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Also known as Benralizumab, benralizumab
Benralizumab+ Mometasone Furoate · 1 trial · 1 indication
Change from baseline in total nasal polyps score (NPS) at week 40 was defined as the endpoint value at week 40 minus the baseline value. The total NPS was the sum of the right and left nostril scores and maximum total NPS is 8, as evaluated by nasal endoscopy and the left and right score were based on central read with scale from 0 to 4 where higher score reflects heavier bilateral nasal polyp burden. Baseline was the last valid value on or prior to the date of randomization. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis.
Change from baseline in nasal blockage score (NBS) at week 40 was defined as the endpoint value at week 40 minus the baseline value. The NBS was captured by an item in NPSD. Patients were asked to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0-none; 1-mild; 2-moderate; 3-severe. The NBS and the changes from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of the WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis.
| Arm | Type | Description |
|---|---|---|
| Benralizumab 30mg SC + MF | EXPERIMENTAL | SC - subcutaneously MF - Mometasone Furoate |
| Placebo SC + MF | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Benralizumab 30 mg SC + Mometasone Furoate | BIOLOGICAL | Benralizumab injection is 30mg/ml SC clear to opalescent, colourless to yellow solution in accessorized pre-filled syringe. Benralizumab 30 mg SC will be injected every 4 weeks for the first 3 doses - Weeks 0 , 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48. Total of 8 doses. Mometasone Furoate Nasal Spray (MFNS) - intranasal corticosteroid - 2 doses (1 dose = 50 micrograms/actuation) in each nostril twice daily. Total daily dose of 400mcg. MFNS will be used for a minimum of 4 weeks prior to randomization and will be continued throughout the study. |
| Matching placebo SC + Mometasone Furoate | BIOLOGICAL | Matching placebo injection is SC clear to opalescent, colourless to yellow solution in accessorized pre-filled syringe. Matching placebo SC will be injected every 4 weeks for the first 3 doses - Weeks 0 , 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48. Total of 8 doses. Mometasone Furoate Nasal Spray (MFNS) - intranasal corticosteroid - 2 doses (1 dose = 50 micrograms/actuation) in each nostril twice daily. Total daily dose of 400mcg. MFNS will be used for a minimum of 4 weeks prior to randomization and will be continued throughout the study. |
Inclusion Criteria: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions, listed in the informed consent form (ICF) and in protocol. 2. Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific ...
Benralizumab is an investigational monoclonal antibody being studied for multiple eosinophilic conditions, including Eosinophilic Granulomatosis With Polyangiitis (EGPA), severe uncontrolled asthma, nasal polyposis, hypereosinophilic syndrome, and severe eosinophilic asthma. It is also being evaluated in healthy subjects and for other conditions like atopic dermatitis and COPD.
Benralizumab is a monoclonal antibody that targets the interleukin-5 receptor alpha subunit on eosinophils. By binding to this receptor, it is designed to deplete eosinophils, which are white blood cells involved in allergic and eosinophilic inflammation. This mechanism is being studied across several eosinophil-driven diseases.
Benralizumab is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the NASDAQ under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple indications, including respiratory and dermatological conditions.
Benralizumab is in Phase 3 clinical development for several indications, including severe eosinophilic asthma and chronic obstructive pulmonary disease. It has completed Phase 3 trials, such as NCT04053634 in COPD and NCT04305405 in pediatric asthma, and is also being studied in earlier phases for other conditions.
Benralizumab has been studied in 20 clinical trials, with 2 active and 18 completed. Notable trials include NCT04053634, a Phase 3 study in COPD with 689 participants, and NCT06465485, a Phase 3b study in severe eosinophilic asthma with 504 participants. Other trials cover atopic dermatitis and pediatric asthma.
Benralizumab is also known by the brand name Fasenra. It is a monoclonal antibody developed by AstraZeneca for eosinophilic conditions. While Fasenra is an approved treatment for severe eosinophilic asthma in some regions, the drug remains investigational for other indications like EGPA and nasal polyposis.