A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis

Официальное название

A Double Blind, Randomized, Placebo-controlled Exploratory Trial to Investigate the Efficacy and Safety of Nerandomilast Over 24 Months When Administered in Individuals With Interstitial Lung Abnormalities and a Family History of Pulmonary Fibrosis to Reduce the Risk of Worsening (DROP-FPF)

Обзор

This study is open to people aged 40 years or older who have at least 1 family member with pulmonary fibrosis. Pulmonary fibrosis is a condition where lung tissue becomes scarred, making it harder to breathe. People can join if a lung scan shows early changes in the lung, called interstitial lung abnormalities, which may lead to lung scarring. People with family members who have pulmonary fibrosis are more likely to develop it themselves. That is why it is important to check early for lung changes and find ways to prevent the condition from getting worse. The purpose of this study is to find out whether a medicine called nerandomilast can help slow down changes in the lung in people with a family history of pulmonary fibrosis. Participants are put into one of 2 groups randomly, which means the group is chosen by chance. One group takes nerandomilast tablets, and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet twice a day for about 2 to 3 years. There is a 3 out of 5 chance that participants will receive nerandomilast instead of the placebo. Participants are in the study for about 2 to 3 years. Participants visit the study site multiple times: more frequently during the first 2 years (about every 3 months), and then every 6 months thereafter. In the 3rd year, participants also have phone calls with the site staff every 3 months. Doctors regularly test lung function and take chest scans to see if the treatment works. The results are compared between the 2 groups to see if nerandomilast helps. The doctors also check participants' health and take note of any unwanted effects.

Вмешательства

• Препарат Nerandomilast
  Nerandomilast
• Препарат Placebo
  Placebo

Первичные конечные точки

• Time to physiologic or radiologic worsening of ILA/ILD over the whole trial [Срок оценки: up to 164 weeks]

Вторичные конечные точки (9)

• Absolute change from baseline in wRVS on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104 [Срок оценки: at baseline, at weeks 26, 52 and 104]
• Absolute change from baseline in TDE on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104 [Срок оценки: at baseline, at weeks 26, 52 and 104]
• Absolute change from baseline in FVC (% predicted) at weeks 26, 52, and 104 [Срок оценки: at baseline, at weeks 26, 52 and 104]
• Absolute change from baseline in DLCO (% predicted) at weeks 26, 52, and 104 [Срок оценки: at baseline, at weeks 26, 52 and 104]
• Time to relative decline from baseline in FVC (% predicted) of >10% over 52 weeks and over the whole trial [Срок оценки: up to 164 weeks]
• Time to absolute decline from baseline in FVC (% predicted) of >5% over 52 weeks and over the whole trial [Срок оценки: up to 164 weeks]
• Time to absolute decline from baseline in DLCO (% predicted) of >10% over 52 weeks and over the whole trial [Срок оценки: up to 164 weeks]
• Time to absolute increase in wRVS >2% and TDE >2.5% on chest HRCT, as measured by e-lung quantitative HRCT scoring over 52 weeks and over the whole trial [Срок оценки: up to 164 weeks]
• Time to physiologic or radiologic worsening of ILA/ILD over 52 weeks [Срок оценки: up to 52 weeks]

Критерии участия

Критерии включения

• Individuals ≥40 years of age at the time of first signed informed consent at Visit 1a
• Participants must have at least 1 first-degree relative (biological parent, sibling, or child) with confirmed pulmonary fibrosis (idiopathic pulmonary fibrosis \[IPF\], idiopathic nonspecific interstitial pneumonia \[NSIP\], and/or pulmonary fibrosis due to known genetic cause \[e.g. short telomere syndrome, mucin 5B (MUC5B) mutation, surfactant protein mutations\])
• High resolution computed tomography (HRCT) scan with evidence of interstitial lung abnormalities involving at least 5% of a single lung zone or interstitial lung disease (ILD), based on central evaluation
• Forced vital capacity (FVC) ≥80% of predicted normal at Visit 1b
• Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥70% of predicted normal at Visit 1b Further inclusion criteria apply.

Критерии исключения

• Prior known pulmonary fibrosis that, in the opinion of the Investigator, requires treatment with approved therapies
• Prebronchodilator forced expiratory volume in 1 second (FEV1)/FVC <0.7 at Visit 1b
• HRCT findings consistent with probable or definite usual interstitial pneumonia (UIP) pattern
• Any medical condition that is known to predispose to the development of pulmonary fibrosis (e.g. known connective tissue disease)
• Prior or current use of nerandomilast, nintedanib, or pirfenidone Further 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

США · 13 центров

• University of California Los Angeles — Los Angeles
• University of Colorado Denver — Aurora
• Clinical Research Specialists LLC - Kissimmee — Kissimmee
• University of Kansas Medical Center — Kansas City
• Brigham and Women's Hospital — Boston
• University of Michigan — Ann Arbor
• University of Minnesota — Minneapolis
• Weill Cornell Medicine-New York-60569 — New York
• … и ещё 5 центров

Япония · 6 центров

• Tosei General Hospital — Aichi, Seto
• Tsuboi Hospital — Fukushima, Koriyama
• Kanagawa Cardiovascular and Respiratory Center — Kanagawa, Yokohama
• National Hospital Organization Kinki-Chuo Chest Medical Center — Osaka, Sakai
• Hamamatsu University Hospital — Shizuoka, Hamamatsu
• National Center for Global Health and Medicine — Tokyo, Shinjuku-ku

Аргентина · 5 центров

• Centro de Investigaciones Metabolicas (CINME) — Buenos Aires
• Hospital Italiano de Buenos Aires — CABA
• Centro de Investigación Clinica Belgrano — CABA
• CEDIC - Centro de Investigacion Clinica — CABA
• Consultorios Médicos del Buen Ayre — Capital Federal

Франция · 5 центров

• Hôpital Louis Pradel — Bron
• INS Coeur Poumon — Lille
• HOP Bichat — Paris
• HOP Pontchaillou — Rennes
• Hôpital Larrey - CHU de Toulouse — Toulouse

Австралия · 4 центра

• Royal Prince Alfred Hospital — Camperdown
• Lung Research Queensland — Chermside
• The Prince Charles Hospital — Chermside
• The Alfred Hospital — Melbourne

Германия · 4 центра

• Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH — Essen
• Medizinische Hochschule Hannover — Hanover
• Lungenfachklinik Immenhausen — Immenhausen
• Krankenhaus Bethanien gGmbH — Solingen

Испания · 4 центра

• Hospital de Galdakao — Galdakao
• Hospital Universitari de Bellvitge — L'Hospitalet Del Llobregat
• Hospital Universitario De La Princesa — Madrid
• Hospital Virgen del Rocío — Seville

Италия · 3 центра

• IRCCS MultiMedica — Milan
• Azienda Ospedaliera Universitaria di Padova — Padova
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma

South Korea · 3 центра

• Severance Hospital — Seoul
• Asan Medical Center — Seoul
• Samsung Medical Center — Seoul

Бельгия · 2 центра

• Cliniques Universitaires Saint-Luc — Brussels
• UZ Leuven — Leuven

Канада · 2 центра

• St. Joseph's Healthcare Hamilton — Hamilton
• McGill University Health Centre (MUHC) — Montreal

Нидерланды · 2 центра

• St. Antonius Ziekenhuis — Nieuwegein
• Erasmus Medisch Centrum — Rotterdam

Великобритания · 2 центра

• Royal Devon and Exeter Hospital, Wonford — Exeter
• Royal Brompton Hospital — London

Идентификаторы

NCT: NCT07201922 · 1305-0069 · 2025-522383-33-00 · U1111-1322-6453

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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