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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
210
Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control
Percentage reduction of OCS dose was calculated as (optimized OCS dose \[mg/day\] at baseline - final OCS dose at Week 24)/optimized OCS dose at baseline x 100. Result is presented as Least Squares Mean (Standard Error) percentage reduction from baseline derived from ANCOVA model with missing data multiply imputed.
Time frame: Baseline, Week 24
Supplementary Presentation of Primary Outcome Measure Data: Median Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
The Primary Outcome Measure (Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control) is summarized above, as LS Mean (SE). Table below provides a supplementary presentation of the Primary Outcome Measure data; result is presented as median (inter-quartile range). Percentage reduction of OCS dose was calculated as (optimized OCS dose \[mg/day\] at baseline - final OCS dose at Week 24)/optimized OCS dose at baseline x 100.
Time frame: Baseline, Week 24
Percentage of Participants Achieving >= 50% Reduction in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
Participants were classified according to the binary status of whether or not the 50% OCS dose reduction criterion was achieved at week 24.
Time frame: Week 24
Percentage of Participants Achieving a Reduction in Oral Corticosteroids Dose to <5 mg/Day at Week 24 While Maintaining Asthma Control
Participants were classified according to the binary status of whether or not the reduction of OCS dose to \<5 mg/day was achieved at Week 24.
Time frame: Week 24
Percentage of Participants Achieving Maximum Possible Reduction in Oral Corticosteroids Dose Per Protocol at Week 24 While Maintaining Asthma Control
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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.
Investigational Site Number 840022
Los Angeles, California, United States
Investigational Site Number 840014
Rolling Hills Estates, California, United States
Investigational Site Number 840002
St Louis, Missouri, United States
Investigational Site Number 840010
Pittsburgh, Pennsylvania, United States
Investigational Site Number 840062
Amarillo, Texas, United States
Investigational Site Number 840070
McKinney, Texas, United States
Investigational Site Number 840128
McKinney, Texas, United States
Investigational Site Number 840118
Plano, Texas, United States
Investigational Site Number 032003
Buenos Aires, Argentina
Investigational Site Number 032001
Caba, Argentina
...and 70 more locations
For all participants except those with baseline OCS dose at 35 mg/day, the maximum possible reduction corresponds to reduction to 0 mg/day (no longer requiring OCS). For participants starting with 35 mg/day at baseline, the maximum possible reduction is 32.5 mg/day (i.e. minimum dose per protocol is 2.5 mg).
Time frame: Week 24
Percentage of Participants Who No Longer Required Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
Participants were classified according to the binary status of whether or not the participant still required OCS at Week 24 while maintaining asthma control.
Time frame: Week 24
Absolute Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
Absolute reduction was calculated by subtracting Week 24 value from baseline value.
Time frame: Baseline and Week 24