A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)
Latest Information Update: 13 Jul 2023
At a glance
- Drugs Benralizumab (Primary)
- Indications Asthma; Eosinophilia
- Focus Registrational; Therapeutic Use
- Acronyms CALIMA
- 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
The purpose of this study was to determine whether benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.
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.
CALIMA is the first study in the phase III Windward programme for benralizumab for severe uncontrolled asthma. Other studies in the programme include SIROCCO, PAMPERO, ZONDA and BORA [see trial profiles 700236411, 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 benralizumab on asthma exacerbations in adult and adolescent patients with uncontrolled asthma
Time Frame: Immediately following the first administration of study drug through Study Week 56
safety issue: No [1]
Other Endpoints
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline 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 56.
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils ≥300/uL
time_frame: Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL
time_frame: Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils ≥300/uL
description: Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint 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 56.
Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL
description: Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint 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 56.
Change in Asthma Rescue Medication Use
description: Change from Baseline to Week 56 in number of Rescue medication use (puffs/day) time_frame: Immediately following the first administration of study drug through Study Week 56.
Home Lung Function Assessments Based on PEF
description: Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow [PEF]) time_frame: Immediately following the first administration of study drug through Study Week 56.
Proportion of Nights With Awakening Due to Asthma
description: Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma time_frame: Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in ACQ-6 for Patients With 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 56.
Mean Change From Baseline to Week 56 in ACQ-6 for Patients With 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 56.
Number of Patients With ≥1 Asthma Exacerbation
time_frame: Immediately following the first administration of study drug through Study Week 56
Time to First Asthma Exacerbation
time_frame: Immediately following the first administration of study drug through Study Week 56
Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations
description: Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated) time_frame: Immediately following the first administration of study drug through Study Week 56.
Pharmacokinetics of Benralizumab
description: Mean PK Concentration at each visit time_frame: Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60
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 first and 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
Extent of Exposure
description: Extent of exposure is defined as the duration of treatment in days time_frame: Immediately following the first administration of study drug through Study Week 56
Mean Change From Baseline to Week 56 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 56
Change From Baseline to Week 56 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 56
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. This is only applicable to patients who were employed. time_frame: Immediately following the first administration of study drug through Study Week 56
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 for patients who took classes. time_frame: Immediately following the first administration of study drug through Study Week 56
Number of Participants That Utilized Health Care Resources
time_frame: Immediately following the first administration of study drug through Study Week 56
Patient and Clinician Assessment of Response to Treatment
description: CGIC (clinician 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 a 7-point rating scale, ranging from 1 (Very much Improved), to 7 (Very much Worse). This endpoint was added after the second protocol amendment, thus not all patients had data to be analyzed. time_frame: Immediately following the first administration of study drug through Study Week 56 [2]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| Asthma | treatment | disease exacerbations, severe |
| Eosinophilia | treatment | - |
Biomarker
| NCT Number | Biomarker Name | Biomarker Function |
|---|---|---|
| NCT01914757 | alpha-1 antitrypsin (SERPINA1) | Eligibility Criteria |
| COPD | Eligibility Criteria |
Subjects
- Subject Type patients
-
Number
Planned: 1296
Actual: 1306
- Sex male & female
- Age Group 12-75 years; adolescent; adult; child; elderly
Patient Inclusion Criteria
1. Provision of informed consent prior to any study specific procedures 2. Female and male aged 12 to 75 years, inclusively, at the time of Visit 1 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. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.
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 |
|---|---|
| D3250C00018 | AstraZeneca |
| NCT01914757 | ClinicalTrials.gov: US National Institutes of Health |
| EudraCT2013-002163-26 | European Clinical Trials Database |
| P018-2015 | Paediatric Investigation Plan EMA Decision number |
Organisations
- Sponsors AstraZeneca
- Affiliations AstraZeneca; Kyowa Hakko Kirin; Kyowa Kirin
Trial Dates
-
Initiation Dates
Planned : 01 Aug 2013
Actual : 21 Aug 2013
-
Primary Completion Dates
Planned : 01 Mar 2016
Actual : 01 Mar 2016
-
End Dates
Planned : 01 Mar 2016
Actual : 11 Mar 2016
Other Details
- Design double-blind; multicentre; parallel; prospective; randomised
- Phase of Trial Phase III
- Location Argentina; Canada; Chile; Germany; Japan; Philippines; Poland; Romania; Sweden; Ukraine; USA
- 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 52 inclusive.)
