Do you have
a patient with
eosinophilic asthma?
Consider referring your patients to an Areteia EXHALE study or joining a study as an investigator.
If approved, dexpramipexole will be a first-in-class oral medicine that inhibits the maturation of eosinophils before they can cause inflammation. Areteia has initiated three worldwide Phase III clinical trials in eosinophilic asthma, with the goal of securing regulatory approvals for dexpramipexole commercialization.
About The EXHALE Studies
The purpose of the EXHALE studies is to test dexpramipexole to determine its safety, efficacy, and tolerability in patients with eosinophilic asthma. Dexpramipexole is an oral eosinophil-lowering therapy. Across multiple clinical trials, dexpramipexole showed significant reduction in eosinophil counts in both blood and tissue.
Each EXHALE study includes groups of participants with inadequately controlled eosinophilic asthma taking dexpramipexole at either 75 mg twice a day, 150 mg twice a day, or placebo in addition to their usual asthma medications. Large population sizes will be used in all three studies, with study site locations around the globe.
Questions About the EXHALE Studies:
Why should I refer my patients?
Dexpramipexole has been studied in clinical trials with over 1,500 participants. Within those trials tolerability and eosinophil-lowering efficacy has been assessed, opening the potential for the first oral treatment for eosinophilic asthma. Following the successful Phase II EXHALE-1 trial of dexpramipexole in moderate-to-severe eosinophilic asthma, Areteia is conducting three global Phase III trials in patients with eosinophilic asthma.
Who can participate in the EXHALE studies?
To determine if your patient may be eligible to participate in these studies, they must meet all criteria found in the study-specific protocols. The following highlights key eligibility criteria for the EXHALE studies, but each study may vary:
- Males and females age 12 and older
- Have documented physician diagnosis of asthma for ≥12 months prior to the first visit
- Have been on a stable dose of inhaled corticosteroid (ICS) asthma controller medications (strength and length of treatment specific to each study)
What is required to refer patients?
If you would like to learn more about the EXHALE studies and speak to a research team member to find out if your patients may be eligible, please complete the form below and you will be contacted by a member of the research team. You may also use the form to find out more about joining the study as an investigator. Thank you for your interest.
Questions About the EXHALE Studies:
Why should I refer my patients?
Dexpramipexole has been studied in clinical trials with over 1,500 participants. Within those trials tolerability and eosinophil-lowering efficacy has been assessed, opening the potential for the first oral treatment for eosinophilic asthma. Following the successful Phase II EXHALE-1 trial of dexpramipexole in moderate-to-severe eosinophilic asthma, Areteia is conducting three global Phase III trials in patients with eosinophilic asthma.
Who can participate in the EXHALE studies?
To determine if your patient may be eligible to participate in these studies, they must meet all criteria found in the study-specific protocols. The following highlights key eligibility criteria for the EXHALE studies, but each study may vary:
- Males and females age 12 and older
- Have documented physician diagnosis of asthma for ≥12 months prior to the first visit
- Have been on a stable dose of inhaled corticosteroid (ICS) asthma controller medications (strength and length of treatment specific to each study)
What is required to refer patients?
If you would like to learn more about the EXHALE studies and speak to a research team member to find out if your patients may be eligible, please complete the form below and you will be contacted by a member of the research team. You may also use the form to find out more about joining the study as an investigator. Thank you for your interest.
EXHALE-2 is a Phase III, randomized, double-blind placebo-controlled, parallel-group study. Participants will be assigned to take dexpramipexole at 75 mg twice a day, 150 mg twice a day, or placebo in addition to their usual asthma medications. Eligible participants are aged 12 and older with severe eosinophilic asthma.
Participation Overview
Participants who are eligible and successfully enroll in this study will participate for 14 months with screening, treatment, and follow-up periods of:
- Screening of up to 4 weeks
- 52 weeks with active treatment or placebo
- Follow-up period of 4 weeks after the last study drug treatment is complete
Qualified participants will receive all study-related care and study medication at no cost. Compensation for time and travel may be available. Participants will be asked to visit the study site:
- 2 times during screening
- 8 times during the treatment period (most of which are at 8-week intervals)
- 1 telephone visit for the follow-up period
These scheduled visits may include physical exams, spirometry, vital signs, blood sampling, questionnaires, electrocardiograms, and/or urine testing. There are approximately 350 study sites throughout 20 countries around the world.
