Recruiting
Phase 3

Deupirfenidone vs. Pirfenidone

Sponsor:

PureTech

Code:

NCT07284602

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Deupirfenidone

Pirfenidone (PFD)

Study Details

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Study ID

NCT07284602

Start date

Jun 26, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.
  • 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 (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).

Study Design

Enrollment

1100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active

deupirfenidone 825 mg TID

active comparator: Active Comparator

pirfenidone 801 mg TID

Interventions

Deupirfenidone

size AA Swedish orange capsule

Pirfenidone (PFD)

size AA Swedish orange capsule

Primary outcome measure

  • Absolute change in forced vital capacity (FVC) measured in mL [ Time Frame: Baseline to Week 52 ]

Central Contacts and Locations

Locations

Palmtree Clinical Research Inc.

Recruiting

Palm Spring, California, United States, 92262

Contacts

Ayad M Gharghoury, MD

760-778-7799drangel@palmtreeclinical.com

Paradigm Clinical Research Centers LLC

Recruiting

Redding, California, United States, 96001

Contacts

Rafael Lupercio

530-247-7049mswanson@paradigm-research.com

Infinity Medical Research

Recruiting

North Dartmouth, Massachusetts, United States, 02747

Contacts

Curtis J Mello, MD

508-998-3041lfernandes@infinitymedicalresearch.com

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Contacts

Farah Madhani-Lovely, MD

5417067715farah.madhani-lovely@renown.org

Clinical Research Associates of Central PA

Recruiting

DuBois, Pennsylvania, United States, 15801

Contacts

Sandeep Bansal, MD, FCCP, FACP

814-940-1212akansha@clinicalresearchassoc.com

Clinical Research of Rock Hill

Recruiting

Rock Hill, South Carolina, United States, 29732

Contacts

Michael B Denenberg, MD

803-251-9502creynolds@cresrh.com

Clinical Trials Center of Middle Tennesee LLC

Recruiting

Franklin, Tennessee, United States, 37067

Contacts

Aaron Milstone, MD

615-840-1692sbolton@ctcmidtn.com

Premier Pulmonary Critical Care and Sleep Medicine

Recruiting

Denison, Texas, United States, 75020

Contacts

Sanober Kable, MD

469-714-9864crc@premierpsm.com

Renovatio Clinical

Recruiting

The Woodlands, Texas, United States, 77380

Contacts

Ather Siddiqi, MD

713-703-2398pablo.villarreal@renovatioclinical.com

Renovatio Clinical

Recruiting

Webster, Texas, United States, 77598

Contacts

Alfred Maksoud, MD

713-703-2398iryna.litvinenko@renovatioclinical.com

More Information

Sponsor

PureTech

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Idiopathic Pulmonary Fibrosis
  • IPF
  • Pulmonary Fibrosis
  • Deupirfenidone
  • Pirfenidone
  • Lung Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by PureTech on 2026-09-03.