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Werkzaamheid en veiligheid van Benralizumab in EGPA in vergelijking met Mepolizumab. (MANDARA)

26 oktober 2026 bijgewerkt door: AstraZeneca

Een gerandomiseerde, dubbelblinde, actief gecontroleerde studie van 52 weken met een open-label verlenging om de werkzaamheid en veiligheid van benralizumab te evalueren in vergelijking met mepolizumab bij de behandeling van eosinofiele granulomatose met polyangiitis (EGPA) bij patiënten die standaardbehandeling krijgen

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).

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

140

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • België
      • Brussels, België, 1090
        • Research Site
      • Brussels, België, 1070
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Research Site
      • Toronto, Ontario, Canada, M5G 1E2
        • Research Site
      • Toronto, Ontario, Canada, M5T 3A9
        • Research Site
  • Duitsland
      • Bamberg, Duitsland, 96049
        • Research Site
      • Freiburg im Breisgau, Duitsland, 79106
        • Research Site
      • Hamburg, Duitsland, 20251
        • Research Site
      • Kirchheim, Duitsland, 73230
        • Research Site
      • Lübeck, Duitsland, 23538
        • Research Site
  • Frankrijk
      • Dijon, Frankrijk, 21079
        • Research Site
      • Marseille, Frankrijk, 13915
        • Research Site
      • Montpellier, Frankrijk, 34090
        • Research Site
      • Nantes, Frankrijk, 44093
        • Research Site
      • Paris, Frankrijk, 75014
        • Research Site
      • Paris, Frankrijk, 75877
        • Research Site
      • Suresnes, Frankrijk, 92151
        • Research Site
      • Toulouse, Frankrijk, 31059
        • Research Site
  • Israël
      • Ashkelon, Israël, 7830604
        • Research Site
      • Beersheba, Israël, 84101
        • Research Site
      • Jerusalem, Israël, 91120
        • Research Site
      • Ramat Gan, Israël, 52621
        • Research Site
      • Rehovot, Israël, 7661041
        • Research Site
      • Tel Aviv, Israël, 6423906
        • Research Site
  • Italië
      • Cuneo, Italië, 12100
        • Research Site
      • Florence, Italië, 50141
        • Research Site
      • Milan, Italië, 20132
        • Research Site
      • Milan, Italië, 20162
        • Research Site
      • Naples, Italië, 80131
        • Research Site
      • Roma, Italië, 00168
        • Research Site
      • Torino, Italië, 10128
        • Research Site
  • Japan
      • Chiba, Japan, 260-0877
        • Research Site
      • Kita-gun, Japan, 761-0793
        • Research Site
      • Sagamihara-shi, Japan, 228-0815
        • Research Site
      • Sendai, Japan, 980-8574
        • Research Site
      • Shinjuku-ku, Japan, 162-8666
        • Research Site
  • Verenigd Koninkrijk
      • Cambridge, Verenigd Koninkrijk, CB2 0QQ
        • Research Site
      • Leicester, Verenigd Koninkrijk, LE3 9QP
        • Research Site
      • London, Verenigd Koninkrijk, SE19RT
        • Research Site
      • Portsmouth, Verenigd Koninkrijk, PO6 3LY
        • Research Site
  • Verenigde Staten
    • Colorado
      • Denver, Colorado, Verenigde Staten, 80206
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • Research Site
    • Minnesota
      • Rochester, Minnesota, Verenigde Staten, 55905-0001
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87106
        • Research Site
    • New York
      • Great Neck, New York, Verenigde Staten, 11021
        • Research Site
      • New York, New York, Verenigde Staten, 10021
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • Research Site
    • Texas
      • Denison, Texas, Verenigde Staten, 75020
        • Research Site
    • Washington
      • Seattle, Washington, Verenigde Staten, 98115
        • Research Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 130 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Benralizumab arm

1x benralizumab SC injection + 3x placebo to mepolizumab SC injections
Biologisch: Benralizumab

30 mg/mL solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC)

Biologisch: 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)
Actieve vergelijker: Mepolizumab arm

3x mepolizumab SC injections + 1x placebo to benralizumab SC injection
Biologisch: 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)

Biologisch: Placebo to Benralizumab

Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48
Tijdsspanne: Week 36 and Week 48

Percentage of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 4 mg/day (main remission definition) at both Weeks 36 and 48.
Week 36 and Week 48
Supportive Endpoint: Proportion of Subjects Who Achieved Supportive Remission at Both Weeks 36 and 48
Tijdsspanne: Week 36 and Week 48

Supportive endpoint: Proportion of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 7.5 mg/day (supportive remission definition) at both Weeks 36 and 48.
Week 36 and Week 48

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Total Accrued Duration of Remission During DB Treatment Period
Tijdsspanne: from baseline to end of DB period, 52 Weeks.

