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

December 18, 2025 updated by: PureTech

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 3 randomized, double-blind, head-to-head study comparing deupirfenidone 825 mg TID to pirfenidone 801 mg TID over 52 weeks of treatment in participants with IPF who are not on background therapy. This study is designed to demonstrate superior efficacy of deupirfenidone over pirfenidone as well as support the overall safety profile of deupirfenidone. Prospective participants will initially enter the Screening Period to determine study eligibility (Section 5). Eligible participants will be randomized 1:1 to receive either blinded deupirfenidone 825 mg TID or pirfenidone 801 mg TID as part of the Double-Blind Treatment Period for at least 52 weeks (Period 1). Depending on when participants enter the study, they may continue being treated for up to two more years (Period 2).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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, and has <12 months of prior exposure to nintedanib or any other approved antifibrotic therapies.
  • 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.
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active
deupirfenidone 825 mg TID
Drug: Deupirfenidone
size AA Swedish orange capsule
Active Comparator: Active Comparator
pirfenidone 801 mg TID
Drug: Pirfenidone (PFD)
size AA Swedish orange capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline to Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absolute change in FVC percent predicted (FVCpp)
Time Frame: 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
Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PureTech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LYT-100-2025-301
  • 2025-524493-42-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient data protection laws in participating countries do not allow for IPD data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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