LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Purpose
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.
Condition
- Idiopathic Pulmonary Fibrosis
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
Placebo oral administration |
|
|
Active Comparator pirfenidone 801 mg TID |
pirfenidone 801 mg TID oral administration |
|
|
Experimental LYT-100 550 mg TID |
LYT-100 (Deupirfenidone) 550 mg TID oral administration |
|
|
Experimental LYT-100 825 mg TID |
LYT-100 (Deupirfenidone) 825 mg TID oral administration |
|
Recruiting Locations
Birmingham, Alabama 35294
Greensboro, North Carolina 27403
Richmond, Virginia 23230
The Woodlands, Texas 77380
McKinney, Texas 75069
Dallas, Texas 75204
Franklin, Tennessee 37067
Philadelphia, Pennsylvania 19140
Cincinnati, Ohio 45267
Winston-Salem, North Carolina 27103
Kansas City, Kansas 66160
Los Angeles, California 90089
Indianapolis, Indiana 46202
Decatur, Georgia 30030
Atlanta, Georgia 30309
Hialeah, Florida 33016
DeLand, Florida 32720
Torrance, California 90502
Redding, California 96001
Newport Beach, California 92663
Los Angeles, California 90230
Williamsburg, Virginia 23188
More Details
- NCT ID
- NCT05321420
- Status
- Recruiting
- Sponsor
- PureTech
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.