Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis

Официальное название

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis

Обзор

This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in participants with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.

Подробное описание

This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and PK of PIPE-791 in participants with a diagnosis of Idiopathic Pulmonary Fibrosis with or without background treatment. The treatment period is 26 weeks and full study duration is up to 36 weeks including Screening and Follow-Up. Approximately 324 participants will be enrolled into one of three treatment arms, PIPE-791 Dose A, PIPE-791 Dose B, or placebo.

Вмешательства

• Препарат PIPE-791 Dose A
  Participants will receive a daily oral dose of PIPE-791 in tablet form
• Препарат PIPE-791 Dose B
  Participants will receive a daily oral dose of PIPE-791 in tablet form
• Препарат Placebo
  Participants will receive a daily oral dose of matching Placebo in tablet form

Первичные конечные точки

• Absolute change in forced vital capacity (FVC) (mL) [Срок оценки: From baseline to Week 26]

Вторичные конечные точки (7)

• To investigate the safety and tolerability of PIPE-791 compared to placebo based on percentage of treatment-emergent adverse events (TEAE) [Срок оценки: From baseline to Week 30]
• Relative change in FVC (mL) [Срок оценки: From baseline to Week 26]
• Proportion of participants with a ≥10% absolute decline in percent predicted FVC (ppFVC) [Срок оценки: From baseline to Weeks 12 and Week 26]
• Time to first ≥10% absolute decline in ppFVC [Срок оценки: From baseline to time of first ≥10% absolute decline, up to Week 26]
• Absolute change in ppFVC [Срок оценки: From baseline to Week 26]
• Relative change in ppFVC [Срок оценки: From baseline to Week 26]
• Change in quantitative CT-derived lung fibrosis burden on HRCT [Срок оценки: From baseline to Week 26]

Критерии участия

Критерии включения

• Male or female ≥ 40 years of age at the time of Randomization.
• A diagnosis of IPF within 7 years prior to Screening, based on the 2022 ATS/ERS/JRS/ALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT consistent with usual interstitial pneumonia (UIP) or probable UIP.
• Percent predicted (pp) FVC ≥ 40% on Screening spirometry.
• Participants may enter the study whether or not they are receiving background nintedanib or pirfenidone therapy approved for the treatment of IPF, but not both concurrently.

Критерии исключения

• Those with a history of interstitial lung disease (ILD) other than IPF are not eligible.
• Those with pulmonary arterial hypertension (PAH) requiring multi-drug therapy are not eligible.
• Those who have experienced an IPF exacerbation within 6 weeks of Screening, or during Screening, are not eligible.
• Those with an estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) (Inker 2021) or who have Child-Pugh Class B or C hepatic impairment are not eligible.
• Female participants must not be of childbearing potential.

Additional inclusion and exclusion criteria apply.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Аргентина · 11 центров

• Instituto de Especialidades de la Salud Rosario - Clínica del Tórax — Rosario
• Instituto Médico de la Fundación Estudios Clínicos — Rosario
• Centro de Investigaciones Médicas Tucumán - PPDS — San Miguel de Tucumán
• CIMER-Centro Integral de Medicina Respiratoria — San Miguel de Tucumán
• IPR-Investigaciones en Patologías Respiratorias — San Miguel de Tucumán
• Centro Modelo de Cardiología-Laprida 554 — San Miguel de Tucumán
• STAT Research S.A. — Buenos Aires
• Consultorios Médicos Organización del Buen Ayre SRL — Buenos Aires
• … и ещё 3 центра

Израиль · 11 центров

• Shamir Medical Center — Be’er Ya‘aqov
• Meir Medical Center — Kafr Saba
• Rabin Medical Center - PPDS — Petah Tikva
• The Chaim Sheba Medical Center - PPDS — Ramat Gan
• Kaplan Medical Center — Rehovot
• Hillel Yaffe Medical Center — Hadera
• Hadassah Medical Center- Ein Kerem - PPDS — Jerusalem
• Assuta Ashdod University Medical Center — Ashdod
• … и ещё 3 центра

South Korea · 8 центров

• The Catholic University of Korea - Eunpyeong St. Mary's Hospital — Seoul
• The Catholic University of Korea, Bucheon St. Mary's Hospital — Bucheon-si
• Seoul National University Bundang Hospital — Seongnam-si
• Severance Hospital Yonsei University Health System — Seoul
• Samsung Medical Center — Seoul
• Soon Chun Hyang University Hospital — Seoul
• Gachon University Gil Medical Center — Incheon
• Korea University Anam Hospital — Seoul

Австралия · 7 центров

• Royal Prince Alfred Hospital — Camperdown
• Westmead Hospital — Westmead
• The Prince Charles Hospital — Chermside
• Austin Health — Heidelberg
• The Alfred Hospital — Melbourne
• Institute for Respiratory Health — Midland
• TrialsWest Pty Ltd — Spearwood

Великобритания · 7 центров

• NIHR Leicester Biomedical Research Centre - Glenfield Hospital — Leicester
• St Bartholomew's Hospital - PPDS — London
• Southampton General Hospital — Southampton
• Royal Infirmary of Edinburgh — Edinburgh
• Perth Royal Infirmary — Perth
• Birmingham Heartlands Hospital — Birmingham
• Royal Brompton Hospital — London

Канада · 5 центров

• Vancouver General Hospital — Vancouver
• Toronto General Hospital — Toronto
• Dynamic Drug Advancement Ltd. — Ajax
• Dr. Anil Dhar Medicine Professional Corporation — Windsor
• Centre d'investigation Clinique Mauricie — Trois-Rivières

Новая Зеландия · 4 центра

• Greenlane Clinical Centre — Epsom
• Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS — Papatoetoe
• Canterbury Respiratory Research Group — Christchurch
• Health New Zealand - Te Whatu Ora - Waikato Hospital — Hamilton

Сербия · 4 центра

• Institute of Pulmonary Diseases of Vojvodina — Kamenitz
• University Clinical Center of Serbia - Koste Todorovica - PPDS — Belgrade
• University Clinical Center Kragujevac — Kragujevac
• University Clinical Center Nis — Niš

Чили · 3 центра

• Centro de Investigacion Curicó — Curicó
• CEC SpA — Ñuñoa
• Biocinetic Servicios Medicos Ltda — Santiago

Идентификаторы

NCT: NCT07284459 · CTX-791-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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