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

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

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Dexpramipexole Administered Orally for 52 Weeks in Participants With Severe Eosinophilic Asthma

NCT05763121•Areteia Therapeutics

View on ClinicalTrials.gov

Summary

This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an eosinophilic phenotype and a history of asthma exacerbations.

Detailed Description

This is a multicenter, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of dexpramipexole in adults and adolescents with severe, inadequately controlled asthma with eosinophilic phenotype on medium to high-dose inhaled corticosteroids (ICS )and at least one additional asthma controller medication with or without oral corticosteroids (OCS). Approximately 1400 participants will be randomized globally. Participants will receive dexpramipexole, or placebo, administered orally, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 4 weeks.

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
•Asthma-related criteria
•3. Documented physician diagnosis of asthma for ≥12 months prior to Screening Visit 1.
•4. Treatment of asthma, participants must satisfy all the below (items a to c):
•1. Participants who have received asthma controller medication with medium or high dose inhaled corticosteroids (ICS; ≥500 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per Global Initiative for Asthma (GINA) 2021) on a regular basis for at least 12 months prior to Screening Visit 1.
•2. Documented treatment with a stable dose of either medium or high dose ICS for at least 3 months prior to Screening Visit 1. The ICS may be contained within an ICS/LABA (long-acting β2 agonist) combination product. Daily oral corticosteroids are an allowed concomitant medication; participants on daily oral corticosteroids must be on a stable dose for 3 months before Screening Visit 1.
•3. Use of one of more additional daily maintenance asthma controller medications according to standard practice of care is required. Use of a stable dose of any additional asthma controller medications must be documented for at least 3 months prior to Screening Visit 1.
•5. 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.
•6. Variable airflow obstruction documented with at least one of the following criteria:
+16 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 due to asthma, or treatment with systemic corticosteroids) at any time from 4 weeks prior to Screening 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, hypereosinophilic syndrome, 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.
•4. For participants aged 12 to 17 years old, AEC of \<0.15x10⁹/L at Screening Visit 1.
•Prohibited medications/procedures
•5. 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-IL-5) in the past 12 months.
•6. Treatment with any of the following monoclonal antibody therapies within 120 days prior to Baseline Visit: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab.
•7. Treatment with pramipexole (Mirapex®) within 30 days of Baseline Visit.
+27 more criteria

Locations (401)

Research Site 20001-374

Bakersfield, California, United States

Research Site 20001-440

La Palma, California, United States

Research Site 20001-062

Newport Beach, California, United States

Research Site 20001-043

Newport Beach, California, United States

Research Site 20001-380

Redding, California, United States

Research Site US-20001-488

San Diego, California, United States

Research Site 20001-003

West Covina, California, United States

Research Site 20001-419

Westminster, California, United States

Research Site 20001-048

Aventura, Florida, United States

Research Site 20001-005

Brandon, Florida, United States

Key Dates

Start Date

January 30, 2023

Primary Completion Date

December 8, 2025

Completion Date

December 8, 2025

Last Updated

December 15, 2025

Enrollment

1,061

ACTUAL participants

Conditions

Eosinophilic AsthmaAsthma; EosinophilicAsthma

Interventions

Dexpramipexole Dihydrochloride

DRUG

Placebo

DRUG

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Asthma

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RECRUITING

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

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Asthma

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RECRUITINGNA

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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: December 15, 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 Severe Eosinophilic Asthma.

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma