Evaluation of Dupilumab in Children With Uncontrolled Asthma

• Status: Completed
• Trial end date: 2020-08-26
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Prednisolone; Prednisone

Criteria

Inclusion criteria :

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.

Exclusion criteria:

• 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.