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Clinical Trials in the UK / NCT04157348
Active, not recruiting Phase 3

Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.

NCT04157348 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2019-10-29
Last updated
2026-08-12

Condition(s) studied

Eosinophilic Granulomatous Vasculitis

Investigational drug(s) / intervention(s)

BenralizumabMepolizumabPlacebo to MepolizumabPlacebo to Benralizumab

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

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female subjects age 18 years or older. 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: 1. Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) 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.

Primary outcome measure(s)

Trial sites (50)

FacilityCityRegionStatus
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.

On this site

📄 Fasenra (benralizumab) drug profile → 📄 Nucala (mepolizumab) drug profile →

More AstraZeneca trials in the UK

Official registry record

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 the UK