Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab. (MANDARA)
Primary Purpose
Eosinophilic Granulomatous Vasculitis
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Benralizumab
Mepolizumab
Placebo to Mepolizumab
Placebo to Benralizumab
Sponsored by
About this trial
This is an interventional treatment trial for Eosinophilic Granulomatous Vasculitis focused on measuring Benralizumab, Inhaled corticosteroids, Eosinophilic Granulomatous Vasculitis
Eligibility Criteria
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-α 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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Benralizumab arm
Mepolizumab arm
Arm Description
1x benralizumab SC injection + 3x placebo to mepolizumab SC injections
3x mepolizumab SC injections + 1x placebo to benralizumab SC injection
Outcomes
Primary Outcome Measures
Proportion of patients who are in remission at both weeks 36 and 48
Patients must be in remission at both of these timepoints of weeks 36 and 48.
Main definition: Remission is defined as BVAS=0 and OCS dose ≤ 4mg/day. Supportive definition: Remission is defined by BVAS =0 and OCS dose ≤ 7.5 mg/day.
Analysis will be repeated based on main and supportive remission definitions.
Secondary Outcome Measures
Number of patients in each category of accrued duration of remission
The categories of accrued duration of remission are: 0 wk, >0 to <12 wk, 12 to <24 wk, 24 to <36 wk, ≥36 wk. Analysis will be repeated based on main and supportive remission definitions.
Time from randomisation to first EGPA relapse
Relapse is defined as any of the following:
Active vasculitis (BVAS >0); OR
Active asthma symptoms and/or signs with a corresponding worsening in ACQ-6 score; OR
Active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions
warranting any of the following:
an increase of OCS therapy (>4mg prednisolone total daily dose or equivalent);
an increased dose or addition of an immunosuppressive agent;
Hospitalisation related to EGPA worsening.
Based on the average daily prednisolone/prednisone dose during Weeks 48 through 52:
Proportion of patients in each category of average daily prednisolone/prednisone dose during Weeks 48 through 52 using the following categories: 0 mg; > 0 to ≤4 mg; > 4 to ≤ 7.5 mg and > 7.5 mg.
Proportion of patients in each category of percent reduction from baseline: no reduction or withdrawal from treatment; < 25% reduction; 25 to < 50% reduction; 50 to < 75% reduction; 75 to < 100% reduction; 100% reduction.
Proportion of patients with ≥ 50% reduction from baseline.
Proportion of patients with 100% reduction from baseline.
Proportion of patients with ≤ 4 mg in average daily dose.
Proportion of patients who have achieved any clinical benefit when meeting any of the criteria below. Proportion of patients who have achieved complete response when meeting all of the criteria below.
Remission (defined as BVAS = 0 and prednisolone/prednisone dose ≤ 4 mg/day) at any time during the double-blind treatment period
≥ 50% reduction in average daily prednisolone/prednisone dose during Weeks 48 through 52
EGPA relapse free during the double-blind treatment period. Analysis will be repeated for the supportive remission definition.
Annualized relapse rate
Proportion of patients who have achieved remission within the first 24 weeks and remained in remission for remainder of the double-blind treatment period
Analysis will be repeated based on main and supportive remission definitions.
Change from baseline in VDI
Vasculitis Damage Index (VDI)
Vasculitis Damage Index measures accrued damage across 11 organ systems since diagnosis. Total score is sum of all systems and ranges from 0 to 64 with higher scores indicating more damage.
Change from baseline in BVAS
Birmingham Vasculitis Activity Score (BVAS)
Birmingham Vasculitis Activity Score (BVAS) measures vasculitis disease activity across 9 organ systems. Total score is sum of the weighted organ scores and ranges from 0 to 63 with higher scores indicating higher disease activity.
Change from baseline in pulmonary function
As measured by Forced vital capacity (FVC) and Forced Expiratory Volume during first second (FEV1), unit L
Change from baseline in ACQ-6
Asthma Control Questionnaire (6-item version) (ACQ-6 )
The 6 items in ACQ-6 have a 7-point scale ranging from 0=no impairment to 6=maximum impairment. The ACQ-6 score is calculated by taking the mean of the 6 equally weighted items ranging from 0=well controlled to 6=extremely poorly controlled. Higher scores indicate worse disease control.
