Trial | NCT02799446  Report issue

Title

Effect of Reslizumab in Chronic Rhinosinusitis
Efficacy of Reslizumab for the Treatment of Chronic Rhinosinusitis A Double Blind, Randomized, Placebo-controlled, Phase III Trial

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    reslizumab ...

  • Study Participants

    30
The purpose of this study is to determine whether Reslizumab is effective for the treatment of chronic sinusitis.
Study Started
Jun 30
2016
Primary Completion
Jul 31
2019
Anticipated
Study Completion
Jul 31
2019
Anticipated
Last Update
Feb 01
2018

Drug Reslizumab

Reslizumab 3mg/kg intravenous (IV)

Drug Placebo

Matching Placebo intravenous (IV)

Reslizumab Experimental

Reslizumab will be administered intravenously every 4 weeks at a dose of 3mg/kg.

Placebo Placebo Comparator

Matching placebo.

Criteria 

Inclusion Criteria:

Written informed consent
Willingness and ability to comply with the requirements of the study
Female or male patients ages 18-75 at the time of screening
A diagnosis of chronic rhinosinusitis according to the clinical practice guideline (update) of the American academy of otolaryngology - head and neck surgery
Elevated blood eosinophils
Significant findings on computed tomography (CT) scan

Exclusion Criteria:

Unable to sign informed consent form
A woman that is pregnant or nursing a child
Known hypersensitivity to Reslizumab
Active cigarette smoking in the year prior to screening
Known underlying immunodeficiency
History of alcohol or drug abuse in the year prior to screening

Other criteria may apply. Please contact the investigator for more information
No Results Posted