Protocol Summary for 114092
| Protocol Id: | 114092 |
| Secondary Ids: |
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| Title: | A multicenter, open-label, dose ranging study to determine the pharmacokinetics and pharmacodynamics of mepolizumab administered intravenously or subcutaneously to adult asthmatic subjects with elevated blood eosinophil levels |
| Phase: | phase 2 |
| Acronym: | |
| FDA Regulated Intervention?: | Yes |
| Section 801 Clinical Trial?: | Yes |
| Delayed Posting: | No |
| IND/IDE Protocol?: | yes |
| IND/IDE Grantor: | CBER |
| IND/IDE Number: | 006971 |
| IND/IDE Serial Number: | |
| Has Expanded Access?: | no |
| Study Type: | Interventional |
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| Brief Summary: | A multi-center, randomized, open-label, parallel-group, repeat dose study in asthma patients with elevated eosinophils. Eligible subjects will receive 3 doses (28 days apart) of mepolizumab given intravenous (IV) or subcutaneously (SC). Blood samples for safety, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity analysis, as well as safety/tolerability assessments will be collected throughout the study |
| Detailed Description: | Mepolizumab (SB-240563) is a humanized monoclonal antibody that blocks human interleukin 5 (IL-5) from binding to its receptor. Mepolizumab is currently under development for severe refractory asthma and a Phase IIB dose-ranging study using the IV route of administration is currently on-going. This study will be a multi-center, randomized, open-label, parallel-group, repeat dose study conducted in approximately 65 subjects with established asthma and elevated blood eosinophil levels. Dosing will occur on three occasions, every four weeks [Day 1, Day 28 (+/- 3 days) and Day 56 (+/- 3 days)]. Blood samples for safety, pharmacodynamics (PD), pharmacokinetics (PK) and immunogenicity analysis, as well safety and tolerability assessments will be collected/assessed throughout the study. Each subject will participate in the study for up to approximately 22 weeks, including screening, dosing and follow-up. |
| Record Verification Date: | October 2011 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | November 2011 |
| Study Completion Date Type: | Anticipated |
| Estimated Primary Completion Date: | October 2011 |
| Primary Completion Date Type: | Anticipated |
| Primary Purpose: | treatment |
| Allocation: | Randomized |
| Masking: | Open Label |
| Masked Subject: | no |
| Masked Caregiver: | no |
| Masked Investigator: | no |
| Masked Assessor: | no |
| Study Design (Assignment): | Parallel Assignment |
| Study Classification (Endpoint): | Pharmacodynamics Study |
| Primary Outcomes: |
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| Keywords: |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 18 Year |
| Maximum Age: | 65 Year |
| Enrollment: | 70 |
| Enrollment Type: | Anticipated |
| Healthy Volunteers?: | none |
| Central Contact: | Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
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| Overall Study Official: | GSK Clinical Trials |
| Overall Study Official Affiliation: | GlaxoSmithKline |
| Overall Study Official Role: | Study Director |
| Responsible Party Name/Official Title: | Cheri Hudson; Clinical Disclosure Advisor |
| Responsible Party Organization: | GSK Clinical Disclosure |
| Location and Contact Information: |
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Click to view inclusion/exclusion criteria