LIBERTY SINUS-24 PHASE3 COMPLETED n=276
Drug: Dupixent · REGN
Study Design
DesignRandomized, double-blind, placebo-controlled, multicenter
Randomization1:1
BlindingDouble-blind
Enrollment276
Duration24 weeks
Treatment Arms
Dupilumab 300mg Q2W 300mg SC Q2W n=143
Placebo Matching placebo SC Q2W n=133
Primary Endpoints
[{"id":"sinus24-nps","name":"Change in nasal polyp score (NPS) at Week 24","type":"CO_PRIMARY","unit":"points","results":[{"notes":"LS mean difference vs placebo: -1.89 (p<0.0001)","value":-1.89,"arm_id":"dupixent-sinus24","arm_name":"Dupilumab"},{"value":0.17,"arm_id":"placebo-sinus24","arm_name":"Placebo"}],"timepoint":"Week 24","description":"Change from baseline in bilateral endoscopic nasal polyp score (0-8 scale, higher = more severe). Polyps physically block nasal passages."},{"id":"sinus24-lms","name":"Change in Lund-Mackay CT score (LMS) at Week 24","type":"CO_PRIMARY","unit":"points","results":[{"notes":"LS mean difference vs placebo: -8.82 (p<0.0001)","value":-8.82,"arm_id":"dupixent-sinus24","arm_name":"Dupilumab"},{"value":-0.09,"arm_id":"placebo-sinus24","arm_name":"Placebo"}],"timepoint":"Week 24","description":"CT-based sinus opacification score. Measures extent of sinus disease. Lower = less disease."}]
Efficacy Results
SINUS-24 met co-primary endpoints: NPS -1.89 (p<0.0001) and LMS -8.82 (p<0.0001) vs placebo. SNOT-22: -21.12 (>2x MCID). First biologic for CRSwNP.
Safety Results
SINUS-24 (n=276, 24 weeks): Well-tolerated. Nasopharyngitis 12% vs 14%, ISR 6% vs 3%.
Assessment
SINUS-24: first biologic to show polyp shrinkage on endoscopy+CT. -1.89 NPS is visually meaningful. SNOT-22 improvement >2x MCID = dramatic QoL improvement.
Background & Context
CRSwNP driven by type 2 inflammation. Polyps recur after surgery in 40-80% of patients.
Data from Supabase · Updated 2026-03-24