A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to High-dose Inhaled Corticosteroid Plus Long-acting Beta2 Agonist in Patients With Uncontrolled Asthma
Latest Information Update: 13 Jul 2023
At a glance
- Drugs Benralizumab (Primary)
- Indications Asthma
- Focus Registrational; Therapeutic Use
- Acronyms SIROCCO
- Sponsors AstraZeneca
- 24 May 2023 Results of an analysis assessing rates of clinical remission after treatment with benralizumab in patients with SEA with or without CRSwNP from 5 clinical studies (SIROCCO, CALIMA, ZONDA, ANDHI and PONENTE) presented at the 119th International Conference of the American Thoracic Society
- 24 May 2023 Meta analysis from NCT01000506, NCT01691521, NCT01287039, NCT01285323, NCT01928771, and NCT01914757, presented at the 119th International Conference of the American Thoracic Society
- 14 Mar 2022 Results of post-hoc pooled analysis assessing composite remission definition to characterize individual responses to benralizumab after 6 and 12 months in 3 phase III studies (SIROCCO (NCT01928771); CALIMA (NCT01914757); ZONDA (NCT02075255)) were published in the Advances in Therapy.
Most Recent Events
Trial Overview
Outcome
Purpose
This study compared the efficacy and tolerability of benralizumab (arm A vs arm B) in reducing the number of asthma exacerbations in patients with asthma who remain uncontrolled despite high doses of inhaled corticosteroids + long-acting β2 agonists.
Comments
Health Canada has approved Fasenra (benralizumab injection) as an add-on maintenance treatment for adult patients with severe eosinophilic asthma, based on results from the WINDWARD clinical program.
Based on the data from SIROCCO CALIMA and ZONDA, US Food and Drug Administration (FDA) has approved FASENRA™ (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. The European Commission (EC) has also approved Fasenra (benralizumab) as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists. In January 2018, Fasnera has been approved by the Japanese Ministry of Health, Labour and Welfare.
SIROCCO is a pivotal study in the phase III Windward programme for benralizumab for severe uncontrolled asthma. Other studies in the programme include CALIMA, PAMPERO, ZONDA and BORA [see trial profiles 700235439, 700237155, 700241858 and 700238596]. The data from ZONDA, SIROCCO and CALIMA trials were included in regulatory submission for benralizumab which is under regulatory review in the US, EU, Japan and several other countries with a US PDUFA data in the fourth quarter of 2017.
Primary Endpoints
To evaluate the effect of 2 dosing regimens of benralizumab on asthma exacerbations in adult patients with uncontrolled asthma
safety issue: No
Time Frame: Immediately following the first administration of study drug through Study Week 48
Description: Annual asthma exacerbation rate [1]
Other Endpoints
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL
description: The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF
time_frame: Immediately following the first administration of study drug through Study Week 48.
Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations
description: The annual exacerbation rate associated with an emergency room visit or a hospitalization (adjudicated)
time_frame: Immediately following the first administration of study drug through Study Week 48.
Number of Patients With ≥1 Asthma Exacerbations
time_frame: Immediately following the first administration of study drug through Study Week 48.
Time to First Asthma Exacerbation
time_frame: Immediately following the first administration of study drug through Study Week 48.
Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils ≥300/uL
time_frame: Immediately following the first administration of study drug through Study Week 48.
Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL
time_frame: Immediately following the first administration of study drug through Study Week 48.
Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils ≥300/uL
description: Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
time_frame: Immediately following the first administration of study drug through Study Week 48.
Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL
description: Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
time_frame: Immediately following the first administration of study drug through Study Week 48.
Change in Asthma Rescue Medication
description: Change from baseline to week 48 in number of rescue medication use (puffs/day)
time_frame: Immediately following the first administration of study drug through Study Week 48.
Home Lung Function Assessment Based on Morning PEF
description: Change from baseline to week 48 in home lung function morning peak expiratory flow [PEF]
time_frame: Immediately following the first administration of study drug through Study Week 48.
Home Lung Function Assessment Based on Evening PEF
description: Change from baseline to week 48 in home lung function evening peak expiratory flow [PEF]
time_frame: Immediately following the first administration of study drug through Study Week 48.
Proportion of Night Awakening Due to Asthma
description: Change from baseline to Week 48 on proportion of night awakening due to asthma
time_frame: Immediately following the first administration of study drug through Study Week 48.
Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils ≥300/uL
description: ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of ≤0.75 indicates well-controlled asthma, scores between 0.75 to ≤1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
time_frame: Immediately following the first administration of study drug through Study Week 48.
Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL
description: ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of ≤0.75 indicates well-controlled asthma, scores between 0.75 to ≤1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
time_frame: Immediately following the first administration of study drug through Study Week 48.
Pharmacokinetics of Benralizumab
description: Mean PK concentrations at each visit
time_frame: Baseline, week 4, week 4 day 6, week 8, week 16, week 24, week 32, week 40, week 48, week 56
Immunogenicity of Benralizumab
description: Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at ≥2 post baseline assessments (with ≥16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive.
time_frame: Pre-treatment until end of follow-up
Extend of Exposure
description: Extend of exposure is defined as duration of treatment in days
time_frame: Immediately following the first administration of study drug through Study Week 48.
Mean Change From Baseline to Week 48 in AQLQ(S)+12
description: AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of ≥0.5 are considered clinically meaningful.
time_frame: Immediately following the first administration of study drug through Study Week 48.
Mean Change From Baseline to Week 48 in EQ-5D-5L VAS
description: EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.
time_frame: Immediately following the first administration of study drug through Study Week 48.
Mean Work Productivity Loss Due to Asthma
description: WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. The work productivity loss is only applicable to patients who employed, which is only subset of the study population.
time_frame: Immediately following the first administration of study drug through Study Week 48.
Mean Productivity Loss Due to Asthma in Classroom
description: WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable to patients who attending classes
time_frame: Immediately following the first administration of study drug through Study Week 48.
Number of Participants That Utilized Health Care Resources
time_frame: Immediately following the first administration of study drug through Study Week 48.
Patient and Clinician's Responder Assessment to Treatment
description: CGIC (Clinical global impression of change), and PGIC (Patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse). This is additional measures collected after second Amendment, thus not all patients had data to be analyzed.
time_frame: Immediately following the first administration of study drug through Study Week 48 [2]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| Asthma | treatment | disease exacerbations, severe |
Biomarker
| NCT Number | Biomarker Name | Biomarker Function |
|---|---|---|
| NCT01928771 | alpha-1 antitrypsin (SERPINA1) | Eligibility Criteria |
| COPD | Eligibility Criteria |
Subjects
- Subject Type patients
-
Number
Planned: 2681
Actual: 1204
- Sex male & female
- Age Group 12-75 years; adult; elderly
Patient Inclusion Criteria
1. Written informed consent for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent[s]/guardian[s]) and according to international guidelines and/or applicable European Union guidelines. 2. Female and Male aged 12 to 75 years inclusively, at the time of visit 1. For those patients, who are 17 on the day of Visit 1 but will turn 18 after this day, will be considered an adolescent for the purposes of this trial. 3. History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1 4. Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers. - For subjects 18 years of age and older, the ICS dose must be >500 mcg/day fluticasone propionate dry powder formulation or equivalent daily. - For subjects ages 12-17, the ICS dose must be ≥500 mcg /day fluticasone propionate dry powder formulation or equivalent daily.
