Active not recruitingPHASE2INTERVENTIONAL

MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

This research study, called MAXPIRe, is testing a new drug called axatilimab for people who have Idiopathic Pulmonary Fibrosis, or IPF. IPF is a serious lung condition that causes scarring. The main goal of this study is to find out if axatilimab is both safe and helpful in treating IPF. Participants will either receive the new medicine or a placebo (a dummy treatment). This is a Phase 2 trial, which means researchers are still learning about the medicine's effects and looking for the right dose. By taking part, you could help doctors understand more about treating IPF, potentially leading to new options for patients in the future.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Syndax Pharmaceuticals

Enrolment target

145

Start

11 Dec 2023

Estimated completion

01 Nov 2026

Idiopathic Pulmonary Fibrosis

What is this study about?

Idiopathic Pulmonary Fibrosis (IPF) is a lung condition where the lungs become scarred and stiff, making it harder to breathe. We don't fully understand why it happens, and currently, there's no cure. However, treatments are available that can help slow down the progression of the disease. This study, called MAXPIRe, is trying to find new ways to help people living with IPF.

The MAXPIRe study is testing a new medicine called axatilimab. Researchers want to see if this medicine can stop or slow down the build-up of scarring in the lungs. They will also be closely watching to make sure the medicine is safe for people with IPF. It’s important to remember that this is a Phase 2 study, which means it’s still in the earlier stages of research. Doctors are trying to learn more about how axatilimab works and what effects it might have.

Taking part in a study like this helps doctors learn more about IPF and how to treat it. Every new medicine and treatment goes through careful testing to make sure it’s safe and effective. If axatilimab proves to be helpful, it could one day offer another treatment option for people with IPF.

Key takeaways

New medicine (axatilimab) for IPF being tested.
Aims to check safety and effectiveness.
Involves receiving either the new medicine or a placebo.
Participation will help future IPF patients.
Open to men and women aged 40 and over.
Requires regular clinic visits and tests.

Who may be eligible?

To join this study, people need to have a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF). This diagnosis must have been made using specific medical guidelines, and recent detailed scans of your chest (HRCT) will be checked by experts to confirm this. Your lung function also needs to be within certain ranges, measured by breathing tests. For example, a key test called FVC, which measures how much air you can exhale after a deep breath, needs to be at least 45% of what's expected for someone of your age and size.

There are also some reasons why you might not be able to join. For instance, if you have other types of lung disease that are linked to different conditions like arthritis, or if scans show a lot of emphysema (another lung condition) that is worse than your lung scarring, you might not be eligible. Also, certain heart problems shown on an ECG test could prevent you from taking part, unless your doctor and the study team decide it's safe after consulting with a heart specialist.

The study is open to both men and women, aged 40 years or older. The research team will carefully check all your medical information to see if this study is right for you.

Quick self-check

Do I have a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF)?
Have I had a recent detailed chest scan (HRCT) for IPF?
Are my breathing test results (lung function) within certain limits?
Do I have any serious heart problems that might affect taking part?
Is my extent of emphysema less than my lung scarring (if I have both)?
Am I at least 40 years old?

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

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure you meet all the necessary requirements. This would involve specific medical tests, lung function tests, and scans. Once accepted, you would be randomly assigned to receive either the new medicine, axatilimab, or a placebo (a dummy treatment that looks like the real medicine but has no active drug).

You would need to attend appointments at the study clinic throughout the trial. These visits will include check-ups, repeated lung function tests, blood tests, and possibly more scans to monitor your health and how well the treatment is working. The study team will provide all the necessary medication. The exact number of visits and the total length of time you'd be involved would be explained in detail by the study team, as it varies depending on the specific design of the trial. All your medical care related to the study will be provided by the research team.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as receiving a new investigational treatment for IPF that isn't yet available, and under close medical supervision. You would also contribute valuable information that could help others with IPF in the future. However, there are also potential risks; the new medicine might cause side effects, and some tests involve minor discomfort or very small risks. It's also possible that the treatment may not help your condition. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (78)

Royal Prince Alfred Hospital
Camperdown, Australia
Sunshine Coast University Hospital
Birtinya, Australia
Wallace Street Specialist Centre
Brisbane, Australia
Mater Misericordiae Ltd
South Brisbane, Australia
Griffith University Clinical Trial Unit
Southport, Australia
Mackay Hospital & Health Service
West Mackay, Australia
Monash Health
Clayton, Australia
Institute for Respiratory Health
Perth, Australia
OLV Hospital Aalst
Aalst, Belgium
AZ Groeninge
Kortrijk, Belgium
Centre de Recherche Clinique - CHUS
Sherbrooke, Canada
Dynamic Drug Advancement
Ajax, Canada

+66 more sites — see the official record for the full list.

Common questions

What is Idiopathic Pulmonary Fibrosis (IPF)?

IPF is a lung condition where scars grow in your lungs, making them stiff and difficult to breathe. 'Idiopathic' means we don't know why it happens.

What is axatilimab?

Axatilimab is a new medicine being tested in this study to see if it can help slow down the scarring in the lungs caused by IPF.

What does Phase 2 mean?

Phase 2 means this is an earlier stage of drug testing. Researchers are looking at whether the medicine is safe and effective, and trying to find the right dose.

Will I get the actual medicine?

You will either receive the new medicine (axatilimab) or a placebo (a dummy treatment) as part of the study. It’s a random choice, and usually, neither you nor your doctor will know which one you are getting.

How long does the study last?

The exact length of time for your participation will be fully explained by the study team. It involves regular visits and monitoring over a period that supports gathering enough data.