Benralizumab in Patients With Inadequate Response to Anti-IL5 Monoclonal Antibody Therapies
NCT03470311 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2023-01-20
Summary
In severe prednisone-dependent eosinophilic asthma, Benralizumab would suppress airway eosinophilia that is not suppressed by either Mepolizumab or Reslizumab and this would be associated with greater asthma control
Conditions
- Severe Prednisone Dependent Eosinophilic Asthma
Interventions
- BIOLOGICAL
-
Benralizumab
30mg in 1mL pre-filled syringe
- BIOLOGICAL
-
Matched placebo (1mL) in pre-filled syringe
Sponsors & Collaborators
-
St. Joseph's Healthcare Hamilton
collaborator OTHER - collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
Parameswaran Nair, MD, PhD · McMaster University and St. Joseph's Healthcare Hamilton
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-26
- Primary Completion
- 2022-06-14
- Completion
- 2022-11-30
Countries
- Canada
Study Locations
More Related Trials
-
Anti-Interleukin-5 (IL5) Monoclonal Antibody (MAb) in Prednisone-dependent Eosinophilic Asthma
NCT02559791 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Evaluating the Effect of Benralizumab in Severe, Poorly-controlled Eosinophilic Asthma Using Inhaled Hyperpolarized 129-Xenon MRI
NCT03733535 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients With Mild to Moderate Persistent Asthma
NCT02322775 ·Status: COMPLETED ·Phase: PHASE3
-
Benralizumab Initiated During Severe Asthma Attack
NCT04617171 ·Status: UNKNOWN ·Phase: PHASE2
-
BenRalizumab Effect on Airway Remodeling in Severe asTHma
NCT06288516 ·Status: RECRUITING ·Phase: PHASE4
-
Patient-reported Outcomes in Real-world Use of Benralizumab in Patients With Severe Eosinophilic Asthma in Belgium
NCT04221802 ·Status: COMPLETED
-
Patients With Severe Eosinophilic Asthma Treated With Benralizumab
NCT05078281 ·Status: UNKNOWN
-
Impact of Benralizumab Treatment on Circulating Dendritic Cells in Patients With Eosinophilic Asthma
NCT03652376 ·Status: UNKNOWN ·Phase: PHASE4
-
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)
NCT05692180 ·Status: RECRUITING ·Phase: PHASE3
-
Change in Patient-Reported Outcomes in Severe Eosinophilic Asthma Patients Treated With Benralizumab Under Real-life Conditions
NCT04184284 ·Status: COMPLETED
-
A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered Benralizumab (MEDI-563).
NCT00768079 ·Status: COMPLETED ·Phase: PHASE2
-
A Non-interventional, Prospective Study With Benralizumab
NCT06422078 ·Status: RECRUITING
-
Real World Evidence of Benralizumab in Eosinophilic Severe AsThma in Russia (BEST)
NCT05271526 ·Status: COMPLETED
-
A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy
NCT07214753 ·Status: RECRUITING
-
Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
NCT01947946 ·Status: TERMINATED ·Phase: PHASE3
-
Effect of Benralizumab on Airway Remodeling in Asthma
NCT04365205 ·Status: RECRUITING
-
Benralizumab Exacerbation Study
NCT04102800 ·Status: COMPLETED ·Phase: PHASE4
-
PK/PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma
NCT04305405 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 2a Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Adults With Asthma
NCT00783289 ·Status: COMPLETED ·Phase: PHASE2
-
STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma
NCT06465485 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Efficacy and Safety Study of Benralizumab to Reduce OCS Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus LABA and Chronic OCS Therapy
NCT02075255 ·Status: COMPLETED ·Phase: PHASE3
-
Study in Portuguese Hospitals to Describe Patient Characteristics, Treatment Patterns and Outcomes
NCT07159295 ·Status: COMPLETED
-
ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab
NCT04272463 ·Status: COMPLETED
-
Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma
NCT04710134 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
NCT01928771 ·Status: COMPLETED ·Phase: PHASE3