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To study the effectiveness and safety of multiple-doses of MEDI-528 on asthma control in adult participants with uncontrolled, moderate-to-severe, persistent asthma.
Full description
The primary objective of this study is to evaluate the effect of multiple-dose subcutaneous (SC) administration of MEDI-528 on asthma control in adults with uncontrolled, moderate-to-severe, persistent asthma.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria
Subjects must meet all of the following criteria:
Male or female
Age 18 through 65 years at the time of screening
Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Female subjects of childbearing potential who are sexually active with non-sterilized male partner must use adequate contraception from screening through the end of the study. An acceptable method of contraception is defined as one that has no higher than a 1% failure rate. Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception
Weight ≥ 45 kg but ≤ 120 kg and body mass index (BMI) between 18 and 35 kg/m2
Physician-diagnosed asthma by medical chart
Currently taking inhaled corticosteroids (ICS) or is a candidate to receive ICS per Expert Panel Report (EPR)-3
Pre-bronchodilator forced expiratory volume in 1 second (FEV1) value ≥ 40% at Day -28 and Day 1
A post-bronchodilator increase in FEV1 and/or FVC ≥ 12% and ≥ 200 mL at Day -28 OR meeting any one of the following criteria:
Uncontrolled asthma consistent with EPR-3. In the 28 days before screening, subjects should have a history of one or more of the following:
An Asthma Control Questionnaire (ACQ) score ≥ 1.5 at Day -28 and at Day 1.
At least one asthma exacerbation in the 12 months before screening that required intake of systemic corticosteroids after an unscheduled medical encounter or as agreed with a physician based on an asthma action plan that defines when oral steroids can be taken by the subject
Ability and willingness to complete the follow-up period through Day 323 as required by the protocol.
Exclusion Criteria
Any of the following would exclude the subject from participation in the study:
Primary purpose
Allocation
Interventional model
Masking
329 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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