A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects With Inadequately Controlled, Severe Asthma

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

The primary objective of the study is to evaluate the effect of 3 dose levels of MEDI9929 (AMG 157) on asthma exacerbations in adult subjects with inadequately controlled, severe asthma.

Who is eligible to participate?

Inclusion Criteria: - Age 18 through 75 - BMI between 18-40 kg/m2 and weight greater than or equal 40 kg - Documented physician-diagnosed asthma - Subjects must have received a physician-prescribed asthma controller regimen with medium- or high-dose ICS plus LABA -If on asthma controller medications in addition to ICS plus LABA, the dose of the other asthma controller medications (leukotriene receptor inhibitors, theophylline, secondary ICS, LAMA, cromones, or maintenance oral prednisone or equivalent up to a maximum of 10 mg daily or 20 mg every other day for the maintenance treatment of asthma) must be stable. -Subjects must have a documented history of at least 2 asthma exacerbation events. Exclusion Criteria: - Diagnosis of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation and panic attacks, or other mimics of asthma. - Current smokers or subjects with a smoking history of ≥ 10 pack years - Former smokers with < 10 pack years must have stopped for at least 1 year to be eligible. - Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (eg, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome). - Evidence of active liver disease. - History of Cancer, except for basal cell carcinoma or insitu carcinoma of the cervix treated with apparent success with curative therapy or other malignancies are eligible provided that curative therapy was completed -Known history of active tuberculosis (TB) - History of anaphylaxis to any biologic therapy - Positive medical history for hepatitis B or C - Subject with HIV or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report.

Last updated:

5/13/2014

NCT ID:

NCT02054130

IRB Number:

13-008047