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

NCT ID: NCT07201922

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-23

Study Completion Date

2029-05-23

Brief Summary

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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.

Detailed Description

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Conditions

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Familial Pulmonary Fibrosis Interstitial Lung Abnormalities Interstitial Lung Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nerandomilast

Group Type EXPERIMENTAL

Nerandomilast

Intervention Type DRUG

Nerandomilast

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Nerandomilast

Nerandomilast

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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BI 1015550, JASCAYD®

Eligibility Criteria

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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

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)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California Los Angeles

Los Angeles, California, United States

Site Status

University of Colorado Denver

Aurora, Colorado, United States

Site Status

Clinical Research Specialists LLC

Kissimmee, Florida, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Weill Cornell Medicine-New York-60569

New York, New York, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553

C.a.b.a, , Argentina

Site Status

Hospital Italiano de Buenos Aires

CABA, , Argentina

Site Status

Centro de Investigación Clinica Belgrano

CABA, , Argentina

Site Status

CEDIC - Centro de Investigacion Clinica

CABA, , Argentina

Site Status

Consultorios Médicos del Buen Ayre

Capital Federal, , Argentina

Site Status

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

UZ Leuven

Leuven, , Belgium

Site Status

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

HOP Louis Pradel

Bron, , France

Site Status

INS Coeur Poumon

Lille, , France

Site Status

HOP Bichat

Paris, , France

Site Status

HOP Pontchaillou

Rennes, , France

Site Status

HOP Larrey

Toulouse, , France

Site Status

Fachkrankenhaus Coswig GmbH

Coswig, , Germany

Site Status

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, , Germany

Site Status

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Lungenfachklinik Immenhausen

Immenhausen, , Germany

Site Status

Krankenhaus Bethanien gGmbH

Solingen, , Germany

Site Status

IRCCS MultiMedica

Milan, , Italy

Site Status

Azienda Ospedaliera Universitaria di Padova

Padua, , Italy

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Tosei General Hospital

Aichi, Seto, , Japan

Site Status

Tsuboi Hospital

Fukushima, Koriyama, , Japan

Site Status

Kanagawa Cardiovascular and Respiratory Center

Kanagawa, Yokohama, , Japan

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National Hospital Organization Kinki-Chuo Chest Medical Center

Osaka, Sakai, , Japan

Site Status

Hamamatsu University Hospital

Shizuoka, Hamamatsu, , Japan

Site Status

National Center for Global Health and Medicine

Tokyo, Shinjuku-ku, , Japan

Site Status

St. Antonius ziekenhuis, locatie Nieuwegein

Nieuwegein, , Netherlands

Site Status

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Site Status

Severance Hospital

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Hospital de Galdakao

Galdakao, , Spain

Site Status

Hospital Universitari de Bellvitge

L'Hospitalet Del Llobregat, , Spain

Site Status

Hospital La Princesa

Madrid, , Spain

Site Status

Hospital Virgen del Rocío

Seville, , Spain

Site Status

Royal Devon and Exeter Hospital, Wonford

Exeter, , United Kingdom

Site Status

Royal Brompton Hospital

London, , United Kingdom

Site Status

Countries

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United States Argentina Belgium Canada France Germany Italy Japan Netherlands South Korea Spain United Kingdom

Central Contacts

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Boehringer Ingelheim

Role: CONTACT

Phone: 1-800-243-0127

Email: [email protected]

Facility Contacts

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Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

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Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Related Links

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http://www.mystudywindow.com

Related Info

Other Identifiers

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2025-522383-33

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1322-6453

Identifier Type: REGISTRY

Identifier Source: secondary_id

1305-0069

Identifier Type: -

Identifier Source: org_study_id