Hope for High-Risk families: drug aims to stop lung scarring before it starts
NCT ID NCT07201922
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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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
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Get notified about this study
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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.
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The places running it
54 sites in 13 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
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Azienda Ospedaliera Universitaria di Padova
RECRUITINGPadova, 35128, Italy
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Baylor College of Medicine
RECRUITINGHouston, Texas, 77030, United States
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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CEDIC - Centro de Investigacion Clinica
RECRUITINGCABA, C1060ABN, Argentina
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Centro de Investigacion Clinica Belgrano
RECRUITINGCABA, 1425, Argentina
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Centro de Investigaciones Metabolicas (CINME)
RECRUITINGBuenos Aires, C1056ABJ, Argentina
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Clinical Research Specialists LLC - Kissimmee
RECRUITINGKissimmee, Florida, 34746, United States
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Cliniques Universitaires Saint-Luc
RECRUITINGBrussels, 1200, Belgium
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Consultorios Medicos del Buen Ayre
RECRUITINGCapital Federal, 1425, Argentina
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Erasmus Medisch Centrum
RECRUITINGRotterdam, 3015 GD, Netherlands
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITINGRoma, 00168, Italy
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HOP Bichat
RECRUITINGParis, 75877, France
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HOP Pontchaillou
RECRUITINGRennes, 35033, France
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Hamamatsu University Hospital
RECRUITINGShizuoka, Hamamatsu, 431-3192, Japan
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Hopital Louis Pradel
RECRUITINGBron, 69677, France
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Hospital Italiano de Buenos Aires
RECRUITINGCABA, 1181, Argentina
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Hospital Universitari de Bellvitge
RECRUITINGL'Hospitalet Del Llobregat, 08907, Spain
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Hospital Universitario De La Princesa
NOT_YET_RECRUITINGMadrid, 28006, Spain
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Hospital Virgen del Rocío
RECRUITINGSeville, 41013, Spain
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Hospital de Galdakao
RECRUITINGGaldakao, 48960, Spain
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Hôpital Larrey - CHU de Toulouse
RECRUITINGToulouse, 31059, France
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INS Coeur Poumon
RECRUITINGLille, 59037, France
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IRCCS MultiMedica
RECRUITINGMilan, 20123, Italy
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Kanagawa Cardiovascular and Respiratory Center
ACTIVE_NOT_RECRUITINGKanagawa, Yokohama, 236-0051, Japan
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Krankenhaus Bethanien gGmbH
RECRUITINGSolingen, 42699, Germany
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Lung Research Queensland
RECRUITINGChermside, Queensland, 4032, Australia
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Lungenfachklinik Immenhausen
RECRUITINGImmenhausen, 34376, Germany
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McGill University Health Centre (MUHC)
NOT_YET_RECRUITINGMontreal, Quebec, H4A 3J1, Canada
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Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
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Medizinische Hochschule Hannover
RECRUITINGHanover, 30625, Germany
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National Center for Global Health and Medicine
RECRUITINGTokyo, Shinjuku-ku, 162-8655, Japan
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National Hospital Organization Kinki-Chuo Chest Medical Center
RECRUITINGOsaka, Sakai, 591-8555, Japan
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Royal Brompton Hospital
RECRUITINGLondon, SW3 6HP, United Kingdom
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Royal Devon and Exeter Hospital, Wonford
RECRUITINGExeter, EX2 5DW, United Kingdom
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Royal Prince Alfred Hospital
RECRUITINGCamperdown, New South Wales, 2050, Australia
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Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
RECRUITINGEssen, 45239, Germany
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Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
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Severance Hospital
RECRUITINGSeoul, 03722, South Korea
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St. Antonius Ziekenhuis
RECRUITINGNieuwegein, 3435 CM, Netherlands
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St. Joseph's Healthcare Hamilton
NOT_YET_RECRUITINGHamilton, Ontario, L8N 4A6, Canada
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The Alfred Hospital
RECRUITINGMelbourne, Victoria, 3004, Australia
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The Prince Charles Hospital
RECRUITINGChermside, Queensland, 4032, Australia
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Tosei General Hospital
RECRUITINGAichi, Seto, 489-8642, Japan
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Tsuboi Hospital
RECRUITINGFukushima, Koriyama, 963-0197, Japan
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UZ Leuven
RECRUITINGLeuven, 3000, Belgium
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University of California Los Angeles
NOT_YET_RECRUITINGLos Angeles, California, 90095, United States
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University of Colorado Denver
RECRUITINGAurora, Colorado, 80045, United States
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University of Kansas Medical Center
RECRUITINGKansas City, Kansas, 66160, United States
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
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University of Minnesota
RECRUITINGMinneapolis, Minnesota, 55455, United States
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Vanderbilt University Medical Center
NOT_YET_RECRUITINGNashville, Tennessee, 37204, United States
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Virginia Commonwealth University
RECRUITINGRichmond, Virginia, 23219, United States
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Weill Cornell Medicine-New York-60569
RECRUITINGNew York, New York, 10065, United States
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