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Recruiting Phase 3 NCT07201922

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

Phase 3 – large-scale trial before approval
Conditions: Familial Pulmonary Fibrosis Interstitial Lung Abnormalities Interstitial Lung Diseases

Sponsor: Boehringer Ingelheim

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Locations 13
Argentina (1)
Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
C.a.b.a
NOT_YET_RECRUITING
Australia (1)
Royal Prince Alfred Hospital
Camperdown , New South Wales
NOT_YET_RECRUITING
Belgium (1)
Cliniques Universitaires Saint-Luc
Brussels
NOT_YET_RECRUITING
Canada (1)
QEII Health Sciences Centre
Halifax , Nova Scotia
NOT_YET_RECRUITING
France (1)
Hôpital Louis Pradel
Bron
NOT_YET_RECRUITING
Germany (1)
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen
NOT_YET_RECRUITING
Italy (1)
IRCCS MultiMedica
Milan
NOT_YET_RECRUITING
Japan (1)
Tosei General Hospital
Aichi, Seto
NOT_YET_RECRUITING
Netherlands (1)
St. Antonius Ziekenhuis
Nieuwegein
NOT_YET_RECRUITING
South Korea (1)
Severance Hospital
Seoul
Spain (1)
Hospital de Galdakao
Galdakao
NOT_YET_RECRUITING
United Kingdom (1)
Royal Devon and Exeter Hospital
Exeter
United States (1)
University of California Los Angeles
Los Angeles , California
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
40 Years
Healthy volunteers
No
Start date
10.02.2026
Completion date
23.05.2029
Registry ID
NCT07201922
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.