Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma

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).

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.