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Protocol Summary for 114092

Protocol Summary
Protocol Id: 114092
Secondary Ids:
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
Oversight Authority:
  • France: Afssaps - French Health Products Safety Agency
  • United States: Food and Drug Administration
  • Estonia: State Agency of Medicines
  • Germany: Pau-Ehrlich Institute
Collaborators:
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:
  • Area under the blood eosinophil time curve (AUC) 140 days
  • time to maximum change in blood eosinophil levels (Tmaxeos) 140 days
  • maximum change from baseline in blood eosinophils (Emax) 140 days
  • terminal half-life (t½) of mepolizumab 140 days
  • time to Cmax (Tmax) of mepolizumab 140 days
  • time to 50% eosinophil repletion (Trep) 140 days
  • Area under the plasma-concentration time curve (AUC) of mepolizumab 140 days
  • Change from baseline in blood eosinophil levels 140 days
  • maximum plasma concentration (Cmax) of mepolizumab 140 days
Secondary Outcomes:
  • change from baseline in electrocardiogram (ECG) 140 days
  • change from baseline in clinical laboratory 140 days
  • area under the curve (AUC) of mepolizumab 140 days
  • Spontaneous and elicited adverse events (AEs) 140 days
  • change from baseline in vital signs 140 days
  • Levels of anti-mepolizumab antibodies 140 days
  • maximum plasma concentration (Cmax) of mepolizumab 140 days
Conditions:
  • Asthma
Keywords:
Eligibility Criteria: Click to view inclusion/exclusion 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
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
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: Click to view location information