Southeastern Research Center | Winston-Salem, NC
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About
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.
Full description
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.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC < 0.7 at Visit 1)
Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer
Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion)
Cardiovascular diseases, any of the following:
Prior hospitalization for confirmed COVID-19, acute exacerbation of IPF or any lower respiratory tract infection within 3-months of Visit 1
Primary purpose
Allocation
Interventional model
Masking
240 participants in 4 patient groups, including a placebo group
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Central trial contact
Sarah Santipadri; Carol Satler, MD
Data sourced from clinicaltrials.gov
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