JHU ICTR
Johns Hopkins Clinical Research Study

Benralizumab Effect on Severe Chronic Rhinosinusitis with Eosinophilic Polyposis: A Phase II Randomized Placebo Controlled Trial
ClinicalTrials.gov

IRB Number: IRB00112910
Principal Investigator: Tversky, Jody

Study Description:

Purpose of the Study

This research is being done to examine how well a new injectable medication called benralizumab works for severe nasal polyps. This injection will be performed every 1-2 months for about six months. The medication is approved by the U.S. Food and Drug Administration (FDA) for the tretament of asthma but is not yet approved to treat polyps. The goal of the study is to understand how well this new medication works for polyps and how well it is tolerated.

 

Who can partcipate

People aged 18 to 75 with severe nasal polyps and at least one prior sinus surgery may join.

 

What happens duting the study

Nasal rhinoscopy, sinus CT scan, blood test, smell test, allergy skin testing and a clinical survey will be performed to detrmine if you qualify for the study. If you qualify and agree to participate you will recieve injections every 1-2 months for a period of 6 months. You will be asked to record symptoms and medication use at each visit.



Eligibility Criteria:

Inclusion Criteria

·       Adults aged 18-75

·       Severe bilateral nasal polyps with average endoscopic score of at least 5

·       Blood eosinophil count of at least 300/ul at screening

·       At least one course of oral steroids over the previous 12 months to control symptoms

·       At least one prior nasal surgical polypectomy

·       Women of childbearing potential must use an effective form of birth control (confirmed by the Investigator), or remain abstenant.

·       All male subjects who are sexually active must agree to use an acceptable method of contraception (condom with or without spermicide, vasectomy) from Visit 0 until 16 weeks after their last dose.



Recruitment Contact Name:Nurse Jeanne Hoddinott
Contact Phone:410-550-8017
Contact E-Mail: hoddin1@jhmi.edu


Location of Study Visits:

  • Johns Hopkins Bayview Medical Center

Study will provide compensation: Yes



Keywords:

  • Nasal Polyps
  • Sinusitis