NCT03560466

Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 378 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

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

Detailed description

Study duration per participant is approximatively 64 weeks including a 52 weeks treatment period and 12 weeks post treatment follow-up. Japan substudy: Study duration per participant is approximately 68 weeks including 3-5 weeks screening period, 52 weeks treatment period and 12 weeks post treatment follow-up period.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Dupilumab (SAR231893/REGN668)	Pharmaceutical form: solution for injection Route of administration: subcutaneous (sc)
DRUG	Asthma controller therapies (incl. prednisone/prednisolone)	Pharmaceutical form: powder, or solution, or pill Route of administration: inhaled, oral or parenteral
DRUG	Asthma reliever therapies	Pharmaceutical form: powder or solution Route of administration: inhaled

Timeline

• Start date: 2018-06-21
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2018-06-18
• Last updated: 2025-11-21
• Results posted: 2025-11-21

Locations

81 sites across 18 countries: United States, Argentina, Australia, Brazil, Canada, Chile, Colombia, Hungary, Italy, Japan, Lithuania, Mexico, Poland, Russia, South Africa, Spain, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study