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

NCT07540442 | Not Yet Recruiting Phase 3

• 1 other identifier: MG-K10-AD-006
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

MG-K10

EXPERIMENTAL

loading dose (SC) at Week 0, followed by a single dose Q2W through Week 52

Drug: MG-K10 Injection (Humanized Monoclonal Antibody)

Placebo

PLACEBO COMPARATOR

Initial loading dose (SC), then single dose Q2W through Week 52

Drug: Placebo for MG-K10

Interventions

MG-K10 Injection (Humanized Monoclonal Antibody) DRUG

loading dose (SC) at Week 0, followed by a single dose Q2W through Week 52

MG-K10

Placebo for MG-K10 DRUG

Initial loading dose (SC), then single dose Q2W through Week 52

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Inability to tolerate venipuncture, or a history of needle phobia or hematophobia;
• Inability to receive subcutaneous injections, such as patients currently receiving anticoagulant therapy, or those with known bleeding disorders or idiopathic thrombocytopenic purpura;
• 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;
• History of parasitic infection within 6 months prior to screening;
• Planned major surgery during the study period;
• 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
• History of alcohol or drug abuse within 6 months prior to screening; Known allergy or intolerance to any component of the investigational product.
• Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in the study.

Sponsors & Collaborators

• Shanghai Mabgeek Biotech.Co.Ltd: lead

Study Sites (1)

The First Hospital Of China Medical University

Shenyang, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Antibodies, Monoclonal, Humanized

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Xiaofeng Cai, bachelor

CONTACT

021-51371305; xiaofeng.cai@mabgeek.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): January 5, 2027
• Study Completion (Estimated): November 9, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CN (1)