Nerandomilast to slow lung changes in people with a family history of pulmonary fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Colorado Denver
  Aurora, Colorado, United States Recruiting
• Clinical Research Specialists LLC - Kissimmee
  Kissimmee, Florida, United States Recruiting
• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

+5 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.