A Study of MG-K10 in Subjects With Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Phase II Clinical Trial of Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: MG-K10
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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key Inclusion Criteria: Aged 18 - 70 years (inclusive), male or female; Patients diagnosed with AD according to American Academy of Dermatology Consensus Criteria (2014) for at least 6 months prior to screening and meet the following criteria: EASI score ≥ 16 at the screening and baseline visits; IGA score ≥ 3 at the screening and baseline visits; AD affected body surface area (BSA) percent ≥10% at the screening and baseline visits; Documented recent history (within 6 months before the screening) of inadequate response to treatment with potent topical corticosteroids for at least 4 weeks or super-potent topical corticosteroids for at least 2 weeks, or topical calcineurin inhibitors for 4 weeks, or prior systemic use of corticosteroids or immunosuppressive agents for more than 2 weeks; Key Exclusion Criteria: Subjects currently diagnosed with other active skin disorders (e.g., psoriasis or lupus erythematosus) that may affect AD evaluation; Subjects with concomitant diseases that may require systemic hormone therapy or other interventions or require active and frequent monitoring; Subjects with unstable or not well controlled apparent cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological and psychological diseases that is considered by the investigator to be clinically significant； Patients with ocular diseases that are not suitable for enrollment by the investigator； Use of biological agents within 12 weeks prior to randomization or within 5 half-lives (whichever is longer)； Use of topical corticosteroids, topical calcineurin inhibitors, antibiotic compound cream and other topical products for AD treatment within 1 week prior to randomization; chest X-ray or CT examination within 3 months prior to screening/during the screening period suggests the presence of active tuberculosis infection； History of parasitic infection or travel to endemic areas (South America and Africa) half a year prior to screening。

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Phase II Study of the Safety, Pharmacokinetics, Dose-Ranging and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Patients with Moderate-to-Severe Atopic Dermatitis
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MG-K10 Regimen 1<br>subcutaneous injection every 4 weeks (placebo injections at 2, 6, 10, 14 weeks to maintain blindness) | Drug: MG-K10<br>* MG-K10 Humanized Monoclonal Antibody Injection<br>|
| Experimental: MG-K10 Regimen 2<br>subcutaneous injection every 2 weeks | Drug: MG-K10<br>* MG-K10 Humanized Monoclonal Antibody Injection<br>|
| Experimental: MG-K10 Regimen 3<br>subcutaneous injection every 4 weeks (placebo injections at 2, 6, 10, 14 weeks to maintain blindness) | Drug: MG-K10<br>* MG-K10 Humanized Monoclonal Antibody Injection<br>|
| Placebo Comparator: Placebo<br>subcutaneous injection every 2 weeks | Drug: Placebo<br>* MG-K10 Humanized Monoclonal Antibody Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from baseline in EASI | Percentage change from baseline in eczema area and severity index (EASI) score | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportions of subjects achieving EASI-75 | Proportions of subjects achieving EASI-75 (≥ 75% decrease from baseline in EASI score) at W16 | 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 | 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 | 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 | 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 | 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 | 2, 4, 8, 12, 20 ,24 weeks | 
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 2, 4, 8, 12, 16, 20 ,24 weeks | 
| Pharmacokinetic concentration | To evaluate the Pharmacokinetic concentration of MG-K10 | 24 weeks | 
| thymus activation regulated chemokine (TARC) | At each evaluation time point, the changes of thymus activation regulated chemokine (TARC) were compared with baseline | 24 weeks | 
| serum immunoglobulin E (IgE) | At each evaluation time point, the changes of serum immunoglobulin E (IgE)were compared with baseline | 24 weeks | 
| Incidence of Adverse events (AEs) | Including vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms (ECGs) | 24 weeks | 
| Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) | Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable) | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic dermatitis