This study evaluates the preliminary efficacy of MG-K10 in subjects with moderate to severe asthma, and provides a basis for the design and dosing regimen of phase III clinical trials.
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II study. It is planned to enroll approximately 160 adult patients with moderate-to-severe AD uncontrolled by topical therapy, who will receive multiple subcutaneous injections. The study was divided into a screening period (1-5 weeks), a treatment period (16 weeks), and a safety follow-up (8 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
163
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Huashan Hospital Affiliated to Fudan University
Shanghai, China
Percentage change from baseline in EASI
Percentage change from baseline in eczema area and severity index (EASI) score
Time frame: 16 weeks
Proportions of subjects achieving EASI-75
Proportions of subjects achieving EASI-75 (≥ 75% decrease from baseline in EASI score) at W16
Time frame: 16 weeks
Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline
Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline
Time frame: 2, 4, 8, 12, 16, 20 ,24 weeks
The change in NRS weekly
The change in NRS weekly mean score and percentage change from baseline at W2, W4, W8, W12, W16, W20, and W24
Time frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Percentage change from baseline in EASI score
Percentage change from baseline in EASI score at Weeks W2, W4, W8, W12, W20, and W24
Time frame: 2, 4, 8, 12, 20 ,24 weeks
Proportions of subjects achieving EASI-50
Proportions of subjects achieving EASI-50 (≥ 50% decrease in EASI score from baseline) at W2, W4, W8, W12, W16, W20, and W24
Time frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Proportions of subjects achieving EASI-75
Proportions of subjects achieving EASI-75 at W2, W4, W8, W12, W20, and W24
Time frame: 2, 4, 8, 12, 20 ,24 weeks
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Proportions of subjects achieving EASI-90
Proportions of subjects achieving EASI-90 (≥ 90% decrease in EASI score from baseline) at W2, W4, W8, W12, W16, W20, and W24
Time frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Absolute change from baseline in EASI scores
Absolute change from baseline in EASI scores at W2, W4, W8, W12, W16, W20, and W24
Time frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Absolute and percentage change from baseline in BSA score of Atopic Dermatitis
Absolute and percentage change from baseline in BSA score of Atopic Dermatitis at W2, W4, W8, W12, W16, W20, and W24
Time frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Proportions of subjects with a decrease in IGA score from baseline of ≥ 2
Proportions of subjects with a decrease in IGA score from baseline of ≥ 2 at W2, W4, W8, W12, W16, W20 and W24
Time frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Proportions of subjects with a decrease in IGA score from baseline of ≥ 3
Proportions of subjects with a decrease in IGA score from baseline of ≥ 3 at W2, W4, W8, W12, W16, W20 and W24
Time frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Absolute change in POEM from baseline
Absolute change in patient oriented eczema measure (POEM) from baseline at W2, W4, W8, W12, W16, W20 and W24
Time frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Absolute change in DLQI score from baseline
Absolute change in dermatology life quality index (DLQI) score from baseline at W2, W4, W8, W12, W16, W20 and W24
Time frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Pharmacokinetic concentration
To evaluate the Pharmacokinetic concentration of MG-K10
Time frame: 24 weeks
thymus activation regulated chemokine (TARC)
At each evaluation time point, the changes of thymus activation regulated chemokine (TARC) were compared with baseline
Time frame: 24 weeks
serum immunoglobulin E (IgE)
At each evaluation time point, the changes of serum immunoglobulin E (IgE)were compared with baseline
Time frame: 24 weeks
Incidence of Adverse events (AEs)
Including vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms (ECGs)
Time frame: 24 weeks
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs)
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable)
Time frame: 24 weeks