This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Knopp Biosciences
ClinicalTrials.gov Identifier:
NCT02217332
First received: August 12, 2014
Last updated: February 28, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Chronic Sinusitis With Nasal Polyps and Eosinophilia Drug: dexpramipexole Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Preliminary Efficacy of Dexpramipexole in Patients With Chronic Sinusitis With Nasal Polyps and Eosinophilia (CSNP-E)

Resource links provided by NLM:


Further study details as provided by Knopp Biosciences:

Primary Outcome Measures:
  • Peripheral eosinophil count and nasal polyp score [ Time Frame: 6 months ]
    Efficacy of dexpramipexole in reducing the number of eosinophils in the peripheral blood and in improving nasal polyp score when administered to subjects with CSNP-E.


Secondary Outcome Measures:
  • Safety [ Time Frame: 6 months ]
    • frequency and severity of adverse events over time after dexpramipexole is administered to subjects with CSNP-E.
    • changes in clinical safety laboratory parameters over time after dexpramipexole is administered to subjects with CSNP-E.
    • changes in ECG parameters over time after dexpramipexole is administered to subjects with CSNP-E.
    • changes in vital signs over time after dexpramipexole is administered to subjects with CSNP-E.


Other Outcome Measures:
  • anosmia [ Time Frame: 6 months ]
    Effect of dexpramipexole on improving sinusitis symptoms, including reversing anosmia and improving nasal patency

  • CT scan score [ Time Frame: 6 months ]
    Effect of dexpramipexole on improving CT scan evidence of sinonasal disease

  • asthma symptom scores [ Time Frame: 6 months ]
    Effect of dexpramipexole on improving symptoms of asthma

  • Quality of life scores [ Time Frame: 6 months ]
    Effect of dexpramipexole on quality-of-life measures


Enrollment: 20
Study Start Date: August 2014
Study Completion Date: January 20, 2017
Primary Completion Date: December 14, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dexpramipexole
dexpramipexole 150 mg BID
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)
Other Names:
  • KNS-760704
  • BIIB050
  • RPPX

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02217332

Locations
United States, Florida
ENT Associates of South Florida
Boca Raton, Florida, United States, 33487
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Knopp Biosciences
  More Information

Responsible Party: Knopp Biosciences
ClinicalTrials.gov Identifier: NCT02217332     History of Changes
Other Study ID Numbers: KNS-76704-CS201
Study First Received: August 12, 2014
Last Updated: February 28, 2017

Keywords provided by Knopp Biosciences:
Sinusitis
Rhinosinusitis
CRS
CRSwNP
CSNP-E
Nasal polyps
Nasal polyposis
Eosinophilia
Asthma

Additional relevant MeSH terms:
Polyps
Sinusitis
Nasal Polyps
Chronic Disease
Eosinophilia
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Leukocyte Disorders
Hematologic Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 18, 2017