Phase 2, open-label, multi-center study to evaluate the clinical effects of oral administration of dexpramipexole for 6 months in subjects with chronic sinusitis with nasal polyps and eosinophilia.
This open-labelled study will evaluate the safety and preliminary efficacy of dexpramipexole for reducing the number of eosinophils in the peripheral blood and in improving nasal polyp score when administered to 20 subjects with chronic sinusitis with nasal polyps and eosinophilia. Subjects will received dexpramipexole for up to 6 months and will have safety tests performed monthly and will have efficacy evaluations performed at month 1, month 3, and month 6 after beginning study drug.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
ENT Associates of South Florida
Boca Raton, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Wake Research Associates
Raleigh, North Carolina, United States
Ratio to Baseline in Peripheral Blood Eosinophil Counts After 6 Months of Treatment
Change in peripheral blood eosinophil (measured in cells/μL) from baseline to month 6 is presented as ratio to baseline.
Time frame: Baseline and Month 6
Change From Baseline in Total Polyp Score (TPS) After 6 Months of Treatment
The change in Nasal Polyp Score (NPS) score after 6 months of treatment is presented. A blinded Central Endoscopy Rater determined the NPS for each nare on a scale of 0 to 4, and the bilateral NPS scores were added to generate the Total Polyp Score (TPS) on a scale of 0 to 8. A lower TPS corresponds to a lower polyp burden.
Time frame: Baseline and Month 6
Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations
Summary of subjects from the safety population who experienced potentially clinically significant values in hand serum chemistry results
Time frame: 6 months
Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
Summary of subjects from the safety population who experienced potentially clinically significant values or changes in vital signs or weight
Time frame: 6 months
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
Summary of subjects from the safety population who experienced potentially significant values in electrocardiogram parameters
Time frame: 6 months
Ratio to Baseline in Peripheral Blood Eosinophil Counts After 3 Months of Treatment
Change in peripheral blood eosinophil (measured in cells/μL) from baseline to month 3 is presented as ratio to baseline.
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, United States
Time frame: Baseline and Month 3
Change From Baseline in TPS After 3 Months of Treatment
The change in Nasal Polyp Score (NPS) score after 3 months of treatment is presented. A blinded Central Endoscopy Rater determined the NPS for each nare on a scale of 0 to 4, and the bilateral NPS scores were added to generate the Total Polyp Score (TPS) on a scale of 0 to 8. A lower TPS corresponds to a lower polyp burden.
Time frame: Baseline and Month 3