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

NCT07284602 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: LYT-100-2025-3012025-524493-42-00
• Study Type: interventional
• Target: 1,100
• Locations: 0 countries
• Sites: N/A

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to Week 52

Secondary Outcomes (1)

• Absolute change in FVC percent predicted (FVCpp)

  Baseline to Week 52

Study Arms (2)

Active

EXPERIMENTAL

deupirfenidone 825 mg TID

Drug: Deupirfenidone

Active Comparator

ACTIVE COMPARATOR

pirfenidone 801 mg TID

Drug: Pirfenidone (PFD)

Interventions

Deupirfenidone DRUG

size AA Swedish orange capsule

Active

Pirfenidone (PFD) DRUG

size AA Swedish orange capsule

Active Comparator

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• PureTech: lead

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Lung Diseases

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study drugs are over-encapsulated
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized double-blind treatment, 2 arms

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 16, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share