CUPID-A aND CUPID-C: IDENTICAL STUDY DESIGN1,2
Phase 3 studies in biologic-naive patients |
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Randomized | ||
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Study population | ||
All patients continued background therapy with long-acting, nonsedating H1 AH at up to 4x the standard dose. |
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Primary endpoint (Week 24) | ||
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Key secondary endpoint (Week 24) | ||
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Select secondary endpoints (Week 24) |
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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.
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