A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis
This important study is testing a new medicine called Fipaxalparant for people living with a serious lung condition called Idiopathic Pulmonary Fibrosis (IPF). IPF causes scarring in the lungs, making it harder to breathe. The study aims to find out if this new medicine is safe and effective in slowing down or improving changes in lung function compared to a placebo (a dummy pill). It's a randomised, double-blind trial, meaning neither you nor your doctor will know if you're getting the new medicine or the placebo. Participants will take the medicine for up to two years, and researchers will carefully monitor their lung health and general well-being throughout the study.
At a glance
What is this study about?
This study is looking into a new medicine called Fipaxalparant, designed to help people with Idiopathic Pulmonary Fibrosis, often shortened to IPF. IPF is a condition where the lungs become scarred and stiff over time, making it increasingly difficult to breathe. The exact cause isn't fully understood, and the damage is usually permanent.
Researchers want to see if Fipaxalparant can make a real difference for people with IPF. They'll be checking two main things: first, if taking Fipaxalparant is safe, and second, if it can help improve or at least slow down the decline in lung function over time compared to a placebo (which looks like the study medicine but contains no active ingredients). This type of study is crucial for developing new treatments and finding better ways to manage conditions like IPF.
The study is planned in two parts. The first part will last for about a year, and then there's an optional longer part, extending the study to two years in total. During this time, the research team will regularly check how well your lungs are working and how you're feeling overall, using various tests and questionnaires. The aim is to gather strong evidence to see if Fipaxalparant could be a valuable new treatment option.
Key takeaways
- This study is for adults with Idiopathic Pulmonary Fibrosis.
- It tests a new medicine, Fipaxalparant, against a dummy pill (placebo).
- The main goal is to see if the medicine is safe and improves lung function over 1-2 years.
- You would attend regular clinic visits for health checks and breathing tests.
- Participation involves taking tablets and completing questionnaires.
Who may be eligible?
To join this study, you would need to be an adult, aged 18 or older. The study is open to both men and women.
Beyond these basic requirements, there will be other specific medical criteria that determine if this study is right for you. For example, your doctor will need to confirm you have Idiopathic Pulmonary Fibrosis and that it meets certain characteristics defined by the study. They will also check if you have any other health conditions or are taking any other medications that might affect your participation or the study results.
It's important to have an open conversation with your doctor. They can review all the detailed eligibility rules and help you understand if your personal health situation fits what the study is looking for. They will make sure that taking part is safe and potentially beneficial for you.
- Are you 18 years old or older?
- Have you been diagnosed with Idiopathic Pulmonary Fibrosis?
- Are you able to attend regular clinic appointments for about 1-2 years?
- Are you comfortable taking a study medicine, which might be a placebo?
- Are you willing to have your lung function and health closely monitored?
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 be asked to take the study medicine, Fipaxalparant, or a placebo (a dummy pill) as a film-coated tablet. This medicine contains various ingredients like mannitol, microcrystalline cellulose, magnesium stearate, and others – similar to many other tablets.
Throughout the study, you would have regular visits to the clinic so the research team can monitor your health and how the treatment is affecting you. These visits would involve tests to measure your breathing and lung function, specifically looking at changes in your Forced Vital Capacity (FVC), which indicates how much air you can exhale after a deep breath. You'd also complete questionnaires about your quality of life and how you're feeling, such as the King's Brief Interstitial Lung Disease (K-BILD), Living with IPF (L-IPF), and Leicester Cough Questionnaire (LCQ) scores.
The study has a first phase lasting about 52 weeks (one year). After that, there's a chance to continue into an extension phase, which would mean staying in the study for up to 104 weeks (two years) in total. All assessments and medication would be provided by the study team, and you'd have regular check-ups to ensure your safety and monitor your progress.
Potential risks and benefits
Locations (6)
- —France
- —Poland
- —Netherlands
- —Italy
- —Spain
- —Greece
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 unable to work properly, leading to breathlessness.
What is the new medicine, Fipaxalparant?
Fipaxalparant is an experimental medicine being tested to see if it can help slow down or improve the lung changes caused by IPF.
What is a 'placebo' in a study?
A placebo is a dummy pill that looks just like the real medicine but contains no active ingredients. It helps researchers compare the effects of the new medicine accurately.
How long would I be in the study?
The first part of the study lasts about a year, with an option to continue for up to two years in total.
Will I know if I'm getting the medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you're taking Fipaxalparant or the placebo until the study ends.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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