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Nerandomilast for Familial Pulmonary Fibrosis and Early Lung Changes

This study is looking for people aged 40 or older who have a family member with pulmonary fibrosis (scarring of the lungs). You can join if a lung scan shows early changes, called interstitial lung abnormalities (ILA), which might lead to lung scarring. The study aims to see if a medicine called nerandomilast can help slow down these lung changes. Some participants will receive nerandomilast, and others will receive a placebo (an inactive substance). The main goal is to measure how long it takes for your lung condition to worsen, either through physical signs or on lung scans, over a period of up to 164 weeks. The study plans to enroll 80 people, but its current status is unclear.

Study design
This interventional study plans to enroll 80 participants. It compares nerandomilast to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track changes in your lung condition for up to 164 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07201922

A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis

Recruiting
PHASE3Ages 40+InterventionalTreatment
Boehringer Ingelheim
~80 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:NerandomilastPlacebo

At a glance

Recruiting sites
48 of 55 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to physiologic or radiologic worsening of ILA/ILD over the whole trial
Measured over up to 164 weeks

Conditions

Familial Pulmonary Fibrosis
Interstitial Lung Abnormalities
Interstitial Lung Diseases

Explore related trials

Familial Pulmonary FibrosisInterstitial Lung AbnormalitiesInterstitial Lung Disease

Where it's being run

55 sites across 28 states
Japan6
Argentina5
France5
Germany4
Spain4
Italy3
South Korea3
Queensland2

Who to contact

Boehringer Ingelheim
[email protected]
1-800-243-0127
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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)

What this trial measures

  • Time to physiologic or radiologic worsening of ILA/ILD over the whole trialup to 164 weeks

    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