Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients With Mild to Moderate Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Benralizumab; Placebo
Intervention description: Benralizumab administered subcutaneously every 4 weeks; Placebo administered subcutaneously every 4 weeks
Intervention MeSH terms: Benralizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 211.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases,

Summary:

      The purpose of this trial is to confirm the safety and clinical benefit of benralizumab
      administration in asthma patients with mild to moderate persistent asthma in order to gain an
      understanding of the benefit/risk of benralizumab across the spectrum of asthma disease.
    

Eligibility criteria:

        Inclusion Criteria:

        Written informed consent for study participation must be obtained prior to any study
        related procedures being performed and according to international guidelines and/or
        applicable European Union (EU) guidelines.

          -  Female and male aged 18 to 75 years, inclusively, at the time of Visit 1.

          -  Weight of ≥40 kg.

          -  Evidence of asthma as documented by post-bronchodilator (post-BD) reversibility in
             FEV1 of ≥ 12% demonstrated at Visit 2.

          -  Documented use of 1 of the following types of asthma therapy at time of informed
             consent: Low- to medium-dose ICS (ie, 100 to 500 μg fluticasone dry powder formulation
             equivalents total daily dose) with or without other controller medications, eg, an
             LTRA and/or theophylline or Low-dose ICS/LABA fixed combination therapy (eg, the
             lowest regular maintenance dose approved in the local country will meet this
             criterion)

          -  Morning pre-bronchodilator (pre-BD) FEV1 of > 50% to ≤ 90% predicted at Visit 2.

        Exclusion Criteria:

          -  Clinically important pulmonary disease other than asthma (eg, active lung infection,
             COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome
             associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary
             ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other
             than asthma, that are associated with elevated peripheral eosinophil counts (eg,
             allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome,
             hypereosinophilic syndrome).

          -  Any disorder, including, but not limited to, cardiovascular, gastrointestinal,
             hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic,
             hematological, psychiatric, or major physical impairment that is not stable in the
             opinion of the Investigator and could:

          -  Affect the safety of the patient throughout the study

          -  nfluence the findings of the studies or their interpretations,- Impede the patient's
             ability to complete the entire duration of study.

          -  Known history of allergy or reaction to the investigational product formulation.

          -  History of anaphylaxis to any biologic therapy.- History of Guillain-Barré syndrome.

          -  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.- Acute upper or lower respiratory infections requiring
             antibiotics or antiviral medication within 30 days prior to the date informed consent
             is obtained or during the screening/run-in period.

          -  Any clinically significant abnormal findings in physical examination, vital signs,
             hematology, clinical chemistry, or urinalysis during screening period, which in the
             opinion of the Investigator, may put the patient at risk because of his/her
             participation in the study, or may influence the results of the study, or the
             patient's ability to complete entire duration of the study.

          -  Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a
             positive medical history for hepatitis B or C. Patients with a history of hepatitis B
             vaccination without history of hepatitis B are allowed to enroll.

          -  A history of known immunodeficiency disorder including a positive human
             immunodeficiency virus (HIV) test.

          -  History of cancer:

          -  Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the
             skin or in situ carcinoma of the cervix are eligible provided that the patient is in
             remission and curative therapy was completed at least 12 months prior to the date
             informed consent was obtained.

          -  Patients who have had other malignancies are eligible provided that the patient is in
             remission and curative therapy was completed at least 5 years prior to the date
             informed consent was obtained