1. Trial Details/Purpose

Asthma affects approximately 25 million people in the U.S., or 8% of the population. Around 6 million children have asthma, making it a leading chronic condition in children. Asthma is more common in females and Black children, with rates twice as high compared to white children. In 2020, 10 million people experienced asthma attacks, with higher rates in the Northeast and Midwest regions.  The AR-DEX-22-02 trial is a Phase III clinical study designed to evaluate the efficacy and safety of dexpramipexole, an oral medication, in adolescents and adults with eosinophilic asthma—a type of asthma characterized by high levels of eosinophils, a type of white blood cell. The study aims to determine whether dexpramipexole can improve asthma control and reduce exacerbations in this population. ​

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​2. Inclusion Criteria

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• Age: Participants must be 12 years or older.

• Asthma Diagnosis: A documented diagnosis of asthma for at least 12 months prior to the screening.

• Eosinophil Count: An eosinophil count of ≥0.30×10⁹/L at the screening visit.

• Asthma Treatment History: Participants should have been on a stable regimen of medium or high-dose inhaled corticosteroids, with or without additional controller medications, for at least 3 months prior to screening.

 

3. Exclusion Criteria

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• Recent Severe Asthma Exacerbation: Any severe asthma worsening requiring emergency treatment, hospitalization, or systemic corticosteroids within 4 weeks prior to screening.

• Other Respiratory Conditions: Presence of diseases that could interfere with the study, such as chronic obstructive pulmonary disease (COPD) or other significant lung diseases.

• Recent Respiratory Infections: Upper or lower respiratory tract infections within 4 weeks before screening.

• Prohibited Medications: Use of certain medications, including specific biologic therapies or investigational drugs, within a specified period before screening.

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​4. Benefits of Participation

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• Participants may be compensated for time and travel.

• No personal insurance is necessary.

• Participants will receive study medication at no cost.

• Before and during the study, qualified participants will meet with board-certified physicians and highly-trained and skilled research staff and receive one-on-one care.

 

​5. Study Location​

 

     Northridge ​​​​​​