Evaluation of Dupilumab in Children With Uncontrolled Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT02948959

Run by

Sanofi

People needed

408

Starts

2017-04-21

Expected to finish

2020-08-26

Last updated by the study team

2022-03-28

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840002 — Gilbert, Arizona, United States
• Investigational Site Number 840012 — Tucson, Arizona, United States
• Investigational Site Number 840001 — Rolling Hills Estates, California, United States
• Investigational Site Number 840036 — Owensboro, Kentucky, United States
• Investigational Site Number 840016 — Ann Arbor, Michigan, United States
• Investigational Site Number 840006 — St Louis, Missouri, United States
• Investigational Site Number 840022 — Lincoln, Nebraska, United States
• Investigational Site Number 840023 — Great Neck, New York, United States
• Investigational Site Number 840035 — New York, New York, United States
• Investigational Site Number 840013 — New York, New York, United States
• Investigational Site Number 840007 — Rochester, New York, United States
• Investigational Site Number 840004 — Charlotte, North Carolina, United States
• Investigational Site Number 840021 — Durham, North Carolina, United States
• Investigational Site Number 840008 — Cincinnati, Ohio, United States
• Investigational Site Number 840024 — Edmond, Oklahoma, United States
• Investigational Site Number 840003 — San Antonio, Texas, United States
• Investigational Site Number 840018 — La Crosse, Wisconsin, United States
• Investigational Site Number 032004 — Buenos Aires, Argentina
• Investigational Site Number 032003 — Buenos Aires, Argentina
• Investigational Site Number 032002 — Caba, Argentina
• Investigational Site Number 032001 — Caba, Argentina
• Investigational Site Number 032006 — Mendoza, Argentina
• Investigational Site Number 036001 — Campbelltown, Australia
• Investigational Site Number 036005 — North Adelaide, Australia
• Investigational Site Number 840031 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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