Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma

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.

Inclusion criteria:

Medical diagnosis of persistent asthma for at least 12 months whose:

- airway inflammation likely to be eosinophilic,

- asthma partially controlled or uncontrolled on ICS plus LABA therapy.

- On a stable dose of either Fluticasone/Salmeterol, Budesonide/Formoterol,
Mometasone/Formoterol combination therapy for at least 1 month prior to screening.

- Signed an Informed Consent Form and Health Insurance Portability and Accountability
Act (HIPAA) Authorization Form.

Exclusion criteria:

- Less than 18 years or greater than 65 years of age.

- Clinically relevant abnormal laboratory values suggesting an unknown disease and
requiring further evaluation.

- Chronic obstructive pulmonary disease and/or other lung diseases impairing Pulmonary
Function Tests.

- Beta-adrenergic receptor blockers required for any reason.

- Current smoker or cessation of smoking within the 6 months prior to screening.

- Previous smoking with a smoking history >10 cigarette pack/years.

- Participation in another study within 6 months prior to screening if the study
medication was an antibody or within 30 days prior to screening for all other study
medications.

- Known or suspected non-compliance, alcohol or drug abuse.

- Inability to follow the procedures of the study (e.g, due to language problems,
psychological disorders).

- Concomitant severe diseases or diseases for which the use of ICS or LABA were
contraindicated.

- Known allergy to doxycycline or related compounds.

- Pregnancy or intention to become pregnant during the course of the study, breast
feeding, or unwillingness to use a highly effective method of contraception
throughout the study in women of childbearing potential.

- Recent history of a parasitic infection or travel to a parasitic endemic area within
6 months prior to screening.

The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.