Change from baseline in sino-nasal symptoms (SSQ)
Sino-nasal Symptoms Questionnaire (SSQ)
SSQ captures 5 different sino-nasal symptoms over the previous week as scored as none, mild, moderate, severe, or very severe. Higher scores indicate greater severity.
Change from baseline in SNOT-22
Sino-nasal Outcome Test-22 (SNOT-22)
The 22 items in SNOT-22 have a 6-point scale ranging from 0=no problem to 5=problem as bad as it can be. The total score is the sum of item scores and has a range from 0 to 110. Higher scores indicate poorer outcomes.
Change from baseline in SF-36v2
Short Form 36-item health survey (version 2, acute recall) (SF-36v2)
The short form 36-item health survey, version 2 (SF-36v2) is a 36-item, self-report survey of functional health and well-being. The assessment yields 8-domain profile consisting of the following: Physical functioning (PF), role limitations due to physical health (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH). Psychometrically-based physical and mental health component summary scores (PCS and MCS, respectively) are computed from subscale scores to give a broader metric of physical and mental health-related quality of life. The score range is 0 to 100 with higher scores indicating better health status.
Change from baseline in PGIS
Patient Global Impression of Severity (PGIS)
PGIS is a 6-point categorical response scale ranging from 0=no symptoms to 6= very severe symptoms. Higher scores indicate worse severity.
Change from baseline in WPAI
Work productivity and Activity Impairment Questionnaire (WPAI)
WPAI consists of 6 questions regarding absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment. WPAI outcomes are scored as impairment percentages, with a higher percentage indicating greater impairment and less productivity.
Change from baseline in blood eosinophil counts
Proportion of PGIC responders at each weekly assessment
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC) measures the patient´s overall impression of response to treatment since the initial dose using a 7-point scale ranging from "much better", "about the same" to "much worse". Lower scores indicate better health status.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04157348
Brief Title
Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.
Acronym
MANDARA
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 29, 2019 (Actual)
Primary Completion Date
August 10, 2023 (Actual)
Study Completion Date
September 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Granulomatous Vasculitis
Keywords
Benralizumab, Inhaled corticosteroids, Eosinophilic Granulomatous Vasculitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Benralizumab arm
Arm Type
Experimental
Arm Description
1x benralizumab SC injection + 3x placebo to mepolizumab SC injections
Arm Title
Mepolizumab arm
Arm Type
Active Comparator
Arm Description
3x mepolizumab SC injections + 1x placebo to benralizumab SC injection
Intervention Type
Biological
Intervention Name(s)
Benralizumab
Intervention Description
30 mg/mL solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC)
Intervention Type
Biological
Intervention Name(s)
Mepolizumab
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
Placebo to Mepolizumab
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
Placebo to Benralizumab
Intervention Description
Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC)
Primary Outcome Measure Information:
Title
Proportion of patients who are in remission at both weeks 36 and 48
Description
Patients must be in remission at both of these timepoints of weeks 36 and 48.
Main definition: Remission is defined as BVAS=0 and OCS dose ≤ 4mg/day. Supportive definition: Remission is defined by BVAS =0 and OCS dose ≤ 7.5 mg/day.
Analysis will be repeated based on main and supportive remission definitions.
Time Frame
week 36 and week 48
Secondary Outcome Measure Information:
Title
Number of patients in each category of accrued duration of remission
Description
The categories of accrued duration of remission are: 0 wk, >0 to <12 wk, 12 to <24 wk, 24 to <36 wk, ≥36 wk. Analysis will be repeated based on main and supportive remission definitions.
Time Frame
Up to 52 weeks
Title
Time from randomisation to first EGPA relapse
Description
Relapse is defined as any of the following:
Active vasculitis (BVAS >0); OR
Active asthma symptoms and/or signs with a corresponding worsening in ACQ-6 score; OR
Active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions
warranting any of the following:
an increase of OCS therapy (>4mg prednisolone total daily dose or equivalent);
an increased dose or addition of an immunosuppressive agent;
Hospitalisation related to EGPA worsening.
Time Frame
During first 52 weeks
Title
Based on the average daily prednisolone/prednisone dose during Weeks 48 through 52:
Description
Proportion of patients in each category of average daily prednisolone/prednisone dose during Weeks 48 through 52 using the following categories: 0 mg; > 0 to ≤4 mg; > 4 to ≤ 7.5 mg and > 7.5 mg.