Benralizumab 30 mg q.8 weeks ((Q8W; first 3 doses Q4W)
Benralizumab administered subcutaneously every 8 weeks Biological: Benralizumab (Benralizumab subcutaneously on study week 0 until study week 52 inclusive.)
Placebo (Q4W)
Placebo administered subcutaneously Biological: Placebo (Placebo subcutaneously on study week 0 until study week 52 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 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 [6] [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 [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 -
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 -
J Mark FitzGerald, Prof Eugene R Bleecker, Prof Parameswaran Nair, Stephanie Korn, Ken Ohta, Prof Marek Lommatzsch, et al. Benralizumab, an anti-interleukin-5 receptor ? monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Internet-Doc 2016;.
Available from: URL: http://link.adisinsight.com/Sq38P -
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 -
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;.
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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.
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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.
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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;.
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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;.
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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.
PubMed | CrossRef Fulltext -
FitzGerald JM, Ohta K, Adachi M, Tohda Y, Kamei T, Kato M, et al. Benralizumab Reduces Exacerbations in Japanese Patients with Severe, Uncontrolled Asthma: Subgroup Analysis of the Calima Trial. AAAAI-2017 2017; abstr. 32.
Available from: URL: http://link.adisinsight.com/o9P3L -
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 |
|---|---|---|
|
Goldman M
Phone: +1 302 885 1502
show details
mitchell.goldman@astrazeneca.com |
AstraZeneca |
-
|
| Mark Fitzgerald, MD, PhD, Professor of Medicine | The Lung Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver Canada |
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|
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| - | Łódź | Poland |
| - | Łęczna | Poland |
| - | Żnin | Poland |
| - | Aki-gun, | Japan |
| - | Aleksandrów Łódzki | Poland |
| - | Alhambra, California | USA |
| - | Anaheim, California | USA |
| - | Arlington, Texas | USA |
| - | Asahi-shi | Japan |
| - | Aschaffenburg | Germany |
| - | Austin, Texas | USA |
| - | Avellaneda | Argentina |
| - | Bamberg | Germany |
| - | Bangor, Maine | USA |
| - | Berlin | Germany |
| - | Beverly Hills, California | USA |
| - | Białystok | Poland |
| - | Bielsko Biala | Poland |
| - | Birmingham, Alabama | USA |
| - | Boerne, Texas | USA |
| - | Bonn | Germany |
| - | Bragadiru | Romania |
| - | Brasov | Romania |
| - | Brooklyn, New York | USA |
| - | Bucharest | Romania |
| - | Buenos Aires | Argentina |
| - | Burlington, Ontario | Canada |
| - | Bydgoszcz | Poland |
| - | Bystra Śląska | Poland |
| - | Córdoba | Argentina |
| - | Caba | Argentina |
| - | Calgary, Alberta | Canada |
| - | Celebration, Florida | USA |
| - | Centennial, Colorado | USA |
| - | Chernivtsi | Ukraine |
| - | Chiyoda-ku | Japan |
| - | Chuo-ku | Japan |
| - | Cincinnati, Ohio | USA |
| - | Ciudad Autónoma de Bs. As. | Argentina |
| - | Ciudad de Buenos Aires | Argentina |
| - | Colorado Springs, Colorado | USA |
| - | Columbia, Maryland | USA |
| - | Columbus, Ohio | USA |
| - | Concepción del Uruguay | Argentina |
| - | Concepcion | Chile |
| - | Constanta | Romania |
| - | Corrientes | Argentina |
| - | Corvallis, Oregon | USA |
| - | Covington, Louisiana | USA |
| - | Dallas, Texas | USA |
