A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Dexpramipexole Administered Orally for 24 Weeks in Participants With Eosinophilic Asthma

Areteia Therapeutics333 sites in 7 countries600 target enrollmentJanuary 30, 2023

ConditionsEosinophilic Asthma Asthma; Eosinophilic Asthma Attack

InterventionsDexpramipexole Dihydrochloride Placebo

DrugsDexpramipexole Dihydrochloride Placebo

Overview

Phase: Phase 3
Intervention: Dexpramipexole Dihydrochloride
Conditions: Eosinophilic Asthma
Sponsor: Areteia Therapeutics
Enrollment: 600
Locations: 333
Primary Endpoint: Change in pre-BD FEV₁ from baseline
Status: Active, not recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate dexpramipexole as an add-on oral therapy in participants with inadequately controlled eosinophilic asthma to evaluate improvements in lung function, asthma control, and quality of life. In addition, the study will further evaluate the safety and tolerability of dexpramipexole in participants with eosinophilic asthma.

Registry

clinicaltrials.gov

Start Date

January 30, 2023

End Date

December 1, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Areteia Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed informed consent form and assent form, as appropriate.
•Male or female ≥12 years of age at Screening Visit
•Sites in Poland will only include participants aged ≥18 years.
•Asthma-related criteria
•Documented physician diagnosis of asthma for ≥12 months prior to Screening Visit
•Participants requiring at a minimum daily low dose inhaled corticosteroids (ICS; ≥100 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per GINA 2021), plus one or more additional daily maintenance asthma controller medications, eg, long-acting β2 agonist (LABA), leukotriene antagonist, theophylline, long-acting muscarinic antagonists, cromolyn/nedocromil. Note: In Poland, this will instead include participants requiring a minimum daily medium dose ICS (≥500 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per GINA 2021). Use of daily ICS must be for at least 12 weeks prior to Screening Visit 1 and the doses of all controller medications must be stable for at least 4 weeks prior to Screening Visit
•Pre-BD FEV1 ≥40% and \<80% (\<90% for participants 12 to 17 years of age) of predicted at Screening Visit
•Bronchodilator reversibility, at Screening Visit 2, as evidenced by ≥12% and ≥200 mL improvement in FEV1, 15 to 30 minutes following inhalation of 400 μg (four puffs) of albuterol/salbutamol (≥12% and ≥160 mL for ages 12 to 17).Participants who do not meet the bronchodilator reversibility inclusion criterion but have ≥10% and ≥160 mL reversibility, may repeat the reversibility spirometry assessment once during the Screening Period, at an unscheduled visit at least 7 days prior to baseline.
•ACQ-6 ≥1.5 at Screening Visit
•Eosinophil count of ≥0.30x10⁹/L at Screening Visit

Exclusion Criteria

•Asthma-related criteria
•A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization prior to the Screening Visit 1 up to and including the Baseline Visit.
•Participants who experience an asthma exacerbation during the Screening/Run-in Period may remain in screening and proceed with study visits 14 days after they have completed their course of oral steroids or returned to their pre-Screening visit maintenance dose of oral steroids and the investigator considers participant has returned to baseline status.
•Current diagnosis of diseases which may confound interpretation of this study's findings such as allergic bronchopulmonary aspergillosis, eosinophilic granulomatosis with polyangiitis, eosinophilic gastrointestinal diseases, or hypereosinophilic syndrome, or lung diseases (eg, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis).
•Respiratory infection: Upper or lower respiratory tract, sinus, or middle ear infection within the 4 weeks before Screening Visit
•Prohibited medications/procedures
•Treatment with a biologic investigational drug in the last 5 months prior to Screening Visit
•Treatment with non-biologic investigational drugs in the previous 30 days or five-half-lives prior to Screening Visit 1, whichever is longer. Treatment with GSK3511294 (long acting anti-interleukin-5) in the past 12 months.
•Treatment with any of the following monoclonal antibody therapies within 120 days prior to Baseline: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab.
•Treatment with pramipexole (Mirapex®) within 30 days of Baseline.

Arms & Interventions

150 mg BID

Dexpramipexole 150 mg oral tablet taken twice a day

Intervention: Dexpramipexole Dihydrochloride

75 mg BID

Dexpramipexole 75 mg oral tablet taken twice a day

Intervention: Dexpramipexole Dihydrochloride

Placebo

Placebo oral tablet taken twice a day

Intervention: Placebo

Outcomes

Primary Outcomes

Change in pre-BD FEV₁ from baseline

Time Frame: Day 1 (baseline, pre-dose), Weeks 20, 24

Pre-bronchodilator forced expiratory volume (pre-BD) FEV₁, absolute change from baseline, averaged over Weeks 20 and 24.

Secondary Outcomes

Change from baseline in Asthma Control Questionnaire-6 (ACQ-6)(Day 1 (baseline, pre-dose), Weeks 20, 24)
Change in Standardized version of the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) from baseline to Week 24.(Day 1 (baseline, pre-dose) through Week 24)
Change from baseline absolute eosinophil count (AEC) averaged across Weeks 20 and 24.(Day 1 (baseline, pre-dose) through Week 24)
Change from baseline forced vital capacity (FVC) averaged over Weeks 20 and 24.(Day 1 (baseline, pre-dose), Weeks 20, 24)
Change from baseline forced vital capacity (FVC) at Weeks 4, 8, 12, 16, 20, and 24.(Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, and 24)
Change from baseline post-bronchodilator (post-BD) forced expiratory volume (FEV₁) at Week 24.(Day 1 (baseline, pre-dose) through Week 24)
The EuroQol 5-dimensional questionnaire (EQ-5D-5L) change from baseline to Week 24(Day 1 (baseline, pre-dose) through Week 24)