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Trial of Deupirfenidone vs. Pirfenidone for Idiopathic Pulmonary Fibrosis (IPF)

This study is for adults aged 40 and older with idiopathic pulmonary fibrosis (IPF), a chronic lung disease. It compares two medications, deupirfenidone and pirfenidone, to see how well they improve lung function and how safe they are. You cannot have taken pirfenidone or deupirfenidone before, and you cannot be on other antifibrotic treatments during the study. About 1100 participants will be randomly assigned to receive either deupirfenidone or pirfenidone, both given as orange capsules three times a day. Neither you nor your study team will know which medication you are receiving. The main goal is to measure changes in your forced vital capacity (FVC), which is how much air you can exhale after a deep breath, over 52 weeks. The study could last up to approximately 3 years. The current status of this study is unclear.

Study design
This is a Phase 3, randomized, double-blind study comparing deupirfenidone to pirfenidone in about 1100 participants. Participants will be randomly assigned to one of the two treatment groups, and neither they nor the study staff will know which drug is being given.
What's involved
You would take either deupirfenidone or pirfenidone three times a day. Your lung function will be measured at the beginning and again at Week 52. The study could last for up to approximately 3 years.
Compensation
Not stated in the trial record.
Follow-up
The primary measure of lung function will be assessed at Week 52. Participants may continue treatment for up to two more years after the initial 52 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07284602

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

Recruiting
PHASE3Ages 40+InterventionalTreatment
PureTech
~1,100 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:DeupirfenidonePirfenidone (PFD)

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Absolute change in forced vital capacity (FVC) measured in mL
Measured over Baseline to Week 52

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Explore related trials

Idiopathic Pulmonary Fibrosis

NCT07284602

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Clinical Research Associates of Central PA

    DuBois, Pennsylvaniastudy coordinator listed

    Recruiting

  • Clinical Research of Rock Hill

    Rock Hill, South Carolinastudy coordinator listed

    Recruiting

  • Clinical Trials Center of Middle Tennesee LLC

    Franklin, Tennesseestudy coordinator listed

    Recruiting

  • Infinity Medical Research

    North Dartmouth, Massachusettsstudy coordinator listed

    Recruiting

  • Palmtree Clinical Research Inc.

    Palm Spring, Californiastudy coordinator listed

    Recruiting

  • Paradigm Clinical Research Centers LLC

    Redding, Californiastudy coordinator listed

    Recruiting

  • Premier Pulmonary Critical Care and Sleep Medicine

    Denison, Texasstudy coordinator listed

    Recruiting

  • Renovatio Clinical

    The Woodlands, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Ayad M Gharghoury, MD
[email protected]
760-778-7799
Email the study team

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Absolute change in forced vital capacity (FVC) measured in mLBaseline to Week 52

    Evaluate the efficacy of deupirfenidone compared with pirfenidone on reduction in lung function decline in participants with IPF