Asthma Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of SAR231893/REGN668 Administered Subcutaneously Once Weekly for 12 Weeks in Patients With Persistent Moderate to Severe Eosinophilic Asthma Who Are Partially Controlled/Uncontrolled by Inhaled Corticosteroid Plus Long-acting beta2 Agonist Therapy
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.
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.
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