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

a study on Fibrosis Idiopathic Pulmonary Fibrosis

Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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.

Official Title

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)

Details

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.

Keywords

Idiopathic Pulmonary Fibrosis, IPF, lung fibrosis, respiratory disease, Pulmonary Fibrosis, Fibrosis, Pirfenidone, Deupirfenidone, pirfenidone 801 mg TID, LYT-100 550 mg TID, LYT-100 825 mg TID

Eligibility

You can join if…

Open to people ages 40 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • Science 37 accepting new patients
    Los Angeles California 90230 United States
  • NewportNativeMD, Inc. accepting new patients
    Newport Beach California 92663 United States
  • University of Southern California accepting new patients
    Los Angeles California 90089 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
PureTech
Links
Recruiting website for patients in the United States
ID
NCT05321420
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated