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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)

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Trial Profile

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 of Trial: Phase III

Latest Information Update: 09 Mar 2026

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At a glance

  • Drugs Dupilumab (Primary)
  • Indications Chronic urticaria
  • Focus Pharmacokinetics; Registrational
  • Acronyms CINDU CUPIDKids; LIBERTY-CSU; LIBERTY-CSU/CINDU CUPIDKids
  • Sponsors Sanofi

Most Recent Events

  • 27 Feb 2026 According to Regeneron Pharmaceuticals media release, Based on data from LIBERTY-CUPID clinical trial program, and CUPIDKids trial,the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent in the European Union (EU) for the treatment of chronic spontaneous urticaria (CSU). This recommendation covers children aged 2 to 11 years with moderate-to-severe CSU,A final decision is expected in the coming months
  • 30 Jan 2026 According to Regeneron Pharmaceuticals media release, the company announced that regulatory applications are under review for CSU in children aged 2 to 11 years in the United States, European Union (EU), and Japan.
  • 26 Feb 2025 Status changed from active, no longer recruiting to completed.

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