Idiopathic Pulmonary Fibrosis
Conditions
Keywords
IPF, lung fibrosis, respiratory disease
Brief summary
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.
Detailed 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.
Interventions
Sponsors
PureTech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Treatment naïve patients or those with \<6 months of exposure to nintedanib with physician diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines * Idiopathic Pulmonary Fibrosis on HRCT, performed within 12 months of Visit 1 as confirmed by central readers * DLCO corrected for Hemoglobin (Hb) \[visit 1\] ≥ 30% and ≤90% of predicted of normal * FVC ≥ 45% of predicted normal 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: * Uncontrolled hypertension, within 3 months of Visit 1 * Myocardial infarction within 6 months of Visit 1 * Unstable cardiac angina within 6 months of Visit 1 * Prior hospitalization for confirmed COVID-19, acute exacerbation of IPF or any lower respiratory tract infection within 3-months of Visit 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of decline in Forced Vital Capacity over 26 weeks (Part A) | 26 weeks | Rate of decline in Forced Vital Capacity (FVC; in mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Vital Capacity (FVC) percent predicted change (Part A) | Baseline to Week 26 | FVC percent predicted (FVCpp) change from baseline to Week 26 |
| Time to hospitalization or mortality (Part A) | 26 weeks | Time to hospitalization or mortality due to respiratory cause through 26 weeks |
| Rate of decline in Forced Vital Capacity over 26 weeks (Part B) | 26 Weeks | Rate of decline in Forced Vital Capacity (FVC; in mL) from Week 26 to Week 52 |
| Forced Vital Capacity (FVC) percent predicted change (Part B) | 26 Weeks | FVC percent predicted (FVCpp) change from Week 26 to Week 52 |
| Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part B) | 26 Weeks | Time to IPF progression from Week 26 to Week 52, as defined by a decline in FVC% of 5% or greater or death |
| Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part A) | 26 weeks | Time to IPF progression through 26 weeks, as defined by a decline in FVC% of 5% or greater or death |
Countries
Argentina, Chile, Colombia, Georgia, Greece, India, Malaysia, Mexico, Philippines, Romania, South Africa, South Korea, Thailand, United States
Outcome results
None listed