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Clinical Trial 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.


Clinical Trial Description

The total duration of the study period per participant was 20-22 weeks broken down as follows:

- Screening period: up to 14 days,

- Treatment period: 12 weeks,

- Follow-up period: 6-8 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01312961
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2
Start date March 2011
Completion date October 2012

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