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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 is an investigational monoclonal antibody being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is administered to patients aged 45 years and older. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
MEDI8968 is a monoclonal antibody, but its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated for its efficacy in patients with Chronic Obstructive Pulmonary Disease, though the precise mechanism of action is not publicly detailed.
MEDI8968 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Chronic Obstructive Pulmonary Disease.
MEDI8968 is in Phase 2 clinical development. It is an investigational drug and has not received regulatory approval. The Phase 2 trial has been completed, and the drug is no longer in active clinical testing according to the available trial records.
MEDI8968 has been studied in one completed Phase 2 clinical trial with the identifier NCT01448850. This randomized, double-blind, placebo-controlled study enrolled 464 participants with Chronic Obstructive Pulmonary Disease across multiple countries, including the United States, Bulgaria, Czechia, Hungary, Latvia, Lithuania, Philippines, Poland, Ukraine, and the United Kingdom.
MEDI8968 is a unique investigational drug candidate developed by AstraZeneca. No alternative names or brand names have been associated with this compound in the available clinical trial information. It is distinct from other medications in the same therapeutic area.