Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 104
Healthy volunteers: no

Brief summary:
Primary Objective:

To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic asthma.

Secondary Objectives:

* To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.
* To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.

Detailed description:
The total duration of the study period per participant was 20-22 weeks broken down as follows:

* Screening period: up to 14 days,
* Treatment period: 12 weeks,
* Follow-up period: 6-8 weeks.

Arms:
arm 1: Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of inhaled corticosteroids/long-acting beta2-adrenergic agonist (ICS/LABA) (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. arm 2: Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.

Interventions: intervention 1: Dupilumab intervention 2: Placebo (for Dupilumab) intervention 3: Fluticasone/Salmeterol combination therapy intervention 4: Fluticasone monotherapy intervention 5: Albuterol intervention 6: Levalbuterol
Intervention descriptions: intervention 1: Solution for injection, one subcutaneous injection. intervention 2: Solution for injection, one subcutaneous injection. intervention 3: Oral inhalation twice daily. intervention 4: Oral inhalation twice daily. intervention 5: Oral inhalation as needed. intervention 6: Oral inhalation as needed.

Protocol document: