Trials / Completed
CompletedNCT04046939
Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma
A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Biomarker Study of the Effects of Dexpramipexole on Eosinophils in Subjects With Eosinophilic Asthma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 534 (actual)
- Sponsor
- Knopp Biosciences · Industry
- Sex
- All
- Age
- 18 Years – 74 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging, multi-center study to evaluate the clinical effects of oral administration of dexpramipexole for 12 weeks on peripheral blood eosinophil count in subjects with eosinophilic asthma.
Detailed description
One hundred subjects will receive study drug or matching placebo over 12 weeks of consecutive dosing. Following a short Run-in Period, eligible subjects will enter the Primary Assessment Period and receive twice-daily dosing of study drug or placebo for 12 weeks. Following 12 weeks of treatment, subjects will enter a 12-week Eosinophil Recovery Period. The primary endpoint for the study is the change in blood absolute eosinophil count from Baseline to Week 12.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexpramipexole | dexpramipexole twice daily oral dosing for up to 12 weeks |
| DRUG | Placebo | placebo twice daily oral dosing for up to 12 weeks |
Timeline
- Start date
- 2019-08-15
- Primary completion
- 2020-12-03
- Completion
- 2021-03-02
- First posted
- 2019-08-06
- Last updated
- 2023-04-13
- Results posted
- 2021-12-22
Locations
36 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04046939. Inclusion in this directory is not an endorsement.