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临床试验/NCT06026891
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

Shanghai Mabgeek Biotech.Co.Ltd1 个研究点 分布在 1 个国家目标入组 498 人开始时间: 2024年1月13日最近更新:
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

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

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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