NCT07103174

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
19mo left

Started Aug 2025

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Aug 2025Dec 2027

First Submitted

Initial submission to the registry

June 30, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

August 16, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2027

Last Updated

August 5, 2025

Status Verified

June 1, 2025

Enrollment Period

1.9 years

First QC Date

June 30, 2025

Last Update Submit

August 1, 2025

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 Regimen 1

EXPERIMENTAL

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

Biological: MG-K10 placebo

MG-K10 Regimen 2

ACTIVE COMPARATOR

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

Biological: MG-K10 placebo

Interventions

MG-K10 placeboBIOLOGICAL

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

MG-K10 Regimen 1MG-K10 Regimen 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Liming Wu

CONTACT

15258567080xiaofeng.cai@mabgeek.com

Xiaofeng Cai

CONTACT

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
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2025

First Posted

August 5, 2025

Study Start

August 16, 2025

Primary Completion (Estimated)

July 16, 2027

Study Completion (Estimated)

December 16, 2027

Last Updated

August 5, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)