| - | Darby, Pennsylvania | USA |
| - | Dayton, Ohio | USA |
| - | Decatur, Georgia | USA |
| - | Deva | Romania |
| - | Dnipropetrovsk | Ukraine |
| - | Donetsk | Ukraine |
| - | Durham, North Carolina | USA |
| - | Eagle, Idaho | USA |
| - | El Paso, Texas | USA |
| - | Fairfax, Virginia | USA |
| - | Falls Church, Virginia | USA |
| - | Flagstaff, Arizona | USA |
| - | Flint, Michigan | USA |
| - | Florida | Argentina |
| - | Fort Lauderdale, Florida | USA |
| - | Fort Mitchell, Kentucky | USA |
| - | Fort Smith, Arkansas | USA |
| - | Fountain Valley, California | USA |
| - | Frankfurt | Germany |
| - | Frankfurt/Main | Germany |
| - | Fujieda-shi | Japan |
| - | Fukuoka-shi | Japan |
| - | Gainesville, Georgia | USA |
| - | Gaithersburg, Maryland | USA |
| - | Garden Grove, California | USA |
| - | Gdańsk | Poland |
| - | Gdynia | Poland |
| - | Geesthacht | Germany |
| - | Gelsenkirchen | Germany |
| - | Glendale, Arizona | USA |
| - | Glendale, California | USA |
| - | Godoy Cruz | Argentina |
| - | Gorzów Wlkp | Poland |
| - | Goteborg | Sweden |
| - | Halle | Germany |
| - | Hamburg | Germany |
| - | Hamilton, Ontario | Canada |
| - | Hannover | Germany |
| - | Henderson, Nevada | USA |
| - | Hendersonville, Tennessee | USA |
| - | Herford | Germany |
| - | Hialeah, Florida | USA |
| - | Himeji-shi | Japan |
| - | Hiroshima-shi | Japan |
| - | Homestead, Florida | USA |
| - | Houston, Texas | USA |
| - | Iasi | Romania |
| - | Ikeda-shi | Japan |
| - | Iloilo City | Philippines |
| - | Indian Land, South Carolina | USA |
| - | Itabashi-ku | Japan |
| - | Itami-shi | Japan |
| - | Ivano-Frankivsk | Ukraine |
| - | Izumo-shi | Japan |
| - | Jacksonville, Florida | USA |
| - | Jefferson Hills, Pennsylvania | USA |
| - | Joyo-shi | Japan |
| - | Kagoshima-shi | Japan |
| - | Kahoku-gun | Japan |
| - | Kamogawa-shi | Japan |
| - | Kanazawa-shi | Japan |
| - | Karczew | Poland |
| - | Katowice | Poland |
| - | Katy, Texas | USA |
| - | Kettering, Ohio | USA |
| - | Kharkiv | Ukraine |
| - | Kishiwada-shi | Japan |
| - | Kitakyusyu-shi | Japan |
| - | Knoxville, Tennessee | USA |
| - | Kobe-shi | Japan |
| - | Kochi-shi | Japan |
| - | Kokubunji-shi | Japan |
| - | Koszalin | Poland |
| - | Kraków | Poland |
| - | Kumamoto-shi | Japan |
| - | Kyiv | Ukraine |
| - | Kyoto-shi | Japan |
| - | La Plata | Argentina |
| - | Lakewood, California | USA |
| - | Langhorne, Pennsylvania | USA |
| - | Lanus | Argentina |
| - | Lehigh Acres, Florida | USA |
| - | Leipzig | Germany |
| - | Lenexa, Kansas | USA |
| - | Lipa City | Philippines |
| - | Livonia, Michigan | USA |
| - | Lubin | Poland |
| - | Lublin | Poland |
| - | Luleå | Sweden |
| - | Lund | Sweden |
| - | Lutsk | Ukraine |
| - | München | Germany |
| - | Madison, Wisconsin | USA |
| - | Maebashi-shi | Japan |
| - | Mainz | Germany |
| - | Mar del Plata | Argentina |
| - | Marburg | Germany |
| - | Matsue-shi | Japan |
| - | McAllen, Texas | USA |
| - | Mendoza | Argentina |
| - | Miami, Florida | USA |
| - | Middleburg Heights, Ohio | USA |
| - | Midvale, Utah | USA |
| - | Milwaukee, Wisconsin | USA |
| - | Minato-ku | Japan |
| - | Minneapolis, Minnesota | USA |
| - | Mississauga, Ontario | Canada |
| - | Mizunami-shi | Japan |
| - | Moncton, New Brunswick | Canada |
| - | Montreal, Quebec | Canada |
| - | Murray, Utah | USA |
| - | Mykolayiv | Ukraine |
| - | Nagoya-shi | Japan |
| - | Neu-Isenburg | Germany |
| - | Niigata-shi | Japan |
| - | North Hollywood, California | USA |
| - | Northridge, California | USA |
| - | Obihiro-shi | Japan |
| - | Ocala, Florida | USA |
| - | Ogaki-shi | Japan |
| - | Ohota-ku | Japan |
| - | Oita-shi | Japan |
| - | Oklahoma City, Oklahoma | USA |
| - | Omaha, Nebraska | USA |
| - | Orlando, Florida | USA |
| - | Osakasayama-shi | Japan |
| - | Ostrów Wielkopolski | Poland |
