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A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma

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

NCT05748600•Areteia Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent form and assent form, as appropriate.
•2. Male or female ≥12 years of age at Screening Visit 1. Sites in Poland will only include participants aged ≥18 years.
•Asthma-related criteria
•3. Documented physician diagnosis of asthma for ≥12 months prior to Screening Visit 1.
•4. 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 1.
•5. Pre-BD FEV1 ≥40% and \<80% (\<90% for participants 12 to 17 years of age) of predicted at Screening Visit 2.
•6. 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.
•7. ACQ-6 ≥1.5 at Screening Visit 2.
•8. Eosinophil count of ≥0.30x10⁹/L at Screening Visit 1. If the initial value is between 0.250x10⁹/L to 0.299x10⁹/L, then this may be repeated once at an unscheduled visit (prior to Screening Visit 2).
•General medical history
+8 more criteria

Exclusion Criteria

•Asthma-related criteria
•1. 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.
•2. 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).
•3. Respiratory infection: Upper or lower respiratory tract, sinus, or middle ear infection within the 4 weeks before Screening Visit 1.
•Prohibited medications/procedures
•4. Treatment with a biologic investigational drug in the last 5 months prior to Screening Visit 1. 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.
•5. Treatment with any of the following monoclonal antibody therapies within 120 days prior to Baseline: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab.
•6. Treatment with pramipexole (Mirapex®) within 30 days of Baseline.
•7. Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days prior to Screening Visit 1.
+27 more criteria

Locations (335)

Research Site 40001-487

Chandler, Arizona, United States

Research Site 40001-462

Peoria, Arizona, United States

Research Site 40001-322

Surprise, Arizona, United States

Research Site 40001-374

Bakersfield, California, United States

Research Site 40001-227

Encinitas, California, United States

Research Site 40001-349

Huntington Beach, California, United States

Research Site 40001-485

Inglewood, California, United States

Research Site 40001-440

La Palma, California, United States

Research Site 40001-357

Lancaster, California, United States

Research Site 40001-089

Los Angeles, California, United States

Key Dates

Start Date

January 30, 2023

Primary Completion Date

September 1, 2025

Completion Date

December 1, 2025

Last Updated

September 5, 2025

Enrollment

600

ESTIMATED participants

Conditions

Eosinophilic AsthmaAsthma; EosinophilicAsthma Attack

Interventions

Dexpramipexole Dihydrochloride

DRUG

Placebo

DRUG

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ENROLLING_BY_INVITATIONPHASE4

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NCT07343661

EGPA - Eosinophilic Granulomatosis With PolyangiitisSevere Asthma+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma

Inclusion Criteria

Exclusion Criteria

Individualizing Treatment for Asthma in Primary Care (Full Study)

Beyond EOsinophils: proteoMICS to Identify Potential Biomarker of Organ Damage and Response to MEPOLIZUMAB in EGPA

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