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

NCT07103174 | Completed Phase 2

• 1 other identifier: MG-K10-AD-005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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)

Outcome Measures

Primary Outcomes (2)

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

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

  24 weeks

• The percentage of subjects who achieved the IGA score standard at 24 weeks of treatment

  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;

  24 weeks

Study Arms (2)

MG-K10 Q8W

ACTIVE COMPARATOR

First dose MG-K10 600 mg (4 mL), followed by MG-K10 600 mg (4 mL) administered subcutaneously once every 8 weeks, for a total of 3 doses.

Drug: MG-K10/Placebo

MG-K10 Q4W

ACTIVE COMPARATOR

First dose of MG-K10 600 mg (4 mL), followed by MG-K10 300 mg (2 mL) administered subcutaneously once every 4 weeks, for a total of 6 doses;

Drug: MG-K10/Placebo

Interventions

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.

MG-K10 Q8W

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Shanghai Mabgeek Biotech.Co.Ltd: lead

Study Sites (2)

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

Shanghai, Shanghai Municipality, 201203, China

Location

Hangzhou First People's Hospital

Zhejiang, 杭州, 310000, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: August 5, 2025
• Study Start: June 30, 2025
• Primary Completion: March 9, 2026
• Study Completion: April 29, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)