RecruitingPHASE2INTERVENTIONAL

An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)

This study is designed for individuals who have already participated in and completed a study involving an inhaled medication, AP01, for conditions like Idiopathic Pulmonary Fibrosis (IPF) or Progressive Pulmonary Fibrosis (PPF). It's an extension of that previous trial, aiming to understand the long-term effects of the medicine. Participants will continue to use the AP01 inhaled solution twice daily with a special nebuliser. The study involves an initial visit, an open-label treatment period where everyone receives the active medicine, and a follow-up phone call. This helps researchers gather more information on the medicine's safety and how well it works over time.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Avalyn Pharma Inc.

Enrolment target

340

Start

17 Apr 2025

Estimated completion

31 Dec 2031

Progressive Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF)

What is this study about?

This study is a follow-on for people who have already been taking part in a research study looking at an inhaled medicine called AP01. This medicine is being developed to help with lung conditions that cause scarring, specifically Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF). These conditions make it harder for your lungs to work properly over time.

The main aim of this 'extension' study is to gather more information on the long-term effects of AP01. By continuing to give the medicine to people who have already been in the initial trial, researchers can learn more about its safety and how effectively it helps manage these lung conditions over a longer period. This is really important for understanding if the medicine could become a valuable treatment option in the future.

Taking part means you would continue to use the AP01 medicine, administered as an inhaled solution using a special device, twice a day. All participants in this study will receive the active medicine, unlike some initial trials where some people might receive a placebo (dummy medicine). This is called an 'open-label' study and is common in extension phases once a medicine has shown promise in earlier stages.

Key takeaways

This study is an extension for people already in a previous AP01 trial for lung scarring.
It aims to understand the long-term effects of the inhaled medicine AP01.
Participants will use the AP01 inhaler twice daily.
This is an 'open-label' study, meaning everyone receives the active medicine.
You'll need to use birth control if you or your partner can become pregnant.
You can discuss any concerns or questions with your study doctor.

Who may be eligible?

To join this study, you must have already taken part in a specific previous study (sponsored by Avalyn Pharma) that looked at an inhaled medicine for lung scarring (pulmonary fibrosis). You also need to have completed that study, including the final visit, and have received the full dose of either the active medicine or a placebo during that time. Your study doctor in the previous trial also needs to agree that it's suitable for you to join this extension study.

There are also some reasons why you wouldn't be able to join. For example, if you didn't complete the previous study for any reason, or if you had serious flare-ups of asthma, COPD, or your lung scarring condition in the last three months. You also can't be taking part in another clinical study where you're receiving a different experimental medicine.

Both men and women can join. If you are a woman who could become pregnant, or a man whose partner could become pregnant, you'll need to agree to use effective birth control during the study and for a period after your last dose of medicine. This is to make sure that no one becomes pregnant while the medicine might still be in your system.

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.

I have already completed a study with an inhaled anti-scarring medicine (AP01) sponsored by Avalyn.
My previous study doctor thinks it's a good idea for me to join this extension study.
I have not had a serious flare-up of my lung condition (or asthma/COPD) needing steroid medicine in the last 3 months.
I am not currently taking part in another study that involves a different experimental medicine.
If I am a woman who could get pregnant, or a man, I am willing to use effective birth control during and after the study.

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will begin with a 'Screening/Baseline Visit.' This might happen on the same day as your very last visit for the previous study you were in. After this, you'll enter the 'Treatment Period,' where you'll take the AP01 inhaled solution twice a day using a special nebuliser device. You'll keep a simple paper diary to record when you take your medicine.

You'll continue using the medication for a period, and there will be regular check-ups. After you've finished taking the study medicine, there will be a final 'Follow-up' phone call about two weeks later. The doctors and nurses involved in the study will monitor your health throughout. The total duration of your participation will depend on the study schedule, but it involves ongoing treatment with the study drug.

Potential risks and benefits

Participating in this study might offer a potential benefit of continuing to receive an investigational medicine that could help manage your lung condition. However, as with all medicines, there's always a possibility of side effects, even though AP01 has been studied before. The study team will explain all known potential risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care. Discuss any concerns you have with your study doctor.

Locations (52)

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

University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Recruiting
University of Southern California
Verified postcode
Los Angeles, United States· Recruiting
University of Colorado, Anschutz Medical Campus
Verified postcode
Aurora, United States· Recruiting
Renstar Medical Research
Verified postcode
Ocala, United States· Recruiting
Piedmont Healthcare, Inc.
Verified postcode
Atlanta, United States· Recruiting
University of Maryland
Verified postcode
Baltimore, United States· Recruiting
Mayo Clinic Rochester
Verified postcode
Rochester, United States· Recruiting
Hannibal Regional Healthcare System, Inc.
Verified postcode
Hannibal, United States· Recruiting
Icahn School of Medicine at Mount Sinai
Verified postcode
New York, United States· Recruiting
Columbia University
Verified postcode
New York, United States· Recruiting
Piedmont HealthCare, PA
Verified postcode
Statesville, United States· Recruiting
Southeastern Research Center
Verified postcode
Winston-Salem, United States· Recruiting

Common questions

What is the medicine AP01?

AP01 is an inhaled medicine being tested for lung scarring conditions like Idiopathic Pulmonary Fibrosis (IPF). It's designed to be breathed in using a special device.

Why is this study only for people who were in another study?

This is an 'extension' study. It builds on what researchers learned in an earlier trial to see how the medicine works over a longer period in people who have already started taking it.

What does 'open-label' mean?

In an 'open-label' study, all participants know they are receiving the active medicine, and the study team also knows. This is different from a 'blinded' study where some might get a dummy medicine (placebo).

How often do I take the medicine?

You would take the AP01 inhaled solution twice a day using the special nebuliser device provided.

Can I still join if I had a flare-up of my lung condition recently?

Unfortunately, if you had a serious flare-up of your lung scarring, asthma, or COPD in the last three months that needed steroids, you would not be able to join this study.

How to find out more

Dr. Felix Woodhead, MB BChir,PhD

fwoodhead@avalynpharma.com +44 7999 885973 Official trial record

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