A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease

Phase 2 Completed 464 enrolled MedImmune LLC

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the effect of MEDI8968 on the rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with symptomatic, moderate to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease - GOLD stage II-IV) receiving standard maintenance therapy for the underlying disease condition.

Timeline

Start: 2011-11
Primary completion: 2014-02
Completion: 2014-02

Outcome

Missed primary endpoint

registry Placebo vs MEDI8968 600 mg IV, 300 mg SC; p = 0.645; Rate ratio 0.92 (90% CI 0.68 to 1.25) NCT01448850 ↗

paper There were neither statistically significant differences between treatment groups in moderate/severe AECOPD rate PMID 28793896 ↗

Publications

Calverley PMA, Sethi S, Dawson M, Ward CK, Finch DK, Penney M, Newbold P, van der Merwe R. A randomised, placebo-controlled trial of anti-interleukin-1 receptor 1 monoclonal antibody MEDI8968 in chronic obstructive pulmonary disease. Respir Res. 2017 Aug 9;18(1):153. doi: 10.1186/s12931-017-0633-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MEDI8968	Monoclonal antibody	300 mg	Intravenous