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Dexpramipexole in severe eosinophilic asthma
NCT05813288Phase 3
Key facts
- Status
- Terminated
- Start
- Mar 2023
- Primary completion
- Dec 2025
- Countries
- 26
- Sponsor
- Areteia Therapeutics
- Modality
- Small Molecules
- Drugs
- dexpramipexole
- Conditions
- eosinophilic asthma (EA)
01
Overview
Phase 3, randomised, double-blind trial of dexpramipexole in eosinophilic asthma (EA) (3 arms), sponsored by Areteia Therapeutics. Primary endpoint: Annualized rate of severe asthma exacerbations at 52 weeks. Started Mar 2023; status: terminated.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Dexpramipexole 150 mg BID
Dexpramipexole 150 mg oral tablet taken twice a day for 52 weeks
Dexpramipexole 75 mg BID
Dexpramipexole 75 mg oral tablet taken twice a day for 52 weeks
Placebo
Placebo oral tablet taken twice a day for 52 weeks
03
Who it enrols
Patients aged ≥12 years with physician-diagnosed severe eosinophilic asthma (eosinophil count ≥0.30x10^9/L) for ≥12 months, on medium or high dose ICS for ≥12 months, with FEV1 40-80% predicted, ACQ-6 ≥1.5, and ≥2 exacerbations in past 12 months requiring systemic corticosteroids
04
Endpoints
Primary
Annualized rate of severe asthma exacerbations
Secondary
Pre-bronchodilator forced expiratory volume in 1 second
Asthma Control Questionnaire-6
Standardized Asthma Quality of Life Questionnaire for 12 Years and Older
Annualized rate of severe exacerbations requiring emergency department visit or hospitalization
Annualized rate of severe exacerbations from Week 4 to Week 52
Absolute eosinophil count
Forced vital capacity
Post-bronchodilator forced expiratory volume in 1 second
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