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).
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.
Buenos Aires, Argentina
Caba, Argentina
Caba, Argentina