Areteia Therapeutics is commencing recruitment for the clinical trial of Dexpramipexole in adolescents and adults with severe eosinophilic asthma.
The trial officially began on the January 30, 2023 in several US research sites in California, Florida, Missouri, Oklahoma, and it is planned to complete by December 2025.
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.
The potential participants must be ≥12 years of age at randomization with documented physician diagnosis of asthma for ≥12 months. They must satisfy all the below (items a to c):
a). 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.
b). Documented treatment with a stable dose of either medium or high dose ICS for at least 3 months prior to 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.
c) 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.
For more detailed inclusion and exlcusion criteria, as well as for the research sites contact details, please visit: https://ichgcp.net/clinical-trials-registry/NCT05763121