Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)
Start Date
6/26/2026
Completion Date
7/1/2029
Summary
This is a study for adults with a lung disease called idiopathic pulmonary fibrosis. The main purpose of this study is to look at how well deupirfenidone improves lung function and how safe it is for people with idiopathic pulmonary fibrosis (IPF) when compared with pirfenidone. Participants may have been treated with an approved antifibrotic drug for up to a year in the past, but they cannot be on background antifibrotic treatment during this study. Participants will be randomly assigned (meaning by chance) to take either deupirfenidone or pirfenidone 3 times a day, and neither a participant nor their study team will know which study drug participants are on. Participants will be in the study for up to approximately 3 years. During the first year, participants visit the study site up to ten times and afterwards they visit the site every three months. All participants will remain on blinded study drug until the last participant has completed Week 52 Visit. They will have lung function tests, a check of their health, and will tell the study team about any unfavorable effects.
Detailed Description
This is a Phase 3 randomized, double-blind, head-to-head study comparing deupirfenidone 825 mg TID to pirfenidone 801 mg TID over 52 weeks of treatment in participants with IPF who are not on background therapy. This study is designed to demonstrate superior efficacy of deupirfenidone over pirfenidone as well as support the overall safety profile of deupirfenidone. Prospective participants will initially enter the Screening Period to determine study eligibility (Section 5). Eligible participants will be randomized 1:1 to receive either blinded deupirfenidone 825 mg TID or pirfenidone 801 mg TID as part of the Double-Blind Treatment Period for at least 52 weeks (Period 1). Depending on when participants enter the study, they may continue being treated for up to two more years (Period 2).
Eligibility Criteria
Age Range: 40 years to No maximum
Interventions
Deupirfenidone
Pirfenidone (PFD)
Conditions
Locations
Palmtree Clinical Research Inc.
Palm Spring, California 92262
United States
Paradigm Clinical Research Centers LLC
Redding, California 96001
United States
Infinity Medical Research
North Dartmouth, Massachusetts 02747
United States
Clinical Research Associates of Central PA
DuBois, Pennsylvania 15801
United States
Clinical Research of Rock Hill
Rock Hill, South Carolina 29732
United States
Clinical Trials Center of Middle Tennesee LLC
Franklin, Tennessee 37067
United States
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas 75020
United States
Renovatio Clinical
The Woodlands, Texas 77380
United States
Renovatio Clinical
Webster, Texas 77598
United States