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

Recruiting now · Phase 3

Conditions studied: Idiopathic Pulmonary Fibrosis (IPF)

In brief

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 facts

Study ID

NCT07284602

Run by

PureTech

People needed

1100

Starts

2026-06-26

Expected to finish

2029-07-01

Last updated by the study team

2026-07-17

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Has definite or probable unusual interstitial pneumonia (UIP) on HRCT, performed within 12 months prior to Visit 1 and confirmed by the central reader.
• Has an FVC ≥45% of predicted normal at Visit 1.

You may not qualify if…

• Has, in the opinion of the Investigator, significant clinical worsening of IPF between Visit 1 and Visit 2 (eg, clinically significant hospitalization, clinically significant respiratory event).
• 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.
• Has a diagnosis of any condition that could be an explanation for interstitial lung disease (ILD).
• Has a major extrapulmonary condition that could affect spirometry.
• Has a current diagnosis of other relevant respiratory disorders.
• Has significant pulmonary hypertension (PH).
• Has had a lung transplant.
• Has cardiovascular disease.
• Has underlying chronic liver disease/impairment.
• Has relevant chronic or acute infections including active viral hepatitis or poorly controlled HIV.
• Has had any major surgical procedures performed within 6 weeks prior to Visit 1 or is planning to have a major surgical procedure during the study.
• Has any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1.
• Has any of the following laboratory abnormalities at Visit 1:
• Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >1.5 × upper limit of normal (ULN).
• Total bilirubin >1.5 × ULN. Exceptions may be made on a case-by-case basis for participants with Gilbert's syndrome in consultation with the Medical Monitor.
• Creatinine clearance <30 mL/min calculated by Cockcroft-Gault formula.
• Is currently taking prednisone at a steady dose >10 mg/day or equivalent (a steady dose ≤10 mg/day is not exclusionary but the individual must be on a stable dose for at least 30 days prior to Visit 2).
• Use of any tobacco or combustible cannabis products within 3 months prior to Visit 1 or is unable to refrain from use during the trial.
• Has known symptoms of dysphagia, difficulty in swallowing capsules or tablets, or has had a total gastrectomy.
• Is currently enrolled in another clinical study (except observational/registry or biobank studies) or has used any investigational drug or device within 90 days prior to Visit 1.
• Has ever received stem cell therapy for the treatment of pulmonary fibrosis.
• Is currently pregnant, breastfeeding, or is planning to become pregnant during the study.
• Has had any prior exposure to LYT-100 or pirfenidone (even one dose).

Where it is running

• Palmtree Clinical Research Inc. — Palm Spring, California, United States (enrolling)
• Paradigm Clinical Research Centers LLC — Redding, California, United States (enrolling)
• Infinity Medical Research — North Dartmouth, Massachusetts, United States (enrolling)
• Clinical Research Associates of Central PA — DuBois, Pennsylvania, United States (enrolling)
• Clinical Research of Rock Hill — Rock Hill, South Carolina, United States (enrolling)
• Clinical Trials Center of Middle Tennesee LLC — Franklin, Tennessee, United States (enrolling)
• Premier Pulmonary Critical Care and Sleep Medicine — Denison, Texas, United States (enrolling)
• Renovatio Clinical — The Woodlands, Texas, United States (enrolling)
• Renovatio Clinical — Webster, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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