Proportion of patients in each category of percent reduction from baseline: no reduction or withdrawal from treatment; < 25% reduction; 25 to < 50% reduction; 50 to < 75% reduction; 75 to < 100% reduction; 100% reduction.
Proportion of patients with ≥ 50% reduction from baseline.
Proportion of patients with 100% reduction from baseline.
Proportion of patients with ≤ 4 mg in average daily dose.
Time Frame
week 48 through week 52
Title
Proportion of patients who have achieved any clinical benefit when meeting any of the criteria below. Proportion of patients who have achieved complete response when meeting all of the criteria below.
Description
Remission (defined as BVAS = 0 and prednisolone/prednisone dose ≤ 4 mg/day) at any time during the double-blind treatment period
≥ 50% reduction in average daily prednisolone/prednisone dose during Weeks 48 through 52
EGPA relapse free during the double-blind treatment period. Analysis will be repeated for the supportive remission definition.
Time Frame
Up to 52 weeks
Title
Annualized relapse rate
Time Frame
Over first 52 weeks
Title
Proportion of patients who have achieved remission within the first 24 weeks and remained in remission for remainder of the double-blind treatment period
Description
Analysis will be repeated based on main and supportive remission definitions.
Time Frame
Up to 52 weeks
Title
Change from baseline in VDI
Description
Vasculitis Damage Index (VDI)
Vasculitis Damage Index measures accrued damage across 11 organ systems since diagnosis. Total score is sum of all systems and ranges from 0 to 64 with higher scores indicating more damage.
Time Frame
Up to 52 weeks
Title
Change from baseline in BVAS
Description
Birmingham Vasculitis Activity Score (BVAS)
Birmingham Vasculitis Activity Score (BVAS) measures vasculitis disease activity across 9 organ systems. Total score is sum of the weighted organ scores and ranges from 0 to 63 with higher scores indicating higher disease activity.
Time Frame
Up to 52 weeks
Title
Change from baseline in pulmonary function
Description
As measured by Forced vital capacity (FVC) and Forced Expiratory Volume during first second (FEV1), unit L
Time Frame
Up to 52 weeks
Title
Change from baseline in ACQ-6
Description
Asthma Control Questionnaire (6-item version) (ACQ-6 )
The 6 items in ACQ-6 have a 7-point scale ranging from 0=no impairment to 6=maximum impairment. The ACQ-6 score is calculated by taking the mean of the 6 equally weighted items ranging from 0=well controlled to 6=extremely poorly controlled. Higher scores indicate worse disease control.
Time Frame
Up to 52 weeks
Title
Change from baseline in sino-nasal symptoms (SSQ)
Description
Sino-nasal Symptoms Questionnaire (SSQ)
SSQ captures 5 different sino-nasal symptoms over the previous week as scored as none, mild, moderate, severe, or very severe. Higher scores indicate greater severity.
Time Frame
Up to 52 weeks
Title
Change from baseline in SNOT-22
Description
Sino-nasal Outcome Test-22 (SNOT-22)
The 22 items in SNOT-22 have a 6-point scale ranging from 0=no problem to 5=problem as bad as it can be. The total score is the sum of item scores and has a range from 0 to 110. Higher scores indicate poorer outcomes.
Time Frame
Up to 52 weeks
Title
Change from baseline in SF-36v2
Description
Short Form 36-item health survey (version 2, acute recall) (SF-36v2)
The short form 36-item health survey, version 2 (SF-36v2) is a 36-item, self-report survey of functional health and well-being. The assessment yields 8-domain profile consisting of the following: Physical functioning (PF), role limitations due to physical health (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH). Psychometrically-based physical and mental health component summary scores (PCS and MCS, respectively) are computed from subscale scores to give a broader metric of physical and mental health-related quality of life. The score range is 0 to 100 with higher scores indicating better health status.
Time Frame
Up to 52 weeks
Title
Change from baseline in PGIS
Description
Patient Global Impression of Severity (PGIS)
PGIS is a 6-point categorical response scale ranging from 0=no symptoms to 6= very severe symptoms. Higher scores indicate worse severity.
