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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01448850 | A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease | PHASE2 | COMPLETED | 464 | — | — | Nov 1, 2011 | Feb 1, 2014 | Jan 30, 2017 | 60 | United States, Bulgaria +8 |
An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53. |
| MEDI8968 600 mg IV, 300 mg SC | EXPERIMENTAL | MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53. |
| Name | Type | Description |
|---|---|---|
| MEDI8968 600 mg IV, 300 mg SC | BIOLOGICAL | MEDI8968 600 mg as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53. |
| Placebo | OTHER | Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53. |
Inclusion Criteria: * Age 45 through 75 years * Predicted (Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] stage II, III, and IV) at Screening * History of previous acute exacerbations of chronic obstructive pulmonary disease (AECOPD) 12 months prior to Screening * Clinically stable...