A Study to Evaluate the Efficacy and Safety of Vixarelimab Compared with Placebo in Patients with Idiopathic Pulmonary Fibrosis and in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease

Prior treatment

• Percentage of predicted FVC value showing improvement in the 6-month period prior to screening and including screening value, as assessed by the investigator
• Receipt of nintedanib in combination with pirfenidone. Receipt of systemic (oral, IV, IM, or IA) corticosteroids equivalent to prednisone >10 mg/day or equivalent within 2 weeks prior to screening

Other illness

• History of lung transplant

Other

• Known post-bronchodilator response in FEV1 and/or FVC (defined as an increase in percent predicted values by ≥ 10)
• Resting oxygen saturation of <89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude (5000 feet [1524 meters] above sea level) during screening
• Inability to refrain from use of the following: – Short-acting bronchodilators within 4 hours before pulmonary function test (PFT), DLCO, and 6MWT assessments – Once-daily, long-acting bronchodilators within 24 hours before PFT, DLCO, and 6MWT assessments – Twice-daily, long-acting bronchodilators within 12 hours before PFT, DLCO, and 6MWT assessments

• Forced vital capacity (FVC) ≥45% predicted during screening as determined by the over-reader
• FEV1/FVC ratio >0.70 during screening as determined by the over-reader
• Diffusion capacity of the lung for carbon monoxide (DLCO) ≥30% and ≤90% of predicted during screening (Hgb corrected) as determined by the over-reader
• Minimum 6-minute walk test (6MWT) distance of 150 meters with maximum use of 6 L/min at sea-level and up to 8 L/min at altitude (>5000 feet [1524 meters] above sea level) of supplemental oxygen while maintaining oxygen saturation of >83% during the 6MWT during screening
• Cohort 1: Documented diagnosis of idiopathic pulmonary fibrosis (IPF) or IPF (likely) per the 2022 American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/ Latin American Thoracic Society (ALAT) Clinical Practice Guideline or high-resolution computed tomography (HRCT) pattern consistent with the diagnosis of IPF
• Cohort 2: Diagnosis of systemic sclerosis (SSc), as defined using the American College of Rheumatology/European League against Rheumatism (EULAR) criteria