Inclusion Criteria
- Male or female age 12 and older
- Diagnosis of asthma for ≥12 months prior to first visit
- Received asthma controller medication with medium or high dose ICS on a regular basis for at least 12 months prior to screening
- Stable dose of either medium or high dose ICS for at least 3 months prior to screening
- Use of one or more additional daily maintenance asthma controller medications is required
- History of at least 2 asthma exacerbations requiring treatment with systemic corticosteroids within the last 12 months
Exclusion Criteria
- Experience of a severe asthma exacerbation, which resulted in emergency treatment or hospitalization, 4 weeks prior to first visit
- Diagnosed with respiratory infection 4 weeks prior to first visit
- Current smoker
- Currently pregnant or breastfeeding
Additional inclusion/exclusion criteria apply
Participants who are eligible and successfully enroll in this study will participate for 14 months with screening, treatment, and follow-up periods of:
- Screening of up to 4 weeks
- 52 weeks with active treatment or placebo
- Follow-up period of 4 weeks after the last study drug treatment is complete
Qualified participants will receive all study-related care and study medication at no cost. Compensation for time and travel may be available. Participants will be asked to visit the study site:
- 2 times during screening
- 8 times during the treatment period (most of which are at 8-week intervals)
- 1 telephone visit for the follow-up period
These scheduled visits may include physical exams, spirometry, vital signs, blood sampling, questionnaires, electrocardiograms, and/or urine testing. There are approximately 350 study sites throughout 20 countries around the world.
- Male or female age 12 and older
- Diagnosis of asthma for ≥12 months prior to first visit
- Received asthma controller medication with medium or high dose ICS on a regular basis for at least 12 months prior to screening
- Stable dose of either medium or high dose ICS for at least 3 months prior to screening
- Use of one or more additional daily maintenance asthma controller medications is required
- History of at least 2 asthma exacerbations requiring treatment with systemic corticosteroids within the last 12 months
- Experience of a severe asthma exacerbation, which resulted in emergency treatment or hospitalization, 4 weeks prior to first visit
- Diagnosed with respiratory infection 4 weeks prior to first visit
- Current smoker
- Currently pregnant or breastfeeding
Additional inclusion/exclusion criteria apply
EXHALE-3 is a Phase III, randomized, double-blind placebo-controlled, parallel-group study. Participants will be assigned to take dexpramipexole at 75 mg twice a day, 150 mg twice a day, or placebo in addition to their usual asthma medications. Eligible participants are aged 12 and older with severe eosinophilic asthma.
Participation Overview
Participants who are eligible and successfully enroll in this study will participate for 14 months with screening, treatment, and follow-up periods of:
- Screening of up to 4 weeks
- 52 weeks with active treatment or placebo
- Follow-up period of 4 weeks after the last study drug treatment is complete
Qualified participants will receive all study-related care and study medication at no cost. Compensation for time and travel may be available. Participants will be asked to visit the study site:
- 2 times during screening
- 8 times during the treatment period (most of which are at 8-week intervals)
- 1 telephone visit for the follow-up period
These scheduled visits may include physical exams, vital signs, spirometry, blood sampling, questionnaires, electrocardiograms, and/or urine testing. There are approximately 300 study sites throughout 27 countries around the world.
Inclusion Criteria
- Male or female age 12 and older
- Diagnosis of asthma for ≥12 months prior to first visit
- Eosinophil count of ≥0.30×10⁹/L at Screening
- Received asthma controller medication with medium or high dose ICS on a regular basis for at least 12 months prior to screening
- Stable dose of either medium or high dose ICS for at least 3 months prior to screening
- Use of one or more additional daily maintenance asthma controller medications is required
- Variable airflow obstruction documented
- Have documented history of at least 2 asthma exacerbations requiring treatment with systemic corticosteroids within the last 12 months
Exclusion Criteria
- Experience of a severe asthma exacerbation, which resulted in emergency treatment or hospitalization, 4 weeks prior to first visit
- Diagnosed with respiratory infection 4 weeks prior to first visit
- Current smoker
- Currently pregnant or breastfeeding
Additional inclusion/exclusion criteria apply
Participants who are eligible and successfully enroll in this study will participate for 14 months with screening, treatment, and follow-up periods of:
- Screening of up to 4 weeks
- 52 weeks with active treatment or placebo
- Follow-up period of 4 weeks after the last study drug treatment is complete
Qualified participants will receive all study-related care and study medication at no cost. Compensation for time and travel may be available. Participants will be asked to visit the study site:
- 2 times during screening
- 8 times during the treatment period (most of which are at 8-week intervals)
- 1 telephone visit for the follow-up period
These scheduled visits may include physical exams, vital signs, spirometry, blood sampling, questionnaires, electrocardiograms, and/or urine testing. There are approximately 300 study sites throughout 27 countries around the world.
