Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)
Condition(s) studied
Investigational drug(s) / intervention(s)
Deupirfenidone: size AA Swedish orange capsule
Pirfenidone (PFD): size AA Swedish orange capsule
Study 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.
Eligibility
Primary outcome measure(s)
- Absolute change in forced vital capacity (FVC) measured in mL — Baseline to Week 52
Evaluate the efficacy of deupirfenidone compared with pirfenidone on reduction in lung function decline in participants with IPF
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Palmtree Clinical Research Inc. | Palm Spring | California | Recruiting |
| Paradigm Clinical Research Centers LLC | Redding | California | Recruiting |
| Harmony Medical Research Institute, Inc | Hialeah | Florida | Recruiting |
| Clinical Research Specialists, LLC | Kissimmee | Florida | Recruiting |
| Infinity Medical Research | North Dartmouth | Massachusetts | Recruiting |
| Renown Regional Medical Center | Reno | Nevada | Recruiting |
| Pulmonix LLC | Greensboro | North Carolina | Recruiting |
| Clinical Research Associates of Central PA | DuBois | Pennsylvania | Recruiting |
| Clinical Research of Rock Hill | Rock Hill | South Carolina | Recruiting |
| Clinical Trials Center of Middle Tennesee LLC | Franklin | Tennessee | Recruiting |
| StatCare Pulmonary Consultants | Knoxville | Tennessee | Recruiting |
| Horizon Clinical Research Group. | Cypress | Texas | Recruiting |
| Premier Pulmonary Critical Care and Sleep Medicine | Denison | Texas | Recruiting |
| Renovatio Clinical | El Paso | Texas | Recruiting |
| Renovatio Clinical | The Woodlands | Texas | Recruiting |
| Renovatio Clinical | Webster | Texas | Recruiting |
| Dynamic Drug Advancement Limited | Ajax | Ontario | Recruiting |
| Dr. Syed Anees Medicine Professional Corporation | Windsor | Ontario | Recruiting |
More PureTech trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07284602 on ClinicalTrials.gov ↗ ← All trials in the USA