A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      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 the 24-week
      treatment in patients with uncontrolled, severe asthma with an eosinophilic phenotype. A
      subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal
      polyps. The study design has been updated to include a 56-week open label ANDHI in Practice
      (ANDHI IP) sub study upon the completion of the 24-week double-blind period of the ANDHI
      study.
    

Detailed description: 
      This is a Phase IIIb, randomized, double-blind, placebo controlled, parallel group study
      designed to evaluate the efficacy and the safety of repeat dosing of benralizumab 30 mg
      subcutaneous (sc) versus placebo on top of standard of care asthma therapy in patients with
      severe uncontrolled asthma. Approximately 630 patients with peripheral blood eosinophil
      counts ≥150 cells/μL will be randomized 2:1 to receive benralizumab 30 mg sc or matched
      placebo for 24 weeks.

      After enrolment, eligible patients will enter an up to 42-day screening/run-in period.
      Patients who meet eligibility criteria will be randomized 2:1 on Day 0 to receive either
      benralizumab or placebo every 56 days (every 8 weeks) through Week 16, with end of treatment
      (EOT) at Day 168 (Week 24). At the completion of the 24-week doubleblind period of the ANDHI
      study, eligible patients in benralizumab and placebo arm may enter a 56-week open label
      period (ANDHI in Practice [ANDHI IP] substudy), in which concomitant asthma therapies will be
      tapered as directed by the protocol in those patients who achieve and maintain asthma control
      (defined as ACQ6 score <1.5 and no clinically significant asthma exacerbations that required
      a burst of systemic corticosteroid or a hospitalization due to asthma between reduction
      visits) with add-on benralizumab.
    

Intervention name(s): Benralizumab (Medi-563); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30mg Benralizumab administered as a subcutaneous injection at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days) In the open label ANDHI IP sub study, all patients will receive benralizumab subcutaneously at Day 168 (Week 24), Day 196 (Week 28), Day 224 (Week 32), Day 280 (Week 40), Day 336 (Week 48), Day 392 (Week 56), Day 448 (Week 64), and Day 504 (Week 72).; Placebo administered as a subcutaneous injection at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days)
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases; Additional relevant MeSH terms:; Asthma; Inflammation; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes