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

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.

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Key information

Conditions

Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

The subject currently has a diagnosis of other active skin diseases (such as psoriasis or lupus erythematosus) that may affect the evaluation of AD
Patients with eye diseases that the researchers judged as unsuitable for inclusion
Patients with malignant tumors within 5 years
There is evidence of active tuberculosis, or there has been evidence of active tuberculosis before and no appropriate documented treatment has been received
Confirm active parasitic infection
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)
Women who are breastfeeding or pregnant, or women planning to become pregnant or breastfeed during the study period
Those who the researchers consider to have other circumstances that make them unsuitable to participate in the study

Treatment and study plan

MG-K10/Placebo

Drug

To ensure blinding, 4 mL of placebo will be administered subcutaneously at Weeks 4, 12 and 20., for a total of 3 doses.

Primary outcomes

The percentage of subjects reaching EASI-75 at 24 weeks of treatment

Time frame: 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

Time frame: 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;

Sponsors and collaborators

Lead sponsor

Shanghai Mabgeek Biotech.Co.Ltd

Industry

Registry information

Official study title

A Phase II Clinical Study on the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Moderate to Severe Atopic Dermatitis

Acronym: MG-K10

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Aug 5, 2025
Registry last updated: Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed