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

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What is this study about?

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 frequent asthma attacks and breathing difficulties. The purpose of the study is to evaluate how well dexpramipexole can reduce severe asthma attacks over a period of 52 weeks.

Participants in the study will receive either dexpramipexole, a placebo, or other medications such as Budesonide/Formoterol and Ventolin, which are commonly used to manage asthma symptoms. Budesonide/Formoterol is an inhalation powder that helps to reduce inflammation and open the airways, while Ventolin, which contains Salbutamol sulfate, is a pressurized inhalation suspension that helps to quickly relieve asthma symptoms by relaxing the muscles in the airways.

The study will last for one year, during which participants will take the assigned medication and attend regular visits to monitor their asthma symptoms and overall health. The goal is to determine if dexpramipexole can effectively reduce the number of severe asthma attacks and improve the quality of life for those with severe eosinophilic asthma. Participants will be closely monitored to ensure their safety and to assess the effectiveness of the treatment.

1 randomization and baseline assessment

Upon joining the study, participants are randomly assigned to receive either the active medication, dexpramipexole, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

Baseline assessments are conducted to establish initial health status and asthma severity. These assessments include lung function tests and questionnaires about asthma control and quality of life.

2 medication administration

Participants take dexpramipexole or placebo orally in the form of film-coated tablets. The medication is administered over a period of 52 weeks.

The dosage and frequency of administration are determined by the study protocol and are consistent throughout the trial.

3 regular follow-up visits

Participants attend regular follow-up visits to monitor their health and the effects of the medication. These visits include lung function tests and completion of questionnaires to assess asthma control and quality of life.

The visits are scheduled at specific intervals, including weeks 36, 44, and 52, to evaluate changes from baseline.

4 end of study assessment

At the end of the 52-week period, a final assessment is conducted. This includes a comprehensive evaluation of lung function, asthma control, and quality of life.

The results are compared to baseline measurements to determine the efficacy of dexpramipexole in reducing severe asthma exacerbations.

Who Can Join the Study?

You must sign a form that shows you understand the study and agree to participate.
If you are a woman who can have children, you need to have a negative pregnancy test before starting the study.
Women who can have children must use a reliable method of birth control during the study. This can include options like not having sex, a partner who has had a vasectomy, certain birth control implants, sterilization, or birth control pills.
You must be at least 12 years old to join the study.
You need to have been diagnosed with asthma by a doctor for at least 12 months before starting the study.
Your blood test must show a certain level of eosinophils, which are a type of white blood cell, at the first screening visit.
You must have been using asthma medication regularly, including medium or high doses of inhaled corticosteroids, for at least 12 months before the first screening visit.
You need to have been on a stable dose of your asthma medication for at least 3 months before the first screening visit.
You must use at least one additional daily asthma medication, like a long-acting bronchodilator or other asthma controllers, for at least 3 months before the first screening visit.
Your lung function test, called FEV1, must be between 40% and 80% of what is expected for your age at the second screening visit.
You need to show variable airflow obstruction, which means your breathing can change, as proven by certain tests or records from the past 24 months.
Your asthma control questionnaire score must be 1.5 or higher at the second screening visit.
You must have had at least two asthma flare-ups in the past year that required treatment with systemic corticosteroids, which are strong anti-inflammatory medications.

Who Cannot Join the Study?

Patients with other types of asthma that are not severe eosinophilic asthma cannot participate. Eosinophilic asthma is a type of asthma where there are high levels of a certain type of white blood cell called eosinophils.
Patients who are not within the specified age range for the study cannot participate. The study includes specific age groups, so those outside these groups are excluded.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients with other medical conditions that might interfere with the study or make it unsafe for them to participate cannot join the study.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have participated in another clinical trial recently may not be eligible to join this study.
Patients who have a history of allergic reactions to the study medication or similar medications cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
MUDr. Jaroslav Mares – ordinace pro TBC a respiracní nemoci	Strakonice	Czechia

Other Sites

Site Name	City	Country
MediTrial s.r.o.	Prague	Czechia
Fakultni Nemocnice Brno	Brno	Czechia
University Hospital Olomouc	Olomouc	Czechia
Plicni Stredisko Teplice s.r.o.	Teplice	Czechia
Cpchpvzaf szqzzb	Lovosice	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not yet recruiting	30.09.2023

Trial locations

Investigated drugs:

Dexpramipexole is an oral medication being studied for its potential to reduce severe asthma attacks in people with severe eosinophilic asthma. This medication is being tested to see if it can help decrease the frequency and severity of asthma exacerbations, which are episodes where asthma symptoms become much worse. The study aims to evaluate how well dexpramipexole works, how safe it is for patients, and how well patients can tolerate it over a period of 52 weeks.

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 inflammation in the airways is persistent and can be more challenging to control compared to other forms of asthma. Symptoms may worsen over time, especially if not managed properly. This condition can significantly impact daily activities and quality of life. It is often resistant to standard asthma treatments, requiring specialized management strategies.

Trial ID:

2023-503693-20-00

Protocol code:

AR-DEX-22-02

NCT ID:

NCT05813288

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?