Active not recruitingPHASE2INTERVENTIONAL

A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.

The ASPIRE study is looking into a new treatment called Buloxibutid for people with Idiopathic Pulmonary Fibrosis (IPF). IPF is a lung disease that makes it harder to breathe. This study will last 52 weeks and will compare Buloxibutid to a dummy pill, known as a placebo. Some people will take Buloxibutid alongside their usual IPF medicine, while others will take it alone if they can't take other treatments or have stopped them. Researchers will check if Buloxibutid is safe, how well it works, and how the body handles the medicine. The main goal is to see if it helps improve lung function, measured by how much air you can breathe out.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Vicore Pharma AB

Enrolment target

378

Start

09 Dec 2024

Estimated completion

01 Jun 2027

Idiopathic Pulmonary Fibrosis (IPF)

What is this study about?

This study, called ASPIRE, is investigating a new oral medication called Buloxibutid for people with Idiopathic Pulmonary Fibrosis (IPF). IPF is a serious lung condition where the lungs become scarred and stiff, making it increasingly difficult to breathe. Current treatments for IPF aim to slow down the disease, but researchers are constantly looking for new and better options.

Buloxibutid works by targeting specific cells in the lungs that are thought to be important in IPF. Early studies have suggested it might help to improve lung function, protect lung cells, and reduce scarring. This trial aims to confirm these findings in a larger group of people over a longer period.

The study will involve 360 participants and run for 52 weeks. It's a 'double-blind' study, meaning neither you nor your doctor will know if you're taking Buloxibutid or a placebo (a dummy pill). This is done to make sure the results are as fair and unbiased as possible. The main way they'll measure if the treatment works is by checking your lung function, specifically how much air you can breathe out after taking a deep breath.

Key takeaways

This study is testing a new oral drug called Buloxibutid for IPF.
It lasts for 52 weeks and is comparing the drug to a dummy pill (placebo).
It's a 'double-blind' study, meaning you won't know if you're getting the drug or placebo.
The main goal is to see if Buloxibutid improves lung function.
You might be able to join if you're not on IPF treatment or on some types of stable IPF treatment (but not pirfenidone).
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you need to be at least 40 years old and have been diagnosed with IPF within the last seven years. Doctors will also check your recent lung scans to confirm your diagnosis and make sure your fibrosis (scarring) is more significant than any emphysema you might have.

Your current lung function will be checked using tests like FVC and DLCO, and these need to be above certain levels. You might be able to join if you're already taking an approved IPF treatment and have been on a stable dose for at least eight weeks. However, if you are currently taking pirfenidone, unfortunately, you won't be able to join this study due to potential interactions with the new drug.

Alternatively, you could also join if you're not currently on any licensed IPF treatment. This could be because you've had problems with other medications, they didn't work for you, your doctor advised against them, or you chose not to take them. You also need to be expected to live for at least another 12 months, and while being on a lung transplant list doesn't exclude you, your doctors will consider if you're likely to need a transplant during the study period.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 40 years old?
Were you diagnosed with IPF in the last 7 years?
Is your current lung function (FVC and DLCO) above 50% and 30% of what's expected, respectively?
Are you NOT currently taking pirfenidone?
Do you anticipate living for at least another 12 months?
Could you commit to regular clinic visits for over a year?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first go through a screening period that could last up to six weeks to make sure you meet all the study requirements. If you qualify, you'll then be randomly assigned to one of three groups: one taking a higher dose of Buloxibutid, one taking a lower dose, or one taking a placebo (dummy pill). You'll take your study medication twice a day for 52 weeks.

Throughout the study, you'll have regular visits to the clinic for various checks. These will include measurements of your lung function, blood tests, and other health assessments to monitor your safety and how well the treatment is working. Neither you nor your study doctor will know which treatment you are receiving until the study is over. After the 52-week treatment period, there will be a follow-up period of 2-4 weeks to ensure your well-being.

Potential risks and benefits

Taking part in a clinical trial might offer the potential benefit of accessing a new treatment before it's widely available, which could potentially improve your lung function or slow down your IPF. However, there's always a chance that the new drug might not work for you, or you might be in the placebo group and not receive the active treatment. All medications, including Buloxibutid, can have side effects, and some might be serious. The research team will carefully monitor your health throughout the study to identify any potential risks. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (111)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

UAB Hospital, School of Medicine/Lung Health Center
Verified postcode
Birmingham, United States
Keck Medicine of University of Southern California
Verified postcode
Los Angeles, United States
Paradigm Clinical Research Centers, Inc.
Verified postcode
Redding, United States
UC Davis Health System
Verified postcode
Sacramento, United States
UC San Diego Medical Center - Hillcrest
Verified postcode
San Diego, United States
Paradigm Clinical Research
Verified postcode
San Diego, United States
National Jewish Medical and Research Center
Verified postcode
Denver, United States
University of Florida Health (UF Health)
Verified postcode
Gainesville, United States
Clinical Research Specialists
Verified postcode
Kissimmee, United States
Emory Saint Joseph's Hospital
Verified postcode
Atlanta, United States
Endeavor Health - Evanston Hospital
Verified postcode
Evanston, United States
University of Kansas Medical Center
Verified postcode
Kansas City, United States

Common questions

What is Idiopathic Pulmonary Fibrosis (IPF)?

IPF is a lung disease where the lungs become scarred and stiff, making it hard to breathe. The cause isn't fully known, which is why it's called 'idiopathic'.

What is Buloxibutid?

Buloxibutid is an experimental medication being tested to see if it can help improve lung function and slow down the progression of IPF.

What does 'double-blind, placebo-controlled' mean?

It means neither you nor your doctor will know if you're getting the active drug or a dummy pill (placebo). This helps make the study results more reliable.

How long will I be in the study?

The treatment phase of the study lasts for 52 weeks, with an initial screening period of up to 6 weeks and a follow-up period of 2-4 weeks afterwards.

Can I take part if I'm already on IPF medication?

Yes, potentially, as long as you've been on a stable dose for at least 8 weeks. However, if you're taking pirfenidone, you won't be able to join this particular study.