Status:
ACTIVE_NOT_RECRUITING
LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Lead Sponsor:
PureTech
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40+ years
Phase:
PHASE2
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 wi...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
July 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05321420
Start Date
July 22 2022
End Date
December 31 2025
Last Update
October 16 2025
Active Locations (103)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
2
Science 37
Los Angeles, California, United States, 90230
3
NewportNativeMD, Inc.
Newport Beach, California, United States, 92663
4
Paradigm Clinical Research Centers, Inc.
Redding, California, United States, 96001