Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.
Condition(s) studied
Investigational drug(s) / intervention(s)
Benralizumab: 30 mg/mL solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC)
Mepolizumab: 3x100 mg vials of powder for solution for injection reconstituted into 3 separate 1 mL syringes for administration on each dosing occasion. Injection volume per syringe is 1 mL. Mepolizumab active solution will be administered subcutaneously (SC)
Placebo to Mepolizumab: Matching placebo: 0.9% sodium chloride, solutions for injection in 1mL syringes (3 syringes will be used on each dosing occasion). Injection volume per syringe is 1mL. Placebo to Mepolizumban will be administered subcutaneously (SC)
Placebo to Benralizumab: Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC)
Study 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).
Eligibility
Primary outcome measure(s)
- Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48 — Week 36 and Week 48
Percentage of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 4 mg/day (main remission definition) at both Weeks 36 and 48. - Supportive Endpoint: Proportion of Subjects Who Achieved Supportive Remission at Both Weeks 36 and 48 — Week 36 and Week 48
Supportive endpoint: Proportion of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 7.5 mg/day (supportive remission definition) at both Weeks 36 and 48.
Trial sites (50)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Denver | Colorado | |
| Research Site | Ann Arbor | Michigan | |
| Research Site | Rochester | Minnesota | |
| Research Site | Albuquerque | New Mexico | |
| Research Site | Great Neck | New York | |
| Research Site | New York | New York | |
| Research Site | Philadelphia | Pennsylvania | |
| Research Site | Denison | Texas | |
| Research Site | Seattle | Washington | |
| Research Site | Brussels | Belgium | |
| Research Site | Brussels | Belgium | |
| Research Site | Calgary | Alberta | |
| Research Site | Hamilton | Ontario | |
| Research Site | Toronto | Ontario | |
| Research Site | Toronto | Ontario | |
| Research Site | Dijon | France | |
| Research Site | Marseille | France | |
| Research Site | Montpellier | France | |
| Research Site | Nantes | France | |
| Research Site | Paris | France | |
| Research Site | Paris | France | |
| Research Site | Suresnes | France | |
| Research Site | Toulouse | France | |
| Research Site | Bamberg | Germany | |
| Research Site | Freiburg im Breisgau | Germany | |
| Research Site | Hamburg | Germany | |
| Research Site | Kirchheim | Germany | |
| Research Site | Lübeck | Germany | |
| Research Site | Ashkelon | Israel | |
| Research Site | Beersheba | Israel | |
| Research Site | Jerusalem | Israel | |
| Research Site | Ramat Gan | Israel | |
| Research Site | Rehovot | Israel | |
| Research Site | Tel Aviv | Israel | |
| Research Site | Cuneo | Italy | |
| Research Site | Florence | Italy | |
| Research Site | Milan | Italy | |
| Research Site | Milan | Italy | |
| Research Site | Naples | Italy | |
| Research Site | Roma | Italy |
+ 10 more sites — see the full list on the official registry below.
More AstraZeneca trials in Japan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04157348 on ClinicalTrials.gov ↗ ← All trials in Japan