This study a randomized, double-blind, four arm study to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis.
This study is a randomized, double-blind, being conducted at centers globally to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in 240 treatment naïve adult patients with IPF ≥ 40 years in age. Patients will be randomized in a ratio of 1:1:1:1 to receive treatment of LYT-100, pirfenidone, or placebo to be taken daily for up to 183 days (26 week treatment period) with the primary outcome of Rate of decline in Forced Vital Capacity (FVC; in mL) over 26 weeks. Secondary endpoints, including spirometry, inflammatory biomarkers, and patient-reported outcomes will also be evaluated. After completion of the double-blind period of the study, patients may participate in a long-term extension to evaluate tolerability and long-term safety. Patients receiving LYT-100 in the double-blind period will continue the dose throughout the long-term extension. Patients receiving pirfenidone or placebo in the double-blind period will be re-randomized in a 1:1 ratio to receive LYT-100 550mg or 825mg TID dose throughout the long-term extension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Rate of decline in Forced Vital Capacity over 26 weeks (Part A)
Rate of decline in Forced Vital Capacity (FVC; in mL)
Time frame: 26 weeks
Forced Vital Capacity (FVC) percent predicted change (Part A)
FVC percent predicted (FVCpp) change from baseline to Week 26
Time frame: Baseline to Week 26
Time to hospitalization or mortality (Part A)
Time to hospitalization or mortality due to respiratory cause through 26 weeks
Time frame: 26 weeks
Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part A)
Time to IPF progression through 26 weeks, as defined by a decline in FVC% of 5% or greater or death
Time frame: 26 weeks
Forced Vital Capacity (FVC) percent predicted change (Part B)
FVC percent predicted (FVCpp) change from Week 26 to Week 52
Time frame: 26 Weeks
Rate of decline in Forced Vital Capacity over 26 weeks (Part B)
Rate of decline in Forced Vital Capacity (FVC; in mL) from Week 26 to Week 52
Time frame: 26 Weeks
Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part B)
Time to IPF progression from Week 26 to Week 52, as defined by a decline in FVC% of 5% or greater or death
Time frame: 26 Weeks
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