Not recruitingRare disease

Study on the Effects of Dexpramipexole in Adolescents and Adults with 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 eosinophilic asthma. Eosinophilic asthma is a type of asthma characterized by high levels of a specific type of white blood cell called eosinophils, which can cause inflammation and breathing difficulties. The purpose of the study is to evaluate how well Dexpramipexole can improve lung function in people with this condition.

Participants in the study will receive either Dexpramipexole or a placebo, which is a substance with no active medication. The medication is taken orally in the form of a film-coated tablet. The study will last for 24 weeks, during which participants will be monitored to assess the safety and effectiveness of the treatment. The maximum daily dose of Dexpramipexole will be either 75 milligrams or 150 milligrams, depending on the specific group within the study.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their asthma symptoms. The main focus will be on measuring improvements in lung function and overall asthma control. This trial aims to provide valuable information on whether Dexpramipexole can be a beneficial treatment option for people with eosinophilic asthma.

The research process

The trial runs in 4 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 are randomly assigned to receive either dexpramipexole or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives which treatment.
Step 2
Medication administration
Participants take the assigned medication orally in the form of a film-coated tablet. The medication is taken regularly as prescribed for a duration of 24 weeks.
Step 3
Monitoring and assessments
Throughout the 24-week period, participants undergo regular assessments to monitor the effects of the medication. These assessments include measuring lung function and evaluating asthma control.
The primary focus is on the change in lung function, specifically the pre-bronchodilator forced expiratory volume (FEV1), which is measured at various points, particularly at weeks 20 and 24.
Step 4
Completion of the study
At the end of the 24-week period, participants complete the study. Final assessments are conducted to evaluate the overall impact of the treatment on asthma symptoms and quality of life.

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. If you are not able to have children, this does not apply to you.
Be at least 12 years old. In Poland, participants must be at least 18 years old.
Have a doctor's diagnosis of asthma for at least 12 months before the first screening visit.
Need to use daily asthma medications, including a low dose of inhaled corticosteroids (a type of asthma medication) and at least one other asthma controller medication. In Poland, a medium dose of inhaled corticosteroids is required. You must have been using these medications for at least 12 weeks before the first screening visit, and the doses must be stable for at least 4 weeks before the first screening visit.
Have a lung function test result (called FEV1) that is less than 80% of what is predicted for your age and size, or less than 90% if you are between 12 and 17 years old, at the second screening visit.
Show improvement in lung function after using a bronchodilator (a medication that helps open the airways) at the second screening visit. This means an increase of at least 12% and 200 mL in FEV1, or 12% and 160 mL if you are between 12 and 17 years old. If you do not meet this requirement, you may have another chance to meet it during the screening period.
Have a score of 1.5 or higher on the Asthma Control Questionnaire (ACQ-6) at the second screening visit. This questionnaire measures how well your asthma is controlled.
Have an eosinophil count (a type of white blood cell) of at least 0.30x10⁹/L at the first screening visit. If your initial count is between 0.250x10⁹/L and 0.299x10⁹/L, you may have it checked again before the second screening visit.
If you are a woman who can have children, you must have a negative urine pregnancy test at the screening and baseline visits.

Who cannot join the trial?

10 criteria

Patients who do not have eosinophilic asthma, a type of asthma with high levels of a certain type of white blood cell called eosinophils.
Patients who are not within the specified age ranges for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not willing or able to follow the study procedures.
Patients who have other medical conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are taking medications that might interfere with the study drug.
Patients who have participated in another clinical trial recently.
Patients who have a history of drug or alcohol abuse.
Patients who have a known allergy to the study drug or its ingredients.

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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
Santa Sp. z o.o.
Verified
Lodz, Poland
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ
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Lodz, Poland

Trial locations

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Investigated drugs

Dexpramipexole is a medication being studied for its potential to improve lung function in people with eosinophilic asthma. Eosinophilic asthma is a type of asthma characterized by high levels of eosinophils, a type of white blood cell, in the lungs. This medication is taken orally and is being tested to see if it can help reduce asthma symptoms and improve breathing over a 24-week period.

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 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 improve lung function in individuals with eosinophilic asthma. At the molecular level, dexpramipexole is believed to work by reducing the number of eosinophils, a type of white blood cell involved in inflammation. It is classified pharmacologically as a small molecule with potential anti-inflammatory properties.

Investigated diseases

Eosinophilic asthma – Eosinophilic asthma is a type of asthma characterized by high levels of eosinophils, a type of white blood cell, in the lungs. This condition often leads to inflammation and swelling of the airways, causing symptoms such as wheezing, coughing, and shortness of breath. Unlike typical asthma, eosinophilic asthma may not respond well to standard asthma treatments. The disease can vary in severity, with some individuals experiencing frequent and severe asthma attacks. It is often associated with other allergic conditions, such as rhinitis or sinusitis. The progression of the disease can lead to chronic respiratory issues if not managed properly.