Protocol Summary for 112997
| Protocol Id: | 112997 |
| Secondary Ids: |
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| Title: | A multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to determine the effect of mepolizumab on exacerbation rates in subjects with severe uncontrolled refractory asthma |
| Phase: | phase 2 |
| Acronym: | DREAM |
| FDA Regulated Intervention?: | Yes |
| Section 801 Clinical Trial?: | Yes |
| Delayed Posting: | No |
| IND/IDE Protocol?: | yes |
| IND/IDE Grantor: | CDER |
| IND/IDE Number: | 006971 |
| IND/IDE Serial Number: | |
| Has Expanded Access?: | no |
| Study Type: | Interventional |
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| Brief Summary: | The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma despite receiving high doses of standard asthma medications. The study will look at different doses of mepolizumab in comparison to a placebo. |
| Detailed Description: | A double-blind, placebo-controlled study to evaluate the efficacy, safety and pharmacodynamics of three doses (75 mg, 250 mg and 750 mg) of mepolizumab intravenous (i.v.) administered every 4 weeks compared with placebo over a 52-week treatment period in subjects with severe uncontrolled refractory asthma. Efficacy will be measured by the frequency of asthma exacerbations. In addition lung function, rescue medication usage, daily symptoms, asthma control score, asthma quality of life score and withdrawals due to asthma exacerbations will be assessed. Safety will be assessed by adverse events, clinical laboratory evaluations, ECGs, immunogenicity and vital signs. Pharmacodynamics will be assessed by eosinophil levels in blood, serum IL-5 and eosinophil levels in induced sputum. |
| Record Verification Date: | November 2012 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | November 2009 |
| Study Completion Date: | March 2012 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | December 2011 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | treatment |
| Allocation: | Randomized |
| Masking: | Double Blind |
| Masked Subject: | yes |
| Masked Caregiver: | yes |
| Masked Investigator: | yes |
| Masked Assessor: | yes |
| Study Design (Assignment): | Parallel Assignment |
| Study Classification (Endpoint): | Safety/Efficacy Study |
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| Eligibility Criteria: | 
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 12 Year |
| Maximum Age: | 65 Year |
| Enrollment: | 621 |
| Enrollment Type: | Actual |
| 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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