LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) (ELEVATE)
D
Damien G. Patel, MD
Primary Investigator
Enrolling By Invitation
40 years and older
All
Phase
2
240 participants needed
1 Location
Brief description of study
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 of study
This study is a randomized, double-blind, being conducted at centers globally to evaluate they and efficacy of LYT-100 compared to pirfenidone or placebo in 240 treatment naïvedult patients with IPF ≥ 40 years in age. Patients will be randomized in a ratio of 1:1:1:1ve 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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Idiopathic Pulmonary Fibrosis
-
Age: 40 Years
-
Gender: All
Key Inclusion Criteria:
- Treatment naïve patients or those with <6 months of exposure to nintedanib withhysician diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines
- Idiopathic Pulmonary Fibrosis on HRCT, performed within 12 months of Visit 1 asd 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 todiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliteransganizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer
- Diagnosis of any connective tissue disease, including but not limited toderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupusythematosus, and rheumatoid arthritis
- Major extrapulmonary physiological restriction (e.g., chest wall abnormality, largeural 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
Updated on
01 Aug 2024.
Study ID: LYT-100-2022-204
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