Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.

Key facts

Study ID

NCT01238861

Run by

MedImmune LLC

People needed

964

Starts

2010-12-01

Expected to finish

2013-08-01

Last updated by the study team

2016-11-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — Orange, California, United States
• Research Site — San Diego, California, United States
• Research Site — Stockton, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Denver, Colorado, United States
• Research Site — Waterbury, Connecticut, United States
• Research Site — Kissimmee, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Stockbridge, Georgia, United States
• Research Site — Normal, Illinois, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Bellevue, Nebraska, United States
• Research Site — Summit, New Jersey, United States
• Research Site — Rochester, New York, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Blue Bell, Pennsylvania, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Warwick, Rhode Island, United States
• Research Site — Boerne, Texas, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.