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Phase 2 study for Adults with Chronic Rhinosinusitis with Nasal Polyps Study

University of North Carolina at Chapel Hill


Description

The purpose of this clinical trial is to test the safety and effectiveness of the study drug, etokimab (ANB020).


Keywords:

Allergy, Asthma, Breathing, Mouth/Nose/Throat


Category:

Drug or Biologic
Phase:2

Qualifications

 


Age
18 - 65 years


Gender
Any


Study Population

Adults with moderate to severe Chronic Rhinosinusitis with Nasal Polyps


Investigator

Edwin Kim
Clinical Assistant Professor
Medicine-UNCP A Allergy and Immunology

For questions, contact:

Julie Walker, CCRC
julie_walker@med.unc.edu
(919) 843-6619


Recruitment Period End

June 28, 2019

Location

Primary Location
Clinical & Translational Research Center
Burnett-Womack Building, 160 Dental Cir, Chapel Hill, NC 27514, USA

Study Qualifications

Gender Any

Age Range 18 - 65 years

Participant qualification(s) Present with at least 2 of the following symptoms prior to screening: a. Nasal blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip) b. Facial pain/pressure, and c. Reduction or loss of smell

Not eligible if: - Have required a burst of oral corticosteroids (OCS) or intranasal corticosteroid drops in the last 2 months or are scheduled to receive OCS during the study period for another condition. - Have received high dose systemic corticosteroids (equivalent to > 15 mg/day prednisone),nonsteroidal, immunosuppressant, or immunomodulating treatments within 8 weeks before screening - Have received treatment with dupilumab, mepolizumab, or omalizumab in the past 3 months -Positive blood screen for hepatitis C virus antibody, hepatitis B virus surface antigen, human immunodeficiency virus (HIV) 1 and 2 antibodies, or Mycobacterium tuberculosis (TB). -Planned surgery during the study or 30 days before screening. -History of malignancy within 5 years, except non-melanoma skin cancer that has been fully treated with no current active disease. - Undergone any nasal surgery within last 6 months or has a history of > 2 surgeries for nasal polyps. - Evidence of drug/substance abuse

Number of Visits

    » 10 In person visit(s)

    1 Screening, 9 clinic visits (4 of those are treatment visits)

    » 0 Remote visit(s)

Participation Period

24 weeks/6 months

Compensation

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.