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

Korábbi kezelés

• 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.

Más betegség

• 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.

Laborértékek

• 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

• 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.