| - | Ota-shi | Japan |
| - | Ottawa, Ontario | Canada |
| - | Palm Springs, California | USA |
| - | Palmdale, California | USA |
| - | Phoenix, Arizona | USA |
| - | Pittsburgh, Pennsylvania | USA |
| - | Portland, Oregon | USA |
| - | Poznań | Poland |
| - | Quebec | Canada |
| - | Quezon City | Philippines |
| - | Quillota | Chile |
| - | Rüdersdorf | Germany |
| - | Rancho Mirage, California | USA |
| - | Ranelagh | Argentina |
| - | Rapid City, South Dakota | USA |
| - | Redondo Beach, California | USA |
| - | Rockville, Maryland | USA |
| - | Rolling Hills Estate, California | USA |
| - | Rosario | Argentina |
| - | Roseville, California | USA |
| - | Rostock | Germany |
| - | Ruda Slaska | Poland |
| - | Rzeszów | Poland |
| - | Sacramento, California | USA |
| - | Sagamihara-shi | Japan |
| - | Sakai-shi | Japan |
| - | Sakaide-shi | Japan |
| - | San Antonio, Texas | USA |
| - | San Miguel de Tucuman | Argentina |
| - | Santiago | Chile |
| - | Sapporo-shi | Japan |
| - | Sendai-shi | Japan |
| - | Setagaya-ku | Japan |
| - | Seto-shi | Japan |
| - | Sherwood Park, Alberta | Canada |
| - | Shibuya-ku | Japan |
| - | Shiloh, Illinois | USA |
| - | Shinagawa-ku | Japan |
| - | Simferopol | Ukraine |
| - | Skierniewice | Poland |
| - | Smyrna, Georgia | USA |
| - | South Setauket, New York | USA |
| - | St Charles Borromee, Quebec | Canada |
| - | St. Louis, Missouri | USA |
| - | Stockton, California | USA |
| - | Sugarland, Texas | USA |
| - | Suita-shi | Japan |
| - | Sumida-ku | Japan |
| - | Szczecin | Poland |
| - | Takamatsu-shi | Japan |
| - | Talcahuano | Chile |
| - | Tampa, Florida | USA |
| - | Tarnów | Poland |
| - | Thousand Oaks, California | USA |
| - | Timisoara | Romania |
| - | Toronto, Ontario | Canada |
| - | Toruń | Poland |
| - | Toshima-ku | Japan |
| - | Toyama-shi | Japan |
| - | Toyota-shi | Japan |
| - | Traverse City, Michigan | USA |
| - | Tsukubo-gun | Japan |
| - | Tucson, Arizona | USA |
| - | Union, New Jersey | USA |
| - | Urasoe-shi | Japan |
| - | Utsunomiya-shi | Japan |
| - | Uzhgorod | Ukraine |
| - | Valparaiso | Chile |
| - | Vancouver, British Columbia | Canada |
| - | Ventura, California | USA |
| - | Viña del Mar | Chile |
| - | Vinnytsia | Ukraine |
| - | Vinnytsya | Ukraine |
| - | Virginia Gardens, Florida | USA |
| - | Walnut Creek, California | USA |
| - | Warszawa | Poland |
| - | Waterbury, Connecticut | USA |
| - | Wheat Ridge, Colorado | USA |
| - | Wieluń | Poland |
| - | Wilmington, North Carolina | USA |
| - | Witten | Germany |
| - | Woodland, California | USA |
| - | Wrocław | Poland |
| - | Wroclaw | Poland |
| - | Yanagawa-shi | Japan |
| - | Yokohama-shi | Japan |
| - | Yokosuka-shi | Japan |
| - | Yonago-shi | Japan |
| - | Zabrze | Poland |
| - | Zaporizhzhia | Ukraine |
| - | Zaporizhzhya | Ukraine |
| - | Zaporozhye | Ukraine |
|
AstraZeneca
Phone: +1 800-236-9933, 1-877-240-9479
show details
information.center@astrazeneca.com ClinicalTrialTransparency@astrazeneca.com |
-
|
-
|
|
Astrazeneca AB
Vastra Malarehamnen 9
show details
Sodertalje 151 85 Sweden Tel:46855326000 Fax:46855329000 information.center@astrazeneca.com |
Sodertalje | Sweden |
| The Lung Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver Canada |
-
|
-
|
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, 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 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 |
| 01 Jul 2019 | Other trial event | According to a Kyowa Kirin International media release, the Kyowa Hakko Kirin changed its name to Kyowa Kirin. Updated 23 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 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 |
| 06 Mar 2017 | Results | Results of subgroup analysis (n=83) assessing benralizumabs efficacy and safety for Japanese patients who participated in CALIMA, presented at the 2017 Annual Meeting of the American Academy of Allergy, Asthma and Immunology. Updated 22 Mar 2017 |
