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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorPureTech

About this trial

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 criteria

Qualifiers

Is ≥40 years of age at the time of informed consent.

Meets the diagnostic criteria of IPF American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) 2022 guidelines.

Has a maximum time from initial IPF diagnosis of 7 years.

Has no prior exposure to pirfenidone or LYT-100, and has <12 months of prior exposure to nintedanib or any other approved antifibrotic therapies.

Disqualifiers

Has, in the opinion of the Investigator, significant clinical worsening of IPF between Visit 1 and Visit 2.

Has been hospitalized within 3 months prior to Visit 1 for acute exacerbation of IPF or other significant respiratory complication.

Has prebronchodilator forced expiratory volume in 1 second (FEV1)/FVC <0.7 at Visit 1.

Has a greater extent of emphysema vs fibrosis on the most recent HRCT scan as confirmed by the central reader.

Trial design

Treatments tested in this trial

  • Deupirfenidone
  • Pirfenidone (PFD)

Treatment groups

1,100 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators