NCT06026891招募中3 期
Randomized, Double-blind, Placebo-controlled Phase III Clinical Study on the Effectiveness and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Moderate to Severe Atopic Dermatitis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 498
- 试验地点
- 1
- 主要终点
- Proportions of subjects achieving EASI-75
研究概览
简要总结
The study is to reflect the effectiveness and safety of MG-K10 humanized monoclonal antibody injection in patients with moderate to severe atopic dermatitis.administered every 4 weeks for 52 week
详细描述
The study was a multicenter, randomized, double-blind, placebo-controlled Phase III study. Approximately 498 adults with moderate-to-severe AD who were not controlled by local therapy were scheduled to receive multiple subcutaneous injections (administered every 4 weeks for 52 weeks). The study was divided into screening period (1-5 weeks), double-blind treatment period (16 weeks), treatment maintenance period (36 weeks), and follow-up period (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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-75 years (inclusive of 18 and 75 years), both sexes;
- •patients with AD diagnosed in accordance with the American Academy of Dermatology Consensus Criteria (2014), with a pre-screening diagnosis of AD or history of eczema for ≥1 year, and the following:
- •Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline visit;
- •Investigator's Overall Assessment (IGA) ≥3 points at screening and baseline visit;
- •BSA ≥10% of area of AD involvement at screening and baseline visit
- •Weekly mean of peak daily itch NRS score ≥4 at randomization;
- •the patient had an inadequate treatment effect on topical medication or systemic therapy within 6 months prior to the screening visit, or the use of topical medication or systemic therapy was medically inappropriate
- •negative screening blood pregnancy test results in women of childbearing age;
- •Exclusion Criteria.
- •subjects with a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) that may interfere with AD evaluation;
- •Patients with ocular disease that, in the judgment of the Investigator, makes enrollment in the study inappropriate, e.g., past history of atopic keratoconjunctivitis with corneal involvement; if the Investigator is unable to make a determination, a diagnosis will be made by an ophthalmologist;
- •those who plan to undergo major surgery during the study period, including inpatient surgery and daytime outpatient surgery;
- •Subjects with the following conditions:
- •Persons who have used a biologic agent within 10 weeks prior to randomization or have not exceeded 5 half-lives (whichever is longer); Targeted inhibitors (e.g., JAK inhibitors, etc.), systemic glucocorticoids, cyclosporine and other immunosuppressants (e.g., methotrexate, mycophenolate mofetil [MMF], and azathioprine, etc.), phosphodiesterase (PDE4) inhibitors, ultraviolet light therapy, and systemic herbal medicine for AD within 4 weeks prior to randomization;
- •Has received topical glucocorticosteroids, topical calcineurin phosphatase inhibitors, antibiotic compound cream, and topical herbal therapy for AD within 1 week before randomization;
- •Has received allergen-specific immunotherapy within 6 months prior to randomization;
- •Live/live attenuated vaccination within 3 months prior to randomization or planned for the duration of the study;
- •Participation in a clinical study of another drug in the 3 months or 5 half-lives, whichever is longer, prior to randomization or planning to participate in a clinical study of another drug during the study period;
- •Subjects with prior use of an interleukin 4 receptor alpha subunit (IL-4Rα) monoclonal antibody drug who, in the judgment of the investigator, have developed drug resistance or drug-related serious AE;
- •Previous participation in the MG-K10 clinical trial;
- •evidence of active tuberculosis, or previous evidence of active tuberculosis without appropriate documented treatment; chest X-ray (frontal and lateral) or CT, etc. within 3 months prior to/surrounding the screening period suggesting the presence of active tuberculosis infection;
- •women who are breastfeeding or pregnant, or who plan to become pregnant or breastfeed during the study;
排除标准
- 未提供
研究组 & 干预措施
MG-K10 Humanized Monoclonal Antibody Injection
Experimental
Every four weeks, subcutaneous injection ，total of 52W
干预措施: MG-K10/Placebo (Drug)
MG-K10 placebo
Placebo Comparator
Every four weeks, subcutaneous injection，The drug was transferred to the trial after 16 weeks
干预措施: MG-K10/Placebo (Drug)
结局指标
主要结局
Proportions of subjects achieving EASI-75
时间窗: 16 weeks
Proportions of subjects achieving EASI-75 (≥ 75% decrease from baseline in EASI
Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2
时间窗: 16weeks
Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline
次要结局
- The AD of each evaluation visit involves the change and rate of the baseline of BSA;(16 weeks)
- Other evaluation points of view subjects with an IGA score of 0 or 1(16 weeks)
- The percentage of subjects who reached EASI-75 at other evaluation points;(16 weeks)
- Percentage of subjects who reach EASI-50(16 weeks)
- Percentage of subjects who reach EASI-90(16 weeks)
- The self-evaluation (POEM) score of patients with eczema from each evaluation point of view has changed compared with the baseline;(16 weeks)
- Each evaluation point of view EASI(16 weeks)
- Percentage of subjects with a weekly average of daily peak itching NRS score ≥3(16 weeks)
- The European Five-dimensional Health Scale (EQ-5D)(16 weeks)
- Percentage of subjects with a decrease of ≥2(16 weeks)
- The DLQI score of each evaluation interview has changed compared with the baseline.(16 weeks)
研究者
研究点 (1)
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