Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo; MEDI9929 70 mg; MEDI9929 210 mg; MEDI9929 280 mg
Intervention description: Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.; Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.; Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.; Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 584.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 through 75

          -  Body mass index (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 inhaled
             corticosteroids (ICS) plus long acting β2 agonist (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, long-acting
             anti-muscarinics (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 OR at least 1 severe asthma exacerbation resulting in
             hospitalization within the 12 months prior to first study visit.

        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 human immunodeficiency virus (HIV) or subject taking antiretroviral
             medications, as determined by medical history and/or subject's verbal report.