This study is in progress, not accepting new patients

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
study ends 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, Respiration Disorders, 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
    Torrance California 90502 United States
  • Science 37
    Los Angeles California 90230 United States
  • NewportNativeMD, Inc.
    Newport Beach California 92663 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
PureTech
ID
NCT05321420
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated