Benralizumab

Generic Name
Benralizumab
Brand Names
Fasenra
Drug Type
Biotech
Chemical Formula
-
CAS Number
1044511-01-4
Unique Ingredient Identifier
71492GE1FX
Background

Benralizumab is a humanized recombinant monoclonal antibody of the isotype IgG1k immunoglobulin that specifically binds to the alpha chain of the interleukin 5 receptor (IL-5R) expressed on eosinophils and basophils. It inhibits the binding of IL-5 as well as the hetero-oligomerization of the alpha and beta subunits of the IL-5R, thus blocking, signal transduction. Besides, it is an afucosylated IgG which gives it high affinity for the FcγRIIIα receptor in natural killer cells, macrophages and neutrophils. Benralizumab, FDA approved on November 14, 2017, was developed by MedImmune, the AstraZeneca's global biologic research and development arm.

Indication

Benralizumab is indicated as a maintenance treatment of patients 12 years or older with severe asthma and an eosinophilic phenotype. The pathology of severe asthma with eosinophilic phenotype is also denotated as TH2-high phenotype. The patients with this phenotype are characterized by the expression of IL-5 and IL-13, airway hyperresponsiveness, responsiveness to inhaled corticosteroids, high serum IgE and eosinophilia in blood and airway. In the TH2-high phenotype, IL-5 presents a central role as it is responsible for eosinophil differentiation, survival, activation and migration to the lungs.

Associated Conditions
Severe Eosinophilic Asthma
Associated Therapies
-

Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies

First Posted Date
2020-09-17
Last Posted Date
2024-08-16
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
50
Registration Number
NCT04552288
Locations
🇺🇸

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States

🇺🇸

Memorial Sloan Kettering Cancer Center Suffolk - Hauppauge (Limited Protocol Activities), Hauppauge, New York, United States

🇺🇸

Memorial Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States

and more 2 locations

PK/PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma

Phase 3
Completed
Conditions
Interventions
First Posted Date
2020-03-12
Last Posted Date
2023-05-18
Lead Sponsor
AstraZeneca
Target Recruit Count
30
Registration Number
NCT04305405
Locations
🇯🇵

Research Site, Zentsuji-shi, Japan

A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)

First Posted Date
2019-12-09
Last Posted Date
2024-08-15
Lead Sponsor
AstraZeneca
Target Recruit Count
120
Registration Number
NCT04191304
Locations
🇬🇧

Research Site, London, United Kingdom

NAsal Polyps: Inflammatory & Molecular Phenotyping of Responders to Benralizumab

Phase 3
Completed
Conditions
Interventions
First Posted Date
2019-12-04
Last Posted Date
2024-10-31
Lead Sponsor
Humanitas Clinical and Research Center
Target Recruit Count
14
Registration Number
NCT04185012
Locations
🇮🇹

Humanitas Clinical and Research Hospital, Rozzano, MI, Italy

Benralizumab Exacerbation Study

Phase 4
Completed
Conditions
Interventions
First Posted Date
2019-09-25
Last Posted Date
2024-04-25
Lead Sponsor
NHS Greater Glasgow and Clyde
Target Recruit Count
157
Registration Number
NCT04102800
Locations
🇬🇧

Belfast City Hospital, Belfast, United Kingdom

🇬🇧

Birmingham Heartlands Hospital, Birmingham, United Kingdom

🇬🇧

Gartnavel General Hospital, Glasgow, United Kingdom

and more 12 locations

Acute Exacerbations Treated With BenRAlizumab (The ABRA Study)

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2019-09-23
Last Posted Date
2024-01-23
Lead Sponsor
University of Oxford
Target Recruit Count
158
Registration Number
NCT04098718
Locations
🇬🇧

Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire, United Kingdom

Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations

First Posted Date
2019-08-12
Last Posted Date
2024-11-08
Lead Sponsor
AstraZeneca
Target Recruit Count
689
Registration Number
NCT04053634
Locations
🇻🇳

Research Site, Ho Chi Minh, Vietnam

Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics

Phase 4
Recruiting
Conditions
Interventions
First Posted Date
2019-05-16
Last Posted Date
2024-12-09
Lead Sponsor
AstraZeneca
Target Recruit Count
81
Registration Number
NCT03953300
Locations
🇬🇧

Research Site, Wythenshawe, United Kingdom

Evaluating the Effect of Benralizumab in Severe, Poorly-controlled Eosinophilic Asthma Using Inhaled Hyperpolarized 129-Xenon MRI

Not Applicable
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-11-07
Last Posted Date
2024-06-13
Lead Sponsor
Dr. Grace Parraga
Target Recruit Count
29
Registration Number
NCT03733535
Locations
🇨🇦

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre, London, Ontario, Canada

Impact of Benralizumab Treatment on Circulating Dendritic Cells in Patients With Eosinophilic Asthma

Phase 4
Conditions
Interventions
First Posted Date
2018-08-29
Last Posted Date
2018-08-29
Lead Sponsor
University of Rostock
Target Recruit Count
20
Registration Number
NCT03652376
Locations
🇩🇪

University of Rostock, Rostock, Mecklenburg-Vorpommern, Germany

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