The study is to reflect the effectiveness and safety of MG-K10 humanized monoclonal antibody injection in patients with moderate to severe atopic dermatitis.administered every 4 weeks for 52 week
The study was a multicenter, randomized, double-blind, placebo-controlled Phase III study. Approximately 498 adults with moderate-to-severe AD who were not controlled by local therapy were scheduled to receive multiple subcutaneous injections (administered every 4 weeks for 52 weeks). The study was divided into screening period (1-5 weeks), double-blind treatment period (16 weeks), treatment maintenance period (36 weeks), and follow-up period (8 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
498
MG-K10 Humanized Monoclonal Antibody Injection
Peking University People's Hospital
Beijing, China
RECRUITINGProportions of subjects achieving EASI-75
Proportions of subjects achieving EASI-75 (≥ 75% decrease from baseline in EASI
Time frame: 16 weeks
Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2
Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline
Time frame: 16weeks
The percentage of subjects who reached EASI-75 at other evaluation points;
The percentage of subjects who reached EASI-75 at other evaluation points;
Time frame: 16 weeks
Other evaluation points of view subjects with an IGA score of 0 or 1
Other evaluation points of view subjects with an IGA score of 0 or 1 and a decrease of ≥ 2 points from the baseline
Time frame: 16 weeks
Percentage of subjects who reach EASI-50
Percentage of subjects who reach EASI-50 (EASI score is ≥50% lower than the baseline)
Time frame: 16 weeks
Percentage of subjects who reach EASI-90
Percentage of subjects who reach EASI-90 (EASI score is ≥90% lower than the baseline)
Time frame: 16 weeks
Each evaluation point of view EASI
Each evaluation point of view EASI score compared with the baseline change and change rate
Time frame: 16 weeks
Percentage of subjects with a decrease of ≥2
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Percentage of subjects with a decrease of ≥2 points from the baseline IGA score at each evaluation point of view
Time frame: 16 weeks
Percentage of subjects with a weekly average of daily peak itching NRS score ≥3
Percentage of subjects with a weekly average of daily peak itching NRS score ≥3 points lower than the baseline;
Time frame: 16 weeks
The AD of each evaluation visit involves the change and rate of the baseline of BSA;
The AD of each evaluation visit involves the change and rate of the baseline of BSA;
Time frame: 16 weeks
The DLQI score of each evaluation interview has changed compared with the baseline.
The DLQI score of each evaluation interview has changed compared with the baseline.
Time frame: 16 weeks
The self-evaluation (POEM) score of patients with eczema from each evaluation point of view has changed compared with the baseline;
The self-evaluation (POEM) score of patients with eczema from each evaluation point of view has changed compared with the baseline;
Time frame: 16 weeks
The European Five-dimensional Health Scale (EQ-5D)
The European Five-dimensional Health Scale (EQ-5D) at each evaluation point of view is more than the baseline change and rate of change.
Time frame: 16 weeks