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STUDIED IN 2 PIVOTAL TRIALS IN BIOLOGIC-NAIVEa PATIENTS

CUPID-A aND CUPID-C: IDENTICAL STUDY DESIGN1,2

Phase 3 studies in
biologic-naive patients
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; 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 every 2 weeks (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