LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PureTech
• Treatments: Pirfenidone

Criteria

Key Inclusion Criteria:

• Treatment naïve patients 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% 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