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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 6 October 2020
Main ID:  JPRN-JapicCTI-195049
Date of registration: 26/11/2019
Prospective Registration: Yes
Primary sponsor: AstraZeneca KK
Public title: MANDARA
Scientific title: A Randomized, 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
Date of first enrolment: 24/12/2019
Target sample size: 6
Recruitment status: recruiting
URL:  https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-195049
Study type:  INTERVENTIONAL
Study design:  Randomized, Parallel Assignment, Triple  
Phase:  3
Countries of recruitment
Japan, North America, Europe
Contacts
Name: AstraZeneca KK Clinical Trial Information   
Address:  -
Telephone: -
Email: RD-clinical-information-Japan@astrazeneca.com
Affiliation: 
Name: AstraZeneca KK Clinical Trial Information   
Address:  -
Telephone: -
Email: RD-clinical-information-Japan@astrazeneca.com
Affiliation: 
Key inclusion & exclusion criteria
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 or more 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 or more 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 or more (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.

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 signing the informed consent 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 and through randomisation.

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 antiinfective 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-alpha 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.


Age minimum: 18
Age maximum:
Gender: BOTH
Health Condition(s) or Problem(s) studied
Eosinophilic Granulomatous Vasculitis
Intervention(s)
Intervention name : Biological: Benralizumab, Biological: Placebo to Mepolizumab
INN of the intervention : -
Dosage And administration of the intervention : 1x benralizumab SC injection + 3x placebo to mepolizumab SC injections
Control intervention name : Biological: Mepolizumab, Biological: Placebo to Benralizumab
INN of the control intervention : -
Dosage And administration of the control intervention : 3x mepolizumab SC injections + 1x placebo to benralizumab SC injection
Primary Outcome(s)
efficacy
-
Secondary Outcome(s)
safety, efficacy, exploratory, pharmacokinetics
-
Secondary ID(s)
NCT04157348
Source(s) of Monetary Support
-
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 12/11/2019
Contact:
-
NHO sagamihara hospital IRB
-
-
Results
Results available:
Date Posted:
Date Completed:
URL:
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