Idiopathic Pulmonary Fibrosis (IPF)Phase 3SURPASS-IPFNCT07284602
Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 3 study testing Deupirfenidone and Pirfenidone (PFD) in people with Idiopathic Pulmonary Fibrosis (IPF), run by PureTech at 18 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- Deupirfenidone and Pirfenidone (PFD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 26 Jun 2026to Dec 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Show all 25Show fewer
- 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).
Trial locations and contacts
18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 2 countries
United States16 sites, 16 recruiting
- Recruiting
Horizon Clinical Research Group.
Cypress, Texas, 77429
Dileep Puppala, MD, 9494910710, dpuppala@horizoncrg.com
- Recruiting
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, 75020
Sanober Kable, MD, 469-714-9864, crc@premierpsm.com
- Recruiting
Clinical Research Associates of Central PA
DuBois, Pennsylvania, 15801
Sandeep Bansal, MD, FCCP, FACP, 814-940-1212, akansha@clinicalresearchassoc.com
- Recruiting
Renovatio Clinical
El Paso, Texas, 79915
Jeanette Tan, MD, 9155926868, jeanette.tan@renovatioclinical.com
- Recruiting
Clinical Trials Center of Middle Tennesee LLC
Franklin, Tennessee, 37067
Aaron Milstone, MD, 615-840-1692, sbolton@ctcmidtn.com
- Recruiting
Pulmonix LLC
Greensboro, North Carolina, 27403
Murali Ramaswamy, MD, 3365228999, murali.ramaswamy@pulmonix.com
- Recruiting
Harmony Medical Research Institute, Inc
Hialeah, Florida, 33016
Juan Fernandez, MD, 7865439447, jfernandezmd@hmedresearch.com
- Recruiting
Clinical Research Specialists, LLC
Kissimmee, Florida, 34746
Fortune Alabi, MD, 40750726158, falabi@floridalungdoctors.com
- Recruiting
StatCare Pulmonary Consultants
Knoxville, Tennessee, 37919
Eric Weaver, MD, 8655888831, eweaver@statcaremed.net
- Recruiting
Infinity Medical Research
North Dartmouth, Massachusetts, 02747
Curtis J Mello, MD, 508-998-3041, lfernandes@infinitymedicalresearch.com
- Recruiting
Palmtree Clinical Research Inc.
Palm Spring, California, 92262
Ayad M Gharghoury, MD, 760-778-7799, drangel@palmtreeclinical.com
- Recruiting
Paradigm Clinical Research Centers LLC
Redding, California, 96001
Rafael Lupercio, 530-247-7049, mswanson@paradigm-research.com
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
Farah Madhani-Lovely, MD, 5417067715, farah.madhani-lovely@renown.org
- Recruiting
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
Michael B Denenberg, MD, 803-251-9502, creynolds@cresrh.com
- Recruiting
Renovatio Clinical
The Woodlands, Texas, 77380
Ather Siddiqi, MD, 713-703-2398, pablo.villarreal@renovatioclinical.com
- Recruiting
Renovatio Clinical
Webster, Texas, 77598
Alfred Maksoud, MD, 713-703-2398, iryna.litvinenko@renovatioclinical.com
Canada2 sites, 2 recruiting
- Recruiting
Dynamic Drug Advancement Limited
Ajax, Ontario, L1S 2J5
George Philteos, MD, 9054273784, george.philteos@dynamicdrugadvancement.com
- Recruiting
Dr. Syed Anees Medicine Professional Corporation
Windsor, Ontario, N8X 1T3
Syed Anees, MD, 5192524448, aneesresearch@yahoo.com
About this study
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)
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.
Read the 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).
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- Deupirfenidone, Pirfenidone (PFD)
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF, Pulmonary Fibrosis, Deupirfenidone, Pirfenidone, Lung Disease
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeupirfenidoneDrug
size AA Swedish orange capsule
Pirfenidone (PFD)Drug
size AA Swedish orange capsule
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | deupirfenidone 825 mg TID Receives: Drug: Deupirfenidone |
| Active Comparator | Active comparator | pirfenidone 801 mg TID Receives: Drug: Pirfenidone (PFD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in forced vital capacity (FVC) measured in mL
Evaluate the efficacy of deupirfenidone compared with pirfenidone on reduction in lung function decline in participants with IPF
Measured: Baseline to Week 52
Secondary outcomes (1)
Absolute change in FVC percent predicted (FVCpp)
Evaluate the efficacy of deupirfenidone compared with pirfenidone on reduction in lung function decline relative to individual predicted normal lung function
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start26 Jun 2026
- Primary completionNov 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blind treatment, 2 arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PureTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284602
- Sponsor's protocol ID
- LYT-100-2025-301
- Other IDs
- 2025-524493-42-00, 2025
- Acronym
- SURPASS-IPF
- Status last verified
- Oct 2026
- First submitted
- 8 Dec 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data protection laws in participating countries do not allow for IPD data sharing.
Publications
Maher TM, Hamblin MJ, Choi WI, Case AH, Tomos IP, Tzouvelekis AE, Shore JE, Bergna MA, Golod D, Elenko E, Zhang Y, Graham CS, Song JW, Kulkarni T; and the ELEVATE IPF Investigators. Deupirfenidone compared with pirfenidone and placebo in idiopathic pulmonary fibrosis (ELEVATE-IPF): a phase 2b randomized placebo-controlled trial. Am J Respir Crit Care Med. 2026 Aug 1;212(8):1761-1769. doi: 10.1093/ajrccm/aamag155.
PubMed 42085224