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

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

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

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: MG-K10/Placebo

Detailed Description

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
• Enrollment (Estimated): 498
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: xiaofeng Cai, bachelor; Phone Number: 02151371305; Email: xiaofeng.cai@mabgeek.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University People's Hospital
    • Contact: Jianzhong Zhang, Medical Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. age 18-75 years (inclusive of 18 and 75 years), both sexes;

2. 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;
3. 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
4. negative screening blood pregnancy test results in women of childbearing age;

Exclusion Criteria.

1. subjects with a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) that may interfere with AD evaluation;
2. 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;
3. those who plan to undergo major surgery during the study period, including inpatient surgery and daytime outpatient surgery;

4. 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;
5. 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;
6. women who are breastfeeding or pregnant, or who plan to become pregnant or breastfeed during the study;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd
• Investigators: Principal Investigator: Jianzhong Zhang, Medical Ph.D, Feking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2024
• Primary Completion (Estimated): June 11, 2025
• Study Completion (Estimated): December 12, 2025

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Atopic Dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: MG-K10-AD-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No