Patient Exclusion Criteria
1. Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome) 2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: - Affect the safety of the patient throughout the study - Influence the findings of the studies or their interpretations - Impede the patient's ability to complete the entire duration of study 3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period 4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| D3250C00017 | AstraZeneca |
| NCT01928771 | ClinicalTrials.gov: US National Institutes of Health |
| CCRN2018 | Comprehensive Clinical Research Network |
| EudraCT2013-002345-11 | European Clinical Trials Database |
| 14-000876 | Mayo Clinic |
| P020-2014 | Paediatric Investigation Plan EMA Decision number |
| P018-2015 | Paediatric Investigation Plan EMA Decision number |
| P126-2013 | Paediatric Investigation Plan EMA Decision number |
| 15202 | United Kingdom Clinical Research Network |
Organisations
- Sponsors AstraZeneca
- Affiliations AstraZeneca
Trial Dates
-
Initiation Dates
Planned : 01 Sep 2013
Actual : 19 Sep 2013
-
Primary Completion Dates
Planned : 01 Apr 2016
Actual : 05 Apr 2016
-
End Dates
Planned : 01 Apr 2016
Actual : 05 Apr 2016
Substudies/Extensions
This trial contains an ECG Sub-study:
The main Safety Objective is to assess the safety and tolerability of 2 dosing regimens of benralizumab. The sub-study will be conducted in a sub group of approximately 150 adult patients at dedicated centers using dedicated, vendor-supplied equipment.
Other Details
- Design double-blind; multicentre; parallel; prospective; randomised
- Phase of Trial Phase III
- Location Australia; Brazil; Bulgaria; Czech Republic; England; France; Italy; Mexico; Peru; Poland; Russia; Scotland; South Africa; South Korea; Spain; Turkey; United Kingdom; USA; Vietnam
- Focus Registrational; Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| BenralizumabPrimary Drug | Subcutaneous | Injection |
Benralizumab 30 mg q.4 weeks
Benralizumab administered subcutaneously every 4 weeks Biological: Benralizumab (Benralizumab subcutaneously on study week 0 until study week 44 inclusive.)
Benralizumab 30 mg q.8 weeks
Benralizumab administered subcutaneously every 8 weeks Biological: Benralizumab (Benralizumab subcutaneously on study week 0 until study week 44 inclusive.)
Placebo
Placebo administered subcutaneously Biological: Placebo (Placebo subcutaneously on study week 0 until study week 44 inclusive.)
Results
Therapeutic efficacy
Pooled analysis : Pooled data from the patients severe eosinophilic asthma in the phase III SIROCCO/CALIMA/BORA and ZONDA trials showed that treatment with benralizumab, led to a sustained improvement in the exacerbation rates, lung function, asthma control and health-related quality of life of the patients for up to two years. Improvements in prebronchodilator FEV1, ACQ-6 scores, and AQLQ+12 scores were reported in the trials. Benralizumab also reduced the use of oral corticosteroids (OCS) in these patients. The integrated analysis 1,030 patients in the SIROCCO/CALIMA/BORA full analysis set and 131 patients in the ZONDA/BORA analysis set. Among patients in the ZONDA and BORA trials, after 84 weeks, about 75% of patients experienced at least a 50% reduction in the OCS dosages from baseline and 39% of patients had at least a 90% reduction. By the end of the study OCS dosage was reduced by 67%, which was similar to reductions seen in the ZONDA trial of 75% from baseline compared with 25% for placebo. Results were reported from a total of 1,161 patients [3] .
In the phase III CALIMA and SIROCCO clinical trials, treatment with 30mg subcutaneous benralizumab for four weeks and eight weeks, respectively, led to reduction in annual asthma exacerbation rate (upto 51%) in patients with severe eosinophilic asthma. Lung function improvement (change in FEV1 of up to 159mL), was observed at four weeks and was sustained throughout the treatment period. No additional improvement was observed in the 8 week dosing regimen, which supported less frequent dosing. A greater improvement in exacerbation rate reduction, FEV1 and total asthma symptom scores was observed in post hoc analysis in patients with more frequent asthma exacerbations. In a post-hoc pooled analysis of 2 295 patients belonging to the phase III SIROCCO and CALIMA trials (n = 1 204 for SIROCCO and n = 1 091 for CALIMA), benralizumab demonstrated efficacy across the full range of baseline blood eosinophil counts, and displayed an increased number of prior exacerbations along with a higher baseline blood eosinophil count associated with a greater treatment effect. A combination of both higher baseline blood eosinophil count and a history of more frequent exacerbations predicted a greater magnitude of response for patients treated with benralizumab. The results also indicated that patients on oral corticosteroids and nasal polyposis were more likely to have an enhanced treatment response.The randomised, double-blind CALIMA and SIROCCO trials enroled 2 508 and 2 700 patients, respectively [4] [5] .
In the phase III SIROCCO trial treatment with q4w and q8w benralizumab reduced annual exacerbation rate, when compared with placebo (1.33) (0.73 and 0.65, respectively; p ‹ 0.001). Change from baseline in FEV1 values were 0.34 (p = 0.022), 0.40 (p = 0.001), relative to 0.24. Total asthma symptom score was -1.12 (p = 0.442), and -1.30 (p = 0.011), compared with -1.04 [6] .
In the phase III CALIMA and SIROCCO clinical trials, treatment with 30mg subcutaneous benralizumab for four weeks and eight weeks, respectively, led to reduction in annual asthma exacerbation rate (upto 51%) in patients with severe eosinophilic asthma. Lung function improvement (change in FEV1 of up to 159 mL), was observed at four weeks and was sustained throughout the treatment period. No additional improvement was observed in the 8 week dosing regimen, which supported less frequent dosing. A greater improvement in exacerbation rate reduction, FEV1 and total asthma symptom scores was obsereved in post hoc analysis in patients with more frequent asthma exacerbations. The randomised, double-blind CALIMA and SIROCCO trials enroled 2508 and 2700 patients, respectively [5] .
Adverse events
Pooled analysis : Pooled data from the patients severe eosinophilic asthma in the phase III SIROCCO/CALIMA/BORA and ZONDA trials showed that safety profile of benralizumab was similar to that observed in individual trials, with no increase in the frequencies of overall or serious adverse events. Viral upper respiratory infection, upper respiratory tract infection and bronchitis were the three most common adverse events reported for patients in the SIROCCO or CALIMA trials and entered the BORA study. Rates of all treatment-emergent adverse events and serious AEs observed in SIROCCO/CALIMA FAS and ZONDA groups, were similar with that of BORA extension and SIROCCO/CALIMA and ZONDA study periods. No increase in risk of infection over time were observed with benralizumab, and the malignancy rate was low. Results were reported from a total of 1,161 patients [7] [3] .
In a post-hoc pooled analysis of 2 295 patients belonging to the phase III SIROCCO and CALIMA trials (n=1 204 for SIROCCO and n=1 091 for CALIMA), the overall safety profiles of both benralizumab and placebo arms were similar for both the SIROCCO and CALIMA trials, and the overall safety profile for benralizumab was in line with prior experiences [4] .
