Deupirfenidone vs Pirfenidone for IPF in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized, double-blind, head-to-head trial compares deupirfenidone taken three times daily with pirfenidone taken three times daily in adults with IPF. Participants will be screened for eligibility, then randomly receive one of the blinded treatments for up to 52 weeks, with possible extension for up to two additional years. The primary goal is to see if deupirfenidone improves lung function and maintains an acceptable safety profile compared with pirfenidone. Participants will have frequent visits in year one and quarterly visits thereafter, with ongoing blinded treatment until all participants complete the initial 52-week period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Palmtree Clinical Research Inc.
  Palm Spring, California, United States Recruiting
• Paradigm Clinical Research Centers LLC
  Redding, California, United States Recruiting
• Harmony Medical Research Institute, Inc
  Hialeah, Florida, United States Recruiting
• Clinical Research Specialists, LLC
  Kissimmee, Florida, United States Recruiting
• Infinity Medical Research
  North Dartmouth, Massachusetts, United States Recruiting
• Renown Regional Medical Center
  Reno, Nevada, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.