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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01000506 | Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma | PHASE2 | COMPLETED | 621 | — | — | Nov 1, 2009 | Mar 23, 2012 | Jan 24, 2018 | 94 | United States, Argentina +11 |
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...