NCT05748600

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Areteia Therapeutics · Industry
• Sex: All
• Age: 12 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Eosinophilic Asthma
• Asthma; Eosinophilic
• Asthma Attack

Interventions

Type	Name	Description
DRUG	Dexpramipexole Dihydrochloride	administration of dexpramipexole tablet
DRUG	Placebo	administration of placebo tablet

Timeline

• Start date: 2023-01-30
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2023-02-28
• Last updated: 2025-09-05

Locations

335 sites across 18 countries: United States, Argentina, Austria, Brazil, Canada, Israel, Malaysia, Mexico, Poland, Puerto Rico, Romania, South Africa, South Korea, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study