A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered Benralizumab (MEDI-563).
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo; Benralizumab
Intervention description: A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.; A single dose of benralizumab (MEDI-563) 0.3 or 1 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
Intervention MeSH terms: Benralizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Benralizumab; MEDI-563; Asthma

Summary:

      The study will evaluate the effect of two intravenous dose regimens of benralizumab
      (MEDI-563) on the proportion of adult subjects with asthma exacerbations who required an
      urgent healthcare visit for treatment of an acute asthma exacerbation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged 18 to 60 years at the time of the administration of
             investigational product

          -  Written informed consent and Health Insurance Portability and Accountability Act
             (HIPAA) authorization (applies to covered entities in the US only) obtained from the
             subject/legal representative prior to performing any protocol-related procedures,
             including screening evaluations

          -  Physician-diagnosed asthma with a duration of greater than or equal to (>=) 2 years by
             medical chart or subject report

          -  Had an asthma exacerbation requiring urgent care in the year prior to screening

          -  Meets National Heart, Lung, and Blood Institute (NHLBI) for persistent asthma in the 3
             months prior to the current urgent healthcare visit

          -  Current asthma exacerbation that must have lasted >= 2 hours prior to arrival to the
             urgent healthcare setting

          -  Requires at least 2 treatments of inhaled bronchodilators for the current asthma
             exacerbation in the urgent healthcare setting or within the emergency medical system
             (EMS) for >= 1 hour

          -  Shows an FEV1 or PEF of not more than 70 percent (%) predicted after 1 hour of
             treatment of the current asthma exacerbation

          -  Women of child-bearing potential, unless surgically sterile (including tubal ligation)
             and/or at least 2 years post-menopausal, must have used 2 effective methods of
             avoiding pregnancy (including oral, transdermal, or implanted contraceptives,
             intrauterine device, female condom with spermicide, diaphragm with spermicide,
             cervical cap, abstinence, use of a condom with spermicide by the sexual partner, or
             sterile sexual partner) from screening through the end of the study (Day 84; Cessation
             of birth control after this point should be discussed with a responsible physician)

          -  Men, unless surgically sterile, must likewise practice 2 effective methods of birth
             control (condom with spermicide or abstinence) and must use such precautions from Day
             0 through Day 84

          -  Otherwise healthy by medical history and physical examination

          -  A chest x-ray that is normal for an asthmatic population and excludes alternative
             diagnosis per the investigation

          -  Ability to complete the follow-up period until Day 168 as required by protocol

          -  The investigator has determined that the subject is clinically stable and the FEV1, is
             >= 30% predicted prior to receiving investigational product on Day 0.

        Exclusion Criteria:

          -  Known history of allergy or reaction to any component of the investigational product
             formulation

          -  Acute illness other than asthma at the start of the study

          -  Fever more than (>) 38.6 degrees Celsius (C) (>101.5 degrees Fahrenheit [F])

          -  Current acute asthma attack is due to aspirin-induced asthma

          -  Current asthma episode is an anaphylactoid/anaphylactic reaction presenting with acute
             bronchospasm

          -  Evidence of clinically significant non-respiratory active infection, including ongoing
             chronic infection

          -  History or current prolonged diarrhea, abdominal pain, and/or blood and mucus in
             stools or have minor symptoms and have exposure to stream or lake water, been exposed
             to someone who has a parasitic infection (like a family member), or study subject has
             traveled outside the United States of America (USA) and/or Canada within the last year

          -  Use of immunosuppressive medication (except oral prednisone and inhaled and topical
             corticosteroids) within 30 days before randomization into the study

          -  Have received Xolair within 6 months before randomization into the study

          -  Receipt of immunoglobulin or blood products within 30 days before randomization into
             the study

          -  Receipt of any investigational drug therapy within 6 months before the first dose of
             investigational product in this study through Day 168

          -  History of primary immunodeficiency

          -  Previous medical history, or evidence, of an intercurrent illness that may compromise
             the safety of the subject in the study

          -  History of clinically significant abnormality on ECG in the opinion of the
             investigator

          -  Pregnancy (must have a negative serum pregnancy test prior to the first dose of
             investigational product)

          -  Breastfeeding or lactating woman

          -  History of treatment for alcohol or drug abuse within the past year

          -  Diagnosis of chronic obstructive pulmonary disease (COPD) by a healthcare professional

          -  Evidence of any clinically significant systemic disease on physical examination

          -  History of cancer except basal cell carcinoma or in situ carcinoma of the cervix
             treated with apparent success with curative therapy >1 year prior to entry or other
             malignancies treated with apparent success with curative therapy >5 years prior to
             entry

          -  Known exposure to inhaled occupational agents or fumes with an established diagnosis
             of occupational asthma

          -  Any condition (that is, impending ventilatory failure or hemodynamic compromise) that,
             in the opinion of the investigator, would interfere with evaluation of the
             investigational product or interpretation of study results

          -  Any employee of the clinical study site who is involved with the conduct of the study

          -  History of cigarette smoking >20 pack years

          -  Previously received benralizumab (MEDI-563)

          -  Asthma exacerbation due to acute inhalational exposure.