Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mepolizumab 750 · 1 trial · 1 indication
Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance oral corticosteroids \[OCS\], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit. The frequency of clinically significant exacerbations of asthma over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable
| Arm | Type | Description |
|---|---|---|
| Mepolizumab 750mg | ACTIVE_COMPARATOR | Mepolizumab 750mcg i.v. every 4 weeks |
| Mepolizumab 250mg | ACTIVE_COMPARATOR | Mepolizumab 250mcg i.v. every 4 weeks |
| Mepolizumab 75mg | ACTIVE_COMPARATOR | Mepolizumab 75mcg i.v. every 4 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo saline every 4 weeks i.v. |
| Name | Type | Description |
|---|---|---|
| Mepolizumab 750 | BIOLOGICAL | Mepolizumab 750mg every four weeks by i.v. |
| Mepolizumab 250 | BIOLOGICAL | Mepolizumab 250mg every four weeks by i.v. |
| Mepolizumab 75 | BIOLOGICAL | Mepolizumab 75mg every four weeks by i.v. |
| Placebo saline | DRUG | Placebo saline every four weeks by i.v. |
Inclusion Criteria: * Male or female * Aged 12 to 65 years inclusive * Minimum weight 45kg * Clinical features of severe refractory asthma * Well documented requirement for high dose inhaled corticosteroids (ICS) \[i.e. \>= 880mcg/day fluticasone propionate or equivalent daily\] for at least 12 mon...
Mepolizumab 750 is an investigational monoclonal antibody being studied for the treatment of asthma. It is being developed by GSK plc (GSK) and is currently in Phase 2 clinical development. The drug is intended for patients with severe asthma, as evaluated in a dose-ranging efficacy and safety trial.
Mepolizumab 750 is a monoclonal antibody that targets interleukin-5 (IL-5), a key cytokine involved in the inflammation of airways in asthma. By binding to IL-5, it aims to reduce eosinophilic inflammation, which is a hallmark of severe asthma. This mechanism is being investigated in clinical trials for its potential to improve asthma control.
Mepolizumab 750 is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this monoclonal antibody for the treatment of severe asthma.
Mepolizumab 750 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 2 trial has been completed, and the results will inform further development.
Mepolizumab 750 has been studied in one completed Phase 2 clinical trial, identified as NCT01000506. This was a dose-ranging efficacy and safety study in patients with severe asthma, enrolling 621 participants across multiple countries including the United States, Argentina, Australia, and the United Kingdom.
Mepolizumab 750 is a specific dose formulation of mepolizumab, which is the active ingredient in the approved asthma medication Nucala. However, the data provided does not specify whether Mepolizumab 750 is a distinct product or a different dosing regimen. It is being studied as an investigational therapy for severe asthma.