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 2

Recruiting

• Conditions: idiopathic pulmonary fibrosis; idiopathic fibrosis of the lungs; 10024967

• Registration Number: NL-OMON55928
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 6

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

Additional protocol-defined inclusion criteria may apply.

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 exclusion criteria may apply.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Change from baseline to end of treatment epoch (26 weeks of treatment) in<br /><br>Forced Vital Capacity (FVC) expressed in percent predicted</p><br>