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TQH2722注射液治疗中重度特应性皮炎Ⅲ期临床试验评价

2026年11月5日 更新者：Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

评价TQH2722注射液治疗中重度特应性皮炎的有效性和安全性的多中心、随机、双盲、安慰剂对照III期临床试验

This is a randomized, double-blind, placebo-controlled clinical trial with 500 participants. In this study, the safety evaluation used the common toxic reaction criteria of the National Cancer Institute to evaluate the adverse events of the drugs, and the effectiveness evaluation used the eczema area and severity score and the overall investigator score to confirm the efficacy.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

500

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Anhui
      • Bengbu、Anhui、中国、233004
        • The First Affiliated Hospital of Bengbu Medical College
      • Tongling、Anhui、中国、244000
        • Tongling People's Hospital
      • Wuhu、Anhui、中国、241000
        • The Second Affiliated Hospital of Wannan Medical College
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100050
        • Beijing Friendship Hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国、400010
        • The First Affiliated Hospital of Chongqing Medical University
      • Chongqing、Chongqing Municipality、中国、400038
        • The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
      • Chongqing、Chongqing Municipality、中国、400072
        • The Second Affiliated Hospital of Chongqing Medical University
      • Chongqing、Chongqing Municipality、中国、404100
        • Chongqing Three Gorges Medical College affiliated People's Hospital
    • Fujian
      • Xiamen、Fujian、中国、361021
        • The Second Affiliated Hospital of Xiamen Medical College
    • Guangdong
      • Guangzhou、Guangdong、中国、510000
        • Dermatology Hospital of Southern Medical UniversityDermatology Hospital of Southern Medical University
      • Guangzhou、Guangdong、中国、510000
        • The Second Affiliated Hospital of Guangzhou Medical University
      • Shenzhen、Guangdong、中国、518036
        • Peking University Shenzhen Hospital
    • Guangxi
      • Liuzhou、Guangxi、中国、545006
        • Liuzhou People's Hospital
    • Hebei
      • Cangzhou、Hebei、中国、061012
        • Cangzhou Central Hospital
      • Chengde、Hebei、中国、067000
        • The Affiliated Hospital of Chengde Medical College
    • Heilongjiang
      • Harbin、Heilongjiang、中国、150036
        • Heilongjiang Provincial Hospital
      • Harbin、Heilongjiang、中国、151100
        • The Second Affiliated Hospital of Harbin Medical University
      • Qiqihar、Heilongjiang、中国、161005
        • Qiqihar Hospital of Traditional Chinese Medicine
    • Henan
      • Anyang、Henan、中国、455001
        • Anyang District Hospital, Puyang City
      • Luoyang、Henan、中国、471000
        • The Second Affiliated Hospital of Henan University of Science and Technology
      • Nanyang、Henan、中国、473000
        • Nanyang city first People's Hospital
      • Sanmenxia、Henan、中国、472000
        • Sanmenxia Central Hospital
      • Zhengzhou、Henan、中国、450000
        • Henan Provincial People's Hospital
      • Zhengzhou、Henan、中国、471000
        • The First Affiliated Hospital of Henan University of Science and Technology
    • Hubei
      • Jingzhou、Hubei、中国、434000
        • Jingzhou Central Hospital
      • Wuhan、Hubei、中国、430060
        • Wuhan University People's Hospital
      • Yichang、Hubei、中国、443003
        • Yichang Central People's Hospital
    • Hunan
      • Changsha、Hunan、中国、410013
        • Xiangya Third Hospital, Central South University
      • Changsha、Hunan、中国、410011
        • The Second Xiangya Hospital, Central South University
      • Hengyang、Hunan、中国、421001
        • The First Affiliated Hospital of University of South China
      • Huaihua、Hunan、中国、418000
        • Hunan Medical University General Hospital
    • Inner Mongolia
      • Baotou、Inner Mongolia、中国、14017
        • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
      • Baotou、Inner Mongolia、中国、14040
        • Baotou Central Hospital
      • Hohhot、Inner Mongolia、中国、10000
        • Affiliated Hospital of Inner Mongolia Medical University
    • Jiangsu
      • Changzhou、Jiangsu、中国、213000
        • Changzhou First People's Hospital
