NCT07479615

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

A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Adult and Adolescent Patients With Moderate To-Severe Atopic Dermatitis

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 498 (estimated)
• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

• Atopic Dermatitis
• Atopic Eczema

Interventions

Type	Name	Description
BIOLOGICAL	MG-K10 Humanized Monoclonal Antibody Injection	MG-K10 Humanized Monoclonal Antibody Injection

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2026-03-18
• Last updated: 2026-03-18

Regulatory

• FDA-regulated drug study