Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of dexpramipexole administered orally for 52 weeks in participants with severe eosinophilic asthma (EXHALE-2)

This research study is looking at a new medication called dexpramipexole for adults aged 18 and over who have severe asthma, specifically a type linked to high levels of cells called eosinophils. The main aim is to find out if this new medicine can help reduce the number of severe asthma attacks over a 52-week period. We also want to see if it improves breathing, measured by how much air you can breathe out, and if it makes a difference to your daily life by reducing asthma symptoms and making you feel better overall. Some people will get the new medicine, while others will get a dummy pill (placebo) to compare the effects fairly.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Areteia Therapeutics Inc.

Enrolment target

430

Start

23 Sep 2024

Severe Eosinophilic asthma

What is this study about?

This study is called EXHALE-2, and it's looking into a new medicine called dexpramipexole. It's for people aged 18 and over who have severe asthma. Many people with asthma can manage their symptoms with usual treatments, but for some, the asthma is very severe and can be difficult to control. This specific type of severe asthma is linked to higher levels of certain white blood cells called eosinophils.

The main goal of this study is to see if dexpramipexole can help reduce severe asthma attacks. These are times when your asthma gets much worse and you might need extra treatment, like steroid tablets or even a hospital visit. We will be tracking how often these attacks happen over a whole year (52 weeks). Finding a new treatment that could lessen these attacks would be a big step forward for people living with severe asthma.

Beyond just reducing attacks, the study also wants to understand how the new medicine affects other important aspects of living with asthma. This includes checking if it improves your breathing, how well your asthma is controlled in daily life, and your overall quality of life – meaning how asthma impacts your daily activities, sleep, and general well-being. By looking at all these different areas, researchers can get a full picture of whether dexpramipexole could be a helpful treatment.

Key takeaways

Tests a new medicine (dexpramipexole) for severe eosinophilic asthma.
Aims to reduce severe asthma attacks.
Will last for one year, with regular clinic visits.
Participants will receive either the study medicine or a dummy pill.
Also assesses improvements in breathing and quality of life.

Who may be eligible?

This study is for adults, meaning you must be at least 18 years old to take part. There is no upper age limit.

It is open to both men and women.

To be considered, you must have severe asthma that is specifically linked to high levels of tiny cells called eosinophils. Your doctor will be able to tell if this describes your type of asthma.

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 18 years old or older?
Have you been diagnosed with severe asthma?
Has your doctor told you that your severe asthma is linked to high levels of eosinophils?
Are you able to commit to regular clinic visits for about one year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be involved for a total of 52 weeks, which is about one year. During this time, you would take either the study medicine (dexpramipexole) or a dummy pill (placebo) by mouth. You wouldn't know which one you are getting, and neither would your study doctor, to keep the results as fair as possible.

You would have regular visits to the clinic. At these visits, doctors and nurses would check your health, measure your breathing, ask you questions about your asthma symptoms, and how your asthma affects your daily life. They would also monitor for any side effects. All these assessments help the researchers understand how the medicine is working and if it's safe. After the 52 weeks of treatment, there would be a final follow-up to ensure your well-being.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and the chance to contribute to medical knowledge that could help others with severe asthma. However, there are also potential risks; the new medicine might have side effects that are not yet fully known, or it might not work for you. You will be closely monitored by the study team, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Romania
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Unverified
Bulgaria
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Unverified
Poland

Common questions

What is 'severe eosinophilic asthma'?

It's a type of asthma that is very difficult to control, and it's linked to higher levels of specific white blood cells called eosinophils in your body.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but contains no active drug. It helps researchers compare the real medicine's effects accurately.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your study doctor will know. This is called 'double-blind' and ensures the study results are fair and unbiased.

How long will I be in the study?

The treatment part of the study lasts 52 weeks, which is one year, with some follow-up after that.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your regular medical care.