Overview
A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis
Eligibility
Inclusion Criteria:
- Male and female participants at least 40 years of age
- IPF diagnosed based on ATS/ERS/JRS/ALAT IPF 2018 modified guidelines
- FVC ≥45% predicted
- DLCO, corrected for hemoglobin, ≥25% predicted (inclusive)
- Unlikely to undergo lung transplantation during this trial in the opinion of the investigator
- If a participant is taking nintedanib or pirfenidone, they must be on a stable regimen for at least 8 weeks prior to randomization
Exclusion Criteria:
- Airway obstruction (i.e. prebronchodilator FEV1/ FVC < 0.7) or evidence of a bronchodilator response at screening
- Emphysema >20% on screening HRCT
- Fibrosis <10% on screening HRCT
- Clinical diagnosis of any connective tissue disease
- Clinically diagnosed acute exacerbation of IPF (AE-IPF) or other significant clinical worsening within 3 months of randomization
Additional protocol-defined inclusion / exclusion criteria may apply.
