Trials / Terminated
TerminatedNCT05763121
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,061 (actual)
- Sponsor
- Areteia Therapeutics · Industry
- Sex
- All
- Age
- 12 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexpramipexole Dihydrochloride | oral administration of dexpramipexole tablet |
| DRUG | Placebo | oral administration of placebo tablet |
Timeline
- Start date
- 2023-01-30
- Primary completion
- 2025-12-08
- Completion
- 2025-12-08
- First posted
- 2023-03-10
- Last updated
- 2025-12-15
Locations
401 sites across 20 countries: United States, Argentina, Brazil, Bulgaria, Canada, China, Colombia, Georgia, Japan, Lebanon, Mexico, North Macedonia, Peru, Poland, Puerto Rico, Romania, Serbia, South Korea, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05763121. Inclusion in this directory is not an endorsement.