NCT05466877进行中（未招募）2 期
Phase II Clinical Trial of Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Percentage change from baseline in EASI
研究概览
简要总结
This study evaluates the preliminary efficacy of MG-K10 in subjects with moderate to severe asthma, and provides a basis for the design and dosing regimen of phase III clinical trials.
详细描述
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II study. It is planned to enroll approximately 160 adult patients with moderate-to-severe AD uncontrolled by topical therapy, who will receive multiple subcutaneous injections. The study was divided into a screening period (1-5 weeks), a treatment period (16 weeks), and a safety follow-up (8 weeks).
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 - 70 years (inclusive), male or female;
- •Patients diagnosed with AD according to American Academy of Dermatology Consensus Criteria (2014) for at least 6 months prior to screening and meet the following criteria:
- •EASI score ≥ 16 at the screening and baseline visits;
- •IGA score ≥ 3 at the screening and baseline visits;
- •AD affected body surface area (BSA) percent ≥10% at the screening and baseline visits;
- •Documented recent history (within 6 months before the screening) of inadequate response to treatment with potent topical corticosteroids for at least 4 weeks or super-potent topical corticosteroids for at least 2 weeks, or topical calcineurin inhibitors for 4 weeks, or prior systemic use of corticosteroids or immunosuppressive agents for more than 2 weeks;
排除标准
- •Subjects currently diagnosed with other active skin disorders (e.g., psoriasis or lupus erythematosus) that may affect AD evaluation;
- •Subjects with concomitant diseases that may require systemic hormone therapy or other interventions or require active and frequent monitoring;
- •Subjects with unstable or not well controlled apparent cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological and psychological diseases that is considered by the investigator to be clinically significant；
- •Patients with ocular diseases that are not suitable for enrollment by the investigator；
- •Use of biological agents within 12 weeks prior to randomization or within 5 half-lives (whichever is longer)；
- •Use of topical corticosteroids, topical calcineurin inhibitors, antibiotic compound cream and other topical products for AD treatment within 1 week prior to randomization;
- •chest X-ray or CT examination within 3 months prior to screening/during the screening period suggests the presence of active tuberculosis infection；
- •History of parasitic infection or travel to endemic areas (South America and Africa) half a year prior to screening。
研究组 & 干预措施
MG-K10 Regimen 1
Experimental
subcutaneous injection every 4 weeks (placebo injections at 2, 6, 10, 14 weeks to maintain blindness)
干预措施: MG-K10 (Drug)
MG-K10 Regimen 2
Experimental
subcutaneous injection every 2 weeks
干预措施: MG-K10 (Drug)
MG-K10 Regimen 3
Experimental
subcutaneous injection every 4 weeks (placebo injections at 2, 6, 10, 14 weeks to maintain blindness)
干预措施: MG-K10 (Drug)
Placebo
Placebo Comparator
subcutaneous injection every 2 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage change from baseline in EASI
时间窗: 16 weeks
Percentage change from baseline in eczema area and severity index (EASI) score
次要结局
- The change in NRS weekly(2, 4, 8, 12, 16, 20 ,24 weeks)
- Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline(2, 4, 8, 12, 16, 20 ,24 weeks)
- Absolute and percentage change from baseline in BSA score of Atopic Dermatitis(2, 4, 8, 12, 16, 20 ,24 weeks)
- Pharmacokinetic concentration(24 weeks)
- Proportions of subjects achieving EASI-50(2, 4, 8, 12, 16, 20 ,24 weeks)
- Proportions of subjects achieving EASI-75(2, 4, 8, 12, 20 ,24 weeks)
- Percentage change from baseline in EASI score(2, 4, 8, 12, 20 ,24 weeks)
- Proportions of subjects achieving EASI-90(2, 4, 8, 12, 16, 20 ,24 weeks)
- Proportions of subjects with a decrease in IGA score from baseline of ≥ 2(2, 4, 8, 12, 16, 20 ,24 weeks)
- Proportions of subjects with a decrease in IGA score from baseline of ≥ 3(2, 4, 8, 12, 16, 20 ,24 weeks)
- Absolute change in POEM from baseline(2, 4, 8, 12, 16, 20 ,24 weeks)
- Absolute change in DLQI score from baseline(2, 4, 8, 12, 16, 20 ,24 weeks)
- thymus activation regulated chemokine (TARC)(24 weeks)
- serum immunoglobulin E (IgE)(24 weeks)
- Incidence of Adverse events (AEs)(24 weeks)
- Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs)(24 weeks)
- Absolute change from baseline in EASI scores(2, 4, 8, 12, 16, 20 ,24 weeks)
研究者
研究点 (2)
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