Time Frame
Up to 52 weeks
Title
Change from baseline in WPAI
Description
Work productivity and Activity Impairment Questionnaire (WPAI)
WPAI consists of 6 questions regarding absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment. WPAI outcomes are scored as impairment percentages, with a higher percentage indicating greater impairment and less productivity.
Time Frame
Up to 52 weeks
Title
Change from baseline in blood eosinophil counts
Time Frame
Up to 52 weeks
Title
Proportion of PGIC responders at each weekly assessment
Description
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC) measures the patient´s overall impression of response to treatment since the initial dose using a 7-point scale ranging from "much better", "about the same" to "much worse". Lower scores indicate better health status.
Time Frame
Up to 4 weeks
Other Pre-specified Outcome Measures:
Title
Numbers of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Minimum of 52 weeks
Title
Change from baseline in systolic and diastolic blood pressure
Time Frame
Minimum of 52 weeks
Title
Change from baseline in pulse rate
Time Frame
Minimum of 52 weeks
Title
Change from baseline in hematology parameters of hemoglobin, leukocytes, lymphocytes, monocytes, basophils, eosinophils, neutrophils, and platelets
Time Frame
Minimum of 52 weeks
Title
Change from baseline in clinical chemistry parameters of Alanine Aminotransferase (ALT), alkaline phosphatase, Aspartate Aminotransferase (AST), creatinine kinase, indirect and total bilirubin, creatinine and glucose
Time Frame
Minimum of 52 weeks
Title
Overall interpretation of ECG by Investigator
Description
Triplicate measurements of 12-lead electrocardiograms recorded at rest.
Time Frame
Minimum of 52 weeks
Title
Serum benralizumab concentration as a measure of pharmacokinetics
Time Frame
Minimum of 52 weeks
Title
Anti-drug antibodies (ADA) titers as measure of immunogenicity
Time Frame
Minimum of 52 weeks
Title
Cumulative OCS use
Description
Total OCS use (measured in mg) as measured by sum of all daily prednisolone/prednisone doses, over the 52-week double-blind treatment period.
Time Frame
Up to 52 weeks
Title
Number of EGPA related hospitalisations
Time Frame
Up to 52 weeks
Title
Length of hospital stay
Time Frame
Up to 52 weeks
Title
ICU (Intensive Care Unit) days
Time Frame
Up to 52 weeks
Title
Number of EGPA related ER visits
Time Frame
Up to 52 weeks
Title
Number of EGPA related outpatient visits
Time Frame
Up to 52 weeks
Title
Number of EGPA related procedures/tests (by specific procedure/test)
Time Frame
Up to 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
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 anti-infective 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-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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Wechsler, MD
Organizational Affiliation
National Jewish Health, 1400 Jackson St Denver, CO 80206
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Research Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Research Site
City
Denison
State/Province
Texas
ZIP/Postal Code
75020
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Research Site
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1E2
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
Research Site
City
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Facility Name
Research Site
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Research Site
City
Montpellier
ZIP/Postal Code
34090
Country
France
Facility Name
Research Site
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Research Site
City
Suresnes Cedex
ZIP/Postal Code
92151
Country
France
Facility Name
Research Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Research Site
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Facility Name
Research Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Research Site
City
Kirchheim
ZIP/Postal Code
73230
Country
Germany
Facility Name
Research Site
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Research Site
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Research Site
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Research Site
City
Ramat Gan
Country
Israel
Facility Name
Research Site
City
Rehovot
ZIP/Postal Code
7661041
Country
Israel
Facility Name
Research Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Research Site
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50141
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10128
Country
Italy
Facility Name
Research Site
City
Chiba-shi
ZIP/Postal Code
260-0877
Country
Japan
Facility Name
Research Site
City
Kita-gun
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Research Site
City
Sagamihara-shi
ZIP/Postal Code
228-0815
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Research Site
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Research Site
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SE19RT
Country
United Kingdom
Facility Name
Research Site
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD Sharing URL
https://vivli.org/
Citations:
PubMed Identifier
33164993
Citation
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.
Results Reference
derived
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D3253C00001&attachmentIdentifier=f1ea6ab0-2192-44ba-9851-0549ffaf44a1&fileName=MANDARA_Poster_V2.0.pdf&versionIdentifier=
Description
This is a poster.
Learn more about this trial
Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.
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