Asthma Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Severe Steroid Dependent Asthma
Primary Objective:
To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of
maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma.
Secondary Objectives:
- To evaluate the safety and tolerability of dupilumab.
- To evaluate the effect of dupilumab in improving participants-reported outcomes.
- To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug
antibodies.
The total study duration per participant was up to 46 weeks, consisting of a screening period
of 3 to up to 8 weeks (up to 10 weeks for participants who experienced a clinically
significant asthma exacerbation during the screening period), a randomized treatment period
of up to 24 weeks, and a post-treatment period of 12 weeks.
Participants who completed treatment were considered for eligibility into the long term
extension study LTS12551 (NCT02134028).
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