At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
One Year Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Pediatric Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study
In Brief
A Phase 3 clinical trial evaluating Dupilumab (SAR231893/REGN668), Asthma controller therapies (incl. prednisone/prednisolone), and 1 other intervention for Asthma. Completed, enrolled 378 participants across 81 sites in 18 countries.
Detailed Summary
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. * To evaluate the efficacy of dupilumab in children of 6 to \<12 years of age with uncontrolled persistent asthma in the Japan sub-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. * To evaluate the safety and tolerability of dupilumab in pediatric patients with asthma in the Japan sub-study * To evaluate dupilumab in pediatric patients with asthma in the Japan substudy with regard to: * Systemic exposure, * Anti-drug antibodies (ADAs), * Biomarkers
Study Details
Timeline
Interventions
Pharmaceutical form: solution for injection Route of administration: subcutaneous (sc)
Pharmaceutical form: powder, or solution, or pill Route of administration: inhaled, oral or parenteral
Pharmaceutical form: powder or solution Route of administration: inhaled