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

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Placebo oral administration
  • Drug: Placebo
    placebo
Active Comparator
pirfenidone 801 mg TID 		pirfenidone 801 mg TID oral administration
  • Drug: Pirfenidone
    pirfenidone 801 mg TID
Experimental
LYT-100 550 mg TID 		LYT-100 (Deupirfenidone) 550 mg TID oral administration
  • Drug: Deupirfenidone
    Deupirfenidone
Experimental
LYT-100 825 mg TID 		LYT-100 (Deupirfenidone) 825 mg TID oral administration
  • Drug: Deupirfenidone
    Deupirfenidone

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
PureTech

Study Contact

Carol Satler, MD
617-226-4813
clinicaltrials@puretechhealth.com

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.