Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-24 @ 1:05 PM
NCT ID:
NCT01238861
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01238861
Study Brief:
Protocol Section:
NCT01238861