Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History

Summary

The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies.

Timeline

Start

2014-06-25

Primary completion

2018-04-09

Completion

2018-04-09

Outcome

Missed primary endpoint

paper At 56 weeks, none of the annualized COPD exacerbation rate ratios for any dose of benralizumab as compared with placebo reached significance in either trial. PMID 31112385 ↗

release “TERRANOVA trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with chronic obstructive pulmonary disease” astrazeneca.com ↗

Publications

• Criner GJ, Celli BR, Singh D, Agusti A, Papi A, Jison M, Makulova N, Shih VH, Brooks L, Barker P, Martin UJ, Newbold P. Predicting response to benralizumab in chronic obstructive pulmonary disease: analyses of GALATHEA and TERRANOVA studies. Lancet Respir Med. 2020 Feb;8(2):158-170. doi: 10.1016/S2213-2600(19)30338-8. Epub 2019 Sep 28.
• Criner GJ, Celli BR, Brightling CE, Agusti A, Papi A, Singh D, Sin DD, Vogelmeier CF, Sciurba FC, Bafadhel M, Backer V, Kato M, Ramirez-Venegas A, Wei YF, Bjermer L, Shih VH, Jison M, O'Quinn S, Makulova N, Newbold P, Goldman M, Martin UJ; GALATHEA Study Investigators; TERRANOVA Study Investigators. Benralizumab for the Prevention of COPD Exacerbations. N Engl J Med. 2019 Sep 12;381(11):1023-1034. doi: 10.1056/NEJMoa1905248. Epub 2019 May 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Benralizumab	Monoclonal antibody	10 mg	Subcutaneous
Subject	Benralizumab	Monoclonal antibody	30 mg	Subcutaneous
Subject	Benralizumab	Monoclonal antibody	100 mg	Subcutaneous

Indications