      • Suzhou、Jiangsu、中国、215000
        • The Second Affiliated Hospital of Soochow University
      • Suzhou、Jiangsu、中国、Weiling
        • Suzhou Municipal Hospital
      • Xuzhou、Jiangsu、中国、221132
        • Affiliated Hospital of Xuzhou Medical University
      • Yancheng、Jiangsu、中国、224005
        • Yancheng First People's Hospital
      • Zhenjiang、Jiangsu、中国、210039
        • Affiliated Hospital of Jiangsu University
    • Jiangxi
      • Nanchang、Jiangxi、中国、330006
        • The Second Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun、Jilin、中国、130041
        • Second Hospital of Jilin University
    • Liaoning
      • Panjin、Liaoning、中国、124120
        • Panjin Liao oil precious stone flower hospital
    • Ningxia
      • Yinchuan、Ningxia、中国、750010
        • Yinchuan First People's Hospital
    • Qinghai
      • Xining、Qinghai、中国、810000
        • Affiliated Hospital of Qinghai University
    • Shandong
      • Dezhou、Shandong、中国、277102
        • Dezhou People's Hospital
      • Jinan、Shandong、中国、250012
        • Shandong University Qilu Hospital
      • Liaocheng、Shandong、中国、252000
        • Liaocheng People's Hospital
      • Yantai、Shandong、中国、264000
        • Yantai Yuhuangding Hospital
      • Zaozhuang、Shandong、中国、277102
        • Zaozhuang Municipal Hospital
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、545006
        • Shanghai Dermatology Hospital
    • Shanxi
      • Baoji、Shanxi、中国、721008
        • Baoji Central Hospital
      • Taiyuan、Shanxi、中国、030000
        • Shanxi Provincial People's Hospital
      • Taiyuan、Shanxi、中国、030009
        • Peking University First Hospital Taiyuan Hospital
      • Xi’an、Shanxi、中国、710004
        • The Second Affiliated Hospital of Xi 'an Jiaotong University
      • Xi’an、Shanxi、中国、710032
        • The First Affiliated Hospital of PLA Air Force Medical University
      • Xi’an、Shanxi、中国、710032
        • The First Affiliated Hospital of Xi 'an Medical College
      • Xi’an、Shanxi、中国、710032
        • The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University
    • Sichuan
      • Chengdu、Sichuan、中国、610000
        • Sichuan Provincial People's Hospital
      • Chengdu、Sichuan、中国、610000
        • Chengdu Second People's Hospital
      • Chengdu、Sichuan、中国、610072
        • Chengdu Second People's Hospital
      • Luzhou、Sichuan、中国、646000
        • Affiliated Hospital of Southwest Medical University
      • Suining、Sichuan、中国、629000
        • Suining Central Hospital
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300120
        • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
      • Tianjin、Tianjin Municipality、中国、300190
        • Tianjin First Central Hospital
    • Xinjiang
      • Ürümqi、Xinjiang、中国、830002
        • People's Hospital of Xinjiang Uygur Autonomous Region
      • Ürümqi、Xinjiang、中国、830002
        • Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
    • Yunnan
      • Kunming、Yunnan、中国、650032
        • The First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310006
        • Hangzhou First People's Hospital
      • Hangzhou、Zhejiang、中国、310009
        • Hangzhou Third People's Hospital
      • Jiaxing、Zhejiang、中国、545006
        • Jiaxing second Hospital
      • Jinhua、Zhejiang、中国、321000
        • Jinhua Central Hospital
      • Ningbo、Zhejiang、中国、315211
        • The First Affiliated Hospital of Ningbo University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • The age of signing the informed consent is 18-75 years old, regardless of gender.
  • Meet the 2014 American Academy of Dermatology (AAD) standards, diagnosed as AD.
  • During screening and baseline visit, eczema area and severity score (EASI) ≥16 points; Investigator global score (IGA) ≥3 points; Affected body surface area (BSA) ≥10%; Baseline pruritus Peak Value Scale (NRS) weekly mean ≥4 points.
  • Have received at least 4 weeks of moderate-to-strong action or at least 2 weeks of super effective external glucocorticoid (TCS) treatment or sufficient duration of systemic glucocorticoid treatment, the efficacy is not sufficient; Or subjects cannot receive the above treatment due to adverse reactions or potential risks.

