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 transd...

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, responsiven...

Associated Conditions: Severe Eosinophilic Asthma

Associated Therapies: -

Clinical Trials

A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases

Phase 3

Not yet recruiting

Conditions: Eosinophilic Granulomatosis With Polyangiitis (EGPA)

Interventions: Drug: Benralizumab

First Posted Date: 2024-07-22

Last Posted Date: 2024-12-12

Lead Sponsor: AstraZeneca

Target Recruit Count: 14

Registration Number: NCT06512883

Locations: 🇹🇷
Research Site, Altındağ, Turkey

STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma

Phase 3

Recruiting

Conditions: Severe Eosinophilic Asthma

Interventions: Drug: Benralizumab

First Posted Date: 2024-06-18

Last Posted Date: 2024-11-21

Lead Sponsor: AstraZeneca

Target Recruit Count: 200

Registration Number: NCT06465485

Locations: 🇨🇳
Research Site, Zhengzhou, China

A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Drug: Benralizumab
Drug: fulvestrant or AIs) and PI3K inhibition (alpelisib)

First Posted Date: 2023-07-28

Last Posted Date: 2024-08-29

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 1

Registration Number: NCT05966584

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities), Commack, New York, United States

and more 4 locations

Benralizumab Patient Access Programme Study: Retrospective Study in UK Severe Asthma Centres

Completed

Conditions: Asthma

First Posted Date: 2023-07-06

Last Posted Date: 2023-11-28

Lead Sponsor: AstraZeneca

Target Recruit Count: 276

Registration Number: NCT05932849

Locations: 🇬🇧
Addenbrookes Hospital, Cambridge, United Kingdom
🇬🇧
St Bartholomew's Hospital, London, United Kingdom
🇬🇧
St James's University Hospital, Leeds, United Kingdom

and more 5 locations

Beyond the Eosinophil: Understanding the Impact of Eosinophil Depletion on T2 Inflammation. (BEUTI)

Recruiting

Conditions: Asthma

Interventions: Drug: Benralizumab

First Posted Date: 2023-05-06

Last Posted Date: 2023-07-11

Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Target Recruit Count: 12

Registration Number: NCT05847452

Locations: 🇬🇧
Guy's & St Thomas' NHS Foundation Trust, London, United Kingdom

A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)

Phase 3

Recruiting

Conditions: Asthma

Interventions: Drug: Placebo
Drug: Benralizumab

First Posted Date: 2023-01-20

Last Posted Date: 2024-12-20

Lead Sponsor: AstraZeneca

Target Recruit Count: 200

Registration Number: NCT05692180

Locations: 🇬🇧
Research Site, Manchester, United Kingdom

FAsenra Safety Trial in India

Phase 4

Completed

Conditions: In Adult Patients of Severe Asthma With Eosinophilic Phenotype in India

Interventions: Biological: Benralizumab

First Posted Date: 2022-05-20

Last Posted Date: 2024-12-11

Lead Sponsor: AstraZeneca

Target Recruit Count: 139

Registration Number: NCT05384938

Locations: 🇮🇳
Research Site, Vishakhapatnam, India

Immunological Basis for Benralizumab Activity in Chronic Obstructive Pulmonary Disease (COPD)

Phase 2

Not yet recruiting

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Other: Comparison (control) group; no intervention
Other: Benralizumab placebo
Drug: Benralizumab

First Posted Date: 2022-03-10

Last Posted Date: 2023-04-07

Lead Sponsor: Temple University

Target Recruit Count: 45

Registration Number: NCT05273359

A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype

Phase 3

Recruiting

Conditions: Asthma

Interventions: Biological: GSK3511294 (Depemokimab)
Biological: Mepolizumab
Biological: Benralizumab
Biological: Placebo
Drug: Standard of care (SoC)
Device: Pre-filled Syringes (PFS)

First Posted Date: 2021-01-22

Last Posted Date: 2024-04-30

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 1700

Registration Number: NCT04718389

Locations: 🇬🇧
GSK Investigational Site, Wishaw, United Kingdom

A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid.

Phase 3

Terminated

Conditions: Bullous Pemphigoid

Interventions: Biological: Benralizumab
Biological: Placebo

First Posted Date: 2020-11-03

Last Posted Date: 2024-11-28

Lead Sponsor: AstraZeneca

Target Recruit Count: 67

Registration Number: NCT04612790

Locations: 🇪🇸
Research Site, Madrid, Spain

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