drugset / Trial / NCT04157348

Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.

Phase 3 Active not recruiting 140 enrolled AstraZeneca

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, double blind, active-controlled, parallel group, multicenter 52-week Phase 3 study to compare the efficacy and safety of benralizumab 30 mg versus mepolizumab 300 mg administered by subcutaneous (SC) injection in patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy. All patients who complete the 52-week double-blind treatment period on IP may be eligible to continue into an open label extension (OLE) period. The OLE period is intended to allow each patient at least 1 year of treatment with open-label benralizumab 30 mg administered SC (earlier enrolled patients may therefore be in the OLE for longer than 1 year).

Timeline

Start: 2019-10-29
Primary completion: 2023-08-10
Completion: 2026-11-30

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

paper showing noninferiority but not superiority of benralizumab to mepolizumab. reads as mixed primary results PMID 38393328 ↗

registry analysis (superiority test); Benralizumab 30 mg vs Mepolizumab 300 mg; difference in remission rates 0.0544 (95% CI -0.0746 to 0.1834); Regression, Logistic reads as mixed primary results NCT04157348 ↗

release “Positive high-level results from the MANDARA Phase III trial showed AstraZeneca’s Fasenra (benralizumab) met the primary endpoint of the trial” reads as met primary endpoint astrazeneca.com ↗

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Benralizumab	Monoclonal antibody	30 mg	Subcutaneous
Comparator	Mepolizumab	Monoclonal antibody	300 mg	Subcutaneous