NCT02217332

Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia

Safety and Preliminary Efficacy of Dexpramipexole in Patients With Chronic Sinusitis With Nasal Polyps and Eosinophilia (CSNP-E)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Knopp Biosciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Sinusitis With Nasal Polyps and Eosinophilia

Interventions

Type	Name	Description
DRUG	dexpramipexole	Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-12-14
• Completion: 2017-01-20
• First posted: 2014-08-15
• Last updated: 2021-05-18
• Results posted: 2021-05-18

Locations

7 sites across 1 country: United States