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NCT04046939 · ClinicalTrials.gov registry record · Phase 2
Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma
A Phase 2 study of Asthma and Eosinophilic Asthma, sponsored by Knopp Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 534
- Enrollment target
- 20
- Study locations
NCT04046939: Completed Phase 2 study of Asthma and Eosinophilic Asthma, sponsored by Knopp Biosciences.
NCT04046939 is a Phase 2 study of Asthma and Eosinophilic Asthma that has completed, run by Knopp Biosciences. The registered enrollment target is 534 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04046939, a Phase 2 study of Asthma and Eosinophilic Asthma, has completed, sponsored by Knopp Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 534 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The primary endpoint of this study was the change in AEC from Baseline to Week 12 on a ratio scale. The analysis used a mixed effects model repeated-measures (MMRM) with terms for log10 transformed baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and log10 transformed baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the log10 transformed post-baseline value minus t
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dexpramipexole
Study Locations (20)
Florida
- Research Site - Daytona Beach
- Research Site - Miami
- Research Site - Orlando
- Research Site - Tampa
- Research Site - Tampa
California
- Research Site - Los Angeles
- Research Site - Mission Viejo
- Research Site - Westminster
Georgia
- Research Site - Lawrenceville
- Research Site - Winder
Missouri
- Research Site - St Louis
- Research Site - St Louis
New York
- Research Site - Corning
- Research Site - New Hyde Park
Colorado
- Research Site - Denver
Idaho
- Research Site - Boise
Michigan
- Research Site - Farmington Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 534 participants |
| Start Date | 2019-08-15 |
| Est. Completion | 2021-03-02 |
| Phase | Phase 2 |
What the finished NCT04046939 record still lists
NCT04046939 is an interventional study that assigns participants to a tested intervention. The registered 534 participants enrollment target is mid-sized for trials with a published cap, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (66% lower).
The record links to 2 conditions, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04046939 names 20 study sites across 11 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04046939 about?
NCT04046939 is a clinical study titled "Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma". 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.
What is the current status of trial NCT04046939?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 534 participants. The study started on 2019-08-15. Estimated completion is 2021-03-02.
What conditions does trial NCT04046939 study?
This clinical trial studies the following conditions: Asthma, Eosinophilic Asthma.
What interventions are being tested in trial NCT04046939?
The interventions under investigation include: Placebo (DRUG), Dexpramipexole (DRUG).
Who is sponsoring clinical trial NCT04046939?
This trial is sponsored by Knopp Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04046939 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04046939's enrollment target sits among peer trials
534 77th of 374 higher than 298 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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