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A Study to Evaluate the Efficacy and Safety of MG-K10 in Participants Who Have Atopic Dermatitis

NCT07479615 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 498

Last updated 2026-03-18

No results posted yet for this study

Summary

Rationale (What is the reason for this study?) Atopic dermatitis (AD) is a condition that makes the skin dry and itchy and is the most common skin condition that causes redness and irritation.

The exact cause of AD is unclear but genetic and environmental factors are believed to play a role. Common treatment options for participants with AD include basic skin care, medicine that is applied to the skin, and medicine that works in more than one part of the body. Typically, these treatment options work for participants with AD but some have skin lesions (skin sores or damaged skin) over large areas of the body and do not see an improvement in their AD symptoms. MG-K10 has been shown to be effective in treating participants with moderate-to-severeatopic dermatitis in Phase 2 studies (Chaoying Gu et al.2025) and has already completed a Phase 3 clinical study for adults in China. This study aims to evaluate the efficacy and safety of MG-K10 in the adolenscents and adults with moderate-to-severeatopic dermatitis in global population.

Objectives (goals of the study) and Endpoints (how goals are measured) Check how MG-K10 treatment affects atopic dermatitis Study doctors will look at the safety of MG-K10 and if any side effects are reported by participants when they take it.

Check how the body processes MG-K10 Check how MG-K10 affects the biomarkers of effect Check how the body's immune system (the body's defense system) reacts to MG-K10

Conditions

Interventions

BIOLOGICAL

MG-K10 Humanized Monoclonal Antibody Injection

MG-K10 Humanized Monoclonal Antibody Injection

Sponsors & Collaborators

  • Shanghai Mabgeek Biotech.Co.Ltd

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2029-01-31
Completion
2029-01-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07479615 on ClinicalTrials.gov