An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma.

Secondary Objective:

To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to:

• Safety and tolerability

• Dupilumab systemic exposure and anti-drug antibodies

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

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Albuterol

Criteria

Inclusion criteria:

Participants with a physician diagnosis of moderate to severe, uncontrolled asthma for >=12 months, based on the Global Initiative for Asthma (GINA) 2009 Guidelines and:

• Existing treatment with moderate or high-dose inhaled corticosteroid / long-acting beta-2 agonist

• Forced expiratory volume (FEV1) 40 to 80% of predicted normal

• Asthma Control Questionnaire, 5-question version (ACQ-5) score >=1.5

• Reversibility of at least 12% and 200 mL in forced expiratory volume (FEV1)

• Had experienced, within prior year: hospitalization, emergency or urgent care visit or systemic corticosteroid treatment for worsening asthma

Exclusion criteria:

• Participants <18 years

• Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) which impaired pulmonary function tests

• Chest X-ray within 12 months of screening visit or at screening visit with clinically significant findings of lung disease(s) other than asthma

• Current smoker or cessation of smoking within 6 months prior to Visit 1

• Previous smoker with a smoking history >10 pack-years

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