LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Registration Number
- NCT05321420
- Lead Sponsor
- PureTech
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LYT-100 825 mg TID Deupirfenidone LYT-100 (Deupirfenidone) 825 mg TID oral administration Placebo Placebo Placebo oral administration pirfenidone 801 mg TID Pirfenidone pirfenidone 801 mg TID oral administration LYT-100 550 mg TID Deupirfenidone LYT-100 (Deupirfenidone) 550 mg TID oral administration
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Forced Vital Capacity (FVC) percent predicted change (Part B) 26 Weeks FVC percent predicted (FVCpp) change from Week 26 to Week 52
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
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
Trial Locations
- Locations (103)
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Science 37
🇺🇸Los Angeles, California, United States
NewportNativeMD, Inc.
🇺🇸Newport Beach, California, United States
Paradigm Clinical Research Centers, Inc.
🇺🇸Redding, California, United States
Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
🇺🇸Torrance, California, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Accel Research Sites Network
🇺🇸DeLand, Florida, United States
Harmony Medical Research Institute, Inc
🇺🇸Hialeah, Florida, United States
Piedmont Healthcare, Inc.
🇺🇸Atlanta, Georgia, United States
Clinical Research Investments
🇺🇸Decatur, Georgia, United States
Scroll for more (93 remaining)University of Alabama Birmingham🇺🇸Birmingham, Alabama, United States