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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: Placebo
* Drug: Pirfenidone
* Drug: Deupirfenidone


Participation Criteria
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Eligibility Criteria
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Key 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 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo oral administration | Drug: Placebo<br>* placebo<br>|
| Active Comparator: pirfenidone 801 mg TID<br>pirfenidone 801 mg TID oral administration | Drug: Pirfenidone<br>* pirfenidone 801 mg TID<br>|
| Experimental: LYT-100 550 mg TID<br>LYT-100 (Deupirfenidone) 550 mg TID oral administration | Drug: Deupirfenidone<br>* Deupirfenidone<br>|
| Experimental: LYT-100 825 mg TID<br>LYT-100 (Deupirfenidone) 825 mg TID oral administration | Drug: Deupirfenidone<br>* Deupirfenidone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of decline in Forced Vital Capacity over 26 weeks | Rate of decline in Forced Vital Capacity (FVC; in mL) | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FVC percent predicted change | FVC percent predicted (FVCpp) change from baseline to Week 26 | Baseline to Week 26 | 
| Time to hospitalization or mortality | Time to hospitalization or mortality due to respiratory cause through 26 weeks | 26 weeks | 
| Time to IPF progression | Time to IPF progression through 26 weeks, as defined by a decline in FVC% of 5% or greater or death | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IPF, lung fibrosis, respiratory disease