LIBERTY-PN PRIME PHASE3 COMPLETED n=151
Drug: Dupixent · REGN
Study Design
DesignRandomized, double-blind, placebo-controlled, multicenter
Randomization1:1
BlindingDouble-blind
Enrollment151
Duration24 weeks
Treatment Arms
Dupilumab 300mg Q2W 600mg loading then 300mg SC Q2W n=75
Placebo Matching placebo SC Q2W n=76
Primary Endpoints
[{"id":"prime-pp-nrs","name":"Pruritus improvement (WI-NRS ≥4 point reduction) at Week 24","type":"PRIMARY","unit":"%","results":[{"notes":"60% vs 18% placebo","value":60,"arm_id":"dupixent-pn-prime","p_value":"<0.001","arm_name":"Dupilumab"},{"value":18,"arm_id":"placebo-pn-prime","arm_name":"Placebo"}],"timepoint":"Week 24","description":"Proportion achieving clinically meaningful itch reduction (≥4-point on Worst Itch NRS 0-10). PN causes severe, debilitating itch."}]
Efficacy Results
PRIME: 60% itch reduction vs 18% placebo (p<0.001). IGA 0/1: 48% vs 18%. First FDA-approved treatment for PN.
Safety Results
PRIME (n=151): Excellent tolerability. Nasopharyngitis 8% vs 9%.
Assessment
PRIME: 60% vs 18% itch reduction is dramatic for patients with no prior options. PN itch is among the worst in dermatology.
Background & Context
PN: severe intractable itch with hard nodules. No FDA-approved therapy existed.
Data from Supabase · Updated 2026-03-24