RecruitingPHASE2INTERVENTIONAL

WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

The WISPer study is investigating a new medicine, MTX-463, for people with Idiopathic Pulmonary Fibrosis (IPF). This is a Phase 2 study, meaning it's still in the earlier stages of testing. Participants will receive either MTX-463 or a placebo (a treatment with no active medicine) through an IV drip. Some volunteers will also be taking existing IPF medicines like pirfenidone or nintedanib. The main goal is to check the medicine's safety and how well it works. This research helps us understand if MTX-463 could be a future treatment option for IPF, aiming to improve lung health for patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Mediar Therapeutics

Enrolment target

164

Start

05 May 2025

Estimated completion

01 Aug 2027

Idiopathic Pulmonary Fibrosis

What is this study about?

This study, called WISPer, is for people living with a lung condition called Idiopathic Pulmonary Fibrosis, or IPF. IPF causes scarring in the lungs, making it harder to breathe over time. Researchers are trying to find new ways to help manage this condition.

The main aim of this study is to test a new medicine called MTX-463. We want to find out if MTX-463 is safe for people with IPF and if it can help improve their lung function. To do this, some volunteers will receive the new medicine, while others will receive a 'placebo' – which looks like the medicine but doesn't contain any active ingredients. This helps researchers compare the effects fairly.

Taking part in a study like this means you'd be helping doctors learn more about IPF and potentially discover new treatments. The information gathered could lead to better care for people in the future.

Key takeaways

This study is testing a new medicine (MTX-463) for Idiopathic Pulmonary Fibrosis (IPF).
You might receive the new medicine or a dummy medicine (placebo).
The medicine is given through an IV drip every 4 weeks for about 20 weeks.
The total study duration is about 28 weeks.
You can continue certain existing IPF medicines if your dose is stable.
Your lung function and blood will be checked regularly.

Who may be eligible?

To join this study, you need to be at least 40 years old and have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) within the last seven years. Your diagnosis needs to meet specific medical guidelines.

If you're already taking standard IPF medicines like pirfenidone or nintedanib, your dose must have been steady for at least 90 days before the study starts, and you must plan to continue that same dose. You can't be taking both medicines at once. If you stopped taking these medicines, it needs to have been at least 30 days before the study begins, and you can't plan to restart them during the study.

Your lung function will be checked; specifically, your Forced Vital Capacity (FVC) and Diffusion Capacity of the Lung for Carbon Monoxide (DLCO) need to be above certain levels. You must also be able to understand the study, give your written permission to take part, and be able to attend all the study appointments.

Quick self-check

Are you at least 40 years old?
Do you have a diagnosis of IPF made within the last 7 years?
Are you able to attend regular hospital or clinic visits?
If you take pirfenidone or nintedanib, has your dose been stable for at least 3 months?
Do you not need continuous extra oxygen?
Are you able to read and understand information about the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the study, you'll be randomly chosen to receive either the new medicine MTX-463 or a placebo. You won't know which one you're getting, and neither will your study doctor. Both the medicine and the placebo are given as an 'IV infusion,' which means it's delivered directly into your vein.

You'll receive an infusion every four weeks for a total of five infusions, starting on 'Day 0' and ending around 'Week 16'. The study will last about 28 weeks in total. After your last infusion, you'll have an 'End of Treatment' visit after four weeks, and a final 'Safety Follow-Up' visit four weeks after that.

Throughout the study, you'll have regular check-ups where your lung function will be measured using tests like FVC and L-PF. Blood samples will also be taken at various times to check your safety, measure levels of WISP1 (proteins that can be involved in lung scarring), and see how your body handles the study medicine.

Potential risks and benefits

Participating in this study might mean you gain early access to a new potential treatment for IPF, and you'll be contributing to important medical research. However, there's no guarantee the experimental medicine will help you, and you might receive the placebo. All medicines can have side effects, and MTX-463 is still being tested, so its full range of potential side effects isn't yet known. You'll be closely monitored for any changes to your health. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (69)

WISPer Site in Birmingham, AL
Birmingham, United States· Recruiting
WISPer site in Phoenix, AZ
Phoenix, United States· Recruiting
WISPer Site in Los Angeles, CA
Los Angeles, United States· Recruiting
WISPer site in Newport Beach, CA
Newport Beach, United States· Recruiting
WISPer Site in Palm Springs, CA
Palm Springs, United States· Recruiting
WISPer Site in Denver, CO
Denver, United States· Recruiting
WISPer site in Loxahatchee, FL
Loxahatchee Groves, United States· Recruiting
WISPer Site in Atlanta, GA
Atlanta, United States· Recruiting
WISPer site in Champaign, IL
Champaign, United States· Recruiting
WISPer site in Kansas City, KS
Kansas City, United States· Recruiting
WISPer Site in Louisville, KY
Louisville, United States· Recruiting
WISPer site in Shreveport, LA
Shreveport, United States· Recruiting

+57 more sites — see the official record for the full list.

Common questions

What is Idiopathic Pulmonary Fibrosis (IPF)?

IPF is a serious lung disease where scar tissue builds up in your lungs, making them stiff and hard to breathe.

What is a 'placebo'?

A placebo is a substance that looks exactly like the study medicine but contains no active ingredients. It helps researchers compare the effects of the real medicine.

Will I have to stop my current IPF medicine?

No, if you're on pirfenidone or nintedanib and your dose is stable, you can continue taking it during this study. You cannot be on both medications at the same time.

How long will the study last if I join?

The study involves about 20 weeks of treatment and around 8 weeks of follow-up, making the total duration about 28 weeks.

What does 'IV infusion' mean?

It means the medicine will be slowly given to you through a small tube inserted into a vein, usually in your arm.

How to find out more

Jeffrey Bornstein, MD

Jeffrey@mediartx.com (617) 936-0960 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.