| CUPID-A | CUPID-C | ||
| Trial Overview1,2 | Number of patients | 136b | 148c |
| Design | Randomized, phase 3, double-blind, parallel group, multicenter, placebo-controlled trials |
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| Duration | 24 weeks | ||
| Treatment arms | DUPIXENT vs placebo | ||
| Dosing | In the DUPIXENT group: Adults and adolescents ≥60 kg: Initial loading dose: 600 mg (2 x 300 mg) Followed by: 300 mg Q2W (1 x 300 mg) Adolescents 30 kg to <60 kg: Initial loading dose: 400 mg (2 x 200 mg) Followed by: 200 mg Q2W (1 x 200 mg) |
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| Primary endpoint | Change from baseline in itch severity score over 7 days (ISS7) at Week 24 | ||
| Select secondary endpoints | Change from baseline in hives severity score over 7 days (HSS7) at Week 24 Change from baseline in urticaria activity score over 7 days (UAS7) at Week 24 Proportion of patients who were urticaria-free (UAS7=0) at Week 24 Proportion of patients with well-controlled disease (UAS7≤6) at Week 24 |
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| Baseline Disease Severity/ Patient Characteristics1,2 |
ISS7 | ≥8 | |
| UAS7 | ≥16 | ||
| CSU history |
H1 AH at up to 4x the standard dose |
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| CUPID-A | |
| Trial Overview1,2 | |
| Number of patients | 136b |
| Design | Randomized, phase 3, double-blind, parallel group, multicenter, placebo-controlled trials |
| Duration | 24 weeks |
| Treatment arms | DUPIXENT vs placebo |
| Dosing | In the DUPIXENT group: Adults and adolescents ≥60kg: Initial loading dose: 600 mg (2 x 300 mg) Followed by: 300 mg Q2W (1 x 300 mg) Adolescents 30 kg to <60 kg: Initial loading dose: 400 mg (2 x 200 mg) Followed by: 200 mg Q2W (1 x 200 mg) |
| Primary endpoint | Change from baseline in itch severity score over 7 days (ISS7) at Week 24 |
| Select secondary endpoints | Change from baseline in hives severity score over 7 days (HSS7) at Week 24 Change from baseline in urticaria activity score over 7 days (UAS7) at Week 24 Proportion of patients who were urticaria-free (UAS7=0) at Week 24 Proportion of patients with well-controlled disease (UAS7 ≤6) at Week 24 |
| Baseline Disease Severity/ Patient Characteristics1,2 |
|
| ISS7 | ≥8 |
| UAS7 | ≥16 |
| CSU history |
H1 AH at up to 4x the standard dose |
| CUPID-C | |
| Trial Overview1,2 | |
| Number of patients | 148c |
| Design | Randomized, phase 3, double-blind, parallel group, multicenter, placebo-controlled trials |
| Duration | 24 weeks |
| Treatment arms | DUPIXENT vs placebo |
| Dosing | In the DUPIXENT group: Adults and adolescents ≥60kg: Initial loading dose: 600 mg (2 x 300 mg) Followed by: 300 mg Q2W (1 x 300 mg) Adolescents 30 kg to <60 kg: Initial loading dose: 400 mg (2 x 200 mg) Followed by: 200 mg Q2W (1 x 200 mg) |
| Primary endpoint | Change from baseline in itch severity score over 7 days (ISS7) at Week 24 |
| Secondary endpoints | Change from baseline in hives severity score over 7 days (HSS7) at Week 24 Change from baseline in urticaria activity score over 7 days (UAS7) at Week 24 Proportion of patients who were urticaria-free (UAS7=0) at Week 24 Proportion of patients with well-controlled disease (UAS7 ≤6) at Week 24 |
| Baseline Disease Severity / Patient Characteristics1,2 |
|
| ISS7 | ≥8 |
| UAS7 | ≥16 |
| CSU history |
H1 AH at up to 4x the standard dose |
Use of DUPIXENT for the CSU indication in patients aged 2-11 years is supported by evidence from two studies of DUPIXENT in CSU patients 12+ years of age.1
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
aBiologic-naive defined as no anti-IgE treatment.
bStudy population included 132 adults and 4 adolescents (aged 12-17 years).2
cStudy population included 142 adults and 6 adolescents (aged 12-17 years).2
Learn more about significant itch relief
CSU, chronic spontaneous urticaria; Q2W, once every 2 weeks.