
• Phase 2: Change from Baseline in CRP through Week 24. [Срок оценки: From Randomization up to Week 24]
• Phase 2: Change from Baseline in pericarditis pain NRS score through Week 24. [Срок оценки: From Randomization up to Week 24]
• Phase 2: Change from RI Baseline in SF-36v2® Mental Component Summary score through the end of the RI Period [Срок оценки: From Baseline up to the end of the RI Period]
• Phase 3: Time to Treatment Response by the end of the RI Period [Срок оценки: From Baseline up to end of the RI Period]

Критерии участия

Критерии включения

• Phase 2 and 3: Has a diagnosis of recurrent pericarditis
• Phase 2 and 3: Has signs and symptoms of recurrent pericarditis despite treatment with standard therapies
• Phase 2 and 3: Weighs at least 40 kg
• Phase 2: Taking NSAIDS and/or colchicine (in any combination)
• Phase 3: Taking NSAIDs and/or colchicine and/or glucocorticoids (in any combination)

Критерии исключения

• Phase 2 and 3: Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies.
• Phase 2 and 3: Has received an investigational drug during the 4 weeks before screening or is planning to receive an investigational drug at any time during the study.
• Phase 2 and 3: Has a history of active or untreated, latent tuberculosis (TB) prior to screening.
• Phase 2 and 3: Has a history of immunodeficiency.
• Phase 2 and 3: Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.
• Phase 2 and 3: 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.
• Phase 2 and 3: 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).
• Phase 2 and 3: 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.
• Phase 2 and 3: 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.
• Phase 2 and 3: Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration).
• Phase 2 and 3: In the Investigator's opinion, has any other medical condition that could adversely affect the subject's participation or interfere with study evaluations.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 27 центров

• Investigational Site 018 — Gilbert
• Investigational Site 053 — Phoenix
• Investigational Site 030 — Los Angeles
• Investigational Site 008 — San Francisco
• Investigational Site 044 — Santa Monica
• Investigational Site 058 — Ventura
• Investigational Site 016 — Westminster
• Investigational Site 001 — Columbus
• … и ещё 19 центров

Италия · 7 центров

• Investigational Site 029 — Genoa
• Investigational Site 040 — Genoa
• Investigational Site 056 — Milan
• Investigational Site 007 — Milan
• Investigational Site 050 — Padua
• Investigational Site 033 — Udine
• Investigational Site 041 — Varese

Франция · 6 центров

• Investigational Site 028 — Montpellier
• Investigational Site 021 — Paris
• Investigational Site 036 — Pessac
• Investigational Site 019 — Poitiers
• Investigational Site 037 — Toulouse
• Investigational Site 038 — Toulouse

Испания · 5 центров

• Investigational Site 048 — Barcelona
• Investigational Site 010 — Barcelona
• Investigational Site 024 — Madrid
• Investigational Site 011 — Murcia
• Investigational Site 057 — Valencia

Великобритания · 4 центра

• Investigational Site 020 — London
• Investigational Site 047 — London
• Investigational Site 035 — London
• Investigational Site 017 — Southampton

Греция · 3 центра

• Investigational Site 034 — Athens
• Investigational Site 039 — Nea Ionia
• Investigational Site 032 — Voula

Польша · 2 центра

• Investigational Site 051 — Warsaw
• Investigational Site 031 — Warsaw

Сербия · 2 центра

• Investigational Site 025 — Belgrade
• Investigational Site 026 — Belgrade

Канада · 1 центр

• Investigational Site 027 — Ottawa

Германия · 1 центр

• Investigational Site 052 — Dresden

Идентификаторы

NCT: NCT07010159 · KPL-387-C211 · 2025-521933-10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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