Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Dupilumab; Placebo; Oral corticosteroid therapy (prednisone/prednisolone); Inhaled corticosteroid (ICS) therapy; Albuterol/Salbutamol; Levalbuterol/Levosalbutamol
Intervention description: 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.
Intervention MeSH terms: Prednisone; Prednisolone; Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 210.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

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.
    

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 <12 years of age or the minimum legal age for adolescents in the country
             of the investigative site, whichever is higher (for those countries where local
             regulations permit enrollment of adults only, participant recruitment will be
             restricted to those who were >=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.