Phase 2 N=20 Treatment

Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia

Chronic Sinusitis With Nasal Polyps and Eosinophilia

Bottom Line

View on ClinicalTrials.gov: NCT02217332 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

May 2021

Primary outcome: Primary: Ratio to Baseline in Peripheral Blood Eosinophil Counts After 6 Months of Treatment — 0.06 ratio to baseline — p=< 0.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: dexpramipexole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Knopp Biosciences
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Ratio to Baseline in Peripheral Blood Eosinophil Counts After 6 Months of Treatment	0.06	< 0.001 sig
PRIMARY Change From Baseline in Total Polyp Score (TPS) After 6 Months of Treatment	0.07	0.885
SECONDARY Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations	0; 1; 0; 0; 1; 1	—
SECONDARY Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters	2; 0; 1; 0; 0; 0	—
SECONDARY Ratio to Baseline in Peripheral Blood Eosinophil Counts After 3 Months of Treatment	0.05	<.001 sig
SECONDARY Change From Baseline in TPS After 3 Months of Treatment	0.0	1.0

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.

Eligibility Criteria

Inclusion Criteria

Male or female >18 or 300 cells/μL
Bilateral total polyp score of >4
Sino-nasal outcome test (SNOT-22) score of >7
Using an intranasal corticosteroid spray or irrigation ( 1500 IU/ml at any visit prior to baseline
Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) of ≤80 mg/dL at screening (estimation of creatinine clearance using the MDRD formula)
History of long QT syndrome or arrhythmia
Prolongation of QT/QTc interval (e.g., repeated demonstration of a QT/QTc interval >450 ms) at screening or pre-dose on day 1
Clinically important abnormalities in resting ECG that may interfere with the interpretation of QTc interval changes at screening or pre-dose on day 1, including any of the following:
PR interval >210 ms;
QRS >110 ms;
Heart rate 100 bpm (average of 3 assessments).
Pregnant women or women breastfeeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02217332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.