Effect of Reslizumab in Chronic Rhinosinusitis | NCT02799446

Studies
Effect of Reslizumab in Chronic Rhinosinusitis

NCT02799446

Sponsor

Joshua S. Jacobs

Status

Unknown status

Last Update Posted

Feb 1, 2018Actual

Enrollment

30Estimated

Phase

Phase 3

Conditions

Sinusitis

Interventions

Reslizumab
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Jul 2019Estimated

Completion Date

Jul 2019Estimated

First Submitted Date

Jun 10, 2016

First Submission Date that Met QC Criteria

Jun 10, 2016

First Posted Date

Jun 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2018

Last Update Posted Date

Feb 1, 2018Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reslizumab	Experimental	Reslizumab will be administered intravenously every 4 weeks at a dose of 3mg/kg.	Drug: Reslizumab
Placebo	Placebo Comparator	Matching placebo.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reslizumab	Drug	Reslizumab 3mg/kg intravenous (IV)	Reslizumab
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in computed tomography (CT) score		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Quality of life questionnaire		24 weeks
Smell test		24 weeks
Endoscopy score

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Study Coordinator	Contact	925-935-2599

Overall Officials

Name	Affiliation	Role
Joshua Jacobs, MD	Allergy and Asthma Clinical Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allergy and Asthma Clinical Research	Recruiting	Walnut Creek	California	94598	United States

Condition Browse Module

MeSH Terms

ID	Term
D012852	Sinusitis
D012220	Rhinitis
D000096825	Rhinosinusitis
D000092122	Bronchiolitis Obliterans Syndrome

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010254	Paranasal Sinus Diseases
D009668	Nose Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C515492	reslizumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided