Trials / Terminated
TerminatedNCT06388889
Phase III Long-Term Extension Study With Dexpramipexole
An Open-Label Long-Term Phase III Extension Study to Assess the Long-Term Safety and Tolerability of Dexpramipexole in Participants With Severe Eosinophilic Asthma
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 509 (actual)
- Sponsor
- Areteia Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial\] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥18 years, on Global Initiative for Asthma (GINA) 2021 \[GINA, 2021\] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexpramipexole Dihydrochloride | Oral administration of dexpramipexole tablet |
Timeline
- Start date
- 2024-06-12
- Primary completion
- 2025-12-08
- Completion
- 2025-12-08
- First posted
- 2024-04-29
- Last updated
- 2025-12-15
Locations
103 sites across 15 countries: United States, Argentina, Brazil, Bulgaria, Georgia, Japan, Mexico, North Macedonia, Poland, Romania, Serbia, South Africa, South Korea, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06388889. Inclusion in this directory is not an endorsement.