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Dexpramipexole for Asthma (EXHALE-3 Trial)
Verified Trial
Phase 3
Recruiting
Led By Michael E. Wechsler, MD
Research Sponsored by Areteia Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not have
A participant who experiences a severe asthma exacerbation at any time from 4 weeks prior to Screening Visit 1 up to and including the Baseline Visit
Bronchial thermoplasty procedure in the past 12 months prior to Screening Visit 1 or planned during the coming year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (baseline, pre-dose), weeks 36, 44, 52
Awards & highlights
Pivotal Trial
Summary
This trial is testing a medication called dexpramipexole to see if it can help people with severe eosinophilic asthma that isn't well-controlled by current treatments. The medication works by lowering the levels of certain cells in the blood that cause inflammation. The goal is to find out if this can improve asthma symptoms and be safe for patients.
Who is the study for?
This trial is for adolescents and adults over 12 years old with severe eosinophilic asthma that isn't well-controlled. They should have had at least two asthma attacks in the last year needing steroids, an eosinophil count above a certain level, and not be current smokers or have a heavy smoking history. Women who can get pregnant must use birth control.
What is being tested?
The study tests dexpramipexole's safety and effectiveness against a placebo in managing severe eosinophilic asthma. Participants will randomly receive either the actual drug or a placebo to compare outcomes between the two groups.
What are the potential side effects?
While specific side effects of dexpramipexole are not listed here, common ones may include headache, nausea, potential allergic reactions, or issues related to immune system changes due to its effect on white blood cells.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a severe asthma attack within 4 weeks before my first screening visit up to now.
Select...
I have not had a bronchial thermoplasty in the last year nor plan to have one this coming year.
Select...
I have not had a respiratory infection in the last 4 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 (baseline, pre-dose), weeks 36, 44, 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (baseline, pre-dose), weeks 36, 44, 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Annualized rate of severe asthma exacerbations over 52 weeks.
Secondary study objectives
Absolute Change in pre-bronchodilator forced expiratory volume (Pre-BD FEV₁) from Baseline
Mean Change From Baseline at Week 52 in Asthma Control Questionnaire-6 (ACQ-6) (Key Secondary Endpoint)
Mean Change From Baseline at Week 52 in Asthma Symptom Diary (ASD)
+2 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 75 mg BIDExperimental Treatment1 Intervention
Dexpramipexole 75 mg oral tablet taken twice a day
Group II: 150 mg BIDExperimental Treatment1 Intervention
Dexpramipexole 150 mg oral tablet taken twice a day
Group III: PlaceboPlacebo Group1 Intervention
Placebo oral tablet taken twice a day
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Asthma treatments work through various mechanisms to reduce inflammation, relax airway muscles, and prevent exacerbations. Inhaled corticosteroids (ICS) reduce airway inflammation and swelling, making it easier to breathe.
Long-acting beta agonists (LABAs) relax the muscles around the airways, helping to keep them open. Leukotriene modifiers block chemicals that cause inflammation and bronchoconstriction.
Biologics, such as dexpramipexole, target specific pathways involved in asthma, like reducing eosinophil levels and inflammation. These mechanisms are crucial for asthma patients as they help control symptoms, improve lung function, and reduce the frequency and severity of asthma attacks.
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Areteia TherapeuticsLead Sponsor
4 Previous Clinical Trials
3,575 Total Patients Enrolled
3 Trials studying Asthma
3,545 Patients Enrolled for Asthma
Michael E. Wechsler, MDPrincipal InvestigatorNational Jewish Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have smoked within the past year or have a history of smoking more than 10 packs of cigarettes.I have very high blood pressure that isn't controlled by medication.I've needed steroids for asthma attacks at least twice in the last year.I have had a severe asthma attack within 4 weeks before my first screening visit up to now.I had cancer treatment within the last 5 years.You cannot take certain medicines or undergo certain medical procedures while participating in the study.You have evidence of variable airflow obstruction through one or more methodologies.My heart is healthy enough for treatment.You have a history of not following your medication schedule as directed.I have not had a respiratory infection in the last 4 weeks.I have not had a bronchial thermoplasty in the last year nor plan to have one this coming year.I do not have any health conditions that could affect this study's results.Your pre-BD FEV₁ is between 40% and 80% of the predicted value at Screening Visit 2.You are pregnant or currently breastfeeding.I am 12 years old or older.You have a history of alcohol or drug abuse or are currently experiencing substance addiction.
Research Study Groups:
This trial has the following groups:- Group 1: 150 mg BID
- Group 2: 75 mg BID
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.