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

Shanghai Mabgeek Biotech

Status and phase: Not yet enrolling; Phase 2

Conditions: Atopic Dermatitis (AD)

Treatments: Biological: MG-K10 placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07103174

MG-K10-AD-005

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

MG-K10 Regimen 1

Experimental group

Description:

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

Treatment:

Biological: MG-K10 placebo

MG-K10 Regimen 2

Active Comparator group

Description:

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

Treatment:

Biological: MG-K10 placebo