This is a a multicenter, randomized, double-blinded, parallel, positive-controlled, Phase III comparative study to evaluate GS101 Injection versus Dupixent® in participants with moderate-to-severe atopic dermatitis. A total of 572 subjects are planned to be included and randomized at a ratio of 1:1 to receive GS101 injection or Dupixent®
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
572
300mg/2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W);subcutaneous injection
300mg/2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W); subcutaneous injection
The First Hospital of China Medical University
Shenyang, Liaoning, China
Proportion of patients achieving EASI-75 at week 16
EASI-75
Time frame: 16 weeks
Proportion of patients achieving EASI-75
Proportion of patients achieving EASI-50 at Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
Time frame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
Proportion of patients achieving EASI-50
Proportion of patients achieving EASI-50 at Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
Time frame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
Proportion of patients achieving EASI-90
Proportion of patients achieving EASI-90 at Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
Time frame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
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