NCT05526521

A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)

A Multi-center, Single-arm Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Male and Female Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

This was a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study was to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of H1-antihistamine treatment. Study details included: Screening: 2 to 4 weeks; The treatment duration was 24 weeks; Follow-up period: 12 weeks; The study duration was 38 to 40 weeks (including screening and follow-up); The number of study visits was 6.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	Dupilumab	Injection solution Subcutaneous

Timeline

• Start date: 2022-08-25
• Primary completion: 2024-11-11
• Completion: 2025-02-03
• First posted: 2022-09-02
• Last updated: 2025-11-25
• Results posted: 2025-11-19

Locations

15 sites across 3 countries: United States, Canada, Japan

Regulatory

• FDA-regulated drug study