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01
Overview
Phase 3, randomised, double-blind trial in prurigo nodularis (PN) comparing Dupilumab with Placebo (2 arms). Primary endpoint: Percentage of Participants With Improvement in Worst Itch Numeric Rating Scale by ≥4 Points at 24 weeks. Started Dec 2019; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Dupilumab
Dupilumab 600mg loading dose followed by 300mg q2w + background TCS/TCI
Placebo
Placebo matched to dupilumab + background TCS/TCI
03
Who it enrols
Adults 18-80 years with prurigo nodularis diagnosed by dermatologist for ≥3 months, WI-NRS ≥7, minimum 20 PN lesions, failed medium-to-superpotent topical corticosteroids, stable topical emollient use
04
Endpoints
Primary
Percentage of Participants With Improvement in Worst Itch Numeric Rating Scale by ≥4 Points
Secondary
Percentage of Participants With Investigator's Global Assessment For Prurigo Nodularis-Stage of 0 or 1
Percentage of Participants With Both WI-NRS ≥4 Point Improvement and IGA PN-S 0 or 1
Percent Change From Baseline in Worst Itch Numeric Rating Scale
Change From Baseline in Dermatology Life Quality Index
Change From Baseline in Skin Pain Numeric Rating Scale
Change From Baseline in Hospital Anxiety and Depression Scale Total Score
Probability of Participants With WI-NRS ≥4 Point Improvement
Change From Baseline in Worst Itch Numeric Rating Scale
05
Results
Primary endpoints met
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