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

Sponsor
Shanghai Mabgeek Biotech.Co.Ltd
Study ID
NCT07479615
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MG-K10 Humanized Monoclonal Antibody Injection — BIOLOGICAL
    MG-K10 Humanized Monoclonal Antibody Injection

Study Details

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

Key Dates

First listed
Mar 18, 2026
Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
498 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MG-K10 Humanized Monoclonal Antibody Injection
    After W16 patients will be re-randomize to: 1. MG-K10 Humanized Monoclonal Antibody Injection for responder Q4W 2. MG-K10 Humanized Monoclonal Antibody Injection for responder Q8W 3. Placebo Injection for responder Q4W 4. MG-K10 Humanized Monoclonal Antibody Injection for non-responder Q4W
  • Placebo Comparator: Placebo group:
    After W16 patients will be re-randomize to: MG-K10 Humanized Monoclonal Antibody Injection Q4W

Primary Outcome Measure

To evaluate the efficacy of MG K10 monotherapy compared to placebo in adults and adolescents with moderate to severe atopic dermatitis (AD). [ Time Frame: From baseline (D1) to 60 week ]

Central Contacts

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Atopic dermatitis / eczema trialsDermatology trialsRheumatology trialsAutoimmune disease trials

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