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Taking peoplePhase 3

Deupirfenidone compared with pirfenidone in adults with idiopathic pulmonary fibrosis

Compares deupirfenidone with pirfenidone in adults with idiopathic pulmonary fibrosis.

Key facts

Who runs it
PureTech
Where
Braga, Porto, and Senhora Da Hora, PortugalSee the 4 sitesAlso in 13 other countries, 87 sites
Trial code
Registry title
Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)
Status
Recruiting
Phase
Phase 3
People taking part
1,100 people, planned
Started
26 Jun 2026
Expected to end
Dec 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Deupirfenidone
  • Pirfenidone (PFD)
Record updated
23 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 40 or older with idiopathic pulmonary fibrosis (IPF), a scarring lung disease. It compares deupirfenidone with pirfenidone.

Age
40 years or older
Sex
All sexes
Disease stage
IPF diagnosed no more than 7 years ago, with definite or probable UIP pattern on a lung CT scan (HRCT) done within the last 12 months. FVC of 45% or more of predicted normal.
Earlier treatment
No earlier exposure to pirfenidone or LYT-100, not even one dose. Past treatment with an approved antifibrotic drug may be allowed, but not as background treatment during the study.

Main reasons for not taking part

  • Hospitalized within 3 months before the first visit for an IPF flare-up or other serious lung problem
  • More emphysema than fibrosis on the latest lung CT scan
  • Lung transplant, cardiovascular disease, chronic liver disease, or significant pulmonary hypertension
  • Any tobacco or combustible cannabis use within 3 months before the first visit, or unable to stop during the trial
  • Currently pregnant, breastfeeding, or planning to become pregnant during the study

The registry criteria, word for word

Show all 28 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Has been hospitalized within 3 months prior to Visit 1 for acute exacerbation of IPF or other significant respiratory complication
  • Has had a lung transplant
  • 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
  • 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
  • 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
  • Has had any prior exposure to LYT-100 or pirfenidone (even one dose)
  • 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 cardiovascular disease
  • Has underlying chronic liver disease/impairment
  • Has relevant chronic or acute infections including active viral hepatitis or poorly controlled HIV
  • 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
  • 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 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 known symptoms of dysphagia, difficulty in swallowing capsules or tablets, or has had a total gastrectomy
  • Is currently pregnant, breastfeeding, or is planning to become pregnant during the study

Where in Portugal

Also in 13 other countries, 87 sites

  • CCAB Centro Clinico Academico Braga AssociacaoBraga, PortugalNot yet recruiting
  • Unidade Local De Saude De Santo Antonio E.P.E.Porto, PortugalNot yet recruiting
  • Unidade Local de Saude de Sao Joao E.P.E.Porto, PortugalNot yet recruiting
  • Unidade Local De Saude De Matosinhos E.P.E.Senhora Da Hora, PortugalNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • ActiveTreatment being tested

    deupirfenidone 825 mg TID

    Treatment: Deupirfenidone

  • Active ComparatorExisting treatment, for comparison

    pirfenidone 801 mg TID

    Treatment: Pirfenidone (PFD)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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)
Plain-language title
Deupirfenidone compared with pirfenidone in adults with idiopathic pulmonary fibrosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
23 October 2026