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Study on the Effects of Dexpramipexole for Adolescents and Adults with Severe Eosinophilic Asthma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Dexpramipexole (KNS-760704) on individuals with severe eosinophilic asthma. Severe eosinophilic asthma is a type of asthma characterized by high levels of a specific type of white blood cell called eosinophils, which can lead to more frequent and severe asthma attacks. The medication being tested is taken orally in the form of a film-coated tablet.

The purpose of the study is to evaluate how effective Dexpramipexole is in reducing severe asthma attacks over a period of 52 weeks. Participants in the study will be randomly assigned to receive either the medication or a placebo, which is a tablet that looks like the medication but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will take the medication or placebo daily and attend regular visits to monitor their asthma symptoms and overall health. The study will assess various outcomes, including the frequency of severe asthma attacks and changes in lung function and asthma control over time. This research aims to provide valuable information on the potential benefits of Dexpramipexole for people living with severe eosinophilic asthma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be randomly assigned to receive either the active medication, dexpramipexole, or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the active medication or placebo.
Step 2
Medication administration
Participants will take the assigned medication orally in the form of a film-coated tablet. The medication is taken regularly as prescribed for a duration of 52 weeks.
Step 3
Regular assessments
Throughout the 52-week period, participants will undergo regular assessments to monitor the efficacy and safety of the treatment. These assessments will include measuring lung function and evaluating asthma control.
Step 4
Primary outcome measurement
The primary outcome of the study is to measure the annualized rate of severe asthma exacerbations over the 52-week period.
Step 5
Secondary outcome measurements
Secondary outcomes include changes in lung function and asthma control, as well as quality of life assessments at specified intervals during the study.
Step 6
Completion of the study
At the end of the 52-week period, participants will complete a final assessment to evaluate the overall impact of the treatment on their asthma condition.

Who can join the trial?

10 criteria

Sign an informed consent form, which is a document that explains the study and confirms your agreement to participate.
If you are a woman who can have children, you must use a reliable method of birth control during the study. This can include options like abstinence, a partner who has had a vasectomy, certain birth control implants, sterilization, or birth control pills.
Be at least 12 years old. If you are in Poland, you must be at least 18 years old.
Have a doctor's diagnosis of asthma for at least 12 months before the first screening visit.
Be using asthma medication regularly, including medium or high doses of inhaled corticosteroids, for at least 12 months before the first screening visit. You must also be on a stable dose for at least 3 months before the first screening visit and use additional asthma medications as needed.
Have a lung function test result (called FEV1) that is between 40% and 80% of what is expected for your age and size at the second screening visit. For those aged 12 to 17, it should be between 40% and 90%.
Show variable airflow obstruction, which means your lung function can change. This can be shown by improvement after using a bronchodilator (a medicine that helps open airways) or other tests done in the past 24 months.
Have a score of 1.5 or higher on the Asthma Control Questionnaire (ACQ-6) at the second screening visit. This questionnaire helps measure how well your asthma is controlled.
Have a history of at least two asthma flare-ups in the past year that required treatment with systemic corticosteroids, which are strong anti-inflammatory medications.
If you are a woman who can have children, you must have a negative pregnancy test at the screening and baseline visits.

Who cannot join the trial?

7 criteria

Patients who have a different type of asthma that is not severe eosinophilic asthma. This type of asthma involves a high number of a specific type of white blood cell called eosinophils.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding, as the effects of the study medication on unborn babies or infants are not known.
Patients who are currently participating in another clinical trial, as this could affect the results of the study.
Patients who have a history of allergic reactions to the study medication or similar medications.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Gornoslaskie Centrum Mwdyczne
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Katowice, Poland
Michał Bogacki – DOBROSTAN
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Wroclaw, Poland
Military Medical Academy
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Pleven, Bulgaria

Trial locations

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Investigated drugs

Dexpramipexole is a medication being studied for its potential to help people with severe eosinophilic asthma. This type of asthma is characterized by high levels of eosinophils, a type of white blood cell, which can cause inflammation and worsen asthma symptoms. The trial aims to see if dexpramipexole can reduce the number of severe asthma attacks over a year. Participants take this medication orally, and researchers are also looking at how safe and tolerable it is for those who use it.

Dexpramipexole Dihydrochloride Monohydrate

What is already known about the treatment

Dexpramipexole – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating severe eosinophilic asthma. It is not yet widely used in medical practice, as it is still under investigation. The main therapeutic indication for dexpramipexole is to reduce severe asthma exacerbations in patients with this specific type of asthma. At the molecular level, dexpramipexole is believed to work by modulating the immune response, although the exact mechanism is still being researched. It is classified pharmacologically as an investigational drug, as it is not yet approved for general use.

Investigated diseases

Severe Eosinophilic Asthma – This is a type of asthma characterized by high levels of eosinophils, a type of white blood cell, in the lungs. It often leads to frequent and severe asthma attacks, which can cause difficulty in breathing, wheezing, and coughing. The condition is chronic and can significantly impact daily activities and quality of life. Symptoms may worsen over time, especially if not managed properly. It is often resistant to standard asthma treatments, requiring specialized care. The disease can vary in severity and may require ongoing monitoring and adjustments in management strategies.