Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia
Completed · Phase 2
Conditions studied: Chronic Sinusitis With Nasal Polyps and Eosinophilia
In brief
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.
Key facts
- Study ID
- NCT02217332
- Run by
- Knopp Biosciences
- People needed
- 20
- Starts
- 2014-08-01
- Expected to finish
- 2017-01-20
- Last updated by the study team
- 2021-05-18
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- ENT Associates of South Florida — Boca Raton, Florida, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Wake Research Associates — Raleigh, North Carolina, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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