Idiopathic Pulmonary Fibrosis study: Deupirfenidone vs Pirfenidone
Official title Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)
ClinicalTrials.gov ID: NCT07284602
What this study is testing
What is Deupirfenidone?
This is an investigational pill being studied to see if it helps people with idiopathic pulmonary fibrosis (IPF). It is designed to slow down the scarring process in the lungs, similar to how the approved drug pirfenidone works.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether LYT-100 improves lung function and is safe for people with idiopathic pulmonary fibrosis compared to pirfenidone.
- Who it's for
- You may be able to join if you are an adult with idiopathic pulmonary fibrosis and have not taken an antifibrotic drug in the last year.
- What's involved
- You will take a pill three times a day, either LYT-100 or pirfenidone, and the study team will not know which one you get. You will visit the clinic many times for lung tests, health checks, and to report any side effects.
- Time commitment
- The study lasts about 3 years, with up to ten visits in the first year and then visits every three months thereafter.
- Phase 3: a large, late-stage study
- Time commitment: about 52 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join 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...
- 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...
You likely can't join if
- Has, in the opinion of the Investigator, significant clinical worsening of IPF between Visit 1 and Visit 2 (eg, clinically significant...
- 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.
See the full eligibility 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.
- 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.
- 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).
The study team makes the final eligibility decision.
Where it is enrolling
- Palm Spring, California, United States
- Redding, California, United States
- Hialeah, Florida, United States
- Kissimmee, Florida, United States
- North Dartmouth, Massachusetts, United States
- Reno, Nevada, United States
- Greensboro, North Carolina, United States
- DuBois, Pennsylvania, United States
- Rock Hill, South Carolina, United States
- Franklin, Tennessee, United States
- Knoxville, Tennessee, United States
- Cypress, Texas, United States
- Denison, Texas, United States
- El Paso, Texas, United States
- The Woodlands, Texas, United States
- Webster, Texas, United States
- Ajax, Ontario, Canada
- Windsor, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Palm Spring, California, United States; Redding, California, United States; Hialeah, Florida, United States; Kissimmee, Florida, United States; North Dartmouth, Massachusetts, United States; Reno, Nevada, United States and 12 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.