A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis
Start Date
2/10/2026
Completion Date
5/23/2029
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 Criteria
Age Range: 40 years to No maximum
Interventions
Nerandomilast
Placebo
Conditions
Locations
University of California Los Angeles
Los Angeles, California 90095
United States
University of Colorado Denver
Aurora, Colorado 80045
United States
Clinical Research Specialists LLC - Kissimmee
Kissimmee, Florida 34746
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Weill Cornell Medicine-New York-60569
New York, New York 10065
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37204
United States
Baylor College of Medicine
Houston, Texas 77030
United States
Virginia Commonwealth University
Richmond, Virginia 23219
United States
Centro de Investigaciones Metabolicas (CINME)
Buenos Aires, C1056ABJ
Argentina
Hospital Italiano de Buenos Aires
CABA, 1181
Argentina
Centro de Investigación Clinica Belgrano
CABA, 1425
Argentina
CEDIC - Centro de Investigacion Clinica
CABA, C1060ABN
Argentina
Consultorios Médicos del Buen Ayre
Capital Federal, 1425
Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales 2050
Australia
Lung Research Queensland
Chermside, Queensland 4032
Australia
The Prince Charles Hospital
Chermside, Queensland 4032
Australia
The Alfred Hospital
Melbourne, Victoria 3004
Australia
Cliniques Universitaires Saint-Luc
Brussels, 1200
Belgium
UZ Leuven
Leuven, 3000
Belgium
QEII Health Sciences Centre
Halifax, Nova Scotia B3H 3A7
Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario L8N 4A6
Canada
McGill University Health Centre (MUHC)
Montreal, Quebec H4A 3J1
Canada
Hôpital Louis Pradel
Bron, 69677
France
INS Coeur Poumon
Lille, 59037
France
HOP Bichat
Paris, 75877
France
HOP Pontchaillou
Rennes, 35033
France
Hôpital Larrey - CHU de Toulouse
Toulouse, 31059
France
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239
Germany
Medizinische Hochschule Hannover
Hanover, 30625
Germany
Lungenfachklinik Immenhausen
Immenhausen, 34376
Germany
Krankenhaus Bethanien gGmbH
Solingen, 42699
Germany
IRCCS MultiMedica
Milan, 20123
Italy
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Italy
Tosei General Hospital
Aichi, Seto, 489-8642
Japan
Tsuboi Hospital
Fukushima, Koriyama, 963-0197
Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, 236-0051
Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555
Japan
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192
Japan
National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, 162-8655
Japan
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD
Netherlands
Severance Hospital
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Hospital de Galdakao
Galdakao, 48960
Spain
Hospital Universitari de Bellvitge
L'Hospitalet Del Llobregat, 08907
Spain
Hospital Universitario De La Princesa
Madrid, 28006
Spain
Hospital Virgen del Rocío
Seville, 41013
Spain
Royal Devon and Exeter Hospital, Wonford
Exeter, EX2 5DW
United Kingdom
Royal Brompton Hospital
London, SW3 6HP
United Kingdom