Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.
NCT ID: NCT04157348
Last Updated: 2026-02-03
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
140 participants
INTERVENTIONAL
2019-10-29
2026-03-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Benralizumab arm
1x benralizumab SC injection + 3x placebo to mepolizumab SC injections
Benralizumab
30 mg/mL solution for injection in a single accessorized prefilled syringe (APFS) 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)
Mepolizumab arm
3x mepolizumab SC injections + 1x placebo to benralizumab SC injection
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 Benralizumab
Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
2. EGPA diagnosis based on history or presence asthma and eosinophilia (\>1.0x10\^9/L and/or \>10% of leucocytes) and at least 2 of; biopsy with eosinophilic vasculitis or perivascular/granulomatous inflammation; mono-or polyneuropathy, non-fixed pulmonary infiltrates, sino-nasal abnormality; cardiomyopathy; glomerulonephritis; alveolar haemorrhage; palpable purpura; anti neutrophil cytoplasmic anti-body (ANCA) positivity (Myeloperoxidase or proteinease 3).
3. History of relapsing (at least 1 confirmed EGPA relapse within last 2 years and \> 12 weeks prior to screening), or refractory (failure to attain remission, defined as BVAS=0 and oral corticosteroid (OCS) dose \<=7.5 mg/day of prednisolone or equivalent, following standard induction regimen for at least 3 months and within 6 months prior to screening, or recurrence of symptoms upon OCS tapering at any dose of ≥7.5 mg/day prednisolone or equivalent.
If induction with glucocorticoidsalone, patient must have failed to attain remission after 3 months and the glucocorticoid dose must be ≥15 mg/day prednisolone or equivalent for the 4 weeks prior to randomization.
4. Must be on a stable dose of oral prednisolone or prednisone of ≥7.5 mg/day (but not \>50mg/day) for at least 4 weeks prior to randomization.
5. If receiving immunosuppressive therapy (excluding cyclophosphamide) the dose must be stable for the 4 weeks prior to randomization and during the study (dose reductions for safety reasons will be permitted).
6. QTc(F)\<450 msec or QTc(F)\<480 msec for patients with bundle branch block.
7. Females of childbearing potential must use an acceptable method of birth control from randomization for at least 12 weeks after the last study drug administration.
Exclusion Criteria
2. Organ or life-threatening EGPA \< 3 months prior to screening
3. Currently pregnant or breastfeeding, or planning to become pregnant during study participation.
4. Current malignancy or history of malignancy, unless received curative therapy \>5 years ago, or \>1 year ago for basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix
5. An untreated or refractory helminth parasitic infection \< 24 weeks prior to screening
6. Unstable liver disease
7. Severe or clinically significant, uncontrolled cardiovascular disease
8. Other concurrent disease that may put the patient at risk, or may influence the results of the study, or the patients' ability to complete entire duration of the study
9. Chronic or ongoing infectious disease requiring systemic anti-infective treatment
10. Known immunodeficiency disorder or positive HIV test
11. Prior receipt of mepolizumab, reslizumab, dupilumab or benralizumab. Receipt of intravenous/intramuscular/subcutaneous corticosteroids within 4 weeks prior to randomization, receipt of omalizumab within 130 days prior to screening, rituximab within 6 months prior to screening (or B-cells not recovered), interferon-α or alemtuzumab within 6 months prior to screening, receipt of anti-tumor necrosis factor therapy within 12 weeks prior to screening or an investigational non-biologic product within 30 days or 5 half-lives prior to screening, whichever is longer. Receipt of any other marketed or investigational biologic products within 4 months or 5 half-lives prior to screening, whichever is longer.
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Wechsler, MD
Role: PRINCIPAL_INVESTIGATOR
National Jewish Health, 1400 Jackson St Denver, CO 80206
Locations
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Research Site
Denver, Colorado, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Rochester, Minnesota, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Great Neck, New York, United States
Research Site
New York, New York, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Denison, Texas, United States
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Seattle, Washington, United States
Research Site
Brussels, , Belgium
Research Site
Brussels, , Belgium
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Calgary, Alberta, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
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
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Hamburg, , Germany
Research Site
Kirchheim, , Germany
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Lübeck, , Germany
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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
Napoli, , Italy
Research Site
Roma, , Italy
Research Site
Torino, , Italy
Research Site
Chiba, , Japan
Research Site
Kita-gun, , Japan
Research Site
Sagamihara-shi, , Japan
Research Site
Sendai, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Cambridge, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Portsmouth, , United Kingdom
Countries
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References
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Wechsler ME, Nair P, Terrier B, Walz B, Bourdin A, Jayne DRW, Jackson DJ, Roufosse F, Borjesson Sjo L, Fan Y, Jison M, McCrae C, Necander S, Shavit A, Walton C, Merkel PA; MANDARA Study Group. Benralizumab versus Mepolizumab for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2024 Mar 7;390(10):911-921. doi: 10.1056/NEJMoa2311155. Epub 2024 Feb 23.
Serling-Boyd N, Wallace ZS. Management of primary vasculitides with biologic and novel small molecule medications. Curr Opin Rheumatol. 2021 Jan;33(1):8-14. doi: 10.1097/BOR.0000000000000756.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2023-510248-19-00
Identifier Type: OTHER
Identifier Source: secondary_id
2019-001832-77
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D3253C00001
Identifier Type: -
Identifier Source: org_study_id
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