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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: 28 Apr 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

  • 21 Apr 2026 According to Sanofi media release, The US Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of children aged two to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 antihistamine (H1AH) treatment. The approval is based upon LIBERTY-CUPID clinical study program.
  • 13 Apr 2026 According to Regeneron Pharmaceuticals media release, Based on data from LIBERTY-CUPID clinical trial program( Phase 3 trials Study A and Study C) , the European Commission (EC) has approved Dupixent for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years,with inadequate response to histamine1 antihistamines (H1AH) and who are naive to anti immunoglobulin E.
  • 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

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