Evaluation of Dupilumab in Children with Uncontrolled Asthma (Liberty Asthma Voyage)
- Conditions
- AsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2016-001607-23-HU
- Lead Sponsor
- Sanofi-Aventis Recherche & Développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 785
-Children 6 to <12 years of age, with a physician diagnosis of persistent asthma for =12 months prior to Screening, based on clinical history and examination, pulmonary function parameters according to Global initiative for asthma (GINA) 2015 Guidelines and the following criteria:
-Existing background therapy of medium-dose inhaled corticosteroids (ICS) with second controller medication (ie, long-acting ß2 agonist [LABA], leukotriene receptor antagonist [LTRA], long acting muscarinic antagonist [LAMA], or methylxanthines) or high-dose ICS alone or high dose ICS with second controller, for at least 3 months with a stable dose =1 month prior to Screening Visit 1.
-Pre-bronchodilator forced expiratory volume in 1 second (FEV1) =95% of predicted normal or pre bronchodilator FEV1/forced vital capacity (FVC) ratio <0.85 at Screening and Baseline Visits.
-Reversibility of at least 10% in FEV1 after the administration of 200 to 400mcg (2 to 4 puff inhalations with metered-dose inhaler [MDI] of albuterol/salbutamol or 45 to 90 mcg (2 to 4 puffs with MDI) of levalbuterol/levosalbutamol reliever medication before randomization (up to 3 opportunities during the same visit are allowed with a maximum of 12 puffs of reliever medication if tolerated by the patient).
-Must have experienced within 1 year prior to Screening Visit 1, any of the following events:
-Treatment with a systemic corticosteroid (SCS, oral or parenteral), as prescibed by a healthcare professional for worsening asthma at least once or,
-Hospitalization or emergency room visit for worsening asthma
- Evidence of uncontrolled asthma, with at least one of the following criteria during the 4 (±1) weeks Screening Period:
-Asthma Control Questionnaire–Interviewer Administered (ACQ-IA) ACQ-5 score =1.5 on at least one day of the Screening Period.
-Use of reliever medication (ie, albuterol/salbutamol or levalbuterol/levosalbutamol), other than as a preventive for exercise induced bronchospasm, on 3 or more days per week, in at least one week during the Screening Period.
-Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening Period.
-Asthma symptoms 3 or more days per week in at least one week during the Screening Period.
Are the trial subjects under 18? yes
Number of subjects for this age range: 785
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Patients <6 or =12 years of age.
-Patients with <16 kg bodyweight.
-Any other chronic lung disease (cystic fibrosis, bronchopulmonary dysplasia, etc) which may impair lung function.
-A subject with any history of life threatening asthma (ie, extreme exacerbation that requires intubation).
-Co-morbid disease that might interfere with the evaluation of investigational medicinal product (IMP).
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 dupilumab in children 6 to <12 years of age with uncontrolled persistent asthma.;Secondary Objective: -To evaluate in children 6 to <12 years of age with uncontrolled persistent asthma:<br> -The safety and tolerability of dupilumab.<br> -The effect of dupilumab in improving patient-reported outcomes (PROs) including health related quality of life (HRQoL).<br> -The dupilumab systemic exposure and incidence of anti-drug antibodies.<br> -To evaluate the association between dupilumab treatment and pediatric immune responses to vaccines: any vaccination for tetanus, diphtheria, pertussis and/or seasonal trivalent/quadrivalent influenza vaccine.;Primary end point(s): Annualized rate of severe exacerbation events during treatment period;Timepoint(s) of evaluation of this end point: Baseline, Week 52
- Secondary Outcome Measures
Name Time Method