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NCT07201922PHASE3Recruiting

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

Boehringer Ingelheim

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

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.

Interventions

DRUG

Nerandomilast

DRUG

Placebo

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Conditions

Familial Pulmonary FibrosisInterstitial Lung AbnormalitiesInterstitial Lung Diseases

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