SURPASS-IPFNCT07284602

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

StatusRecruiting

PhasePhase 3

SponsorPureTech

Primary completionNov 2029 (estimated)

At risk: Primary completion moved at least 4 months later.

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Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

Notable Oct 22, 2026 Eligibility criteria expanded, about 16 words
- Trial sites expanded: 10 → 18 locations
- Publications: details revised at 1 of 1 entry
Minor Sep 2, 2026 Primary completion pushed from Jun 2029 to Nov 2029
- Study completion pushed from Jul 2029 to Dec 2029
v5
Minor Aug 26, 2026 Study sites: 9 to 10v4
Notable Jul 15, 2026 Trial status: Not Yet Recruiting to Recruiting
- Eligibility criteria shortened, about 7 words
- Start date changed from estimate of Apr 2026 to Jun 26, 2026
v3
Minor Dec 18, 2025 Study title shortened, about 2 wordsv2
Dec 8, 2025 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Absolute change in forced vital capacity (FVC) measured in mL

Timeframe: Baseline to Week 52

Secondary (1)

Absolute change in FVC percent predicted (FVCpp)

Arms and interventions

ActiveExperimental

deupirfenidone 825 mg TID

Active ComparatorActive comparator

pirfenidone 801 mg TID

Drugs: Deupirfenidone, Pirfenidone (PFD)

Sites

18 sites in 2 countries

United States 16, Canada 2

About this trial

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.

Trial details

Enrollment: 1,100 participants (estimated)
Started: Jun 26, 2026
Study completion: Dec 2029 (estimated)
Eligibility: 40 and older, all sexes, no healthy volunteers
Design: Interventional, randomized, quadruple blind, treatment
Oversight: Data monitoring committee, FDA-regulated drug
Conditions: Idiopathic Pulmonary Fibrosis, Lung Diseases, Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
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)
First posted: Dec 16, 2025
Registry updated: Oct 23, 2026
Last verified: Oct 2026

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