Familial Pulmonary FibrosisPhase 3NCT07201922
A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis
A Phase 3 study testing Nerandomilast in people with Familial Pulmonary Fibrosis and Interstitial Lung Abnormalities, run by Boehringer Ingelheim at 55 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Familial Pulmonary Fibrosis, Interstitial Lung Abnormalities, Interstitial Lung Diseases
- What is being tested?
- Nerandomilast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 55 sitesin 13 countries
- Study dates
- 10 Feb 2026to 23 May 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
55 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
55 sites in 13 countries
United States13 sites, 13 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80045
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Clinical Research Specialists LLC - Kissimmee
Kissimmee, Florida, 34746
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
University of California Los Angeles
Los Angeles, California, 90095
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37204
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Weill Cornell Medicine-New York-60569
New York, New York, 10065
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23219
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Japan6 sites, 5 recruiting
- Recruiting
Tosei General Hospital
Aichi, Seto, 489-8642
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Tsuboi Hospital
Fukushima, Koriyama, 963-0197
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Active, not recruiting
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, 236-0051
- Recruiting
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, 162-8655
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Argentina5 sites, 5 recruiting
- Recruiting
Centro de Investigaciones Metabolicas (CINME)
Buenos Aires, C1056ABJ
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Hospital Italiano de Buenos Aires
CABA, 1181
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Fundacion NIBA Neurologia Infantil Buenos Aires
CABA, 1182
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Centro de Investigacion Clinica Belgrano
CABA, 1425
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Consultorios Medicos del Buen Ayre
Capital Federal, 1425
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
France5 sites, 5 recruiting
- Recruiting
Hopital Louis Pradel
Bron, 69677
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
INS Coeur Poumon
Lille, 59037
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP Bichat
Paris, 75877
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP Pontchaillou
Rennes, 35033
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
Hôpital Larrey - CHU de Toulouse
Toulouse, 31059
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Australia4 sites, 4 recruiting
- Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Lung Research Queensland
Chermside, Queensland, 4032
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
The Prince Charles Hospital
Chermside, Queensland, 4032
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Germany4 sites, 4 recruiting
- Recruiting
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Medizinische Hochschule Hannover
Hanover, 30625
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Lungenfachklinik Immenhausen
Immenhausen, 34376
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Krankenhaus Bethanien gGmbH
Solingen, 42699
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Spain4 sites, 4 recruiting
- Recruiting
Hospital de Galdakao
Galdakao, 48960
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet Del Llobregat, 08907
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario De La Princesa
Madrid, 28006
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Virgen del Rocio
Seville, 41013
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Italy3 sites, 3 recruiting
- Recruiting
IRCCS MultiMedica
Milan, 20123
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
South Korea3 sites, 3 recruiting
- Recruiting
Severance Hospital
Seoul, 03722
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Asan Medical Center
Seoul, 05505
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Samsung Medical Center
Seoul, 06351
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Belgium2 sites, 2 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Recruiting
UZ Leuven
Leuven, 3000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Canada2 sites, 2 recruiting
- Not yet recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Netherlands2 sites, 2 recruiting
- Recruiting
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
- Recruiting
Erasmus Medisch Centrum
Rotterdam, 3015 GD
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Devon and Exeter Hospital, Wonford
Exeter, EX2 5DW
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Royal Brompton Hospital
London, SW3 6HP
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
About this study
Official title: 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)
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.
Read more
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.
- Being tested
- Nerandomilast, Placebo
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NerandomilastDrug
Also called BI 1015550, JASCAYD®
Nerandomilast
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Nerandomilast | Experimental | Not described Receives: Drug: Nerandomilast |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: at baseline, at weeks 26, 52 and 104
Absolute change from baseline in FVC (% predicted) at weeks 26, 52, and 104
Measured: at baseline, at weeks 26, 52 and 104
Absolute change from baseline in DLCO (% predicted) at weeks 26, 52, and 104
Measured: 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
Measured: up to 164 weeks
Time to absolute decline from baseline in FVC (% predicted) of >5% over 52 weeks and over the whole trial
Measured: up to 164 weeks
Time to absolute decline from baseline in DLCO (% predicted) of >10% over 52 weeks and over the whole trial
Measured: up to 164 weeks
Time to absolute increase in wRVS >2% and TDE >2.5% on chest HRCT, as measured by e-lung quantitative HRCT scoring over 52 weeks and over the whole trial
Measured: up to 164 weeks
Time to physiologic or radiologic worsening of ILA/ILD over 52 weeks
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start10 Feb 2026
- Primary completion14 May 2029 (estimated)
- Study completion23 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201922
- Sponsor's protocol ID
- 1305-0069
- Other IDs
- 2025-522383-33-00, U1111-1322-6453, 2025
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.