Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
30 participants
INTERVENTIONAL
2016-06-30
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Reslizumab
Reslizumab will be administered intravenously every 4 weeks at a dose of 3mg/kg.
Reslizumab
Reslizumab 3mg/kg intravenous (IV)
Placebo
Matching placebo.
Placebo
Matching Placebo intravenous (IV)
Interventions
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Reslizumab
Reslizumab 3mg/kg intravenous (IV)
Placebo
Matching Placebo intravenous (IV)
Eligibility Criteria
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Inclusion Criteria
2. Willingness and ability to comply with the requirements of the study
3. Female or male patients ages 18-75 at the time of screening
4. A diagnosis of chronic rhinosinusitis according to the clinical practice guideline (update) of the American academy of otolaryngology - head and neck surgery
5. Elevated blood eosinophils
6. Significant findings on computed tomography (CT) scan
Exclusion Criteria
2. A woman that is pregnant or nursing a child
3. Known hypersensitivity to Reslizumab
4. Active cigarette smoking in the year prior to screening
5. Known underlying immunodeficiency
6. History of alcohol or drug abuse in the year prior to screening
Other criteria may apply. Please contact the investigator for more information
18 Years
75 Years
ALL
No
Sponsors
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Joshua S. Jacobs
OTHER
Responsible Party
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Joshua S. Jacobs
MD
Principal Investigators
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Joshua Jacobs, MD
Role: PRINCIPAL_INVESTIGATOR
Allergy and Asthma Clinical Research
Locations
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Allergy and Asthma Clinical Research
Walnut Creek, California, United States
Countries
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Central Contacts
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Study Coordinator
Role: CONTACT
Facility Contacts
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Role: primary
Other Identifiers
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AACR-01
Identifier Type: -
Identifier Source: org_study_id
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