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 (NCT07201922)

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.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

A/Prof Ian Glaspole

Key inclusion data

INCLUSION: Individuals ≥40 years of age at the time of first signed informed consent at Visit 1a. Participants have 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, MUC5B mutation, surfactant protein mutations]). HRCT scan with evidence of interstitial lung abnormalities involving at least 5% of a single lung zone, or ILD, based on central evaluation. FVC ≥80% of predicted normal at Visit 1b. Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin ≥70% of predicted normal. EXCLUSION: Prior known pulmonary fibrosis that, in the opinion of the Investigator, requires treatment with approved therapies. Prebronchodilator 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.