Phase III: Frequency of adverse events for all benralizumab treated patients (72% and 74%) were similar to placebo treated patients (76% and 78%) in the SIROCCO and CALIMA phase III clinical trials, respectively. The most common adverse events observed in SIROCCO trial were asthma, nasopharyngitis, upper respiratory infection, headache, bronchitis, sinusitis, influenza and pharyngitis and in CALIMA trial were nasopharyngitis, asthma, bronchitis, upper respiratory tract infection, headache and sinusitis [6] [5] .
Publications
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AstraZeneca. Fasenra reduces oral corticosteroid use and maintains long-term efficacy and safety profile in severe eosinophilic asthma. Media-Rel 2019;.
Media Release -
AstraZeneca. AstraZeneca presents new results identifying severe asthma patients who would benefit most from benralizumab. Media-Rel 2017;.
Media Release -
AstraZeneca. Benralizumab Phase III Trials Show Positive Results in Severe Asthma. Media-Rel 2016;.
Media Release -
Bleecker E, FitzGerald JM, Chanez P, Papi A, Weinstein S, Barker P, et al. LATE-BREAKING ABSTRACT: Benralizumab provides significant improvements for patients with severe, uncontrolled asthma: SIROCCO Phase III results. ERS-2016 2016; abstr. OA4832.
Available from: URL: http://erj.ersjournals.com//content/48/suppl_60/OA4832 -
Fitzgerald JM, Bleecker ER, Bourdin A, Busse WW, Ferguson GT, Brooks L, et al. Two-Year Integrated Efficacy and Safety Analysis of Benralizumab SIROCCO, CALIMA, ZONDA, and BORA Trials in Severe Asthma. ATS-2019 2019; abstr. A2676/511.
Available from: URL: http://www.abstractsonline.com/pp8/#!/5789/presentation/12667 -
Bleecker ER, Wechsler ME, Fitzgerald JM, Menzies-Gow A, Wu Y, Hirsch I, et al. Influence of Key Clinical Baseline Factors on Benralizumab Efficacy for Patients with Severe, Uncontrolled Asthma. ATS-2018 2018; abstr. A7703.
Available from: URL: http://link.adisinsight.com/n4A7W -
Maspero J, Harrison T, Werkstrom V, Wu Y, Gopalan G, Zangrilli J. Clinical Efficacy of Benralizumab in Patients With Severe, Uncontrolled Eosinophilic Asthma and Nasal Polyposis: Pooled Analysis of the SIROCCO and CALIMA Trials. AAAAI-WAO-2018 2018; abstr. 36.
Available from: URL: http://link.adisinsight.com/d3K2A -
Ryan O, Bernstein D, Hirsch I, Kreindler J. Pooled Baseline Characteristics of Women in Phase III Benralizumab Asthma Exacerbation Studies (SIROCCO and CALIMA). AAAAI-2019 2019; abstr. 301.
Available from: URL: http://www.jacionline.org/article/S0091-6749(18)32046-3/fulltext -
Khatry DB. Placebo Rates Confound Asthma Exacerbation Rate Reductions: A Meta-regression Analysis of Pivotal Trials of Three Anti-IL5 Biologics. ATS-2023 2023; abstr. N/A.
Available from: URL: https://www.abstractsonline.com/pp8/#!/10703/presentation/7020 -
Chupp G, Ferguson GT, Hirsch I, Goldman M, Zangrilli J, Trudo F. Benralizumab Treatment Produces Rapid Changes in Morning Peak Expiratory Flow in Patients With Severe, Uncontrolled Eosinophilic Asthma. AAAAI-WAO-2018 2018; abstr. 44.
Available from: URL: http://link.adisinsight.com/Qk6m4 -
Wenzel S. Benralizumab efficacy in patients with uncontrolled eosinophilic asthma by age at diagnosis. ERS-2018 2018; abstr. 603.
Available from: URL: https://www.ers-education.org/Media/Media.aspx?idMedia=398204 -
Fitzgerald J. Late Breaking Abstract - Characterizing responders to benralizumab for severe asthma: pooled analysis of the SIROCCO and CALIMA studies. ERS-2017 2017; abstr. 2902.
Available from: URL: http://www.ers-education.org/Media/Media.aspx?idMedia=353850 -
DuBuske L, Newbold P, Wu Y, Trudo F, Gopalan G. Seasonal Variability of Exacerbations in Patients With Severe, Uncontrolled Eosinophilic Asthma and Clinical Benefits of Benralizumab: Pooled Analysis of the SIROCCO and CALIMA Trials. AAAAI-WAO-2018 2018; abstr. 37.
Available from: URL: http://link.adisinsight.com/Hs47Y -
Kreindler J, Katial R, Barker P, Newbold P. Benralizumab Treatment is not Associated with Oral Corticosteroid-Like Increases in Weight and Blood Pressure. ACAAI-2019 2019; abstr. P221.
Available from: URL: http://link.adisinsight.com/Qg3n7 -
Chia YL, Yan L, Yu B, Wang B, Barker P, Goldman M, et al. Relationship Between Benralizumab Exposure and Efficacy for Patients with Severe Eosinophilic Asthma. Clin-Pharmacol-Ther 2019;.
PubMed | CrossRef Fulltext -
Park H-S, Lee SH, Werkstrom V, Wu Y, Zangrilli J, Gopalan G. Benralizumab Reduces Exacerbations and Improves Lung Function in Patients From Republic of Korea With Severe, Uncontrolled Asthma: Subgroup Analysis of the SIROCCO Trial. AAAAI-WAO-2018 2018; abstr. 41.
Available from: URL: http://link.adisinsight.com/Ds9g8 -
Yan L, Wang B, Chia YL, Roskos LK. Population Pharmacokinetic Modeling of Benralizumab in Adult and Adolescent Patients with Asthma. Clin-Pharmacokinet 2019;.
PubMed | CrossRef Fulltext -
Bleecker ER, Li X, Newbold P, Hirsch I, Li H, Zangrilli J, et al. Benralizumab treatment and SARP cluster analysis. ERS-2019 2019; abstr. N/A.
Available from: URL: https://erj.ersjournals.com/content/54/suppl_63/PA1659 -
Chipps B, Corren J, Israel E, Barker P, Kreindler J, Newbold P. Influence of Key Clinical Baseline Characteristics on Benralizumab Response for Patients with Severe, Uncontrolled Asthma and Moderate Blood Eosinophilia. AAAAI-2020 2020; abstr. 068.
Available from: URL: http://annualmeeting.aaaai.org/ -
Trudo F, Hirsch I, Gopalan G, Martin U. Impact of Body Mass Index on Efficacy of Benralizumab in Patients with Severe, Uncontrolled Eosinophilic Asthma: Pooled Analysis of the SIROCCO and CALIMA Trials. ATS-2018 2018; abstr. A2490.
Available from: URL: http://link.adisinsight.com/Bt76D -
Upham JW, Jackson DJ, Barker P, Newbold P, Cook W. Baseline predictors of being exacerbation-free during 2 years of benralizumab treatment. ERS-2019 2019; abstr. N/A.
Available from: URL: https://erj.ersjournals.com/content/54/suppl_63/OA5337 -
Harrison T, Fuhlbrigge AL, Fageras M, Jauhiainen A, Scheepers LEJM, Zangrilli J, et al. Benralizumab Reduces Asthma Worsening Episodes. ATS-2019 2019; abstr. A7087/509.
Available from: URL: http://link.adisinsight.com/Le74C -
Chipps BE, Newbold P, Hirsch I, Trudo F, Goldman M. Benralizumab efficacy by atopy status and serum immunoglobulin E for patients with severe, uncontrolled asthma. Ann-Allergy-Asthma-Immunol 2018;.