| 31 Jan 2017 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 31 Jan 2017 |
| 25 Jan 2017 | Biomarker Update | Biomarkers information updated Updated 07 Nov 2021 |
| 20 Oct 2016 | Results | Results published in the Lancet. Updated 20 Oct 2016 |
| 05 Sep 2016 | Other trial event | 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 |
| 11 Aug 2016 | Other trial event | Last checked against European Clinical Trials Database record. Updated 11 Aug 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 SIROCCO trials will be presented at a medical meeting. Updated 24 May 2016 |
| 17 May 2016 | Endpoint met | Primary endpoint (effect of benralizumab on asthma exacerbations in adult and adolescent patients with uncontrolled asthma) has been met, according to an AstraZeneca media release. Updated 23 May 2016 |
| 11 Apr 2016 | Status change - completed | Status changed from active, no longer recruiting to completed, according to ClinicalTrials.gov record. Updated 13 Apr 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 |
| 13 Nov 2015 | Other trial event | Planned number of patients changed from 1026 to 1296, as reported by ClinicalTrials.gov. Updated 20 Nov 2015 |
| 01 Apr 2015 | Completion date | Planned End Date changed from 1 Jun 2016 to 1 Mar 2016 as reported by ClinicalTrials.gov record. Updated 06 Apr 2015 |
| 01 Apr 2015 | Other trial event | Planned primary completion date changed from 1 Jun 2016 to 1 Mar 2016 as reported by ClinicalTrials.gov record. Updated 06 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 06 Apr 2015 |
| 17 Feb 2015 | Completion date | Planned End Date changed from 1 Mar 2016 to 1 Jun 2016 as reported by ClinicalTrials.gov record. Updated 26 Feb 2015 |
| 23 Nov 2014 | Completion date | Planned End Date changed from 1 May 2016 to 1 Mar 2016 as reported by ClinicalTrials.gov record. Updated 17 Dec 2014 |
| 23 Nov 2014 | Other trial event | Planned primary completion date changed from 1 May 2016 to 1 Mar 2016 as reported by ClinicalTrials.gov record. Updated 17 Dec 2014 |
| 26 Oct 2014 | Completion date | Planned End Date changed from 1 Mar 2016 to 1 May 2016 as reported by ClinicalTrials.gov record. Updated 10 Nov 2014 |
| 28 Sep 2014 | Other trial event | Planned number of patients changed from 2014 to 1026 as reported by ClinicalTrials.gov record. Updated 10 Nov 2014 |
| 16 Jun 2014 | Protocol amendment | Treatment Arm C for adolescent patients in the EU has been added as reported by ClinicalTrials.gov record. Updated 23 Sep 2014 |
| 07 May 2014 | Other trial event | Planned number of patients changed from 2052 to 2014 as reported by ClinicalTrials.gov record. Updated 25 Jun 2014 |
| 16 Apr 2014 | Other trial event | This trial has been initiated in Japan, according to a Kyowa Hakko Kirin media release. Updated 17 Apr 2014 |
| 12 Feb 2014 | Other trial event | Planned number of patients changed from 1026 to 2052 as reported by ClinicalTrials.gov. Updated 19 Feb 2014 |
| 30 Oct 2013 | Other trial event | Initiation of the CALIMA study was based on results from the phase IIb asthma study, according to an AstraZeneca media release. Updated 12 Nov 2013 |
| 30 Oct 2013 | Other trial event | Start of the phase III Windward programme announced in an AstraZeneca media release. Updated 12 Nov 2013 |
| 19 Oct 2013 | Other trial event | New source identified and integrated (European Clinical Trials Database; EudraCT2013-002163-26). Updated 23 Oct 2013 |
| 08 Aug 2013 | New trial record | New trial record Updated 08 Aug 2013 |
| 01 Aug 2013 | Status change - recruiting | Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov. Updated 11 Sep 2013 |
Table of Contents
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