MG-K10 antibody injection for adolescents with moderate-to-severe atopic dermatitis

Trial details

Who runs it

Shanghai Mabgeek Biotech.Co.Ltd

Trial code

NCT07540442

Record updated

20 April 2026

Original description

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)Read full original descriptionShow less

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)

Inclusion: 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.

Exclusion: 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; History of alcohol or drug abuse within 6 months prior to screening; Known allergy or intolerance to any component of the investigational product; Inability to tolerate venipuncture, or a history of needle phobia or hematophobia; Presence of ophthalmic diseases judged by the investigator to be unsuitable for inclusion; Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in the study; 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.

ClinicalTrials.gov NCT07540442