Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mepolizumab 100 milligrams · 1 trial · 1 indication
Clinically significant exacerbation is defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalizations and/or Emergency Department (ED) visits. Analysis of the number of exacerbations was performed using a negative binomial model with covariates of treatment group, baseline maintenance Oral Corticosteroids (OCS) therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted Forced Expiratory Volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.
| Arm | Type | Description |
|---|---|---|
| Mepolizumab 100mg | EXPERIMENTAL | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis |
| Name | Type | Description |
|---|---|---|
| Mepolizumab 100 milligrams | DRUG | Mepolizumab will be given as a lyophilized cake in sterile vials for individual use. The vial will be reconstituted with Sterile Water for Injection, just prior to use. |
| Placebo | DRUG | Placebo will be given as 0.9 percent sodium chloride solution. |
| Salbutamol | DRUG | Salbutamol MDI will be given as a rescue medication to be used on an as needed basis in this study. |
Inclusion Criteria: * Subjects who will be able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficien...
Mepolizumab 100 milligrams is used for the treatment of asthma, specifically severe asthma. It is being investigated as a therapy for patients with this respiratory condition. The drug is currently in Phase 3 clinical development and is not yet approved for use.
Mepolizumab 100 milligrams targets the interleukin-5 (IL-5) pathway, which plays a role in the inflammation associated with severe asthma. By modulating this pathway, the drug aims to reduce eosinophilic inflammation, a key driver of asthma symptoms. This mechanism is being evaluated in clinical trials.
Mepolizumab 100 milligrams is being developed by GSK plc, a global biopharmaceutical company. GSK is conducting clinical trials to evaluate the safety and efficacy of this drug in patients with severe asthma. The company is listed on the stock exchange under the ticker symbol GSK.
Mepolizumab 100 milligrams is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 3 trial is designed to assess its safety and efficacy in patients with severe asthma, and it has been completed.
Mepolizumab 100 milligrams is being studied in a Phase 3 clinical trial with the identifier NCT03562195. This trial, titled 'A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma,' enrolled 300 participants in China. The study was randomized, double-blind, and placebo-controlled, and it has been completed.
Mepolizumab 100 milligrams is a specific dosage form of the drug mepolizumab. The 100 milligram dose is being studied for the treatment of severe asthma. While mepolizumab may be known by other names, this particular formulation is the focus of the ongoing clinical development program.