PubMed | CrossRef Fulltext -
Katial R, Hirsch I, Barker P, Gil EG, Hoyte F. Eosinophil as a Biomarker of Severity and Clinically Important Asthma Outcomes in Benralizumab Phase III Studies. ATS-2021 2021; abstr. A1468.
Available from: URL: https://conference.thoracic.org/program/abstract-search.php?sid=P8778 -
Louis RE, Harrison T, Shavit A, Kwiatek J, Cohen D, Keeling N, et al. Approaching Clinical Remission in Severe Asthma: An Analysis of Patients With Comorbid Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Treated With Benralizumab Across Five Clinical Trials. ATS-2023 2023; abstr. P602.
Available from: URL: https://www.abstractsonline.com/pp8/#!/10703/presentation/10588 -
Kraft M, Brusselle G, FitzGerald JM, Keith M, Hirsch I, Colice G, et al. Patient Clinical Characteristics and Biomarkers Associated with Underlying Exacerbation Risk in Asthma. ATS-2020 2020; abstr. 202.
Available from: URL: https://www.abstractsonline.com/pp8/#/8998/presentation/8420 -
Lugogo NL, Kreindler JL, Martin UJ, Cook B, Hirsch I, Trudo FJ. Blood Eosinophil Count Group Shifts and Kinetics in Severe, Eosinophilic Asthma. Ann-Allergy-Asthma-Immunol 2020;.
PubMed | CrossRef Fulltext -
Bleecker E, Li X, Meyers DA, Li H, Newbold P, Kwiatek J, et al. Longitudinal Blood Eosinophil Counts and Eosinophilic Immune Dysfunction Among Placebo Patients with Severe Asthma from Phase 3 Benralizumab Studies. ATS-2021 2021; abstr. A1469.
Available from: URL: https://conference.thoracic.org/program/abstract-search.php?sid=P8779 -
Chipps BE, Hirsch I, Trudo F, Alacqua M, Zangrilli JG. Demographics, Clinical Characteristics, and Response to Benralizumab Treatment for Patients with Severe, Eosinophilic Asthma and Fixed Airflow Obstruction. ATS-2018 2018; abstr. A2489.
Available from: URL: http://link.adisinsight.com/An6i7 -
Buritica MP, Carmona Marin M, Barriga V, Guzman J, Carlos F. Economic Evaluation of Benralizumab as Add-on Maintenance Treatment of Adult Patients in Mexico with Uncontrolled Severe Eosinophilic Asthma. ISPOR-2020 2020; abstr. N/A.
Available from: URL: https://www.ispor.org/heor-resources/presentations-database/presentation/intl2020-3182/101289 -
Xu X, O?Quinn S, Hirsch I, Gopalan G. Asthma Symptom Improvements with Benralizumab Are Associated with Improvements in Activity Functions and Quality of Life for Patients with Severe, Uncontrolled Asthma: Results of Pooled Phase III Benralizumab Studies. ATS-2017 2017; abstr. A4682.
Available from: URL: https://cms.psav.com/ats2017/confcal -
Bleecker ER, Wechsler ME, Mark FitzGerald J, Menzies-Gow A, Wu Y, Hirsch I, et al. Baseline Patient Factor Impact on the Clinical Efficacy of Benralizumab for Severe Asthma. Eur-Respir-J 2018;.
PubMed | CrossRef Fulltext -
Chupp G, Lugogo NL, Kline JN, Ferguson GT, Hirsch I, Goldman M, et al. Rapid Onset of Effect of Benralizumab on Morning Peak Expiratory Flow in Severe, Uncontrolled Asthma. Ann-Allergy-Asthma-Immunol 2019;.
PubMed | CrossRef Fulltext -
Jackson DJ, Korn S, Mathur SK, Barker P, Meka VG, Martin UJ, et al. Safety of Eosinophil-Depleting Therapy for Severe, Eosinophilic Asthma: Focus on Benralizumab. Drug-Safety 2020;.
PubMed | CrossRef Fulltext -
Jackson DJ, Humbert M, Hirsch I, Newbold P, Garcia Gil E. Ability of Serum IgE Concentration to Predict Exacerbation Risk and Benralizumab Efficacy for Patients with Severe Eosinophilic Asthma. Adv-Ther 2019;.
PubMed | CrossRef Fulltext -
Menzies-Gow A, Hoyte FL, Price DB, Cohen D, Barker P, Kreindler J, et al. Clinical Remission in Severe Asthma: A Pooled Post Hoc Analysis of the Patient Journey with Benralizumab. . Adv-Ther 2022;.
PubMed | CrossRef Fulltext -
Ryan O, Katial R, Hirsch I, Kreindler J. Asthma Exacerbation Severity Is Greater for Women than for Men. AAAAI-2020 2020; abstr. 664.
Available from: URL: http://annualmeeting.aaaai.org/ -
O'Quinn S, Xu X, Hirsch I, Gopalan G. Improvement in Patient-Reported Activity Impairment, Stress, and Tiredness in Patients with Severe, Uncontrolled Asthma with Eosinophilic Inflammation: Pooled Results from Two Phase III Trials of Benralizumab. ATS-2017 2017; abstr. A3188.
Available from: URL: https://cms.psav.com/ats2017/confcal -
Katial R, Siddiqui S, Barker P, Kwiatek J. Clinical Efficacy Characterization of Benralizumab for Patients with Nasal Polyposis and Severe, Uncontrolled Eosinophilic Asthma. ACAAI-2019 2019; abstr. P109.
Available from: URL: https://www.annallergy.org/article/S1081-12061930840-3/fulltext -
Goldman M, Hirsch I, Zangrilli JG, Newbold P, Xu X. The association between blood eosinophil count and benralizumab efficacy for patients with severe, uncontrolled asthma: subanalyses of the Phase III SIROCCO and CALIMA studies. Curr-Med-Res-Opin 2017;33(9):1605-1613.
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Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ?2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Internet-Doc 2016;.
Available from: URL: http://link.adisinsight.com/j8Q4H -
Chipps BE, Hirsch I, Trudo F, Alacqua M, Zangrilli JG. Benralizumab Efficacy for Patients with Fixed Airflow Obstruction and Severe, Uncontrolled Eosinophilic Asthma. Ann-Allergy-Asthma-Immunol 2019;.
