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STUDIED IN 2 PIVOTAL TRIALS IN BIOLOGIC-NAIVEa PATIENTS

CUPID-A and CUPID-C: Identical
phase 3 studies1,2
CUPID-A
(N=136b)		 CUPID-C
(N=148c)
Randomized
DUPIXENT
200 mg Q2W or
300 mg Q2W
(n=68)d
Matched placebo for
24 weeks
(n=68)		 DUPIXENT
200 mg Q2W or
300 mg Q2W
(n=73)d
Matched placebo for
24 weeks
(n=75)
Study population
  • Anti-IgE treatment naive
  • Diagnosis of CSU >6 months prior to screening
  • Symptomatic CSU despite treatment with H1 antihistamines (H1 AH)
  • ISS7 ≥8 and UAS7 ≥16

All patients continued background therapy with long-acting, nonsedating H1 AH at up to 4x the standard dose.
Primary endpoint (Week 24)
  • Change from baseline in itch severity score over 7 days (ISS7)
Key secondary endpoint (Week 24)
  • Change from baseline in urticaria activity score over 7 days (UAS7)
Select secondary endpoints
(Week 24)
  • Change from baseline in hives severity score over 7 days (HSS7)
  • Proportion of patients with complete response (UAS7=0)
  • Proportion of patients with well-controlled symptoms (UAS7 ≤6)

Select inclusion criteria1,2:

  • Anti-IgE treatment naive
  • Diagnosis of CSU >6 months prior to screening
  • Presence of itch and hives for >6 consecutive weeks inadequately controlled by H1 AH
  • Used a study-defined H1 AH for CSU treatment and were on a stable H1 AH dose for at least 3 consecutive days prior to the screening visit
  • ISS7 ≥8 and UAS7 ≥16

Select exclusion criteria2:

  • Weight less than 30 kg in adults and adolescents
  • Clearly defined underlying etiology for chronic urticarias other than CSU (main manifestation being physical urticaria)
  • Patients with atopic dermatitis or with the presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes
  • Severe concomitant illness(es) that would adversely affect the patient’s participation in the study
  • Known or suspected immunodeficiency, including history of invasive opportunistic infections
  • History of systemic hypersensitivity or anaphylaxis to any biologic therapy

CSU, chronic spontaneous urticaria; H1 AH, H1 antihistamines; Q2W, once every 2 weeks.

aBiologic-naive defined as no anti-IgE treatment.

b Study population included 132 adults and 4 adolescents (aged 12-17 years).2

c Study population included 142 adults and 6 adolescents (aged 12-17 years).2

d Adults and pediatric subjects (12 years of age and older) weighing ≥60 kg received a subcutaneous dose of DUPIXENT 600 mg on Day 1, followed by 300 mg Q2W, while pediatric subjects (12 years of age and older) weighing 30 kg to less than 60 kg received a subcutaneous dose of DUPIXENT 400 mg on Day 1, followed by 200 mg Q2W.

Discover itch improvement data

Learn more about significant itch relief.

Explore ISS7 Results