Status:
COMPLETED
An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 dose...
Detailed Description
Total duration per participant of approximately 43 weeks including a screening period (14-21 days), a randomized treatment period (24 weeks), and a post-treatment period (16 weeks).
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
776 Patients enrolled
Trial Details
Trial ID
NCT01854047
Start Date
June 1 2013
End Date
April 1 2015
Last Update
June 26 2017
Active Locations (201)
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1
Investigational Site Number 840050
Fullerton, California, United States, 92835
2
Investigational Site Number 840041
Huntington Beach, California, United States, 92647
3
Investigational Site Number 840019
Los Angeles, California, United States, 90025
4
Investigational Site Number 840029
Los Angeles, California, United States, 90025