Active not recruitingPHASE3INTERVENTIONAL

A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma

This research study is looking at a new oral medicine called dexpramipexole for adolescents and adults with eosinophilic asthma. This is a type of asthma where a particular white blood cell, called an eosinophil, is involved. The study wants to find out if adding dexpramipexole to your current asthma treatment can help you breathe better, control your asthma symptoms more effectively, and improve your overall quality of life. We also want to understand more about how safe the medicine is and if people can take it without too many side effects. This is a special type of study called a 'Phase 3' trial, which means it involves a larger group of people and is a key step before a new medicine can be considered for wider use.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Areteia Therapeutics

Enrolment target

600

Start

30 Jan 2023

Estimated completion

01 Dec 2025

Eosinophilic Asthma Asthma; Eosinophilic Asthma Attack

What is this study about?

This study is focused on people who have a specific type of asthma called eosinophilic asthma. In this kind of asthma, certain immune cells, called eosinophils, are too active and can make asthma symptoms worse. Even with their usual medication, some people with eosinophilic asthma still find their symptoms difficult to manage. This study hopes to find a new way to help these individuals.

The main goal is to test a new oral medicine called dexpramipexole. We want to see if adding this medicine to your current asthma treatment can make a real difference. Specifically, we'll be looking to see if it helps with your lung function (how well you can breathe), brings your asthma more under control, and improves your general well-being and daily life.

Another important aspect of this study is to carefully monitor the safety of dexpramipexole. We'll be keeping a close eye on any side effects and how well people tolerate the medicine. By gathering this information, we hope to understand if dexpramipexole could be a helpful new option for people struggling with eosinophilic asthma.

Key takeaways

This study is testing a new oral medicine for eosinophilic asthma.
It aims to improve breathing, asthma control, and quality of life.
Participants will continue their usual asthma medication.
The study also monitors the new medicine's safety and tolerability.
You might receive the active drug or a placebo.

Who may be eligible?

To join this study, you need to be at least 12 years old. (Please note that if you are in Poland, you must be 18 or older.) You also need to have been diagnosed with asthma by a doctor for at least a year.

Your asthma should be a specific type called eosinophilic asthma, which means you have a certain level of eosinophil cells in your blood. You should also be taking daily asthma medication, including at least a low dose of inhaled corticosteroids, along with one or more other regular asthma controllers. These medications must have been at a stable dose for at least a month.

We will also check your lung function with a breathing test (spirometry) to ensure it falls within a certain range. There will be other health checks and tests to make sure the study is a good fit for you.

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 12 years old or older (18+ in Poland)?
Have you been diagnosed with asthma by a doctor for at least 1 year?
Do you take daily asthma medication, including at least a low-dose inhaled steroid?
Do you have eosinophilic asthma (based on a blood test)?
Is your asthma not fully controlled with your current treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the new medicine, dexpramipexole, or a 'placebo', which looks like the medicine but contains no active drug. This is done to fairly compare the new medicine's effects. Neither you nor your study doctor will know which you are receiving. You'll take your study medication, along with your regular asthma treatment.

Throughout the study, you'll have several visits to the clinic for various assessments. These will include breathing tests to check your lung function, blood tests to monitor your eosinophil levels and overall health, and questionnaires to understand your asthma control and quality of life. There will also be regular checks for any side effects. The total duration of the study will involve a screening period to check if you're suitable, followed by a treatment period and then a follow-up after you finish taking the study medicine.

Potential risks and benefits

Taking part in a clinical trial like this may offer some potential benefits. You will receive close medical monitoring and access to a new experimental medicine that might improve your asthma symptoms or quality of life if it works. However, there are also potential risks; the new medicine might cause side effects, or it might not help your asthma at all. You might also receive the placebo. Your health information will be carefully collected. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (335)

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

Research Site 40001-487
Verified postcode
Chandler, United States
Research Site 40001-462
Verified postcode
Peoria, United States
Research Site 40001-322
Verified postcode
Surprise, United States
Research Site 40001-374
Verified postcode
Bakersfield, United States
Research Site 40001-227
Verified postcode
Encinitas, United States
Research Site 40001-349
Verified postcode
Huntington Beach, United States
Research Site 40001-485
Verified postcode
Inglewood, United States
Research Site 40001-440
Verified postcode
La Palma, United States
Research Site 40001-357
Verified postcode
Lancaster, United States
Research Site 40001-089
Verified postcode
Los Angeles, United States
Research Site 40001-362
Verified postcode
Mission Viejo, United States
Research Site 40001-449
Verified postcode
Napa, United States

Common questions

What is eosinophilic asthma?

It's a type of asthma where a specific white blood cell, called an eosinophil, plays a big role in causing inflammation and making your asthma symptoms worse.

What is a 'placebo'?

A placebo looks exactly like the study medicine but doesn't contain any active drug. It's used to fairly compare the new medicine's effects.

Who can join this study?

Generally, people aged 12 and over with a doctor's diagnosis of eosinophilic asthma and who are already on regular asthma medication.

Will I stop my current asthma medicine if I join?

No, you will continue taking your current asthma medication alongside the study medicine or placebo.

What is a 'Phase 3' study?

This means it's a larger study, usually involving many people, to confirm the new medicine's effectiveness and safety before it can be considered for wider use.