Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03562195 | A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma | PHASE3 | COMPLETED | 300 | — | — | Aug 29, 2018 | Sep 7, 2022 | Sep 19, 2024 | 42 | China |
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...