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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,100
size AA Swedish orange capsule
size AA Swedish orange capsule
Palmtree Clinical Research Inc.
Palm Spring, California, United States
RECRUITINGParadigm Clinical Research Centers LLC
Redding, California, United States
RECRUITINGInfinity Medical Research
North Dartmouth, Massachusetts, United States
RECRUITINGRenown Regional Medical Center
Reno, Nevada, United States
RECRUITINGClinical Research Associates of Central PA
DuBois, Pennsylvania, United States
RECRUITINGClinical Research of Rock Hill
Rock Hill, South Carolina, United States
RECRUITINGClinical Trials Center of Middle Tennesee LLC
Franklin, Tennessee, United States
RECRUITINGPremier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, United States
RECRUITINGRenovatio Clinical
The Woodlands, Texas, United States
RECRUITINGRenovatio Clinical
Webster, Texas, United States
RECRUITINGAbsolute change in forced vital capacity (FVC) measured in mL
Evaluate the efficacy of deupirfenidone compared with pirfenidone on reduction in lung function decline in participants with IPF
Time frame: Baseline to Week 52
Absolute change in FVC percent predicted (FVCpp)
Evaluate the efficacy of deupirfenidone compared with pirfenidone on reduction in lung function decline relative to individual predicted normal lung function
Time frame: Baseline to Week 52
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