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

NCT ID: NCT06026891

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 498 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-13
• Study Completion Date: 2025-12-12

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

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).

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MG-K10 Humanized Monoclonal Antibody Injection

Every four weeks, subcutaneous injection ，total of 52W

Group Type: EXPERIMENTAL

MG-K10/Placebo

Intervention Type: DRUG

MG-K10 Humanized Monoclonal Antibody Injection

MG-K10 placebo

Every four weeks, subcutaneous injection，The drug was transferred to the trial after 16 weeks

Group Type: PLACEBO_COMPARATOR

MG-K10/Placebo

Intervention Type: DRUG

MG-K10 Humanized Monoclonal Antibody Injection

Interventions

MG-K10/Placebo

MG-K10 Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mabgeek Biotech.Co.Ltd

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianzhong Zhang, Medical Ph.D

Role: PRINCIPAL_INVESTIGATOR

Feking University People's Hospital

Locations

Peking University People's Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

xiaofeng Cai, bachelor

Role: CONTACT

xiaofeng.cai@mabgeek.com

02151371305

Facility Contacts

Jianzhong Zhang, Medical Ph.D

Role: primary

Other Identifiers

MG-K10-AD-003

Identifier Type: -

Identifier Source: org_study_id