Transition to KPL-387 Monotherapy Dosing & Administration Study

Официальное название

A Phase 2 Posology Study With Long-Term Extension in Participants With Well-Controlled Recurrent Pericarditis to Evaluate the Efficacy and Safety of Transition Regimens to KPL-387 Monotherapy From Standard Therapies

Обзор

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.

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.

Вмешательства

• Препарат KPL-387
  administered by subcutaneous injection

Первичные конечные точки

• Posology: Proportion of participants free from Pericarditis Recurrence by Week 16 [Срок оценки: From first administration of study drug up to Week 16]
• Long-Term Extension: Annualized rate of Pericarditis Recurrence through the end of the LTE. [Срок оценки: Up to 24 Months]

Вторичные конечные точки (5)

• Posology: Time to Pericarditis Recurrence by Week 16 [Срок оценки: From first administration of study drug up to Week 16]
• Long Term Extension: Change from LTE Baseline in SF-36v2 Physical Component Summary score through the end of the LTE [Срок оценки: Up to 24 Months]
• Long Term Extension: Change from LTE Baseline in SF-36v2 Mental Component Summary score through the end of the LTE [Срок оценки: Up to 24 Months]
• Long Term Extension: Change from LTE Baseline in EQ-5D-5L individual index scores over time through the end of the LTE [Срок оценки: Up to 24 months]
• Long Term Extension: Change from LTE Baseline in EQ-5D-5L visual analog scale (VAS) over time through the end of the LTE. [Срок оценки: Up to 24 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 15 центров

• Investigational Site 031 — Phoenix
• Investigational Site 014 — Los Angeles
• Investigational Site 002 — Santa Monica
• Investigational Site 039 — Jacksonville
• Investigational Site 013 — Chicago
• Investigational Site 025 — Baltimore
• Investigational Site 028 — Rochester
• Investigational Site 011 — New York
• … и ещё 7 центров

Италия · 5 центров

• Investigational Site 034 — Genoa
• Investigational Site 021 — Milan
• Investigational Site 036 — Padua
• Investigational Site 033 — Udine
• Investigational Site 037 — Varese

Испания · 5 центров

• Investigational Site 019 — Barcelona
• Investigational Site 015 — Barcelona
• Investigational Site 017 — Madrid
• Investigational Site 016 — Madrid
• Investigational Site 018 — Valencia

Франция · 4 центра

• Investigational Site 027 — Paris
• Investigational Site 026 — Poitiers
• Investigational Site 032 — Toulouse
• Investigational Site 038 — Toulouse

Греция · 3 центра

• Investigational Site 035 — Athens
• Investigational Site 023 — Nea Ionia
• Investigational Site 024 — Voula

Великобритания · 3 центра

• Investigational Site 012 — London
• Investigational Site 022 — London
• Investigational Site 007 — London

Сербия · 2 центра

• Investigational Site 030 — Belgrade
• Investigational Site 029 — Belgrade

Канада · 1 центр

• Investigational Site 010 — Ottawa

Польша · 1 центр

• Investigational Site 020 — Warsaw

Идентификаторы

NCT: NCT07288216 · KPL-387-C212 · 2025-523234-66

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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