Resumen

Primary Objective: To evaluate the efficacy of dupilumab in children 6 to less than (\<) 12 years of age with uncontrolled persistent asthma. Secondary Objective: To evaluate in children 6 to \<12 years of age with uncontrolled persistent asthma: * The safety and tolerability of dupilumab. * The evaluate the effect of dupilumab in improving participant reported outcomes including health related quality of life. * The dupilumab systemic exposure and incidence of anti-drug antibodies. * The 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.

Descripción detallada

The total study duration per participant was up to 69 weeks, consisted of a screening period of 3-5 weeks, a randomized treatment period of 52 weeks and a post-treatment period of 12 weeks.

Elegibilidad

Edad mínima: 6 YearsEdad máxima: 11 YearsSexo: ALL

Criterios de inclusión

Children 6 to \<12 years of age, with a physician diagnosis of persistent asthma for greater than or equal to (\>=)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 ICS with second controller medication (i.e., long-acting β2 agonist , leukotriene receptor antagonist, long acting muscarinic antagonist, 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 percentage (%) of predicted normal or pre bronchodilator FEV1/forced vital capacity ratio \<0.85 at Screening and Baseline Visits.
Reversibility of at least 10% in FEV1 after the administration of 200 to 400 micrograms (mcg; 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 were allowed with a maximum of 12 puffs of reliever medication if tolerated by the participant).
Must had experienced, within 1 year prior to Screening Visit 1, any of the following events:
Treatment with a systemic corticosteroid (oral or parenteral), as prescribed by a healthcare professional for worsening asthma at least once or,
Hospitalization or emergency 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 (i.e., 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.

Criterios de exclusión

Participants \<6 or \>=12 years of age.
Participants with \<16 kg bodyweight.
Any other chronic lung disease (cystic fibrosis, bronchopulmonary dysplasia, etc.), which may impair lung function.
A participant 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.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Intervenciones

drug

Dupilumab

Pharmaceutical form: Solution Route of administration: Subcutaneous

drug

Placebo

Pharmaceutical form: Solution Route of administration: Subcutaneous

drug

Asthma Controller Therapies

Pharmaceutical form: Aerosol, capsules, tablets, oral solution Route of administration: Inhaled, oral

drug

Asthma Reliever Therapies

Pharmaceutical form: Nebulized, aerosol Route of administration: Inhaled

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Children 6 to <12 Years of Age With Uncontrolled Persistent Asthma

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Dupilumab

Placebo

Asthma Controller Therapies

Asthma Reliever Therapies

Ubicaciones

Investigational Site Number 032004

Investigational Site Number 032003

Investigational Site Number 032002

Investigational Site Number 032001

Investigational Site Number 032006

Patrocinadores