NCT05321420

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

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)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: PureTech · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Placebo	placebo
DRUG	Pirfenidone	pirfenidone 801 mg TID
DRUG	Deupirfenidone	Deupirfenidone

Timeline

• Start date: 2022-07-22
• Primary completion: 2024-10-15
• Completion: 2025-12-31
• First posted: 2022-04-11
• Last updated: 2025-10-16

Locations

103 sites across 14 countries: United States, Argentina, Chile, Colombia, Georgia, Greece, India, Malaysia, Mexico, Philippines, Romania, South Africa, South Korea, Thailand

Regulatory

• FDA-regulated drug study