NCT07540442尚未招募3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving EASI-75 ( ≥75% reduction from baseline )
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
MG-K10
Experimental
loading dose (SC) at Week 0, followed by a single dose Q2W through Week 52
干预措施: MG-K10 Injection (Humanized Monoclonal Antibody) (Drug)
Placebo
Placebo Comparator
Initial loading dose (SC), then single dose Q2W through Week 52
干预措施: Placebo for MG-K10 (Drug)
结局指标
主要结局
Proportion of participants achieving EASI-75 ( ≥75% reduction from baseline )
时间窗: week 16
Proportion of participants achieving IGA score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline
时间窗: week 16
次要结局
- 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)
研究者
研究点 (1)
Loading locations...
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