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

Launched by SHANGHAI MABGEEK BIOTECH.CO.LTD · Aug 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called MG-K10, which is given as an injection, to see if it helps adults with moderate to severe atopic dermatitis (also known as eczema). Atopic dermatitis is a skin condition that causes itching, redness, and irritation. This study will check if the medicine is safe and effective, and how it behaves in the body. About 60 adults with this condition will take part in the study, which is being done at multiple locations.

To join the trial, participants need to have had atopic dermatitis or eczema for at least one year and have not had enough improvement from usual skin treatments, or they cannot use those treatments for medical reasons. Both men and women can join, but women must not be pregnant or breastfeeding and must agree to use birth control during and for six months after the study. People with other active skin diseases, certain infections, recent cancer, or other health issues may not be able to participate. The study is not yet recruiting participants, but those who join will receive either the MG-K10 injection or a comparison treatment without knowing which one they get, to fairly test the medicine’s effects.

Gender

ALL

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