A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis
A Double Blind, Randomized, Placebo-controlled Exploratory Trial to Investigate the Efficacy and Safety of Nerandomilast Over 24 Months When Administered in Individuals With Interstitial Lung Abnormalities and a Family History of Pulmonary Fibrosis to Reduce the Risk of Worsening (DROP-FPF)
3 other identifiers
interventional
80
13 countries
56
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2026
Typical duration for phase_3
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2025
CompletedFirst Posted
Study publicly available on registry
October 1, 2025
CompletedStudy Start
First participant enrolled
February 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 23, 2029
April 15, 2026
April 1, 2026
3.3 years
September 30, 2025
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to physiologic or radiologic worsening of ILA/ILD over the whole trial
Defined as relative decline in forced vital capacity (FVC) % predicted of \>10% from baseline; or absolute decline in diffusing capacity of the lungs for carbon monoxide (DLCO) % predicted \>10% from baseline; or absolute increase in weighted reticulovascular score (wRVS) \>2% and total disease extent (TDE) \>2.5% on chest high resolution CT scan (HRCT), as measured by e-Lung Quantitative HRCT scoring, from baseline
up to 164 weeks
Secondary Outcomes (9)
Absolute change from baseline in wRVS on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104
at baseline, at weeks 26, 52 and 104
Absolute change from baseline in TDE on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104
at baseline, at weeks 26, 52 and 104
Absolute change from baseline in FVC (% predicted) at weeks 26, 52, and 104
at baseline, at weeks 26, 52 and 104
Absolute change from baseline in DLCO (% predicted) at weeks 26, 52, and 104
at baseline, at weeks 26, 52 and 104
Time to relative decline from baseline in FVC (% predicted) of >10% over 52 weeks and over the whole trial
up to 164 weeks
- +4 more secondary outcomes
Study Arms (2)
Nerandomilast
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
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, 10021, 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, 23298, United States
Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
C.a.b.a, 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
Exeter, EX2 5DW, United Kingdom
Royal Brompton Hospital
London, SW3 6HP, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2025
First Posted
October 1, 2025
Study Start
February 10, 2026
Primary Completion (Estimated)
May 14, 2029
Study Completion (Estimated)
May 23, 2029
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.