Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma

Summary

Primary Objective: To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic asthma. Secondary Objectives: * To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in participants with persistent moderate to severe eosinophilic asthma. * To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.

Timeline

Start

2011-03

Primary completion

2012-10

Completion

2012-10

Outcome

Met primary endpoint

registry NUMBER Dupilumab 300 mg qw: Asthma exacerbation: 5.8 percentage of participants NCT01312961 ↗

registry analysis (superiority test); Placebo (for Dupilumab) vs Dupilumab 300 mg qw; p <0.0001; Odds Ratio (OR) 0.077 (95% CI 0.021 to 0.280); NCT01312961 ↗

Publications

• Results Wenzel S, Ford L, Pearlman D, Spector S, Sher L, Skobieranda F, Wang L, Kirkesseli S, Rocklin R, Bock B, Hamilton J, Ming JE, Radin A, Stahl N, Yancopoulos GD, Graham N, Pirozzi G. Dupilumab in persistent asthma with elevated eosinophil levels. N Engl J Med. 2013 Jun 27;368(26):2455-66. doi: 10.1056/NEJMoa1304048. Epub 2013 May 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dupilumab	Monoclonal antibody	300 mg	Subcutaneous
Background	Fluticasone	Other / unclassified	—	Inhaled
Background	Levalbuterol	Other / unclassified	—	Inhaled
Background	Salbutamol	Unknown	—	Inhaled
Background	Salmeterol	Other / unclassified	—	Inhaled

Indications