Phase 2 study of LYT-100 in Patients with IPF
Research type
Research Study
Full title
A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients with Idiopathic Pulmonary Fibrosis (IPF).
IRAS ID
1007014
Contact name
Heather Paden
Contact email
Sponsor organisation
PureTech LYT 100, Inc.
Eudract number
2021-006820-41
Clinicaltrials.gov Identifier
Research summary
This Phase 2b study aims to evaluate the efficacy, tolerability, safety and dose response of LYT-100 in Patients with Idiopathic Pulmonary Fibrosis (IPF). The study is a four-arm placebo-controlled, randomised trial comparing the efficacy, tolerability, and safety of LYT-100 550mg three times a day (TID), LYT-100 825mg TID, pirfenidone 801mg TID, and placebo TID over a 26-week treatment period. This is a double-blind study meaning that the study is designed so that neither the participants nor the study doctor will know which study treatment the participants are receiving. The primary objective is to determine the dose(s) to carry into Phase 3. The participants will have a 2-in-4 (50%) chance of receiving LYT-100, a 1-in-4 (25%) chance of receiving pirfenidone, and a 1-in-4 (25%) chance of receiving placebo. Study participation is expected to last no more than 245 days (about 8 months) and will include visits to the hospital up to 9 times. Eligible patients will have the option to enter in an extension study at Visit 8 after completing 6 months of blinded study treatment in the main study. In the extension study, patients will continue taking the study drug for several months to help determine its long-term safety and effectiveness, as well as how well the patients tolerate it. The study consists of a Screening Period, Treatment Period and Post-Treatment Period (For eligible patients who wish to enroll in the extension study, the Follow up Visit will be performed at the end of the extension study). A total of about 240 patients will be asked to join this study around the world which is planned to run to up to 6 sites in the UK.
REC name
Wales REC 2
REC reference
23/WA/0077
Date of REC Opinion
18 Sep 2023
REC opinion
Further Information Unfavourable Opinion