Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI8968 · 1 trial · 1 indication
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...
MEDI8968 was studied for the treatment of chronic obstructive pulmonary disease (COPD). It is an investigational monoclonal antibody developed by AstraZeneca PLC. The clinical program evaluated it in adults aged 45 years and older with COPD, but it has not been approved for any indication.
MEDI8968 was evaluated in one Phase 2 trial, NCT01448850, titled A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease. The trial enrolled 464 participants across the United States, Bulgaria, Czechia, Hungary, Latvia, Lithuania, the Philippines, Poland, Ukraine, and the United Kingdom, and it is now completed.
MEDI8968 is developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the Phase 2 clinical program evaluating the monoclonal antibody in chronic obstructive pulmonary disease.
MEDI8968 is in Phase 2 development. Its single clinical trial, NCT01448850, was a randomized, double-blind, placebo-controlled Phase 2 study in chronic obstructive pulmonary disease that has been completed. The drug remains investigational and is not approved for any indication.