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First received: August 31, 2022

Clinical Trial: 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)

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Chronic Spontaneous Urticaria

Study Type: INTERVENTIONAL


Official Title: 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 Urtic

Brief Summary: This is a multicenter, single-arm, 24-week treatment, Phase 3 study.The purpose of this study is 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 include: Screening: 2 to 4 weeks; The treatment duration will be 24 weeks; Follow-up period: 12 weeks; The study duration will be 38 to 40 weeks (including screening and follow-up); The number of study visits will be 6.

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