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

Официальное название

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

Обзор

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)

Вмешательства

• Препарат MG-K10 Injection (Humanized Monoclonal Antibody)
  loading dose (SC) at Week 0, followed by a single dose Q2W through Week 52
• Препарат Placebo for MG-K10
  Initial loading dose (SC), then single dose Q2W through Week 52

Первичные конечные точки

• Proportion of participants achieving EASI-75 ( ≥75% reduction from baseline ) [Срок оценки: week 16]
• Proportion of participants achieving IGA score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline [Срок оценки: week 16]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;
• Presence of ophthalmic diseases judged by the investigator to be unsuitable for inclusion;
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Hospital Of China Medical University — Шэньян

Идентификаторы

NCT: NCT07540442 · MG-K10-AD-006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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