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NCT Number: NCT07103174

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

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

Loading trial locations.

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

Biological

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

Primary outcomes

  1. 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

  2. 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;

Study contacts

Contact information is provided by the study sponsor or research team.

Liming Wu

CONTACT

[email protected]

15258567080

Xiaofeng Cai

CONTACT

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
2027
Study completion
2027
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

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.

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