Evaluation of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)
Research type
Research Study
Full title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)
IRAS ID
1012013
Contact name
Mehul Tank
Contact email
Sponsor organisation
Mediar Therapeutics
Clinicaltrials.gov Identifier
Research summary
Idiopathic Pulmonary Fibrosis (IPF) is a chronic lung condition with a poor prognosis and a significant impact on quality of life. Symptoms include shortness of breath and cough. The current treatments, ESBRIET (pirfenidone) and OFEV (nintedanib), can slow the progression of the disease, but they both cause side effects such as vomiting and diarrhoea that limit how much they are used. MTX-463 is a new treatment made by Mediar Therapeutics, which aims to reduce lung damage by targeting WISP1 (a protein that is believed to play a critical role in activating the cells that cause the lung scarring in IPF).
The main goal of this study is to see how effective MTX-463 is as a treatment for IPF in patients aged 40 years or over. The effectiveness of MTX-463 will be assessed by measuring how well it prevents the participants’ forced vital capacity (FVC) from declining over a 24-week period. As the lungs scar in IPF, their ability to inhale air goes down. The FVC provides an estimate of how much air the lungs can take in, so that will be used as the main outcome measure in this study.
Other goals of the study include: assessing how safe MTX-463 is, how much of the dose of MTX-463 stays in the blood until the next dose, and how well MTX-463 relieves symptoms of IPF.
The study will last up to 32 weeks for each participant. This includes a 4-week qualification (screening) period, followed by a 24-week treatment period, and ending with a 4-week period to monitor safety after treatment has ended. During the treatment period of the study, participants will be required to come to the clinic every 4 weeks, when they will receive an intravenous infusion of the study treatment (either MTX-463 or placebo, which is a dummy drug that contains no active ingredient). Participants will also have a test to measure their FVC, blood tests to look at the safety of the study treatment, and questionnaires to see whether IPF symptoms improve with treatment.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
25/NW/0165
Date of REC Opinion
28 Jul 2025
REC opinion
Further Information Favourable Opinion