Exclusion Criteria:

  • Used immunosuppressants/immunomodulatory drugs, ultraviolet phototherapy, systemic Chinese medicine treatment within 4 weeks before randomization.
  • Received topical calcineurin inhibitors (TCS), topical calcineurin inhibitors (TCI), and other topical preparations within 2 weeks before randomization.
  • Received anti-interleukin-4 receptor alpha (IL-4R) monoclonal antibodies, anti-ige monoclonal antibodies, or other biologic agents within 12 weeks or 5 half-lives (whichever is longer) prior to randomization.
  • Had received live attenuated vaccine within 12 weeks prior to randomization or planned to receive it during the study period.
  • Use of antihistamines within 1 week prior to randomization (unless you have received steady doses of antihistamines for at least 7 days).
  • Received allergen specific immunotherapy within 6 months before randomization.
  • There are skin comorbidities that may interfere with study evaluation.
  • There is a history of clinically significant illness that the investigator believes poses a risk to the safety of the subject and is poorly controlled.
  • A known or suspected history of immunosuppression (immune deficiency).
  • Subjects with any type of active malignancy or a history of malignancy (except cervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, and papillary thyroid carcinoma that have been cured for more than 5 years prior to the screening period).
  • Subject may have active Mycobacterium tuberculosis infection.
  • Subjects with severe liver and kidney function impairment.
  • Screening period HIV antibody positive, or have a history of HIV infection.
  • Screening period of treponema pallidum antibody positive.
  • Participated in clinical trials of other drugs or medical devices within 12 weeks prior to randomization.
  • Treatment-requiring infections were present in the 4 weeks prior to randomization.
  • During the study period, subjects plan to undergo major surgical operations.
  • Pregnant or lactating women.
  • Alcohol, drug abuse and known drug dependence.
  • History of atopic keratoconjunctivitis with corneal involvement.
  • The subject has any medical or psychiatric symptoms that interfere with participation in the study or with the interpretation of the study results.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：TQH2722 injection

TQH2722 injection, 14 days for a treatment cycle
药品：TQH2722 injection

Humanized interleukin-4 receptor alpha (4Rα) monoclonal antibody
安慰剂比较：Placebo of TQH2722 injection

Placebo of TQH2722 injection, 14 days for a treatment cycle
药品：Placebo of TQH2722 injection

Placebo without drug substance

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI)
大体时间：Baseline to 16 weeks after treatment

Percentage of participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI)
Baseline to 16 weeks after treatment
Subjects with an Investigator's Overall Rating (IGA) score (5-scale) of 0 or 1 and ≥2 points decline from baseline
大体时间：Baseline to 16 weeks after treatment

Percentage of subjects with an Investigator's Overall Rating (IGA) score (5-scale) of 0 or 1 and ≥2 points decline from baseline.
Baseline to 16 weeks after treatment

次要结果测量

结果测量
措施说明
大体时间
The incidence of adverse events
大体时间：After medication to 60 weeks

Adverse events that occur during treatment
After medication to 60 weeks
Steady valley concentration of TQH2722
大体时间：After medication to 60 weeks

Relatively stable concentration levels of TQH2722
After medication to 60 weeks
The incidence and titer of drug-resistant antibodies (ADA) in subjects
大体时间：After medication to 60 weeks

The incidence and titer of drug-resistant antibodies (ADA) in subjects
After medication to 60 weeks
Incidence of neutralizing antibodies (Nab)
大体时间：After medication to 60 weeks

Incidence of neutralizing antibodies (Nab)
After medication to 60 weeks
Eczema area and severity score (EASI) change from baseline
大体时间：From baseline to week 60

The affected area of each site was assessed. According to the percentage of the affected area, the corresponding Region score was 0 to 6. The higher the score, the more severe the involvement.
From baseline to week 60
Rate of change from baseline in the Investigator's overall Score (IGA)
大体时间：After medication to 60 weeks

The researchers assessed the form of the dermatitis using a 5-point scale (0-5), with higher scores being more severe.
After medication to 60 weeks
Change of body surface area from baseline in moderate to severe atopic dermatitis
大体时间：After medication to 60 weeks

The researchers used a nine-point scale to assess the percentage of AD affected area in the whole body (0-100%), with the larger the value, the more severe the involvement.
After medication to 60 weeks
Change rate of atopic dermatitis score (SCORAD) from baseline
大体时间：After medication to 60 weeks

According to the involvement of skin surface area, the severity of skin lesions and the subjective symptom score, the higher the value, the more severe the dermatitis.
After medication to 60 weeks
Change in daily Peak Itch Digital Rating Scale (NRS) score from baseline
大体时间：After medication to 60 weeks

Rate the most severe itching in the past 24 hours on a scale of 0-10, with higher numbers being more severe.
After medication to 60 weeks
Rate of change in dermatological quality of life (DLQI) score from baseline
大体时间：After medication to 60 weeks

Assess how much the skin problems of the last week have affected the subjects' lives
After medication to 60 weeks
Change in patients' self-assessment of eczema (POEM) from baseline
大体时间：After medication to 60 weeks

The number of days in the past 7 days to assess whether eczema caused skin problems such as itching and bleeding, 0 indicates no days, 1 indicates 1-2 days, 2 indicates 3-4 days, 3 indicates 5-6 days, and 4 indicates all days.
After medication to 60 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年10月8日

初级完成 (实际的)

2025年9月11日

研究完成 (实际的)

2026年7月18日

研究注册日期

首次提交

2024年8月8日

首先提交符合 QC 标准的

2024年8月12日

首次发布 (实际的)

2024年8月14日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • TQH2722-III-01

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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