LYT-100-2025-301 (SURPASS-IPF)
Research type
Research Study
Full 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)
IRAS ID
1014222
Contact name
Sarah Santipadri
Contact email
Sponsor organisation
PureTech LYT 100 Inc
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing a new medicine, LYT-100, for the treatment of idiopathic pulmonary fibrosis (IPF). “Idiopathic” means the cause of the disease is unknown. IPF is a chronic, progressive, and serious lung condition in which lung tissue becomes scarred, leading to a gradual and irreversible loss of lung function.
This Phase 3 study will compare LYT-100 with pirfenidone, an approved standard treatment for IPF, in adults aged 40 years or older. The aim is to determine whether LYT-100 is more effective by measuring changes in lung function (forced vital capacity, FVC), and to further assess its safety.
This is a double-blind study, meaning that neither participants nor study doctors will know which treatment is given, to ensure fair and unbiased results. Participants will first enter a screening period (up to 6 weeks) to confirm eligibility. Those eligible will be randomly assigned (1:1) to receive either LYT-100 (825 mg) or pirfenidone (801 mg), taken orally three times a day (Period 1).
The treatment period will last at least 52 weeks, during which participants will attend regular study visits and undergo assessments such as lung function tests. Participants may continue treatment beyond 52 weeks until all participants complete this phase (Period 2).
At the end of treatment, participants may either join a separate follow‑on study (if available) or stop treatment and enter a follow-up period, including a final safety visit about 4 weeks later.
The study includes a screening period (up to 6 weeks), a treatment period (about 1 to 3 years), and a follow-up period (1 month). Optional sub-studies include a pharmacokinetics sub-study (about 48 participants) and an imaging sub-study using high-resolution CT scans (about 250 participants).
Approximately 1,082 participants will take part worldwide.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
26/NW/0186
Date of REC Opinion
7 Jul 2026
REC opinion
Favourable Opinion