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

• ClinicalTrials.gov Identifier: NCT06026891
• Recruitment Status: Recruiting
• First Posted: September 7, 2023
• Last Update Posted: February 23, 2024
• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd
• Information provided by (Responsible Party): Shanghai Mabgeek Biotech.Co.Ltd

Study Description

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.administered every 4 weeks for 52 week

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: MG-K10/Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 498 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 13, 2024
• Estimated Primary Completion Date: June 11, 2025
• Estimated Study Completion Date: December 12, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Proportions of subjects achieving EASI-75 [ Time Frame: 16 weeks ]
   Proportions of subjects achieving EASI-75 (≥ 75% decrease from baseline in EASI
2. Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 [ Time Frame: 16weeks ]
   Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline

Secondary Outcome Measures :

1. The percentage of subjects who reached EASI-75 at other evaluation points; [ Time Frame: 16 weeks ]
   The percentage of subjects who reached EASI-75 at other evaluation points;
2. Other evaluation points of view subjects with an IGA score of 0 or 1 [ Time Frame: 16 weeks ]
   Other evaluation points of view subjects with an IGA score of 0 or 1 and a decrease of ≥ 2 points from the baseline
3. Percentage of subjects who reach EASI-50 [ Time Frame: 16 weeks ]
   Percentage of subjects who reach EASI-50 (EASI score is ≥50% lower than the baseline)
4. Percentage of subjects who reach EASI-90 [ Time Frame: 16 weeks ]
   Percentage of subjects who reach EASI-90 (EASI score is ≥90% lower than the baseline)
5. Each evaluation point of view EASI [ Time Frame: 16 weeks ]
   Each evaluation point of view EASI score compared with the baseline change and change rate
6. Percentage of subjects with a decrease of ≥2 [ Time Frame: 16 weeks ]
   Percentage of subjects with a decrease of ≥2 points from the baseline IGA score at each evaluation point of view
7. Percentage of subjects with a weekly average of daily peak itching NRS score ≥3 [ Time Frame: 16 weeks ]
   Percentage of subjects with a weekly average of daily peak itching NRS score ≥3 points lower than the baseline;
8. The AD of each evaluation visit involves the change and rate of the baseline of BSA; [ Time Frame: 16 weeks ]
   The AD of each evaluation visit involves the change and rate of the baseline of BSA;
9. The DLQI score of each evaluation interview has changed compared with the baseline. [ Time Frame: 16 weeks ]
   The DLQI score of each evaluation interview has changed compared with the baseline.
10. 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 self-evaluation (POEM) score of patients with eczema from each evaluation point of view has changed compared with the baseline;
11. The European Five-dimensional Health Scale (EQ-5D) [ Time Frame: 16 weeks ]
    The European Five-dimensional Health Scale (EQ-5D) at each evaluation point of view is more than the baseline change and rate of change.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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;

Contacts and Locations

Contacts

Contact: xiaofeng Cai, bachelor; 02151371305; xiaofeng.cai@mabgeek.com

Locations

China

Peking University People's Hospital; Recruiting

Beijing, China

Contact: Jianzhong Zhang, Medical Ph.D

Sponsors and Collaborators

Shanghai Mabgeek Biotech.Co.Ltd

Investigators

• Principal Investigator: Jianzhong Zhang, Medical Ph.D; Feking University People's Hospital

More Information

• Responsible Party: Shanghai Mabgeek Biotech.Co.Ltd
• ClinicalTrials.gov Identifier: NCT06026891
• Other Study ID Numbers: MG-K10-AD-003
• First Posted: September 7, 2023
• Last Update Posted: February 23, 2024
• Last Verified: December 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai Mabgeek Biotech.Co.Ltd:

Atopic Dermatitis

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases