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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)
Status: Recruiting
Location: See all (56) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
University of California Los Angeles
NOT_YET_RECRUITING
Los Angeles
Colorado
University of Colorado Denver
NOT_YET_RECRUITING
Aurora
Florida
Clinical Research Specialists LLC - Kissimmee
NOT_YET_RECRUITING
Kissimmee
Kansas
University of Kansas Medical Center
NOT_YET_RECRUITING
Kansas City
Massachusetts
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Michigan
University of Michigan
NOT_YET_RECRUITING
Ann Arbor
Minnesota
University of Minnesota
NOT_YET_RECRUITING
Minneapolis
New York
Weill Cornell Medicine-New York-60569
NOT_YET_RECRUITING
New York
Pennsylvania
University of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina
NOT_YET_RECRUITING
Charleston
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Texas
Baylor College of Medicine
NOT_YET_RECRUITING
Houston
Virginia
Virginia Commonwealth University
NOT_YET_RECRUITING
Richmond
Other Locations
Argentina
Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
NOT_YET_RECRUITING
C.a.b.a
CEDIC - Centro de Investigacion Clinica
NOT_YET_RECRUITING
Caba
Centro de Investigación Clinica Belgrano
NOT_YET_RECRUITING
Caba
Hospital Italiano de Buenos Aires
NOT_YET_RECRUITING
Caba
Consultorios Médicos del Buen Ayre
NOT_YET_RECRUITING
Capital Federal
Australia
Royal Prince Alfred Hospital
NOT_YET_RECRUITING
Camperdown
Lung Research Queensland
NOT_YET_RECRUITING
Chermside
The Prince Charles Hospital
NOT_YET_RECRUITING
Chermside
The Alfred Hospital
NOT_YET_RECRUITING
Melbourne
Belgium
Cliniques Universitaires Saint-Luc
NOT_YET_RECRUITING
Brussels
UZ Leuven
NOT_YET_RECRUITING
Leuven
Canada
QEII Health Sciences Centre
NOT_YET_RECRUITING
Halifax
St. Joseph's Healthcare Hamilton
NOT_YET_RECRUITING
Hamilton
McGill University Health Centre (MUHC)
NOT_YET_RECRUITING
Montreal
France
Hôpital Louis Pradel
NOT_YET_RECRUITING
Bron
INS Coeur Poumon
NOT_YET_RECRUITING
Lille
HOP Bichat
NOT_YET_RECRUITING
Paris
HOP Pontchaillou
NOT_YET_RECRUITING
Rennes
Hôpital Larrey - CHU de Toulouse
NOT_YET_RECRUITING
Toulouse
Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH