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

NCT07284602
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,100
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Lead sponsor
PureTech
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Start date
2026-06-26
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Number of sites
10
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Summary
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.
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Acronym
SURPASS-IPF
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Short title
Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)
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Official title
A Randomized, Double-Blind, Head-to-Head Phase 3 Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone at 52 Weeks in Adults With Idiopathic Pulmonary Fibrosis (SURPASS-IPF)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-07-01
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First posted
2025-12-16
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Registry last updated
2026-08-27
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Primary completion date
2029-06-01
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Start date
2026-06-26
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Participants
1,100
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Participant count basis
Estimated
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Planned participants
1,100
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Protocol amendments
1
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Randomisation ratio
1:1
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Number of sites
10
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
PureTech
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07284602
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ClinicalTrials.gov ID
NCT07284602
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
Study drugs are over-encapsulated
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Absolute change in forced vital capacity (FVC) measured in mL

    Timeframe: Baseline to Week 52

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

  1. Absolute change in FVC percent predicted (FVCpp)

    Timeframe: Baseline to Week 52

    Evaluate the efficacy of deupirfenidone compared with pirfenidone on reduction in lung function decline relative to individual predicted normal lung function

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Healthy volunteers
No

  • 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.

  • 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).

Sources for eligibility
clinicaltrials.gov

  • Palmtree Clinical Research Inc.Palm Spring, United StatesRecruiting
  • Paradigm Clinical Research Centers LLCRedding, United StatesRecruiting
  • Infinity Medical ResearchNorth Dartmouth, United StatesRecruiting
  • Renown Regional Medical CenterReno, United StatesRecruiting
  • Clinical Research Associates of Central PADuBois, United StatesRecruiting
  • Clinical Research of Rock HillRock Hill, United StatesRecruiting
  • Clinical Trials Center of Middle Tennesee LLCFranklin, United StatesRecruiting
  • Premier Pulmonary Critical Care and Sleep MedicineDenison, United StatesRecruiting
  • Renovatio ClinicalThe Woodlands, United StatesRecruiting
  • Renovatio ClinicalWebster, United StatesRecruiting
Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-524493-42-00
Sources for references
clinicaltrials.gov

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