evaluation of dupilumab in patients with severe steroid dependent asthma

Conditions: Asthma

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.

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).

Eligibility criteria:
inclusion criteria : adult and adolescent (12 years of age or older) participants with a physician diagnosis of asthma for \>=12 months, based on the global initiative for asthma (gina) 2014 guidelines and the following criteria: * participants with severe asthma and a well-documented, regular prescribed treatment of maintenance corticosteroids in the 6 months prior to visit 1 and using a stable ocs dose (ie, no change of ocs dose) for 4 weeks prior to visit 1. participants must be taking 5 to 35 mg/day of prednisone/prednisolone, or the equivalent, at visit 1 and at the randomization visit. in addition, the participants must agree to switch to study-required prednisone/prednisolone as their ocs and use it per protocol for the duration of the study. * existing treatment with high-dose inhaled corticosteroid (ics; \>500 mcg total daily dose of fluticasone propionate or equivalent) in combination with a second controller (ie, long-acting beta agonist \[laba\], leukotriene receptor antagonist \[ltra\]) for at least 3 months with a stable dose of ics for \>=1 month prior to visit 1. in addition, participants requiring a third controller for their asthma are considered eligible for this study, and it should also be used for at least 3 months with a stable dose \>= 1 month prior to visit 1. * a forced expiratory volume in 1 second (fev1) \<80% of predicted normal for adults and \<=90% of predicted normal for adolescents at visit 1. * evidence of asthma as documented by either: reversibility of at least 12% and 200 ml in fev1 after the administration of 200 to 400 mcg (2 to 4 inhalations of albuterol/salbutamol or levalbuterol/levosalbutamol, or of a nebulized solution of albuterol/salbutamol or levalbuterol/levosalbutamol, if considered as a standard office practice) before randomization or documented in the 12 months prior to visit 1 or airway hyperresponsiveness (methacholine: provocative concentration that causes a positive reaction \[pc20\] of \<8 mg/ml) documented in the 12 months prior to visit 1. exclusion criteria: * participants \ =18 years of age). * participants who weighed \<30.0 kg. * chronic obstructive pulmonary disease (copd) or other lung diseases (eg, idiopathic pulmonary fibrosis, churg-strauss syndrome, allergic bronchopulmonary aspergillosis, cystic fibrosis) which may impair lung function. * clinical evidence or imaging (eg, chest x-ray, computed tomography, magnetic resonance imaging) within 12 months of visit 1 with clinically significant findings of lung disease(s) other than asthma, as per local standard of care. * a participant who experiences a deterioration of asthma that results in emergency treatment or hospitalization within 4 weeks of screening visit 1. * a participant who requires 12 puffs or more of rescue medication on any 1 day in the week prior to visit 1. * a participant who has experienced an upper or lower respiratory tract infection within the 4 weeks prior to screening. * current smoker or cessation of smoking within 6 months prior to visit 1. * previous smoker with a smoking history \>10 pack-years. * comorbid disease that might interfere with the evaluation of the investigational medicinal product. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.