This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of patients with moderate-to-severe atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
168
AK139 plus placebo regimen 1-subcutaneous injection.
AK139 regimen 2-subcutaneous injection.
AK139 plus placebo regimen 3-subcutaneous injection.
Incidence and severity grading of Adverse Events (AE)(applicable to Part 1)
Time frame: Up to Week 16 (applicable to the Q4W dosing group); Up to Week 8 (applicable to the Q2W dosing group).
Percentage of patients who achieved Eczema Area and Severity Index (EASI)-75 (applicable to Part 2)
Time frame: at week 16
Percentage of patients achieving an IGA score of 0 or 1 at each visit, with a reduction of ≥2 points from baseline
Time frame: Up to Week 24
Percentage change in affected Body Surface Area (BSA)
Time frame: Up to week 24
Percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores
Time frame: Up to week 24
Percentage changes in the Dermatology Life Quality Index (DLQI) score
Time frame: Up to week 24
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AK139 regimen 4-subcutaneous injection.
AK139 plus placebo regimen 5-subcutaneous injection.
AK139 plus placebo regimen 6-subcutaneous injection.
Placebo-subcutaneous injection