Familial Pulmonary Fibrosis Interstitial Lung Abnormalities Interstitial Lung Diseases
Conditions
Interventions
Nerandomilast/Placebo matching nerandomilast
Sponsors
Yamamoto Akiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals who are 40 years of age or older at the time of first signed informed consent at Visit 1a 2. Participants must have at least one first-degree relative (biological parent, sibling, or child) with confirmed pulmonary fibrosis (such as idiopathic pulmonary fibrosis (IPF), idiopathic nonspecific interstitial pneumonia (NSIP), or pulmonary fibrosis due to a known genetic cause, for example, short telomere syndrome, MUC5B mutation, or surfactant protein mutations) 3. High-resolution computed tomography (HRCT) scan showing evidence of interstitial lung abnormalities involving at least 5 percent of a single lung zone, or interstitial lung disease (ILD), based on central evaluation 4. Forced vital capacity (FVC) equal to or greater than 80 percent of predicted normal at Visit 1b 5. Diffusing capacity of the lungs for carbon monoxide (DLCO), corrected for hemoglobin, equal to or greater than 70 percent of predicted normal at Visit 1b
Exclusion criteria
Exclusion criteria: 1. Prior known pulmonary fibrosis that, in the opinion of the Investigator, requires treatment with approved therapies 2. Prebronchodilator forced expiratory volume in 1 second (FEV1)/FVC <0.7 at Visit 1b 3. HRCT findings consistent with probable or definite usual interstitial pneumonia (UIP) pattern 4. Any medical condition that is known to predispose to the development of pulmonary fibrosis (e.g. known connective tissue disease) 5. Prior or current use of nerandomilast, nintedanib, or pirfenidone Further exclusion criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Absolute change from baseline in wRVS on e-Lung Quantitative HRCT scoring at Weeks 26, 52, and 104 - Absolute change from baseline in TDE on e-Lung Quantitative HRCT scoring at Weeks 26, 52, and 104 - Absolute change from baseline in FVC (percent predicted) at Weeks 26, 52, and 104 - Absolute change from baseline in DLCO (percent predicted) at Weeks 26, 52, and 104 - Time to relative decline from baseline in FVC (percent predicted) of greater than 10 percent over 52 weeks and over the entire trial period - Time to absolute decline from baseline in FVC (percent predicted) of greater than 5 percent over 52 weeks and over the entire trial period - Time to absolute decline from baseline in DLCO (percent predicted) of greater than 10 percent over 52 weeks and over the entire trial period - Time to absolute increase in wRVS of greater than 2 percent and TDE of greater than 2.5 percent on chest HRCT, as measured by e-Lung Quantitative HRCT scoring over 52 weeks and over the entire trial period - Time to physiologic or radiologic worseni | — |
Countries
Argentina, Belgium, France, Germany, Italy, Japan, Netherlands, South Korea, United States
Contacts
Public ContactTomohiro Yamagami
Boehringer Ingelheim
Outcome results
None listed