Conditions: Chronic Sinusitis With Nasal Polyps and Eosinophilia
Keywords: Sinusitis Rhinosinusitis CRS CRSwNP CSNP-E Nasal polyps Nasal polyposis Eosinophilia Asthma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: dexpramipexole 150 mg BID

Interventions: intervention 1: dexpramipexole
Intervention descriptions: intervention 1: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)

Protocol document: