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Nerandomilast to slow lung changes 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)

Phase 3 Interventional Boehringer Ingelheim · NCT07201922

This trial tests whether taking nerandomilast can slow early lung scarring in people aged 40 and older who have a first-degree relative with pulmonary fibrosis and CT evidence of interstitial lung abnormalities.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment80 (estimated)
Ages40 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Locations56 sites (Los Angeles, California and 55 other locations)
Trial IDNCT07201922 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, placebo-controlled trial enrolls adults 40 and older who have at least one first-degree relative with confirmed pulmonary fibrosis and HRCT evidence of interstitial lung abnormalities or ILD. Eligible participants with preserved lung function (FVC ≥80% and DLCO ≥70%) are randomly assigned to receive oral nerandomilast or matching placebo and are followed over time with imaging and lung function tests. The primary aim is to see if nerandomilast slows the development or extent of lung scarring compared with placebo. The trial is conducted at academic and community research centers in California, Colorado, and Florida.

Who should consider this trial

Good fit: Ideal candidates are adults 40 years or older with at least one first-degree relative with confirmed pulmonary fibrosis, HRCT showing at least 5% interstitial lung abnormalities or ILD, and preserved lung function (FVC ≥80%, DLCO ≥70%).

Not a fit: People with already diagnosed or advanced pulmonary fibrosis, worse lung function than the entry criteria, or without a family history of pulmonary fibrosis are unlikely to benefit from this preventive approach.

Why it matters

Potential benefit: If successful, nerandomilast could slow progression of early lung abnormalities and reduce or delay the onset of symptomatic pulmonary fibrosis.

How similar studies have performed: Antifibrotic drugs have slowed progression in established pulmonary fibrosis, but using a preventative drug in relatives with early CT changes is relatively novel and not yet proven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Los Angeles, California and 55 other locations

+6 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Familial Pulmonary FibrosisInterstitial Lung AbnormalitiesInterstitial Lung Diseases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.