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Hope for High-Risk families: drug aims to stop lung scarring before it starts

NCT ID NCT07201922

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 09, 2026 · Updated 11 times

Summary

This study tests a drug called nerandomilast in 80 people aged 40+ who have early lung changes and a family history of pulmonary fibrosis. Participants take either the drug or a placebo twice daily for up to 3 years. Doctors monitor lung function and scans to see if the drug slows worsening of lung scarring.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nerandomilast
What this could lead to
If it works, this could point toward a way to prevent pulmonary fibrosis in people at high risk due to family history.
What could go wrong
This is an early exploratory trial with only 80 participants, so results may not apply to everyone. The drug may not slow lung changes and could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    54 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Azienda Ospedaliera Universitaria di Padova

    RECRUITING

    Padova, 35128, Italy

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CEDIC - Centro de Investigacion Clinica

    RECRUITING

    CABA, C1060ABN, Argentina

  • Centro de Investigacion Clinica Belgrano

    RECRUITING

    CABA, 1425, Argentina

  • Centro de Investigaciones Metabolicas (CINME)

    RECRUITING

    Buenos Aires, C1056ABJ, Argentina

  • Clinical Research Specialists LLC - Kissimmee

    RECRUITING

    Kissimmee, Florida, 34746, United States

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Consultorios Medicos del Buen Ayre

    RECRUITING

    Capital Federal, 1425, Argentina

  • Erasmus Medisch Centrum

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

  • HOP Bichat

    RECRUITING

    Paris, 75877, France

  • HOP Pontchaillou

    RECRUITING

    Rennes, 35033, France

  • Hamamatsu University Hospital

    RECRUITING

    Shizuoka, Hamamatsu, 431-3192, Japan

  • Hopital Louis Pradel

    RECRUITING

    Bron, 69677, France

  • Hospital Italiano de Buenos Aires

    RECRUITING

    CABA, 1181, Argentina

  • Hospital Universitari de Bellvitge

    RECRUITING

    L'Hospitalet Del Llobregat, 08907, Spain

  • Hospital Universitario De La Princesa

    NOT_YET_RECRUITING

    Madrid, 28006, Spain

  • Hospital Virgen del Rocío

    RECRUITING

    Seville, 41013, Spain

  • Hospital de Galdakao

    RECRUITING

    Galdakao, 48960, Spain

  • Hôpital Larrey - CHU de Toulouse

    RECRUITING

    Toulouse, 31059, France

  • INS Coeur Poumon

    RECRUITING

    Lille, 59037, France

  • IRCCS MultiMedica

    RECRUITING

    Milan, 20123, Italy

  • Kanagawa Cardiovascular and Respiratory Center

    ACTIVE_NOT_RECRUITING

    Kanagawa, Yokohama, 236-0051, Japan

  • Krankenhaus Bethanien gGmbH

    RECRUITING

    Solingen, 42699, Germany

  • Lung Research Queensland

    RECRUITING

    Chermside, Queensland, 4032, Australia

  • Lungenfachklinik Immenhausen

    RECRUITING

    Immenhausen, 34376, Germany

  • McGill University Health Centre (MUHC)

    NOT_YET_RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, 30625, Germany

  • National Center for Global Health and Medicine

    RECRUITING

    Tokyo, Shinjuku-ku, 162-8655, Japan

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    RECRUITING

    Osaka, Sakai, 591-8555, Japan

  • Royal Brompton Hospital

    RECRUITING

    London, SW3 6HP, United Kingdom

  • Royal Devon and Exeter Hospital, Wonford

    RECRUITING

    Exeter, EX2 5DW, United Kingdom

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    RECRUITING

    Essen, 45239, Germany

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

  • St. Antonius Ziekenhuis

    RECRUITING

    Nieuwegein, 3435 CM, Netherlands

  • St. Joseph's Healthcare Hamilton

    NOT_YET_RECRUITING

    Hamilton, Ontario, L8N 4A6, Canada

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • The Prince Charles Hospital

    RECRUITING

    Chermside, Queensland, 4032, Australia

  • Tosei General Hospital

    RECRUITING

    Aichi, Seto, 489-8642, Japan

  • Tsuboi Hospital

    RECRUITING

    Fukushima, Koriyama, 963-0197, Japan

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University of California Los Angeles

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • University of Colorado Denver

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Vanderbilt University Medical Center

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37204, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23219, United States

  • Weill Cornell Medicine-New York-60569

    RECRUITING

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.