PubMed | CrossRef Fulltext
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
| Eugene R. Bleecker, MD, Professor of Medicine | Center for Genomics and Personalized Medicine Research, Medical Center Boulevard, Winston-Salem, North Carolina 27157 |
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Goldman M
+1 302 885 1502
show details
ClinicalTrialTransparency@astrazeneca.com |
Astra Zeneca |
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Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| - | Łódź | Poland |
| - | Abingdon, Virginia | USA |
| - | Adana | Turkey |
| - | Albany, Georgia | USA |
| - | Albuquerque, New Mexico | USA |
| - | Allen, Texas | USA |
| - | Ankara | Turkey |
| - | Antalya | Turkey |
| - | Anyang-si | South-Korea |
| - | Bakersfield, California | USA |
| - | Baltimore, Maryland | USA |
| - | Barcelona | Spain |
| - | Bari | Italy |
| - | Bedford Park | Australia |
| - | Bellevue, Nebraska | USA |
| - | Benoni | South-Africa |
| - | Beverly Hills, California | USA |
| - | Białystok | Poland |
| - | Billings, Montana | USA |
| - | Birmingham | United-Kingdom |
| - | Bologna | Italy |
| - | Box Hill | Australia |
| - | Bradford | United-Kingdom |
| - | Brandon, Florida | USA |
| - | Brest Cedex | France |
| - | Brno | Czech-Republic |
| - | Bronx, New York | USA |
| - | Bucheon-si | South-Korea |
| - | Bursa | Turkey |
| - | Busan | South-Korea |
| - | Cambridge | United-Kingdom |
| - | Cape Town | South-Africa |
| - | Catania | Italy |
| - | Charleston, South Carolina | USA |
| - | Chattanooga, Tennessee | USA |
| - | Chelyabinsk | Russia |
| - | Cheongju-si | South-Korea |
| - | Chertsey | United-Kingdom |
| - | Chester | United-Kingdom |
| - | Chippenham | United-Kingdom |
| - | Clayton | Australia |
| - | Clearwater, Florida | USA |
| - | Clermont Ferrand | France |
| - | Cona | Italy |
| - | Concord | Australia |
| - | Costa Mesa, California | USA |
| - | Cottingham | United-Kingdom |
| - | Cusco | Peru |
| - | Cutler Bay, Florida | USA |
| - | Dallas, Texas | USA |
| - | Darlington | United-Kingdom |
| - | DeLand, Florida | USA |
| - | Dickinson, Texas | USA |
| - | Dijon Cedex | France |
| - | Dobre Miasto | Poland |
| - | Duncanville, Texas | USA |
| - | Dupnitsa | Bulgaria |
| - | Durban | South-Africa |
| - | Easley, South Carolina | USA |
| - | Ekaterinburg | Russia |
| - | Erie, Pennsylvania | USA |
| - | Farmington Hills, Michigan | USA |
| - | Feasterville, Pennsylvania | USA |
| - | Firenze | Italy |
| - | Foggia | Italy |
| - | Foley, Alabama | USA |
| - | Fort Mitchell, Kentucky | USA |
| - | Frankston | Australia |
| - | Gainesville, Florida | USA |
| - | Gainesville, Georgia | USA |
| - | Gardner, Massachusetts | USA |
| - | Gdańsk | Poland |
| - | Georgetown, Texas | USA |
| - | Germantown, Tennessee | USA |
| - | Giżycko | Poland |
| - | Glasgow | United-Kingdom |
| - | Grand Forks, North Dakota | USA |
| - | Greenfield, Wisconsin | USA |
| - | Grodzisk Mazowiecki | Poland |
| - | Guadalajara | Mexico |
| - | Gurnee, Illinois | USA |
| - | Gwangju | South-Korea |
| - | Hanoi | Vietnam |
| - | Hartford, Connecticut | USA |
| - | Hazard, Kentucky | USA |
| - | Hialeah, Florida | USA |
| - | High Heaton/Newcastle upon Tyn | United-Kingdom |
| - | Ho Chi Minh | Vietnam |
| - | Hodges, South Carolina | USA |
| - | Hollywood, Florida | USA |
| - | Homestead, Florida | USA |
| - | Hopewell, Virginia | USA |
| - | Hopewell Jct, New York | USA |
| - | Houston, Texas | USA |
| - | Huntersville, North Carolina | USA |
| - | Huntington Beach, California | USA |
| - | Huntington Park, California | USA |
| - | Huntsville, Alabama | USA |
| - | Incheon | South-Korea |
| - | Iowa City, Iowa | USA |
| - | Istanbul | Turkey |
| - | Ivanovo | Russia |
| - | Izhevsk | Russia |
| - | Izmir | Turkey |
| - | Jackonsville, Florida | USA |
| - | Jeju-si | South-Korea |
| - | Jindrichuv Hradec | Czech-Republic |
| - | Karlovy Vary | Czech-Republic |
| - | Kazan | Russia |
| - | Kościan | Poland |
| - | Kocaeli | Turkey |
| - | Las Vegas, Nevada | USA |
| - | Lawrenceville, Georgia | USA |
| - | Le Kremlin Bicêtre | France |
| - | Le Mans Cedex | France |
| - | Leeds | United-Kingdom |
| - | Legnago | Italy |
| - | Legnica | Poland |
| - | Lima | Peru |
| - | Liverpool | United-Kingdom |
| - | London | United-Kingdom |
| - | Los Angles, California | USA |
| - | Louisville, Kentucky | USA |
| - | Lublin | Poland |
| - | Lugo | Spain |
| - | Lynn Haven, Florida | USA |
| - | Lyon Cedex 4 | France |
| - | Málaga | Spain |
| - | Madrid | Spain |
| - | Maidstone | United-Kingdom |
| - | Manchester | United-Kingdom |
| - | Marlton, New Jersey | USA |
| - | Marseille | France |
| - | McAllen, Texas | USA |
| - | McKinney, Texas | USA |
| - | Mersin | Turkey |
| - | Miami, Florida | USA |
| - | Milano | Italy |
| - | Mobile, Alabama | USA |
| - | Monterrey | Mexico |
| - | Montpellier | France |
| - | Morelia | Mexico |
| - | Morgantown, West Virginia | USA |
| - | Moscow | Russia |
| - | Mowbray | South-Africa |
| - | Mt Pleasant, South Carolina | USA |
| - | Napoli | Italy |
| - | Nedlands | Australia |
| - | New Haven, Connecticut | USA |
| - | New Lambton Heights | Australia |
| - | New York, New York | USA |
| - | New York City, New York | USA |
| - | Newport Beach, California | USA |
| - | Nizhny Novgorod | Russia |
| - | Normal, Illinois | USA |
| - | North Dartmouth, Massachusetts | USA |
| - | Northfield, New Jersey | USA |
| - | Nottingham | United-Kingdom |
| - | Novosibirsk | Russia |
| - | Oklahoma City, Oklahoma | USA |
| - | Opelousas, Louisiana | USA |
| - | Orange, California | USA |
| - | Oregon, Ohio | USA |
| - | Orem, Utah | USA |
| - | Orlando, Florida | USA |
| - | Ostrava | Czech-Republic |
| - | Oviedo | Spain |
| - | Palermo | Italy |
| - | Palma de Mallorca | Spain |
| - | Pardubice | Czech-Republic |
| - | Paris | France |
| - | Parkville | Australia |
| - | Pau Cedex | France |
| - | Pavia | Italy |
| - | Pembroke Pines, Florida | USA |
| - | Pernik | Bulgaria |
| - | Perugia | Italy |
| - | Pharr, Texas | USA |
| - | Philadelphia, Pennsylvania | USA |
| - | Phoenix, Arizona | USA |
| - | Phoenixville, Pennsylvania | USA |
| - | Picayune, Mississippi | USA |
| - | Pisa | Italy |
| - | Pittsburgh, Pennsylvania | USA |
| - | Plano, Texas | USA |
| - | Pleven | Bulgaria |
| - | Plymouth | United-Kingdom |
| - | Plzen | Czech-Republic |
| - | Port Charlotte, Florida | USA |
| - | Porto Alegre | Brazil |
| - | Portsmouth | United-Kingdom |
| - | Poznań | Poland |
| - | Praha | Czech-Republic |
| - | Prahran | Australia |
| - | Pringy Cedex | France |
| - | Proszowice | Poland |
| - | Provo, Utah | USA |
| - | Pyatigorsk | Russia |
| - | Quincy, Massachusetts | USA |
| - | Randwick | Australia |
| - | Rio de Janeiro | Brazil |
| - | Riverside, California | USA |
| - | Rochester, Minnesota | USA |
| - | Rock Hill, South Carolina | USA |
| - | Rokycany | Czech-Republic |
