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
[{"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."}]
SOLO 2 (n=708, 16 weeks): Consistent with SOLO 1. Injection site reactions 12% vs 6%, conjunctivitis 9% vs 2%. Well-tolerated.