Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia

• Status: Completed
• Trial end date: 2017-01-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Knopp Biosciences
• Treatments: Pramipexole

Criteria

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