Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)

Part of paid clinical trials in Palm Spring, California.

Sponsor
PureTech
Study ID
NCT07284602
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Deupirfenidone — DRUG
    size AA Swedish orange capsule
  • Pirfenidone (PFD) — DRUG
    size AA Swedish orange capsule

Study Details

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.

Key Dates

First listed
Dec 16, 2025
Start date
Jun 26, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
1,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active
    deupirfenidone 825 mg TID
  • Active Comparator: Active Comparator
    pirfenidone 801 mg TID

Primary Outcome Measure

Absolute change in forced vital capacity (FVC) measured in mL [ Time Frame: Baseline to Week 52 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Palmtree Clinical Research Inc.Palm SpringCalifornia92262
Ayad M Gharghoury, MD
[email protected]
760-778-7799
Paradigm Clinical Research Centers LLCReddingCalifornia96001
Rafael Lupercio
[email protected]
530-247-7049
Infinity Medical ResearchNorth DartmouthMassachusetts02747
Curtis J Mello, MD
[email protected]
508-998-3041
Clinical Research Associates of Central PADuBoisPennsylvania15801
Sandeep Bansal, MD, FCCP, FACP
[email protected]
814-940-1212
Clinical Research of Rock HillRock HillSouth Carolina29732
Michael B Denenberg, MD
[email protected]
803-251-9502
Clinical Trials Center of Middle Tennesee LLCFranklinTennessee37067
Aaron Milstone, MD
[email protected]
615-840-1692
Premier Pulmonary Critical Care and Sleep MedicineDenisonTexas75020
Sanober Kable, MD
[email protected]
469-714-9864
Renovatio ClinicalThe WoodlandsTexas77380
Ather Siddiqi, MD
[email protected]
713-703-2398
Renovatio ClinicalWebsterTexas77598
Alfred Maksoud, MD
[email protected]
713-703-2398

Find similar trials in Palm Spring, CA

By research site
Palmtree Clinical Research Inc.· Palm Spring, CAParadigm Clinical Research Centers LLC· Redding, CAInfinity Medical Research· North Dartmouth, MAClinical Research Associates of Central PA· DuBois, PAClinical Research of Rock Hill· Rock Hill, SCClinical Trials Center of Middle Tennesee LLC· Franklin, TN

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