Study of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The study is to reflect the effectiveness and safety of MG-K10 humanized monoclonal antibody injection in patients with moderate to severe atopic dermatitis.

Detailed Description
-----------------
The study is a multicenter, randomized, double-blind, placebo-controlled phase III study. It is planned to recruit about 498 adult patients with moderate to severe AD who cannot be controlled by local treatment, who will receive multiple subcutaneous injections. The study is divided into screening period (1-5 weeks), double-blind treatment period (16 weeks), treatment maintenance period (36 weeks), and follow-up period (8 weeks)

Official Title
-----------------
Randomized, Double-blind, Placebo-controlled Phase III Clinical Study on the Effectiveness and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Moderate to Severe Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-75 years (inclusive of 18 and 75 years), both sexes; patients with AD diagnosed in accordance with the American Academy of Dermatology Consensus Criteria (2014), with a pre-screening diagnosis of AD or history of eczema for ≥1 year, and the following: Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline visit; Investigator's Overall Assessment (IGA) ≥3 points at screening and baseline visit; BSA ≥10% of area of AD involvement at screening and baseline visit Weekly mean of peak daily itch NRS score ≥4 at randomization; the patient had an inadequate treatment effect on topical medication or systemic therapy within 6 months prior to the screening visit, or the use of topical medication or systemic therapy was medically inappropriate negative screening blood pregnancy test results in women of childbearing age; Exclusion Criteria. subjects with a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) that may interfere with AD evaluation; Patients with ocular disease that, in the judgment of the Investigator, makes enrollment in the study inappropriate, e.g., past history of atopic keratoconjunctivitis with corneal involvement; if the Investigator is unable to make a determination, a diagnosis will be made by an ophthalmologist; those who plan to undergo major surgery during the study period, including inpatient surgery and daytime outpatient surgery; Subjects with the following conditions: Persons who have used a biologic agent within 10 weeks prior to randomization or have not exceeded 5 half-lives (whichever is longer); Targeted inhibitors (e.g., JAK inhibitors, etc.), systemic glucocorticoids, cyclosporine and other immunosuppressants (e.g., methotrexate, mycophenolate mofetil [MMF], and azathioprine, etc.), phosphodiesterase (PDE4) inhibitors, ultraviolet light therapy, and systemic herbal medicine for AD within 4 weeks prior to randomization; Has received topical glucocorticosteroids, topical calcineurin phosphatase inhibitors, antibiotic compound cream, and topical herbal therapy for AD within 1 week before randomization; Has received allergen-specific immunotherapy within 6 months prior to randomization; Live/live attenuated vaccination within 3 months prior to randomization or planned for the duration of the study; Participation in a clinical study of another drug in the 3 months or 5 half-lives, whichever is longer, prior to randomization or planning to participate in a clinical study of another drug during the study period; Subjects with prior use of an interleukin 4 receptor alpha subunit (IL-4Rα) monoclonal antibody drug who, in the judgment of the investigator, have developed drug resistance or drug-related serious AE; Previous participation in the MG-K10 clinical trial; evidence of active tuberculosis, or previous evidence of active tuberculosis without appropriate documented treatment; chest X-ray (frontal and lateral) or CT, etc. within 3 months prior to/surrounding the screening period suggesting the presence of active tuberculosis infection; women who are breastfeeding or pregnant, or who plan to become pregnant or breastfeed during the study;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Effectiveness of MG-K10 humanized monoclonal antibody injection in patients with moderate and severe atopic dermatitis Randomized, double-blind, placebo-controlled phase III clinical study with safety
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MG-K10 Humanized Monoclonal Antibody Injection<br>Every four weeks, subcutaneous injection ，total of 52W | Drug: MG-K10/Placebo<br>* MG-K10 Humanized Monoclonal Antibody Injection<br>|
| Placebo Comparator: MG-K10 placebo<br>Every four weeks, subcutaneous injection，The drug was transferred to the trial after 16 weeks | Drug: MG-K10/Placebo<br>* MG-K10 Humanized Monoclonal Antibody Injection<br>|

What is the study measuring?
-----------------
Primary 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 | 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 | 16weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of subjects who reached EASI-75 at other evaluation points; | The percentage of subjects who reached EASI-75 at other evaluation points; | 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 | 16 weeks | 
| Percentage of subjects who reach EASI-50 | Percentage of subjects who reach EASI-50 (EASI score is ≥50% lower than the baseline) | 16 weeks | 
| Percentage of subjects who reach EASI-90 | Percentage of subjects who reach EASI-90 (EASI score is ≥90% lower than the baseline) | 16 weeks | 
| Each evaluation point of view EASI | Each evaluation point of view EASI score compared with the baseline change and change rate | 16 weeks | 
| Percentage of subjects with a decrease of ≥2 | Percentage of subjects with a decrease of ≥2 points from the baseline IGA score at each evaluation point of view | 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; | 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; | 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. | 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; | 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. | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic Dermatitis