RecruitingPHASE2INTERVENTIONAL

AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF

This research study, called AURA-IPF, is looking at a new way to deliver a medicine called nintedanib for a lung condition called Idiopathic Pulmonary Fibrosis (IPF). IPF causes scarring in the lungs. Instead of pills, this study uses a special liquid form of nintedanib (called AP02) that you breathe in using a nebulizer. Researchers want to find out if AP02 helps improve how well the lungs work and if it's safe for people aged 40 and over with IPF. Some participants will receive the active medicine, while others will get a placebo, which looks the same but contains no drug. This helps us understand if the new treatment works.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Avalyn Pharma Inc.

Enrolment target

160

Start

10 Mar 2026

Estimated completion

01 Jun 2027

Idiopathic Pulmonary Fibrosis (IPF)

What is this study about?

This study is about a lung condition called Idiopathic Pulmonary Fibrosis, or IPF. IPF is a serious illness where the lungs become scarred and stiff, making it hard to breathe. There are some treatments available, but researchers are always looking for better ways to manage the condition and improve people's quality of life.

This particular study is trying out a new way to give a medicine called nintedanib. You might know nintedanib as a tablet. But in this study, it's being given as a liquid solution (named AP02) that you breathe in directly into your lungs using a device called a nebulizer. The main goal is to see if this new breathed-in version of the medicine can help improve how well the lungs work and reduce scarring in people with IPF. They also want to make sure it's safe and doesn't cause too many side effects.

By comparing AP02 to a 'placebo' (a dummy treatment with no active medicine), the scientists can accurately tell if AP02 is making a real difference. If this breathed-in medicine is found to be safe and effective, it could offer a new and potentially easier way for people with IPF to take their medication in the future.

Key takeaways

A new way to give IPF medicine (breathed-in liquid) is being tested.
The study aims to see if it helps lungs work better and is safe.
Participants will get either the new medicine or a dummy treatment by chance.
You'll use a nebulizer twice a day for 12 weeks.
Regular clinic visits will track your health and lung function.
Open to adults aged 40+ with IPF, who are not on other IPF medications.

Who may be eligible?

To join this study, you need to be at least 40 years old and have a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) that was made within the last five years. Doctors will check your medical history, do a physical exam, and look at your breathing test results to make sure you're well enough to take part. For example, your lung capacity must be at least 45% of what's expected for someone your age and height.

There are also some reasons why you might not be able to join. For instance, if you're currently taking nintedanib or pirfenidone (other IPF medications) or have taken them in the last three months, you wouldn't be able to participate. Also, if you have certain serious heart, bleeding, liver, or kidney problems, or have had certain types of cancer recently, you might not be eligible. They also can't include pregnant or breastfeeding women, or people who have smoked in the last three months or use illegal drugs.

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 40 years old or older?
Have you been diagnosed with IPF within the last 5 years?
Are you currently NOT taking oral nintedanib or pirfenidone for IPF, and haven't taken them in the past 3 months?
Do you feel well enough to participate in a study?
Are you able to visit the clinic regularly for check-ups?
Are you a woman who is not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be randomly put into one of three groups. This means you'd have an equal chance of receiving one of two different doses of the AP02 medicine, or a 'placebo', which looks identical but contains no active drug. You would use a special device called a nebulizer to breathe in your assigned medicine or placebo twice a day for 12 weeks.

Throughout the study, you'd have a total of six visits to the clinic and one phone call over 16 weeks. During these visits, doctors would regularly check your health, perform breathing tests to measure how well your lungs are working, and ask you to fill out questionnaires about how you're feeling. They will also keep a close eye on any side effects you might experience.

Potential risks and benefits

Taking part in a clinical trial might offer some potential benefits, as you would receive close medical attention and a new treatment that might help your condition. However, there's no guarantee the treatment will work for you, and it might not improve your IPF. There are also potential risks, including side effects from the study medicine, which could range from mild to more serious. You will be told about all known risks before you agree to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Nepean Lung and Sleep
Verified postcode
Kingswood, Australia· Recruiting
Dynamic Drug Advancement
Verified postcode
Ajax, Canada· Recruiting
CIC Mauricie
Verified postcode
Trois-Rivières, Canada· Active not recruiting

Common questions

What is Idiopathic Pulmonary Fibrosis (IPF)?

IPF is a disease where your lungs become scarred and stiff over time, making it harder and harder to breathe.

What is a nebulizer?

A nebulizer is a device that turns liquid medicine into a fine mist that you can breathe directly into your lungs.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers see if the actual medicine is working.

How long will I be in the study?

You will take the study medicine or placebo for 12 weeks, and the total study period, including follow-up, will be 16 weeks.

Can I still take my usual IPF medicine?

No, if you are currently taking other IPF medicines like nintedanib or pirfenidone, or have taken them recently, you cannot join this study.

How to find out more

Craig S Conoscenti, MD, FCCP, ATSF

ap02-003regulatory@avalynpharma.com 206-707-0340 Official trial record

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