- Male or female age 12 and older
- Diagnosis of asthma for ≥12 months prior to first visit
- Eosinophil count of ≥0.30×10⁹/L at Screening
- Received asthma controller medication with medium or high dose ICS on a regular basis for at least 12 months prior to screening
- Stable dose of either medium or high dose ICS for at least 3 months prior to screening
- Use of one or more additional daily maintenance asthma controller medications is required
- Variable airflow obstruction documented
- Have documented history of at least 2 asthma exacerbations requiring treatment with systemic corticosteroids within the last 12 months
- Experience of a severe asthma exacerbation, which resulted in emergency treatment or hospitalization, 4 weeks prior to first visit
- Diagnosed with respiratory infection 4 weeks prior to first visit
- Current smoker
- Currently pregnant or breastfeeding
Additional inclusion/exclusion criteria apply
EXHALE-4 is a Phase III, randomized, double-blind placebo-controlled, parallel-group study. Participants will be assigned to take dexpramipexole at 75 mg twice a day, 150 mg twice a day, or placebo in addition to their usual asthma medications. Eligible participants are aged 12 and older with eosinophilic asthma.
Participation Overview
Participants who are eligible and successfully enroll in this study will participate for 32 weeks with screening, treatment, and follow-up periods of:
- Screening of up to 4 weeks
- 24 weeks with active treatment or placebo
- Follow-up period of 4 weeks after the last active study drug treatment is completed
Qualified participants will receive all study-related care and study medication at no cost. Compensation for time and travel may be available. Participants will be asked to visit the study site:
- 2 times during screening
- 8 times during the treatment period (at 4-week intervals)
- 1 telephone visit for the follow-up period
These scheduled visits may include physical exams, vital signs, spirometry, blood sampling, questionnaires, electrocardiograms, and/or urine testing. There are approximately 300 study sites throughout 27 countries around the world.
Inclusion Criteria
- Male or female age 12 and older
- Diagnosis of asthma for ≥12 months prior to first visit
- Eosinophil count of ≥0.30×10⁹/L at Screening
- Require at a minimum daily low dose ICS, plus one or more additional daily maintenance asthma controller medications
- Treatment with a stable dose of either low, medium or high dose ICS for at least 3 months prior to screening
- Use of one of more additional daily maintenance asthma controller medications is required
Exclusion Criteria
- Experience of a severe asthma exacerbation, which resulted in emergency treatment or hospitalization, 4 weeks prior to first visit
- Diagnosed with respiratory infection 4 weeks prior to first visit
- Current smoker
- Currently pregnant or breastfeeding
Additional inclusion/exclusion criteria apply
Participants who are eligible and successfully enroll in this study will participate for 32 weeks with screening, treatment, and follow-up periods of:
- Screening of up to 4 weeks
- 24 weeks with active treatment or placebo
- Follow-up period of 4 weeks after the last active study drug treatment is completed
Qualified participants will receive all study-related care and study medication at no cost. Compensation for time and travel may be available. Participants will be asked to visit the study site:
- 2 times during screening
- 8 times during the treatment period (at 4-week intervals)
- 1 telephone visit for the follow-up period
These scheduled visits may include physical exams, spirometry, vital signs, blood sampling, questionnaires, electrocardiograms, and/or urine testing. There are approximately 300 study sites throughout 15 countries around the world.
- Male or female age 12 and older
- Diagnosis of asthma for ≥12 months prior to first visit
- Eosinophil count of ≥0.30×10⁹/L at Screening
- Require at a minimum daily low dose ICS, plus one or more additional daily maintenance asthma controller medications
- Treatment with a stable dose of either low, medium or high dose ICS for at least 3 months prior to screening
- Use of one of more additional daily maintenance asthma controller medications is required
- Experience of a severe asthma exacerbation, which resulted in emergency treatment or hospitalization, 4 weeks prior to first visit
- Diagnosed with respiratory infection 4 weeks prior to first visit
- Current smoker
- Currently pregnant or breastfeeding
Additional inclusion/exclusion criteria apply
Learn more about the studies and how to refer your patients:
If you would like to learn more about the EXHALE studies and speak to study staff to find out if your patients may be eligible, or if you are interested in joining the study as an investigator, please complete the form below and a member of the research team will contact you. Thank you for your interest.