To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF

• Status: Not yet recruiting
• Trial end date: 2025-02-03
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.