NCT07284602 · PureTech
Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)
(SURPASS-IPF)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Deupirfenidone
size AA Swedish orange capsule
DRUG
Pirfenidone (PFD)
size AA Swedish orange capsule
Primary outcome measures
Absolute change in forced vital capacity (FVC) measured in mL
Time frame: Baseline to Week 52
Evaluate the efficacy of deupirfenidone compared with pirfenidone on reduction in lung function decline in participants with IPF
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Palm Spring, California
- Redding, California
- North Dartmouth, Massachusetts
- DuBois, Pennsylvania
- Rock Hill, South Carolina
- Franklin, Tennessee
- Denison, Texas
- The Woodlands, Texas
- Webster, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 17, 2026 · Source of record for eligibility and locations