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

Not Applicable

Not yet recruiting

• Conditions: Atopic Dermatitis (AD)
• Interventions: Biological: MG-K10 placebo

• Registration Number: NCT07103174
• Lead Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-30
• Study First Submitted QC: 2025-08-01
• Last Update Submitted: 2025-08-01
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05
• Study Start: 2025-08-16
• Primary Completion: 2027-07-16
• Study Completion: 2027-12-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MG-K10 Regimen 1	MG-K10 placebo	Administer the drug once every 4 weeks for a total of 6 times
MG-K10 Regimen 2	MG-K10 placebo	Administer the drug once every 4 weeks for a total of 6 times

Primary Outcome Measures

Name	Time	Method
The percentage of subjects reaching EASI-75 at 24 weeks of treatment	24 weeks	The percentage of subjects reaching EASI-75 at 24 weeks of treatment
The percentage of subjects who achieved the IGA score standard at 24 weeks of treatment	24 weeks	The percentage of subjects whose IGA score reached 0 or 1 at 24 weeks of treatment (W24) and decreased by ≥2 points compared with the baseline;

Trial Locations

Locations (2)

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

Hangzhou First People's Hospital; 🇨🇳 Zhejiang, 杭州, China