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Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.
Sponsor: AstraZeneca
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).
Official title: A Randomised, Double-blind, Active-controlled 52-week Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab Compared to Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Patients Receiving Standard of Care Therapy (MANDARA Study)
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2019-10-29
Completion Date
2026-03-31
Last Updated
2026-02-03
Healthy Volunteers
No
Conditions
Interventions
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)
Locations (50)
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Denver, Colorado, United States
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Ann Arbor, Michigan, United States
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Rochester, Minnesota, United States
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Albuquerque, New Mexico, United States
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Great Neck, New York, United States
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New York, New York, United States
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Philadelphia, Pennsylvania, United States
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Denison, Texas, United States
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Seattle, Washington, United States
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Brussels, Belgium
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Brussels, Belgium
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Calgary, Alberta, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Dijon, France
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Marseille, France
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Montpellier, France
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Nantes, France
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Paris, France
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Paris, France
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Suresnes, France
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Toulouse, France
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Bamberg, Germany
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Freiburg im Breisgau, Germany
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Hamburg, Germany
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Kirchheim, Germany
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Lübeck, Germany
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Ashkelon, Israel
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Beersheba, Israel
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Jerusalem, Israel
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Ramat Gan, Israel
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Rehovot, Israel
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Tel Aviv, Israel
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Cuneo, Italy
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Florence, Italy
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Milan, Italy
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Milan, Italy
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Naples, Italy
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Roma, Italy
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Torino, Italy
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Chiba, Japan
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Kita-gun, Japan
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Sagamihara-shi, Japan
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Sendai, Japan
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Shinjuku-ku, Japan
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Cambridge, United Kingdom
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Leicester, United Kingdom
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London, United Kingdom
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Portsmouth, United Kingdom