LIBERTY AD SOLO 2 PHASE3 COMPLETED n=708
Drug: Dupixent · REGN
Study Design
DesignRandomized, double-blind, placebo-controlled, multicenter
Randomization1:1:1
BlindingDouble-blind
Enrollment708
Duration16 weeks
Treatment Arms
Dupilumab 300mg Q2W 600mg loading then 300mg SC Q2W n=233
Dupilumab 300mg QW 600mg loading then 300mg SC QW n=239
Placebo Matching placebo SC n=236
Primary Endpoints
[{"id":"solo2-iga01","name":"IGA 0/1 at Week 16","type":"PRIMARY","unit":"%","results":[{"notes":"36% vs 8% placebo","value":36,"arm_id":"dupixent-300-q2w-solo2","p_value":"<0.001","arm_name":"Dupilumab 300mg Q2W"},{"value":8,"arm_id":"placebo-solo2","arm_name":"Placebo"}],"timepoint":"Week 16","description":"Proportion of patients achieving Investigator Global Assessment score of 0 (clear) or 1 (almost clear) with ≥2-point reduction from baseline. Confirmatory study to SOLO 1."}]
Efficacy Results
SOLO 2 confirmed SOLO 1: 36% IGA 0/1 with dupilumab Q2W vs 8% placebo (p<0.001). EASI-75: 44% vs 12% (p<0.001). Together with SOLO 1, supported FDA approval for moderate-to-severe AD.
Safety Results
SOLO 2 (n=708, 16 weeks): Consistent with SOLO 1. Injection site reactions 12% vs 6%, conjunctivitis 9% vs 2%. Well-tolerated.
Assessment
SOLO 2 is the confirmatory trial to SOLO 1. Results are consistent (36% vs 38% IGA 0/1). Together, they provided the registration package for AD approval.
Background & Context
Confirmatory companion study to SOLO 1. Identical design ensures reproducibility of IL-4Rα blockade in AD.
Data from Supabase · Updated 2026-03-24