Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.

  • STATUS
    Recruiting
  • End date
    Jan 27, 2024
  • participants needed
    140
  • sponsor
    AstraZeneca
Updated on 15 September 2021
corticosteroids
remission
cyclophosphamide
prednisone
immunosuppressive agents
steroid therapy
corticosteroid therapy
cardiomyopathy
immunosuppression
vasculitis
asthma
mepolizumab
purpura
granulomatosis
eosinophilia
anca
nasal abnormality
oral prednisolone

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).

Details
Condition Churg-Strauss Syndrome
Treatment benralizumab, Mepolizumab, Placebo to Mepolizumab, Placebo to Benralizumab
Clinical Study IdentifierNCT04157348
SponsorAstraZeneca
Last Modified on15 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female subjects age 18 years or older
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)
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
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. Stable doses of OCS other than prednisolone or prednisone may be acceptable, but must be discussed with the AstraZeneca study physician
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)
QTc(F)<450 msec or QTc(F)<480 msec for patients with bundle branch block
Females of childbearing potential must use an acceptable method of birth control from signing the informed consent for at least 12 weeks after the last study drug administration

Exclusion Criteria

Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
Organ or life-threatening EGPA < 3 months prior to screening and through randomisation
Currently pregnant or breastfeeding, or planning to become pregnant during study participation
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
An untreated or refractory helminth parasitic infection < 24 weeks prior to screening
Unstable liver disease
Severe or clinically significant, uncontrolled cardiovascular disease
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
Chronic or ongoing infectious disease requiring systemic antiinfective treatment
Known immunodeficiency disorder or positive HIV test
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- or alemtuzumab within 6 months prior to screening, receipt of anti-tumor necrosis factor therapy within 12 weeks prior to screening, receipt of of any other marketed or investigational biologic products within 4 months or 5 half-lives prior to screening, whichever is longer . Or receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to screening (V1), whichever is longer, prior to screening
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