At a glance
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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Severe Steroid Dependent Asthma
In Brief
A Phase 3 clinical trial evaluating Dupilumab, Placebo, and 4 other interventions for Asthma. Completed, enrolled 210 participants across 80 sites in 17 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
Oral administration.
Oral inhalation, stable dose (high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy).
Oral inhalation as needed.
Oral inhalation as needed.