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

Sponsor
PureTech
Study ID
NCT07284602
Phase
PHASE3
Status
Not Yet Recruiting

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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

Start date
Apr 30, 2026
Status verified
Dec 2025
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 ]

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