Recruiting
Phase 3

Reslizumab

Sponsor:

Joshua S. Jacobs

Code:

NCT02799446

Conditions

Sinusitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Reslizumab

Placebo

Study Details

Brief summary:

The purpose of this study is to determine whether Reslizumab is effective for the treatment of chronic sinusitis.

Conditions

Sinusitis

Study ID

NCT02799446

Start date

Jun, 2016

Status verified date

Jan, 2018

Completion date

Jul, 2019

Anticipated

Primary completion date

Jul, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Written informed consent
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:

1. Unable to sign informed consent form
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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Reslizumab

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

placebo comparator: Placebo

Matching placebo.

Interventions

Reslizumab

Reslizumab 3mg/kg intravenous (IV)

Placebo

Matching Placebo intravenous (IV)

Primary outcome measure

  • Change in computed tomography (CT) score [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Study Coordinator

925-935-2599

Locations

Allergy and Asthma Clinical Research

Recruiting

Walnut Creek, California, United States, 94598

Contacts

925-935-2599

More Information

Sponsor

Joshua S. Jacobs

Last update posted

Feb 1, 2018

Last verified

Jan, 2018

Keywords

  • sinusitis, rhinitis, rhinosinusitis, chronic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Joshua S. Jacobs on 2018-02-01.