Набор скоро начнётся NCT07540988

FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression

Фаза III С лечением Interstitial Lung Diseases

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: Nerandomilast, Placebo matching nerandomilast.
Кому может быть актуально: Состояния в реестре: Interstitial Lung Diseases. Базовые параметры: от 18 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, Аргентина, Австрия, Бельгия, Бразилия +13
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 Double-blind, Randomized, Placebo-controlled Trial Investigating the Efficacy and Safety of Nerandomilast Over at Least 52 Weeks in Patients With Fibrosing Interstitial Lung Disease at Risk for Disease Progression (FIBRONEER-ACT)

Обзор

This study is open to adults with fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF). People can join the study if they have been diagnosed with this condition within the last 3 years and are at risk of developing progressive pulmonary fibrosis (PPF). The purpose of this study is to find out whether a medicine called nerandomilast helps people with fibrosing interstitial lung disease who may be at risk for their disease getting worse. Participants are put into 2 groups randomly, which means 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. Nerandomilast is a type of medicine that may help reduce lung function decline and slow disease progression. Participants are in the study for up to about 2 years and 4 months. During this time, they visit the study site regularly. Doctors regularly test lung function using methods like spirometry to measure forced vital capacity (FVC, maximum amount of air a participant can blow out after taking a deep breath) and DLCO (diffusing capacity of the lungs for carbon monoxide; it estimates how well oxygen moves from the lungs into the blood). Additionally, high-resolution computed tomography (HRCT) is performed to monitor how the lung condition is changing over time. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Вмешательства

Препарат Nerandomilast
Nerandomilast
Препарат Placebo matching nerandomilast
Placebo matching nerandomilast

Первичные конечные точки

Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 52 [Срок оценки: at baseline, at week 52]

Вторичные конечные точки (8)

Absolute change from baseline in total disease extent (TDE [%]), as measured by e-Lung quantitative high resolution computed tomography (HRCT) scoring at Week 52 [Срок оценки: at baseline, at week 52]
Absolute change from baseline in reticulovascular score (RVS [%]), as measured by e-Lung quantitative high resolution computed tomography (HRCT) scoring at Week 52 [Срок оценки: at baseline, at week 52]
Absolute change from baseline in FVC (% predicted) at Week 52 [Срок оценки: at baseline, at week 52]
Time to development of incident progressive pulmonary fibrosis (PPF) (as assessed and documented by investigator) or death over the duration of the trial [Срок оценки: up to 28 months]
Time to absolute decline from baseline in FVC (% predicted) of >5% or death over the duration of the trial [Срок оценки: up to 28 months]
Time to relative decline from baseline in FVC (% predicted) of >10% or death over the duration of the trial [Срок оценки: up to 28 months]
Absolute change from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO [% predicted]) at Week 52 [Срок оценки: at baseline, at week 52]
Time to absolute decline from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO [% predicted]) of >10% or death over the duration of the trial [Срок оценки: up to 28 months]

Критерии участия

Критерии включения

Male and female individuals ≥18 years of age at the time of first signed informed consent at Visit 1a
Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial
Diagnosis of fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF) as established by the investigator
Presence of fibrotic lung disease on high resolution computed tomography (HRCT), defined as reticulation with traction bronchiectasis/ bronchiolectasis and/or honeycombing, and extent of fibrosis ≥10%, as assessed by central review prior to randomization
Time since ILD diagnosis ≤3 years before randomization
FVC ≥45% of predicted normal at Visit 1
Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb) at Visit 1
Patients treated with permitted immunosuppressive/immunomodulatory agents for an underlying systemic disease (e.g. methotrexate (MTX), azathioprine (AZA)) need to be on stable treatment for at least 12 weeks prior to Visit 1 and during screening period
Further inclusion criteria apply.

Критерии исключения

Known diagnosis of idiopathic pulmonary fibrosis (IPF) based on multidisciplinary discussion (MDD) and according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2022 guidelines
Known diagnosis of autoimmune-ILDs other than rheumatoid arthritis-associated ILD (RA-ILD)
Known diagnosis of sarcoidosis
Patients with predominant features of organizing pneumonia on HRCT, as assessed by central review
Patients who developed ILD due to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection/Coronavirus Disease 2019 (COVID-19) (based on investigators judgement)
Meeting criteria for progressive pulmonary fibrosis (PPF), as assessed by investigator
Meeting criteria for treatment with currently approved therapies for the fibrosing ILD (e.g. PPF), as assessed by investigator
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 · 27 центров

University of Alabama at Birmingham — Birmingham
University of Southern California — Los Angeles
Newport Native MD, Inc — Newport Beach
Clinical Research Specialists LLC - Kissimmee — Kissimmee
Lakeland Regional Medical Center - Lakeland — Lakeland
Advanced Pulmonary Research Institute — Loxahatchee Groves
Avanza Medical Research Center — Pensacola
Coastal Pulmonary & Critical Care — St. Petersburg
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Beijing Chao-Yang Hospital — Пекин
The Second Xiangya Hospital Of Central South University — Чанша
West China Hospital, Sichuan University — Чэнду
People's Hospital of Sichuan Province — Чэнду
First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
Zhejiang Hospital — Ханчжоу
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine — Ханчжоу
Nanjing Drum Tower Hospital — Нанкин
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Япония · 15 центров