ANDHI placebo controlled & open label
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients with Severe Asthma Uncontrolled on Standard of Care Treatment (ANDHI).
Trial objective: Reduce asthma exacerbation and improve quality of life
Disease area: Severe asthma
CI/PI: Dr Pfeffer
Sponsor: Astra Zeneca
Funder: Astra Zeneca
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 800 patients with peripheral blood eosinophil counts ≥300 cells/μL will be randomized 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 1:1 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). The initial dose of benralizumab will be followed by a single loading dose of benralizumab 30 mg sc or placebo at Day 28 (Week 4) consistent with tested Phase III dosing regimen. This dose and regimen was previously confirmed to be effective in Phase III asthma studies with an overall safety profile similar to placebo, and conforms to the anticipated posology for regulatory approval. A follow-up (FU) visit for final safety assessment will be conducted at Day 182 (Week
Study design has been updated to include a 56-week open label ANDHI in Practice (ANDHI IP) substudy upon the completion of the 24-week double-blind period of the ANDHI study. Patients who do not participate in the open label ANDHI IP substudy, or who do not transition into the open label period will complete the follow-up (FU) Visit 12 for final safety assessment at Day 182 (Week 26). Patients who transition into the open label ANDHI IP substudy prior to the FU Visit 12, will receive the first open label dose of bebenralizumab at Visit 13 on Day 168 and complete the End of ANDHI IP Substudy (EOS) Visit 27 at week 80.
Sample size and duration
2 years/800 patients