| - | Roma | Italy |
| - | Rostov-on-Don | Russia |
| - | Ruse | Bulgaria |
| - | Ryazan | Russia |
| - | Rzeszów | Poland |
| - | São Paulo | Brazil |
| - | Sagunto(Valencia) | Spain |
| - | Saint - Petersburg | Russia |
| - | Saint Petersburg | Russia |
| - | Saint Pierre | France |
| - | Saint-Petersburg | Russia |
| - | Salamanca | Spain |
| - | Salt Lake City, Utah | USA |
| - | Samokov | Bulgaria |
| - | San Jose, California | USA |
| - | San Pietro Vernotico | Italy |
| - | Santa Ana, California | USA |
| - | Santo André | Brazil |
| - | Sao Paulo | Brazil |
| - | Saratov | Russia |
| - | Scottsboro, Alabama | USA |
| - | Sealy, Texas | USA |
| - | Sebring, Florida | USA |
| - | Seoul | South-Korea |
| - | Sheffield, Alabama | USA |
| - | Shelby, North Carolina | USA |
| - | Sliven | Bulgaria |
| - | Smolensk | Russia |
| - | Sofia | Bulgaria |
| - | Soham | United-Kingdom |
| - | Somerset | United-Kingdom |
| - | Sorocaba | Brazil |
| - | Sosnowiec | Poland |
| - | Sparks, Nevada | USA |
| - | Splendora, Texas | USA |
| - | St Petersburg, Florida | USA |
| - | St. Paul, Minnesota | USA |
| - | St. Petersburg | Russia |
| - | Stanger | South-Africa |
| - | Stara Zagora | Bulgaria |
| - | Staten Island, New York | USA |
| - | Stevenage | United-Kingdom |
| - | Stockton | United-Kingdom |
| - | StPetersburg | Russia |
| - | Strakonice | Czech-Republic |
| - | Strasbourg Cedex | France |
| - | Surco | Peru |
| - | Suwon-si | South-Korea |
| - | Tampa, Florida | USA |
| - | Teplice | Czech-Republic |
| - | Toledo, Ohio | USA |
| - | Tomsk | Russia |
| - | Torino | Italy |
| - | Toulouse | France |
| - | Tucson, Arizona | USA |
| - | Tulsa, Oklahoma | USA |
| - | Union, New Jersey | USA |
| - | Valencia | Spain |
| - | Varna | Bulgaria |
| - | Velingrad | Bulgaria |
| - | Vero Beach, Florida | USA |
| - | Verona | Italy |
| - | Vladikavkaz | Russia |
| - | Vladimir | Russia |
| - | Volgograd | Russia |
| - | Warwick, Rhode Island | USA |
| - | Winston-Salem, North Carolina | USA |
| - | Winter Park, Florida | USA |
| - | Wołomin | Poland |
| - | Woolloongabba | Australia |
| - | Wooster, Ohio | USA |
| - | Wrocław | Poland |
| - | Yambol | Bulgaria |
| - | Yaroslavl | Russia |
| - | Yekaterinburg | Russia |
| - | Zgierz | Poland |
| Astra Zeneca |
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AstraZeneca
AstraZeneca Clinical Study Information
show details
Phone: 46855326000 Fax: 46855329000 information.center@astrazeneca.com |
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AstraZeneca
AstraZeneca Clinical Study Information
show details
Phone: 46855326000 Fax: 46855329000 information.center@astrazeneca.com |
Sodertalje | Sweden |
| Center for Genomics and Personalized Medicine Research, Medical Center Boulevard, Winston-Salem, North Carolina 27157 |
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Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 24 May 2023 | Results | Results of an analysis assessing rates of clinical remission after treatment with benralizumab in patients with SEA with or without CRSwNP from 5 clinical studies (SIROCCO, CALIMA, ZONDA, ANDHI and PONENTE) presented at the 119th International Conference of the American Thoracic Society Updated 13 Jul 2023 |
| 24 May 2023 | Results | Meta analysis from NCT01000506, NCT01691521, NCT01287039, NCT01285323, NCT01928771, and NCT01914757, presented at the 119th International Conference of the American Thoracic Society Updated 12 Jul 2023 |
| 14 Mar 2022 | Results | Results of post-hoc pooled analysis assessing composite remission definition to characterize individual responses to benralizumab after 6 and 12 months in 3 phase III studies (SIROCCO (NCT01928771); CALIMA (NCT01914757); ZONDA (NCT02075255)) were published in the Advances in Therapy. Updated 17 Mar 2022 |
| 19 May 2021 | Results | Results of a post-hoc, longitudinal, pooled analysis assessing the variability of Benralizumab and eosinophilic immune dysfunction for patients with severe asthma (SIROCCO (NCT01928771) and CALIMA (NCT01914757)) presented at the 117th International Conference of the American Thoracic Society Updated 27 Jun 2021 |
| 19 May 2021 | Results | Results of post-hoc pooled analysis of two studies ( SIROCCO (NCT01928771) and CALIMA (NCT01914757)) assessing overall treatment response for 48 and 56 weeks, presented at the 117th International Conference of the American Thoracic Society. Updated 26 Jun 2021 |
| 20 May 2020 | Results | Result (N=2016), of a pooled analysis of (SIROCCO, CALIMA, Phase IIb of Bernalizumab, Tralokinumab's STRATOS I, II and Phase IIb and tezepelumab Phase II PATHWAY) assessing clinical characteristics and biomarkers associated with exacerbation risk, presented at the 116th International Conference of the American Thoracic Society Updated 29 Jun 2020 |
| 20 May 2020 | Results | Results assessing cost-effectiveness as well as the budgetary impact of benralizumab compared with omalizumab considering SIROCCO and CALIMA trials for benralizumab, INNOVATE and EXTRA for omalizumab, presented at the 25th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research Updated 24 May 2020 |
| 22 Apr 2020 | Results | Results (n=739) of post-hoc, pooled analysis of SIROCCO and CALIMA trials assessing blood eosinophil count group shifts and kinetics in severe, eosinophilic asthma, published in the Annals of Allergy, Asthma and Immunology Updated 28 Apr 2020 |
| 02 Apr 2020 | Results | Results doing integrated analyses of benralizumab safety data from the phase III SIROCCO and CALIMA trials and subsequent BORA extension trial and ZONDA for patients with asthma, and the phase III GALATHEA and TERRANOVA trials for patients with chronic obstructive pulmonary disease, published in the Drug Safety Updated 07 Apr 2020 |
| 16 Mar 2020 | Results | Results of post-hoc pooled analysis of two studies (SIROCCO & CALIMA) assessing asthma exacerbation severity for female and male patients, published at the 2020 Annual Meeting of the American Academy of Allergy, Asthma and Immunology. Updated 30 Apr 2020 |
| 16 Mar 2020 | Results | Results of post hoc pooled analysis from trials (SIROCCO and CALIMA) presented at the 2020 Annual Meeting of the American Academy of Allergy, Asthma and Immunology Updated 30 Apr 2020 |
| 14 Dec 2019 | Results | Results, analysis of pooled data from two phase III trials (SIROCCO and CALIMA) assessing Benralizumab efficacy in patients with severe Eosinophilic Asthma, published in the Advances in Therapy Updated 18 Dec 2019 |
| 11 Nov 2019 | Results | Results of pooled analysis of two studies (SIROCCO and CALIMA), presented at the 2019 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology. Updated 23 Jan 2020 |
| 11 Nov 2019 | Results | Results of post-hoc analyses of pooled data from SIROCCO and CALIMA assesing clinical efficacy characterization of benralizumab for patients with nasal polyposis and severe, uncontrolled eosinophilic asthma has been presented at the 2019 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology Updated 23 Jan 2020 |
