Effect of Reslizumab in Chronic Rhinosinusitis
Efficacy of Reslizumab for the Treatment of Chronic Rhinosinusitis A Double Blind, Randomized, Placebo-controlled, Phase III Trial
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to determine whether Reslizumab is effective for the treatment of chronic sinusitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2016
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 10, 2016
CompletedFirst Posted
Study publicly available on registry
June 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedFebruary 1, 2018
January 1, 2018
3.1 years
June 10, 2016
January 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in computed tomography (CT) score
24 weeks
Secondary Outcomes (4)
Quality of life questionnaire
24 weeks
Smell test
24 weeks
Endoscopy score
24 weeks
Adverse events by body system
24 weeks
Study Arms (2)
Reslizumab
EXPERIMENTALReslizumab will be administered intravenously every 4 weeks at a dose of 3mg/kg.
Placebo
PLACEBO COMPARATORMatching placebo.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joshua S. Jacobslead
Study Sites (1)
Allergy and Asthma Clinical Research
Walnut Creek, California, 94598, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua Jacobs, MD
Allergy and Asthma Clinical Research
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 10, 2016
First Posted
June 14, 2016
Study Start
June 1, 2016
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
February 1, 2018
Record last verified: 2018-01