What side effects are associated with this type of intervention?

Common treatments for asthma that reduce eosinophil levels and inflammation include inhaled corticosteroids (ICS), long-acting beta agonists (LABA), leukotriene receptor antagonists, and biologics such as mepolizumab and omalizumab. Inhaled corticosteroids can cause oral thrush, hoarseness, and, rarely, systemic effects like adrenal suppression. LABAs may lead to tremors, palpitations, and headaches. Leukotriene receptor antagonists can cause neuropsychiatric events, including agitation and depression. Biologics like mepolizumab and omalizumab are generally well-tolerated but can cause injection site reactions, headaches, and, rarely, anaphylaxis.

What prior FDA approvals exist?

Several biologic drugs have been approved by the FDA for the treatment of severe eosinophilic asthma, focusing on reducing eosinophil levels and inflammation. Mepolizumab (Nucala) and benralizumab (Fasenra) target IL-5, a key cytokine in eosinophil growth and activation, thereby reducing eosinophil levels. Dupilumab (Dupixent) targets the IL-4 receptor alpha, inhibiting IL-4 and IL-13 signaling, which are involved in the inflammatory response. Omalizumab (Xolair) is an anti-IgE antibody that helps reduce allergic responses and has been used in allergic asthma. These treatments have shown efficacy in reducing asthma exacerbations and improving control in patients with severe eosinophilic asthma.

What other types of research exist?

Promising alternatives to dexpramipexole for asthma patients include biologics such as benralizumab, mepolizumab, and dupilumab. These agents target eosinophil levels and inflammation effectively. Benralizumab is an anti-IL-5 receptor alpha monoclonal antibody, mepolizumab targets IL-5, and dupilumab targets IL-4 and IL-13 pathways. These treatments have shown efficacy in reducing asthma exacerbations and improving asthma control.

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Dexpramipexole for Asthma (EXHALE-2 Trial)

Q: What is the mechanism of action of this treatment?

Asthma treatments primarily aim to reduce inflammation and manage symptoms. Dexpramipexole, like other treatments targeting eosinophilic asthma, works by reducing eosinophil levels, thereby decreasing inflammation and preventing exacerbations. Other common treatments include inhaled corticosteroids (ICS), which reduce airway inflammation, and long-acting beta-agonists (LABAs), which relax airway muscles to improve breathing. Biologics such as mepolizumab and reslizumab specifically target and reduce eosinophils, similar to dexpramipexole. These mechanisms are crucial for asthma patients as they help control chronic inflammation, reduce the frequency and severity of asthma attacks, and improve overall lung function and quality of life.

Phase 3

Recruiting

Led By Salman Siddiqui, MD

Research Sponsored by Areteia Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented history of at least two asthma exacerbations requiring treatment with systemic corticosteroids within the past 12-month period prior to Screening Visit 1

Pre-bronchodilator forced expiratory volume (Pre-BD FEV₁) ≥40% and <80% (<90% for participants 12 to 17 years of age) of predicted at Screening Visit 2

Must not have

Treatment with specific prohibited medications/procedures

AEC of <0.15x10⁹/L at Screening Visit 1 for participants aged 12 to 17 years old

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 an oral medication called dexpramipexole in people with severe asthma that isn't well controlled by usual treatments. The medication aims to reduce certain cells in the blood that make asthma worse, helping to better manage symptoms.

Who is the study for?

This trial is for adolescents and adults aged 12 or older with severe eosinophilic asthma that isn't well-controlled, despite current treatments. Participants must have had at least two asthma attacks in the past year requiring steroids. Women who can have children must use effective birth control.

What is being tested?

The study tests Dexpramipexole as an additional oral treatment against a placebo to see if it helps people with a specific type of severe asthma. The goal is to find out if this new medicine can reduce asthma symptoms and prevent attacks.

What are the potential side effects?

While the potential side effects of Dexpramipexole are not detailed here, common side effects may include headache, dizziness, gastrointestinal issues, or allergic reactions. Placebo pills typically do not cause side effects but mimic those of the tested drug due to psychological factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've needed steroids for asthma attacks at least twice in the last year.

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My lung function is between 40% and 80% of the expected value.

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I am being treated for asthma with specific medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken any medications or undergone procedures that are not allowed in this trial.

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My white blood cell count is low.

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I have not had a respiratory infection in the last 4 weeks.

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I have not had a bronchial thermoplasty in the last year nor plan to have one.

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My blood, kidney, and liver tests are within safe ranges.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (baseline, pre-dose), weeks 36, 44, 52 for reporting.

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 FEV)₁ from Baseline

Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6)

Awards & 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

0 / 8Eligibility criteria met

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 primarily aim to reduce inflammation and manage symptoms. Dexpramipexole, like other treatments targeting eosinophilic asthma, works by reducing eosinophil levels, thereby decreasing inflammation and preventing exacerbations. Other common treatments include inhaled corticosteroids (ICS), which reduce airway inflammation, and long-acting beta-agonists (LABAs), which relax airway muscles to improve breathing. Biologics such as mepolizumab and reslizumab specifically target and reduce eosinophils, similar to dexpramipexole. These mechanisms are crucial for asthma patients as they help control chronic inflammation, reduce the frequency and severity of asthma attacks, and improve overall lung function and quality of life.

Mepolizumab versus placebo for asthma.