| 15 Oct 2019 | Results | Results of post hoc pooled analysis of studies (SIROCCO and CALIMA) assessing efficacy of Benralizumab in patients with Fixed airflow obstruction and Asthma, published in the Annals of Allergy, Asthma and Immunology Updated 22 Oct 2019 |
| 02 Oct 2019 | Results | Post-hoc subgroup integrated analysis results from pooled analysis from SIROCCO, CALIMA and BORA studies evaluating the relationship of exacerbation (EX) frequency during 2 years after the treatment of benralizumab, presented at the 29th Annual Congress of the European Respiratory Society. Updated 02 Mar 2020 |
| 02 Oct 2019 | Results | Results from pooled analysis from SIROCCO ( n=1,082 ) and CALIMA ( n=1,199 ) studies, presented at the 29th Annual Congress of the European Respiratory Society. Updated 02 Mar 2020 |
| 22 May 2019 | Results | Results presented at the 115th International Conference of the American Thoracic Society. Updated 23 Sep 2019 |
| 22 May 2019 | Results | Post hoc analysis results were presented at the 115th International Conference of the American Thoracic Society. Updated 20 Sep 2019 |
| 20 May 2019 | Results | Pooled analysis data for phase III SIROCCO, CALIMA exacerbation trials, the BORA extension trial and the 28-week phase III ZONDA OCS-sparing trial presented in a AstraZenec media release. Updated 24 May 2019 |
| 20 May 2019 | Results | According to a AstraZeneca media release, pooled analysis data for phase III SIROCCO, CALIMA exacerbation trials, the BORA extension trial and the 28-week phase III ZONDA OCS-sparing trial were presented at the American Thoracic Society (ATS) 2019 International Conference. Updated 24 May 2019 |
| 11 Mar 2019 | Results | Results assessing pharmacokinetic (PK) data from nine clinical trials (NCT00512486, NCT00659659, NCT00768079, NCT00783289, NCT01238861, NCT01928771, NCT01914757, NCT02322775, NCT02075255) for patients with asthma, published in the Clinical Pharmacokinetics. Updated 15 Mar 2019 |
| 25 Feb 2019 | Results | Results of post hoc analysis describing baseline characteristics of women in phase III benralizumab asthma exacerbation studies (SIROCCO and CALIMA) presented at the 2019 Annual Meeting of the American Academy of Allergy, Asthma and Immunology Updated 19 Mar 2019 |
| 22 Feb 2019 | Results | Results assessing the onset of action of benralizumab by examining change in morning PEF following initiation of treatment in the SIROCCO, CALIMA, and ZONDA clinical trials, published in the Annals of Allergy, Asthma and Immunology Updated 01 Mar 2019 |
| 19 Jan 2019 | Results | Results evaluating the relationship between benralizumab pharmacokinetic (PK) exposure and endpoints of asthma exacerbation rates (AER) and change from baseline in prebronchodilator forced expiratory volume in 1 second (FEV1 ) in SIROCCO/CALIMA Phase III trials published in the Clinical Pharmacology and Therapeutics Updated 14 Feb 2019 |
| 19 Sep 2018 | Results | Results (n=1537) of post-hoc pooled analysis of SIROCCO and CALIMA trials assessing efficacy of Benralizumab by age in patients with uncontrolled eosinophilic asthma, presented at the 28th Annual Congress of the European Respiratory Society. Updated 01 Nov 2018 |
| 23 Aug 2018 | Results | Results of a pooled analysis of SIROCCO and CALIMA trials assessing the impact of baseline factors on benralizumab efficacy for patients with severe asthma, published in the European Respiratory Journal Updated 30 Aug 2018 |
| 23 May 2018 | Results | Results (n=2295) of a post-hoc analysis assessing the influence of previously identified candidate factors and additional baseline factors on benralizumab efficacy in patients with severe, uncontrolled asthma with different degrees of blood eosinophilia using pooled data from the phase III SIROCCO and and CALIMA trials, presented at the 114th International Conference of the American Thoracic Society. Updated 10 Jul 2018 |
| 23 May 2018 | Results | Results (n=1489) of post-hoc analysis assessing the impact of body mass index on the efficacy of benralizumab in patients with severe, uncontrolled eosinophilic asthma using pooled data from SIROCCO and CALIMA trials presented at the 114th International Conference of the American Thoracic Society. Updated 10 Jul 2018 |
| 23 May 2018 | Results | Results of a post-hoc analysis from SIROCCO and CALIMA trials presented at the 114th International Conference of the American Thoracic Society. Updated 06 Jul 2018 |
| 05 Mar 2018 | Results | Results of a post-hoc analysis assessing Changes in Morning Peak Expiratory Flow in patients from SIROCCO and CALIMA trials, presented at the 2018 Annual Meeting of the American Academy of Allergy, Asthma and Immunology Updated 23 Mar 2018 |
| 05 Mar 2018 | Results | Results (n=122) of subanalysis evaluated benralizumab for patients from the Republic of Korea in SIROCCO, were presented at the 2018 Annual Meeting of the American Academy of Allergy, Asthma and Immunology. Updated 23 Mar 2018 |
| 05 Mar 2018 | Results | Results of pooled analysis of phase III SIROCCO and CALIMA assessing seasonal variability of exacerbations in patients with severe, uncontrolled eosinophilic asthma and clinical benefits of benralizumab, were presented at the 2018 Annual Meeting of the American Academy of Allergy, Asthma and Immunology. Updated 23 Mar 2018 |
| 05 Mar 2018 | Results | Results of pooled analysis of phase III SIROCCO and CALIMA assessing clinical efficacy of benralizumab in patients with severe, uncontrolled eosinophilic asthma and nasal polyposis, were presented at the 2018 Annual Meeting of the American Academy of Allergy, Asthma and Immunology. Updated 23 Mar 2018 |
| 26 Feb 2018 | Other trial event | According to an AstraZeneca media release, health Canada has approved Fasenra (benralizumab injection) as an add-on maintenance treatment for adult patients with severe eosinophilic asthma, based on results from the WINDWARD clinical program. Updated 27 Feb 2018 |
| 31 Jan 2018 | Results | Results of pooled analysis from the SIROCCO (NCT01928771) and CALIMA (NCT01914757) Phase III studies published in the Annals of Allergy, Asthma and Immunology Updated 12 Feb 2018 |
| 19 Jan 2018 | Other trial event | According to an AstraZeneca media release, the Japanese Ministry of Health, Labour and Welfare has approved Fasenra (benralizumab) as an add-on treatment for bronchial asthma in patients who continue to experience asthma exacerbations despite treatment with high-dose inhaled corticosteroid and other asthma controllers. The approval is based on the results from the WINDWARD programme, including the SIROCCO, CALIMA and ZONDA trials. Updated 24 Jan 2018 |
| 10 Jan 2018 | Other trial event | According to an AstraZeneca media release, based on the results from the WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the Phase III OCS-sparing trial, ZONDA, the European Commission (EC) has approved Fasenra (benralizumab) as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists. Updated 15 Jan 2018 |
| 14 Nov 2017 | Other trial event | According to an AstraZeneca media release, US Food and Drug Administration (FDA) has approved FASENRA (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Updated 21 Nov 2017 |
| 10 Nov 2017 | Other trial event | The positive opinion from the CHMP will now be reviewed by the European Commission, as reported in a MedImmune media release. Updated 17 Nov 2017 |
| 10 Nov 2017 | Other trial event | Based on the data from the WINDWARD programme including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and Phase III oral corticosteroid (OCS)-sparing trial, ZONDA, the CHMP of the EMA has adopted a positive opinion, recommending the marketing authorisation of benralizumab as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting b-agonists. Updated 17 Nov 2017 |
| 13 Sep 2017 | Results | Results of post-hoc analysis of pooled data from SIROCCO(n=1204) and CALIMA (n=1091) trials, presented at the 27th Annual Congress of the European Respiratory Society. Updated 16 Nov 2017 |
| 11 Sep 2017 | Results | Post-hoc results of SIROCCO and CALIMA trials were published today in The Lancet Respiratory Medicine, according to an AstraZeneca media release. Updated 16 Nov 2017 |
| 11 Sep 2017 | Results | Post-hoc results of SIROCCO and CALIMA trials published in an AstraZeneca media release. Updated 13 Sep 2017 |
| 01 Sep 2017 | Results | Results of a subanalysis from SIROCCO and CALIMA trials published in the Current Medical Research and Opinion. Updated 29 Mar 2018 |
| 24 May 2017 | Results | Results of a pooled analysis assessing patient-reported outcomes in Asthma patients from two phase III trials (NCT01928771 and NCT01914757; n=1530), presented at the 113th International Conference of the American Thoracic Society Updated 12 Jul 2017 |
| 24 May 2017 | Results | Results of pooled analysis of 2 phase II trials (NCT01928771, NCT01914757) presented at the 113th International Conference of the American Thoracic Society Updated 09 Jul 2017 |
| 22 May 2017 | Other trial event | According to an AstraZeneca media release, the data from ZONDA, SIROCCO and CALIMA trials were included in regulatory submission for benralizumab which is under regulatory review in the US, EU, Japan and several other countries with a US PDUFA data in the fourth quarter of 2017. Updated 29 May 2017 |
| 08 May 2017 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 08 May 2017 |
| 03 May 2017 | Biomarker Update | Biomarkers information updated Updated 07 Nov 2021 |
| 23 Mar 2017 | Other trial event | Last checked against European Clinical Trial database record. Updated 23 Mar 2017 |
| 07 Sep 2016 | Results | Results presented at the 26th Annual Congress of the European Respiratory Society Updated 03 Jan 2017 |
| 05 Sep 2016 | Results | According to AstraZeneca media release, results from SIROCCO and CALIMA trials were presented at the European Respiratory Society (ERS) International Congress and published in The Lancet journal. Updated 24 Sep 2016 |
| 04 Sep 2016 | Results | Results of SIROCCO trial published in The Lancet. Updated 21 Oct 2016 |
| 17 May 2016 | Other trial event | According to AstraZeneca media release, top-line results from SIROCCO and CALIMA trials will be presented at a future medical meeting and regulatory submissions in the US and EU are anticipated in the second half of 2016. Updated 26 May 2016 |
| 17 May 2016 | Other trial event | According to Kyowa Hakko Kirin media release, AstraZeneca obtained top-line results of benralizumab in the reduction of the annualized asthma exacerbation. The results from this and CALIMA trials will be presented at a medical meeting. Updated 24 May 2016 |
| 17 May 2016 | Endpoint met | Primary endpoint (Effect of 2 dosing regimens of benralizumab on asthma exacerbations in adult patients with uncontrolled asthma) has been met. Updated 23 May 2016 |
| 09 May 2016 | Status change - completed | Status changed from active, no longer recruiting to completed. Updated 12 May 2016 |
| 23 Apr 2016 | Other trial event | This trial is completed in the following locations Czech Republic, Bulgaria and Poland (end date: 2016-04-05). Updated 27 Apr 2016 |
| 16 Mar 2016 | Completion date | Planned End Date changed from 1 May 2016 to 1 Apr 2016 as per ClinicalTrials.gov record. Updated 22 Mar 2016 |
| 16 Mar 2016 | Other trial event | Planned primary completion date changed from 1 May 2016 to 1 Apr 2016 as per ClinicalTrials.gov record. Updated 22 Mar 2016 |
| 04 Feb 2016 | Other trial event | According to an AstraZeneca media release, regulatory submissions to the agencies in US and EU for benralizumab for the treatment of severe asthma are anticipated in the second half of 2016. Updated 15 Feb 2016 |
| 16 Sep 2015 | Completion date | Planned End Date changed from 1 Apr 2016 to 1 May 2016, as reported by ClinicalTrials.gov. Updated 22 Sep 2015 |
| 16 Sep 2015 | Other trial event | Planned primary completion date changed from 1 Apr 2016 to 1 May 2016, as reported by ClinicalTrials.gov. Updated 22 Sep 2015 |
| 14 Apr 2015 | Other trial event | Last checked against Mayo Clinic record. Updated 14 Apr 2015 |
| 01 Apr 2015 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov record. Updated 14 Apr 2015 |
| 10 Mar 2015 | Other trial event | Last checked against United Kingdom Clinical Research Network. Updated 10 Mar 2015 |
| 08 Dec 2014 | Completion date | Planned End Date changed from 1 Feb 2016 to 1 Apr 2016, as per ClinicalTrials.gov record. Updated 25 Dec 2014 |
| 08 Dec 2014 | Other trial event | Planned primary completion date changed from 1 Feb 2016 to 1 Apr 2016, as per ClinicalTrials.gov record. Updated 25 Dec 2014 |
| 07 Oct 2014 | Other trial event | Planned number of patients changed from 1890 to 1134 as reported by ClinicalTrials.gov record. Updated 13 Nov 2014 |
| 25 Aug 2014 | Other trial event | New source identified and integrated (14-000876; Mayo Clinic) Updated 25 Aug 2014 |
| 08 Jul 2014 | Protocol amendment | Age limit is increased from 18-75 years to 12-75 years. Updated 25 Dec 2014 |
| 26 Feb 2014 | Other trial event | Planned number of patients changed from 1134 to 1890. Updated 26 Feb 2014 |
| 30 Dec 2013 | Other trial event | New source identified and integrated (European Clinical Trial database, EudraCT2013-002345-11) Updated 30 Dec 2013 |
| 12 Dec 2013 | Other trial event | New source identified and integrated (United Kingdom Clinical Research Network: 15202). Updated 14 Dec 2013 |
| 02 Sep 2013 | New trial record | New trial record Updated 02 Sep 2013 |
| 01 Sep 2013 | Status change - recruiting | Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov. Updated 11 Oct 2013 |
Table of Contents
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