A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma


About this study

The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during 24-week treatment in patients with uncontrolled, severe asthma with eosinophilic inflammation. A subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal polyps.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Female and male patients aged 18 to 75 years inclusively at the time of Visit 1 with a history of physician-diagnosed asthma requiring treatment with medium-to-high dose Inhaled Corticosteroids (ICS) plus asthma controller, for at least 12 months prior to Visit 1.
  2. Documented current treatment with high daily doses of ICS plus at least one other asthma controller for at least 3 months prior to Visit 1.
  3. History of at least 2 asthma exacerbations while on ICS plus another asthma controller that required treatment with systemic corticosteroids (IM, IV, or oral) in the 12 months prior to Visit 1.
  4. ACQ6 score ≥1.5 at Visit 1.
  5. Screening pre-bronchodilator (pre-BD) FEV1 of <80% predicted at Visit 2 and airway reversibility (FEV1 ≥12%) demonstrated at Visit 2 or Visit 3.
  6. Peripheral blood eosinophil count of ≥300 cells/μL assessed by central laboratory at Visit 1 or Visit 2.

Exclusion Criteria:

  1. Clinically important pulmonary disease other than asthma
  2. Acute upper or lower respiratory infections within 30 days prior to the date informed consent.
  3. A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy.
  4. History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.
  5. A history of known immunodeficiency disorder.
  6. Current smokers or former smokers with a smoking history of ≥10 pack years.
  7. Previously received benralizumab (MEDI-563).
  8. Receipt of any investigational medication as part of a research study within approximately 5 half-lives prior to randomization.
  9. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.
  10. Receipt of live attenuated vaccines 30 days prior to the date of randomization; other types of vaccines are allowed.
  11. Concurrent enrolment in another interventional or post-authorization safety study

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

John Hagan, M.D.

Closed for enrollment

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