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Master Protocol of Three Randomized, Double-blind, Placebo Controlled, Multi-center, Parallel-group Studies of Dupilumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment in Patients naïve to Omalizumab and in Patients Who Are Intolerant or Incomplete Responders to Omalizumab

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Trial Profile

Master Protocol of Three Randomized, Double-blind, Placebo Controlled, Multi-center, Parallel-group Studies of Dupilumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment in Patients naïve to Omalizumab and in Patients Who Are Intolerant or Incomplete Responders to Omalizumab

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Sep 2025

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At a glance

  • Drugs Dupilumab (Primary) ; Antihistamines
  • Indications Chronic urticaria
  • Focus Registrational; Therapeutic Use
  • Acronyms CUPID; LIBERTY-CSU CUPID Study A; LIBERTY-CSU study C
  • Sponsors Sanofi

Most Recent Events

  • 22 Sep 2025 Results published in a Sanofi media release
  • 22 Sep 2025 According to Sanofi media release, European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Dupixent (dupilumab) in the EU for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents. This recommendation covers those aged 12 years and above with moderate to severe disease, with inadequate response and who are naive to anti-immunoglobulin E (IgE) therapy.
  • 18 Apr 2025 According to Sanofi media release, the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment. The U.S. approval is based on data from two Phase 3 LIBERTY-CUPID clinical trials, Study A (n=136) and Study C (n=148).

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