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

NCT ID: NCT07103174

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-16
• Study Completion Date: 2027-12-16

Brief Summary

This study is a multicenter, randomized, double-blind, parallel controlled phase II study. It is planned to include approximately 60 subjects with moderate to severe atopic dermatitis(AD) to evaluate the efficacy and safety of MG-K10 monotherapy in adult patients with moderate to severe AD, and to observe PK characteristics, PD effects and immunogenicity.

Conditions

Atopic Dermatitis (AD)

Study Design

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

Study Groups

MG-K10 Regimen 1

Administer the drug once every 4 weeks for a total of 6 times

Group Type: EXPERIMENTAL

MG-K10 placebo

Intervention Type: BIOLOGICAL

Administer the drug once every 4 weeks for a total of 6 times

MG-K10 Regimen 2

Administer the drug once every 4 weeks for a total of 6 times

Group Type: ACTIVE_COMPARATOR

MG-K10 placebo

Intervention Type: BIOLOGICAL

Administer the drug once every 4 weeks for a total of 6 times

Interventions

MG-K10 placebo

Administer the drug once every 4 weeks for a total of 6 times

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. AD patients diagnosed in accordance with the consensus criteria of the American Academy of Dermatology (2014) had a history of AD or eczema diagnosis of ≥1 year

2. The patient's response to topical medication treatment is insufficient, or it is medically inappropriate to use topical medication for treatment

3. The subjects and their partners agreed to take effective contraceptive measures from signing the Informed Consent Form (ICF) until 6 months after the end of treatment, and had no plans for childbirth, sperm donation or egg donation

Exclusion Criteria

1. The subject currently has a diagnosis of other active skin diseases (such as psoriasis or lupus erythematosus) that may affect the evaluation of AD

2. Patients with eye diseases that the researchers judged as unsuitable for inclusion

3. Patients with malignant tumors within 5 years

4. There is evidence of active tuberculosis, or there has been evidence of active tuberculosis before and no appropriate documented treatment has been received

5. Confirm active parasitic infection

6. Those with active hepatitis, or positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb), or positive for hepatitis C virus (HCV) antibody, or positive for HIV antibody, or positive for (TP-Ab)

7. Women who are breastfeeding or pregnant, or women planning to become pregnant or breastfeed during the study period

8. Those who the researchers consider to have other circumstances that make them unsuitable to participate in 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

Locations

Tower 5,No.34,Chunxiao Road No.122 Pudong District, Shanghai, 201203.p R. china

Shanghai, Shanghai Municipality, China

Hangzhou First People's Hospital

Zhejiang, 杭州, China

Countries

China

Central Contacts

Liming Wu

Role: CONTACT

xiaofeng.cai@mabgeek.com

15258567080

Xiaofeng Cai

Role: CONTACT

Facility Contacts

xiaofeng cai

Role: primary

xiaofeng.cai@mabgeek.com

15258567080

liming wu

Role: primary

xiaofeng.cai@mabgeek.com

15258567080

Other Identifiers

MG-K10-AD-005

Identifier Type: -

Identifier Source: org_study_id