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

Prior treatment

• Has been hospitalized within 3 months prior to Visit 1 for acute exacerbation of IPF or other significant respiratory complication.
• Has had a lung transplant.
• 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.
• 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.
• 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.
• Has had any prior exposure to LYT-100 or pirfenidone (even one dose).

Other illness

• 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 cardiovascular disease.
• Has underlying chronic liver disease/impairment.
• Has relevant chronic or acute infections including active viral hepatitis or poorly controlled HIV.
• Has any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1.

Lab values

• 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.

Other

• 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 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 known symptoms of dysphagia, difficulty in swallowing capsules or tablets, or has had a total gastrectomy.
• Is currently pregnant, breastfeeding, or is planning to become pregnant during the study.

• 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.