An Evaluation of Dupilumab in Patients with Moderate to Severe Uncontrolled Asthma
- Conditions
- AsthmaMedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-000856-16-IT
- Lead Sponsor
- Sanofi-aventis recherche et développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1500
- Patients 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
- Juniper Asthma Control Questionnaire, 5-question version (ACQ-5) score =1.5
- Reversibility of at least 12% and 200 mL in forced expiratory volume (FEV1)
- Has experienced, within prior year: hospitalization, emergency or urgent care visit or systemic corticosteroid treatment for worsening asthma
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1470
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
- Patients <18 years
- Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg Strauss syndrome, allergic bronchopulmonary aspergillosis) which impair 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of different doses and regimens of dupilumab in patients with moderate to severe, uncontrolled asthma;Secondary Objective: To evaluate different doses and regimens of dupilumab in patients with moderate to severe uncontrolled asthma, with regard to:<br>- Safety and tolerability<br>- Dupilumab systemic exposure and anti-drug antibodies<br>;Primary end point(s): Change from baseline in forced expiratory volume (FEV1);Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Relative change from baseline in FEV1<br>2) Annualized rate of loss of asthma control<br>3) Time to loss of asthma control<br>4) Change from baseline in asthma symptom scores;Timepoint(s) of evaluation of this end point: 1/4) Week 12<br>2/3) Week 24