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

NCT07284602 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: LYT-100-2025-3012025-524493-42-00
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 9

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.
• 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 (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:

Sponsors & Collaborators

• PureTech: lead

Study Sites (9)

Palmtree Clinical Research Inc.

Palm Spring, California, 92262, United States

RECRUITING

Paradigm Clinical Research Centers LLC

Redding, California, 96001, United States

RECRUITING

Infinity Medical Research

North Dartmouth, Massachusetts, 02747, United States

RECRUITING

Clinical Research Associates of Central PA

DuBois, Pennsylvania, 15801, United States

RECRUITING

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

RECRUITING

Clinical Trials Center of Middle Tennesee LLC

Franklin, Tennessee, 37067, United States

RECRUITING

Premier Pulmonary Critical Care and Sleep Medicine

Denison, Texas, 75020, United States

RECRUITING

Renovatio Clinical

The Woodlands, Texas, 77380, United States

RECRUITING

Renovatio Clinical

Webster, Texas, 77598, United States

RECRUITING

Related Publications (1)

• 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; ELEVATE IPF Investigators (listed in Supplementary Appendix). 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 Apr 2:aamag155. doi: 10.1093/ajrccm/aamag155. Online ahead of print.

  PMID: 42085224 BACKGROUND

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: June 26, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)