Status:
NOT_YET_RECRUITING
A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Familial Pulmonary Fibrosis
Interstitial Lung Abnormalities
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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 ...
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
- Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥70% of predicted normal at Visit 1b Further inclusion criteria apply.
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)
- Prior or current use of nerandomilast, nintedanib, or pirfenidone Further exclusion criteria apply.
Key Trial Info
Start Date :
January 23 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 23 2029
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07201922
Start Date
January 23 2026
End Date
May 23 2029
Last Update
December 22 2025
Active Locations (48)
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1
University of California Los Angeles
Los Angeles, California, United States, 90095
2
University of Colorado Denver
Aurora, Colorado, United States, 80045
3
Clinical Research Specialists LLC
Kissimmee, Florida, United States, 34746
4
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160