Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
Lead Sponsor:
MedImmune LLC
Collaborating Sponsors:
MedImmune Ltd
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.
Detailed Description
This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of multiple-dose (7 doses) subcutaneous administration of benralizumab (MEDI-56...
Eligibility Criteria
Inclusion
- Age 18 through 75 years at the time of screening
- Adequate contraception from screening through end of trial
- Weight of more than (\>) 45 kilogram (kg) but less than or equal to (\<=) 150 kg (\>100 pound \[lb\] but \<=330 lb)
- History of physician-diagnosed asthma for at least 12 months prior to screening
- Physician prescribed daily use of medium-dose or high-dose inhaled corticosteroid(s) (ICS) plus long-acting beta 2 agonist (LABA) for at least 12 months prior to screening
- Willingness to switch to an ICS/LABA combination product
- Dose of other asthma controller medications must be stable for at least 30 days prior to screening
- At least 2 documented asthma exacerbations in the 12 months prior to screening that required use of a systemic corticosteroid burst
- For subjects 65 years of age or older, a chest x-ray (CXR) or chest computed tomography (CT) that is normal for an asthmatic population
- Ability and willingness to complete the study to Week 66, and if needed to Week 92.
Exclusion
- Known history of allergy or reaction to any component of the investigational product formulation
- History of anaphylaxis to any biologic therapy
- Unexplained diarrhea within 30 days prior to screening or diagnosis of helminth parasitic infestation within 6 months prior to screening
- Use of immunosuppressive medication within 3 months prior to screening. Chronic oral prednisone or equivalent up to 10 milligram (mg) daily or 20 mg every other day for asthma is allowed
- Oral corticosteroid burst or short-acting systemic corticosteroid within 30 days prior to screening or during the screening/run-in period
- Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to the screening or during the screening/run-in period
- Receipt of immunoglobulin or blood products within 30 days prior to screening
- Receipt of any marketed or investigational biologic within 4 months or 5 half-lives prior to screening, whichever is longer
- Receipt of any investigational nonbiologic within 30 days or 5 half-lives prior to screening, whichever is longer
- Previously received MEDI-563
- Any clinically relevant abnormal findings in physical examination
- Past history of clinically significant cardiac disease or any electrocardiogram (ECG) abnormality
- Breastfeeding or lactating women
- History of alcohol or drug abuse within 12 months prior to screening
- History of any known primary immunodeficiency disorder
- Positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enrol
- A positive human immunodeficiency virus (HIV) test or subject taking antiretroviral medications
- History of cigarette smoking more than or equal to (\>=) 10 pack-years or smoking within 12 months prior to screening.
- Known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma
- History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy \>=12 months prior to screening or other malignancies treated with apparent success with curative therapy \>=5 years prior to screening
- Stable dose of allergy vaccination regimen for less than 30 days prior to screening
- Subjects unable to demonstrate acceptable inhaler and peak flow meter techniques.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
964 Patients enrolled
Trial Details
Trial ID
NCT01238861
Start Date
December 1 2010
End Date
August 1 2013
Last Update
November 17 2016
Active Locations (74)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Los Angeles, California, United States
3
Research Site
Orange, California, United States
4
Research Site
San Diego, California, United States