Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia (CS201)

Knopp Biosciences

Status and phase

Completed

Phase 2

Conditions

Chronic Sinusitis With Nasal Polyps and Eosinophilia

Treatments

Drug: dexpramipexole

Study type

Interventional

Funder types

Industry

Identifiers

NCT02217332

KNS-76704-CS201

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female >18 or <70 years of age
Willing to practice effective contraception during the study and be willing and able to continue contraception for 1 month (females) or 3 months (males) after the last dose of study treatment
Confirmed diagnosis of chronic sinusitis with nasal polyps
Documented history of nasal eosinophilia
Documented peripheral absolute eosinophil count >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 (< 1000 μg/day beclomethasone or equivalent)

Exclusion criteria

Acute sinusitis, concurrent nasal infection, or subjects who have had a nasal or upper respiratory tract infection within 2 weeks prior to baseline
CT scan suggestive of allergic fungal rhinosinusitis
Nasal septal deviation that would occlude at least one nostril
Nasal surgery (including polypectomy) within 6 months prior to baseline
History of more than 5 sinonasal surgeries requiring general anesthesia
History of more than 2 sinonasal surgeries that changed the lateral wall of the nose
History of cystic fibrosis, primary ciliary's dysfunction or Kartagener's syndrome
History of diagnosis with a parasitic infection
Hospitalization or emergency treatment for the treatment of asthma two or more times in the 12 months prior to baseline
Hospitalization for an acute asthmatic attack within 4 weeks prior to baseline
Forced expiratory volume (FEV1) of <60% of predicted normal range
Treatment with a systemic corticosteroid or intra-polyp corticosteroid within 8 weeks prior to baseline or anticipated need for systemic corticosteroids during the study treatment period
Utilization of rescue oral corticosteroids for asthma or chronic sinusitis exacerbation more than one time within the past 1 year
Treatment with an investigational drug in the previous 30 days or 5-half-lives, whichever is longer
Treatment with a monoclonal antibody therapy including omalizumab (Xolair®), within 5-half-lives
Treatment with zileuton (Zyflo®) within 4 weeks of baseline
Treatment with pramipexole (Mirapex®) within 4 weeks of baseline
History of malignancy, including solid tumors and hematologic malignancies (except basal cell and squamous cell cancers of the skin that have been completely excised and cured)
History of human immunodeficiency virus (HIV) or hepatitis B or C
History of unstable or severe cardiac, hepatic, or renal disease, or other medically significant illness
Medical or other condition likely to interfere with subject's ability to undergo study procedures, adhere to visit schedule or comply with study requirements
Absolute neutrophil count <2000 cells/μL at screening, or any documented history of neutropenia
Total IgE >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 <45 bpm or >100 bpm (average of 3 assessments).
Pregnant women or women breastfeeding