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A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA
Phase 3 trial testing Benralizumab in Asthma in 2,133 participants. Completed in 2 July 2018.
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 2,133 |
| Start date | 19 November 2014 |
| Primary completion | 18 October 2017 |
| Estimated completion | 2 July 2018 |
| Sites | 429 locations across Japan, Vietnam, Poland, South Korea, Philippines, Russia, Sweden, Bulgaria |
AstraZeneca — full company profile →
Adults 12 to 75, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change from baseline in hematologic lab parameter of Basophils.
| Group | Value | 95% CI |
|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | -0.005 | ± 0.0223 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | -0.005 | ± 0.0239 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | -0.007 | ± 0.0283 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | -0.005 | ± 0.0244 |
Change from baseline in hematologic lab parameter of Basophils.
| Group | Value | 95% CI |
|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | -0.006 | ± 0.0145 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | 0.001 | ± 0.0208 |
Change from baseline in hematologic lab parameter of Leukocytes.
| Group | Value | 95% CI |
|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | -0.344 | ± 2.0412 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | -0.128 | ± 1.8614 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | -0.808 | ± 1.8177 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | -0.507 | ± 3.3612 |
Change from baseline in hematologic lab parameter of Leukocytes.
| Group | Value | 95% CI |
|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | -0.487 | ± 1.7289 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | -0.079 | ± 1.8432 |
Change from baseline in hematologic lab parameter of Lymphocytes.
| Group | Value | 95% CI |
|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | -0.032 | ± 0.6242 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | 0.003 | ± 0.5402 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | -0.093 | ± 0.6403 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | 0.007 | ± 0.6864 |
Change from baseline in hematologic lab parameter of Lymphocytes.
| Group | Value | 95% CI |
|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | -0.180 | ± 0.6946 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | -0.070 | ± 0.6671 |
Change from baseline in hematologic lab parameter of Neutrophils.
| Group | Value | 95% CI |
|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | -0.171 | ± 1.8746 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | 0.013 | ± 1.7024 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | -0.501 | ± 1.7096 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | -0.368 | ± 3.2057 |
Change from baseline in hematologic lab parameter of Neutrophils.
| Group | Value | 95% CI |
|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | -0.451 | ± 1.7645 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | 0.242 | ± 1.8469 |
Change from baseline in hematologic lab parameter of Eosinophils.
| Group | Value | 95% CI |
|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | -0.1220 | ± 0.30599 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | -0.1271 | ± 0.26161 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | -0.1451 | ± 0.30766 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | -0.1664 | ± 0.35139 |
Change from baseline in hematologic lab parameter of Eosinophils.
| Group | Value | 95% CI |
|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | -0.1294 | ± 0.27973 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | -0.1838 | ± 0.3381 |
Change from baseline in chemistry tests ALT.
| Group | Value | 95% CI |
|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | -0.007 | ± 0.2102 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | 0.017 | ± 0.4651 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | -0.064 | ± 0.3547 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | -0.023 | ± 0.1940 |
Change from baseline in hematologic lab parameter of ALT.
| Group | Value | 95% CI |
|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | 0.048 | ± 0.2195 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | 0.034 | ± 0.2312 |
Time frame: Adults completed 56 weeks of treatment period and 12 weeks follow-up period; and adolescents completed 108 weeks of treatment period and 12 weeks follow-up period.. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | SIROCCO/CALIMA - Benralizu… | SIROCCO/CALIMA - Benralizu… | ZONDA - Benralizumab 30 mg… | ZONDA - Benralizumab 30 mg… |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Pneumonia bacterial | Infections and infestations | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — | — | — |
| Angina unstable | Cardiac disorders | — | — | — | — |
| Diffuse large B-cell lymphoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Gastritis | Gastrointestinal disorders | — | — | — | — |
| Death | General disorders | — | — | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — | — | — |
| Food allergy | Immune system disorders | — | — | — | — |
| Bronchitis | Infections and infestations | — | — | — | — |
| Influenza | Infections and infestations | — | — | — | — |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | — | — | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Ischaemic stroke | Nervous system disorders | — | — | — | — |
| Ureterolithiasis | Renal and urinary disorders | — | — | — | — |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Hypochromic anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Iron deficiency anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — | — |
| Acute coronary syndrome | Cardiac disorders | — | — | — | — |
| Reaction | System | SIROCCO/CALIMA - Benralizu… | SIROCCO/CALIMA - Benralizu… | ZONDA - Benralizumab 30 mg… | ZONDA - Benralizumab 30 mg… |
|---|---|---|---|---|---|
| Viral upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Asthma | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Bronchitis | Infections and infestations | — | — | — | — |
| Acute sinusitis | Infections and infestations | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Influenza like illness | General disorders | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Pharyngitis | Infections and infestations | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Upper respiratory tract infection bacterial | Infections and infestations | — | — | — | — |
| Sinusitis | Infections and infestations | — | — | — | — |
| Bronchitis bacterial | Infections and infestations | — | — | — | — |
| Oral candidiasis | Infections and infestations | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Seasonal allergy | Immune system disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Chronic sinusitis | Infections and infestations | — | — | — | — |
| Respiratory tract infection viral | Infections and infestations | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Conjunctivitis allergic | Eye disorders | — | — | — | — |
| Herpes zoster | Infections and infestations | — | — | — | — |
| Gastritis | Gastrointestinal disorders | — | — | — | — |
| Oedema peripheral | General disorders | — | — | — | — |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Non-cardiac chest pain | General disorders | — | — | — | — |
| Blood pressure increased | Investigations | — | — | — | — |
| Peripheral venous disease | Vascular disorders | — | — | — | — |
| Large intestine polyp | Gastrointestinal disorders | — | — | — | — |
| Injection site bruising | General disorders | — | — | — | — |
| Blood creatinine increased | Investigations | — | — | — | — |
Most-reported serious reactions: Asthma, Pneumonia bacterial, Pneumonia, Acute myocardial infarction, Angina unstable, Diffuse large B-cell lymphoma stage II, Gastritis, Death.
Data from ClinicalTrials.gov NCT02258542 adverse events section.
The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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