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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Albuterol; Antibodies, Monoclonal; Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Salmeterol Xinafoate; Xhance

Criteria

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.