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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. This type of asthma is characterized by high levels of a specific type of white blood cell called eosinophils, which can lead to more severe asthma symptoms. The study aims to evaluate how well Dexpramipexole can reduce severe asthma attacks over a period of 52 weeks.

Participants in the study will receive Dexpramipexole in the form of a film-coated tablet, which is taken orally. Some participants may receive a placebo, which looks like the medication but does not contain the active ingredient. The study will also involve other medications commonly used for asthma, such as Salbutamol and Budesonide/Formoterol, which are administered through inhalation. These medications help to open the airways and reduce inflammation, making it easier to breathe.

The trial will last for one year, during which participants will be monitored regularly to assess the safety and effectiveness of Dexpramipexole in managing severe eosinophilic asthma. The goal is to determine if this medication can help reduce the frequency and severity of asthma attacks, improve lung function, and enhance the overall quality of life for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will begin a 52-week clinical trial designed to evaluate the effects of dexpramipexole on severe eosinophilic asthma.

    The trial is structured to assess the medication's ability to reduce severe asthma attacks.

  2. Step 2

    Medication administration

    Participants will receive dexpramipexole in the form of film-coated tablets for oral use.

    The medication will be administered regularly over the course of 52 weeks.

  3. Step 3

    Additional treatments

    In addition to dexpramipexole, participants may use other asthma medications as part of their regular treatment regimen.

    These may include inhalation treatments such as salbutamol sulfate and budesonide/formoterol.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, participants will undergo regular assessments to monitor lung function and asthma control.

    These assessments will include measuring changes in lung function and evaluating asthma symptoms using standardized questionnaires.

  5. Step 5

    Completion of the trial

    At the end of the 52-week period, participants will complete the trial.

    Final assessments will be conducted to evaluate the overall impact of the treatment on asthma control and quality of life.

Who can join the trial?

11 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 have a negative urine pregnancy test at the start of the study.
  • Women who can have children must use a reliable method of birth control during the study. This can include options like abstinence, a partner with a vasectomy, certain birth control implants, sterilization, or birth control pills. Women who cannot have children due to menopause or sterilization do not need to follow this requirement.
  • Be at least 12 years old. If you are in the EU, you must be at least 18 years old.
  • Have a doctor's diagnosis of asthma for at least 12 months before the study starts.
  • Have a certain level of eosinophils, which are a type of white blood cell, in your blood at the start of the study.
  • Have been using asthma medication with medium or high doses of inhaled corticosteroids regularly for at least 12 months before the study. You must also have been on a stable dose for at least 3 months before the study and use additional asthma medications as needed.
  • Have a specific lung function measurement called FEV1 between 40% and 80% of what is predicted for your age and size at the start of the study.
  • Show variable airflow obstruction, which means your lung function changes, proven by certain tests or measurements in the past 24 months.
  • Have a score of 1.5 or higher on the Asthma Control Questionnaire (ACQ-6) at the start of the study. This questionnaire measures 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.

Who cannot join the trial?

9 criteria

  • Patients who have other types of asthma that are 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. The study may have specific age requirements.
  • 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 study may not be safe for them or their baby.
  • Patients who are currently participating in another clinical trial, as this could affect the results of the study.
  • Patients who have a history of not following medical advice or treatment plans, as this could affect the study's outcomes.
  • Patients who have had a recent severe asthma attack that required hospitalization, as this might affect their ability to participate safely.
  • Patients who are taking certain medications that could interfere with the study drug or affect the study results.
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Investigated drugs

Dexpramipexole is a medication being tested in this clinical trial to see if it can help reduce severe asthma attacks in people with severe eosinophilic asthma. It is taken by mouth and the study will evaluate its effectiveness, safety, and how well it is tolerated over a period of 52 weeks.

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 condition. 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, specifically targeting conditions related to eosinophilic inflammation.

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 airways. It often leads to frequent and severe asthma attacks, which can cause difficulty 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 due to its chronic nature.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503693-20-01Protocol codeAR-DEX-22-02Estimated enrolment1 235 patientsSponsorAreteia Therapeutics Inc.

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