There is one clinical trial.
Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. Secondary Objectives: - To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. - To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to: - Systemic exposure. - Anti-drug antibodies (ADAs). - Biomarkers.
Description: The number (n) and percentage (%) of patients experiencing any TEAE
Measure: Treatment-emergent adverse events (TEAEs) Time: From Day 1 up to Week 64Description: Annualized rate of severe asthma exacerbation events, during the treatment period
Measure: Severe asthma exacerbation events Time: From Day 1 up to Week 52Description: Change in percentage (%) predicted forced expiratory volume in 1 second (FEV1) - Clinically significant changes from baseline
Measure: Change in % predicted FEV1 Time: From Day 1 up to Week 64Description: Change in absolute FEV1 - Clinically significant changes from baseline
Measure: Change in absolute FEV1 Time: From Day 1 up to Week 64Description: Change in forced vital capacity (FVC)
Measure: Change in FVC Time: From Day 1 up to Week 64Description: Change in forced expiratory flow (FEF) 25-75%
Measure: Change in FEF Time: From Day 1 up to Week 64Description: Serum dupilumab concentrations - Changes from first dupilumab injection
Measure: Assessment of dupilumab concentration Time: From Day 1 up to Week 64Description: Titers of Anti-dupilumab antibodies
Measure: Assessment of immunogenicity Time: From Day 1 up to Week 64Description: Blood: Eosinophil count
Measure: Assessment of blood Eosinophil count Time: From Day 1 up to Week 64Description: Serum: total IgE
Measure: Assessment of total immunoglobulin E (IgE) Time: From Day 1 up to Week 64