Total accrued duration of remission for the following categories: 0 week, > 0 to < 12 week, 12 to < 24 week, 24 to < 36 week, ≥ 36 week.
from baseline to end of DB period, 52 Weeks.
Total Accrued Duration of Sustained Remission During DB Treatment Period
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Total accrued duration of sustained remission for the following categories: 0 week, > 0 to < 12 week, 12 to < 24 week, 24 to < 36 week, ≥ 36 week.
from baseline to end of DB period, 52 Weeks
Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Time from randomization to first Eosinophilic Granulomatosis with Polyangiitis (EGPA) relapse, where 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 increased dose of OCS therapy to > 4 mg/day prednisolone total daily dose; OR
  • An increased dose or addition of immunosuppressive therapy; OR
  • Hospitalization related to EGPA worsening Calculated using the Kaplan-Meier technique.
from baseline to end of DB period, 52 Weeks
Annualized Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse Rate
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Annualized Eosinophilic Granulomatosis with Polyangiitis (EGPA) relapse rate through end of DB treatment period. The estimate of annualized relapse rate (relapses per year) and the corresponding 95% CIs were calculated using a negative binomial model. The response variable in the model is the number of relapses experienced by a subject up to Week 52. The logarithm of the subject's corresponding follow-up time up to Week 52 was used as an offset variable to adjust for subjects having different follow-up times during which the events occur. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.
from baseline to end of DB period, 52 Weeks
Average Daily Dose of Prednisolone/Prednisone and Change From Baseline During Week 48 Through 52
Tijdsspanne: last 4 weeks of DB period

Average daily dose of prednisolone/prednisone and change from baseline during Week 48 through 52, or last 28 days prior to last double-blind assessment for those that withdrew
last 4 weeks of DB period
Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
Tijdsspanne: last 4 weeks of DB period

Proportion of patients with average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: 0 mg; >0 to ≤ 4 mg; > 4 to ≤ 7.5 mg and > 7.5 mg
last 4 weeks of DB period
Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
Tijdsspanne: last 4 weeks of DB period

Percentage reduction from baseline in average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: no reduction or withdrawal from treatment; < 25% reduction; 25 to < 50% reduction; 50 to <75% reduction; 75 to < 100% reduction; 100% reduction.
last 4 weeks of DB period
Proportion of Subjects With Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
Tijdsspanne: last 4 weeks of DB period

Proportion of subjects with reduction from baseline in average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: >= 50% reduction; 100% reduction; OCS dose <= 4 mg/day.
last 4 weeks of DB period
Proportion of Subjects Who Achieve Clinical Benefit
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Proportion of subjects who achieved any clinical benefit definition 1 (defined as any of the following:

