A Phase III Study of MG-K10 in Adolescents With Moderate-to-Severe Atopic Dermatitis

Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MG-K10 (a Humanized Monoclonal Antibody Injection) in Adolescents With Moderate-to-Severe Atopic Dermatitis

This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of MG-K10 monotherapy in adolescents with moderate-to-severe atopic dermatitis (AD)

Study Overview

• Status: Not yet recruiting
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: MG-K10 Injection (Humanized Monoclonal Antibody); Drug: Placebo for MG-K10

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xiaofeng Cai, bachelor; Phone Number: 021-51371305; Email: xiaofeng.cai@mabgeek.com

Study Locations

• China
  • Shenyang, China
    • The First Hospital of China Medical University
    • Contact: Xinghua Gao, MD; Phone Number: 024-83283391; Email: gaobarry@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of Atopic Dermatitis (AD) per American Academy of Dermatology (2014) criteria for ≥6 months;
2. Eczema Area and Severity Index (EASI) ≥16;
3. Investigator's Global Assessment (IGA) ≥3;
4. Body Surface Area (BSA) involvement ≥10%;
5. Peak Pruritus Numerical Rating Scale (NRS) weekly average ≥4;
6. Inadequate response to topical treatments within 6 months or medically inadvisable to use topical treatments.

Exclusion Criteria:

1. Inability to tolerate venipuncture, or a history of needle phobia or hematophobia;
2. Inability to receive subcutaneous injections, such as patients currently receiving anticoagulant therapy, or those with known bleeding disorders or idiopathic thrombocytopenic purpura;
3. Presence of ophthalmic diseases judged by the investigator to be unsuitable for inclusion;
4. Concurrent serious diseases including, but not limited to, cardiovascular, metabolic, or neurological diseases, which, in the opinion of the investigator, render the subject unsuitable for immunosuppressive therapy;
5. History of parasitic infection within 6 months prior to screening;
6. Planned major surgery during the study period;

7. Prior or concomitant treatments meeting any of the following:

   • Use of biologics within 10 weeks prior to randomization or within 5 half-lives (whichever is longer)
   • Use of targeted inhibitors (e.g., JAK inhibitors), systemic glucocorticoids, cyclosporine, or other immunosuppressants (e.g., methotrexate, MMF, azathioprine), phosphodiesterase-4 (PDE4) inhibitors, phototherapy (UV), or systemic Chinese herbal medicine for AD within 4 weeks prior to randomization
   • Use of topical treatments for AD (e.g., topical glucocorticoids, topical calcineurin inhibitors, antibiotic combination creams, or topical Chinese herbal medicine) within 2 weeks prior to randomization
   • Receipt of live or attenuated vaccines within 3 months prior to randomization or plans to receive such vaccines during the study
   • Participation in other clinical trials within 3 months or 5 half-lives (whichever is longer) prior to randomization, or plans to participate in other clinical trials during the study period
   • Systemic anti-infective therapy (oral or intravenous antibacterial, antiviral, or antifungal) within 4 weeks prior to randomization, or current acute or subacute infection indicated by symptoms, signs, or laboratory abnormalities
8. History of alcohol or drug abuse within 6 months prior to screening; Known allergy or intolerance to any component of the investigational product.
9. Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MG-K10; loading dose (SC) at Week 0, followed by a single dose Q2W through Week 52	Drug: MG-K10 Injection (Humanized Monoclonal Antibody); loading dose (SC) at Week 0, followed by a single dose Q2W through Week 52
Placebo Comparator: Placebo; Initial loading dose (SC), then single dose Q2W through Week 52	Drug: Placebo for MG-K10; Initial loading dose (SC), then single dose Q2W through Week 52

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants achieving EASI-75 ( ≥75% reduction from baseline )	week 16
Proportion of participants achieving IGA score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline	week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Peak Pruritus NRS	Baseline to week 52
Proportion of participants achieving EASI-50, EASI-90	Baseline to week 52
Change and percent change from baseline in the Quality of Life Score: CDLQI and EQ-5D-Y-3L scores	Baseline to week 52
Incidence in adverse events	Baseline to week 52

Collaborators and Investigators

• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): April 17, 2026
• Primary Completion (Estimated): January 5, 2027
• Study Completion (Estimated): November 9, 2027

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized
• Other Study ID Numbers: MG-K10-AD-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No