  • Main remission at any time in DB period
  • >= 50% reduction in OCS dose in Weeks 48 to 52
  • EGPA relapse free in DB period) and subjects who achieved complete response definition 1 (defined as meeting all the definition 1 criteria above.)
from baseline to end of DB period, 52 Weeks
Proportion of Patients Who Have Achieved Remission Within the First 24 Weeks and Remained in Remission for Remainder of the Double-blind Treatment Period
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Proportion of patients who have achieved remission within the first 24 weeks and remained in remission for remainder of the double-blind treatment period
from baseline to end of DB period, 52 Weeks
Change From Baseline in Birmingham Vasculitis Activity Score (BVAS)
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Birmingham Vasculitis Activity Score (BVAS) change from baseline by timepoint up to week 52. The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The total score on all 9 organ systems gives an indication of the disease activity of each patient at the time of scoring. Total scores range from 0 to 63, with higher scores indicating more active vasculitis.
from baseline to end of DB period, 52 Weeks
Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L)
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Pre-bronchodilator (BD) Forced Expiratory Volume during first second (FEV1) change from baseline by timepoint up to week 52
from baseline to end of DB period, 52 Weeks
Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L)
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Pre-bronchodilator (BD) Forced vital capacity (FVC) change from baseline by timepoint up to week 52
from baseline to end of DB period, 52 Weeks
Change From Baseline in Vasculitis Damage Index (VDI)
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Vasculitis Damage Index (VDI) change from baseline by timepoint up to week 52. The VDI is divided into 11 organ systems and records items of damage, due to vasculitis, treatment or unrelated, that have occurred since the onset of vasculitis. Completion of the form provides a numerical score, ranging from 0 to 64, with a higher score indicating more damage.
from baseline to end of DB period, 52 Weeks
Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6)
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Asthma Control Questionnaire (6-item version) (ACQ-6) change from baseline by timepoint up to week 52. The ACQ-6 score is calculated by taking the mean of 6 equally weighted domains, with a range of 0 (well controlled) to 6 (extremely poorly controlled).
from baseline to end of DB period, 52 Weeks
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS)
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Short Form 36-item health survey (version 2, acute recall) (SF-36v2) component Physical Component Summary (PCS) change from baseline by timepoint up to week 52. PCS score ranges from 10.8 to 75.5, where a higher score indicates better health.
from baseline to end of DB period, 52 Weeks
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS)
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Short Form 36-item health survey (version 2, acute recall) (SF-36v2) component Mental Component Summary (MCS) change from baseline by timepoint up to week 52. MCS score ranges from 5.6 to 69.7, where a higher score indicates better health.
from baseline to end of DB period, 52 Weeks
Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Sino-nasal Outcome Test-22 (SNOT-22) total score change from baseline by timepoint up to week 52. Patient reported symptom severity and symptom impact over the previous 2 weeks on 22 items are captured via a 6-point scale (0 = no problem to 5 = problem as bad as it can be). The total score is the sum of item scores and ranges from 0 to 110 (higher scores indicate poorer outcomes).
from baseline to end of DB period, 52 Weeks
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Sino-nasal Symptoms Questionnaire (SSQ) scores : symptom runny nose by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe).
from baseline to end of DB period, 52 Weeks
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Sino-nasal Symptoms Questionnaire (SSQ) scores : symptom Post-nasal discharge by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe).
from baseline to end of DB period, 52 Weeks
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Sino-nasal Symptoms Questionnaire (SSQ) scores: symptom Facial pain/pressure by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe).
from baseline to end of DB period, 52 Weeks
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Sino-nasal Symptoms Questionnaire (SSQ) scores: symptom Loss or reduction in sense of taste/smell by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe).
from baseline to end of DB period, 52 Weeks
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Sino-nasal Symptoms Questionnaire (SSQ) scores: symptom Blockage/congestion of nose by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe).
from baseline to end of DB period, 52 Weeks
Patient Global Impression of Severity (PGIS) Category
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Patient Global Impression of Severity (PGIS) category by timepoint
from baseline to end of DB period, 52 Weeks
Patient Global Impression of Change (PGIC) Category
Tijdsspanne: from baseline to week 4

Patient Global Impression of Change (PGIC) category by timepoint
from baseline to week 4
WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%)
Tijdsspanne: from baseline to end of DB period, 52 Weeks

The Work Productivity and Activity Impairment questionnaire (WPAI-GH) has 6 questions which address absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (a higher percentage indicating greater impairment and less productivity). Subscale: Absenteeism (work time missed) (%) score, range 0-100.
from baseline to end of DB period, 52 Weeks
WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100.
Tijdsspanne: from baseline to end of DB period, 52 Weeks

The Work Productivity and Activity Impairment questionnaire (WPAI-GH) has 6 questions which address absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (a higher percentage indicating greater impairment and less productivity). Presenteeism (%) score.
from baseline to end of DB period, 52 Weeks
WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%)
Tijdsspanne: from baseline to end of DB period, 52 Weeks

The Work Productivity and Activity Impairment questionnaire (WPAI-GH) has 6 questions which address absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (a higher percentage indicating greater impairment and less productivity). Work productivity loss (%) score, range 0-100.
from baseline to end of DB period, 52 Weeks
WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%)
Tijdsspanne: from baseline to end of DB period, 52 Weeks

The Work Productivity and Activity Impairment questionnaire (WPAI-GH) has 6 questions which address absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (a higher percentage indicating greater impairment and less productivity). Activity impairment (%) score, range 0-100.
from baseline to end of DB period, 52 Weeks
Absolute Eosinophil Count, Change From Baseline
Tijdsspanne: from baseline to end of DB period, 52 Weeks

Absolute eosinophil count, change from baseline by timepoint up to week 52
from baseline to end of DB period, 52 Weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AstraZeneca

Onderzoekers

  • Hoofdonderzoeker: Michael Wechsler, MD, National Jewish Health, 1400 Jackson St Denver, CO 80206

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

29 oktober 2019

Primaire voltooiing (Werkelijk)

10 augustus 2023

Studie voltooiing (Geschat)

30 november 2026

Studieregistratiedata

Eerst ingediend

29 september 2019

Eerst ingediend dat voldeed aan de QC-criteria

5 november 2019

Eerst geplaatst (Werkelijk)

8 november 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 november 2026

Laatste update ingediend die voldeed aan QC-criteria

26 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • D3253C00001
  • 2019-001832-77 (EudraCT-nummer)
  • 2023-510248-19-00 (Andere identificatie: EU Trial (CTIS) Number)
  • 2023 (Subsidie/contract van de Amerikaanse NIH)
  • 2019 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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