To Evaluate the Phase III Clinical Trial of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis

Last updated: August 12, 2024
Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Allergies & Asthma

Skin Infections/disorders

Rosacea

Treatment

Placebo of TQH2722 injection

TQH2722 injection

Clinical Study ID

NCT06552520
TQH2722-III-01
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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) ≥16points; 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 strong action or at least 2 weeks of supereffective external glucocorticoid (TCS) treatment or sufficient duration of systemicglucocorticoid treatment, the efficacy is not sufficient; Or subjects cannot receivethe above treatment due to adverse reactions or potential risks.

Exclusion

Exclusion Criteria:

  • Used immunosuppressants/immunomodulatory drugs, ultraviolet phototherapy, systemicChinese 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-igemonoclonal 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 orplanned to receive it during the study period.

  • Use of antihistamines within 1 week prior to randomization (unless you have receivedsteady 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 believesposes 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 (exceptcervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cellcarcinoma, and papillary thyroid carcinoma that have been cured for more than 5years 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 weeksprior 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 withparticipation in the study or with the interpretation of the study results.

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Placebo of TQH2722 injection
Phase: 3
Study Start date:
September 01, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui 233004
    China

    Site Not Available

  • Tongling People's Hospital

    Tongling, Anhui 244000
    China

    Site Not Available

  • The Second Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui 241000
    China

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

  • Chongqing Three Gorges Medical College affiliated People's Hospital

    Chongqing, Chongqing 404100
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400010
    China

    Site Not Available

  • The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University

    Chongqing, Chongqing 400038
    China

    Site Not Available

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400072
    China

    Site Not Available

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen, Fujian 361021
    China

    Site Not Available

  • Dermatology Hospital of Southern Medical UniversityDermatology Hospital of Southern Medical University

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong 518036
    China

    Site Not Available

  • Liuzhou People's Hospital

    Liuzhou, Guangxi 545006
    China

    Site Not Available

  • Cangzhou Central Hospital

    Cangzhou, Hebei 061012
    China

    Site Not Available

  • The Affiliated Hospital of Chengde Medical College

    Chengde, Hebei 067000
    China

    Site Not Available

  • Heilongjiang Provincial Hospital

    Ha'erbin, Heilongjiang 150036
    China

    Site Not Available

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 151100
    China

    Site Not Available

  • Qiqihar Hospital of Traditional Chinese Medicine

    Qiqihar, Heilongjiang 161005
    China

    Site Not Available

  • Anyang District Hospital, Puyang City

    Anyang, Henan 455001
    China

    Site Not Available

  • The Second Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan 471000
    China

    Site Not Available

  • Nanyang city first People's Hospital

    Nanyang, Henan 473000
    China

    Site Not Available

  • Sanmenxia Central Hospital

    Sanmenxia, Henan 472000
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science and Technology

    Zhengzhou, Henan 471000
    China

    Site Not Available

  • Jingzhou Central Hospital

    Jingzhou, Hubei 434000
    China

    Site Not Available

  • Wuhan University People's Hospital

    Wuhan, Hubei 430060
    China

    Site Not Available

  • Yichang Central People's Hospital

    Yichang, Hubei 443003
    China

    Site Not Available

  • The Second Xiangya Hospital, Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • Xiangya Third Hospital, Central South University

    Changsha, Hunan 410013
    China

    Site Not Available

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan 421001
    China

    Site Not Available

  • Hunan Medical University General Hospital

    Huaihua, Hunan 418000
    China

    Site Not Available

  • Baotou Central Hospital

    Baotou, Inner Mongolia 14040
    China

    Site Not Available

  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

    Baotou, Inner Mongolia 14017
    China

    Site Not Available

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia 10000
    China

    Site Not Available

  • Changzhou First People's Hospital

    Changzhou, Jiangsu 213000
    China

    Site Not Available

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu Weiling
    China

    Site Not Available

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215000
    China

    Site Not Available

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221132
    China

    Site Not Available

  • Yancheng First People's Hospital

    Yancheng, Jiangsu 224005
    China

    Site Not Available

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 210039
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Second Hospital of Jilin University

    Changchun, Jilin 130041
    China

    Site Not Available

  • Panjin Liao oil precious stone flower hospital

    Panjin, Liaoning 124120
    China

    Site Not Available

  • Yinchuan First People's Hospital

    Yinchuan, Ningxia 750010
    China

    Site Not Available

  • Affiliated Hospital of Qinghai University

    Xining, Qinghai 810000
    China

    Site Not Available

  • Dezhou People's Hospital

    Dezhou, Shandong 277102
    China

    Site Not Available

  • Shandong University Qilu Hospital

    Jinan, Shandong 250012
    China

    Site Not Available

  • Liaocheng People's Hospital

    Liaocheng, Shandong 252000
    China

    Site Not Available

  • Yantai Yuhuangding Hospital

    Yantai, Shandong 264000
    China

    Site Not Available

  • Zaozhuang Municipal Hospital

    Zaozhuang, Shandong 277102
    China

    Site Not Available

  • Shanghai Dermatology Hospital

    Shanghai, Shanghai 545006
    China

    Site Not Available

  • Baoji Central Hospital

    Baoji, Shanxi 721008
    China

    Site Not Available

  • Peking University First Hospital Taiyuan Hospital

    Taiyuan, Shanxi 030009
    China

    Site Not Available

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi 030000
    China

    Site Not Available

  • The First Affiliated Hospital of PLA Air Force Medical University

    Xi'an, Shanxi 710032
    China

    Site Not Available

  • The First Affiliated Hospital of Xi 'an Medical College

    Xi'an, Shanxi 710032
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an, Shanxi 710004
    China

    Site Not Available

  • The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University

    Xi'an, Shanxi 710032
    China

    Site Not Available

  • Chengdu Second People's Hospital

    Chengdu, Sichuan 610000
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan 610000
    China

    Site Not Available

  • Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan 646000
    China

    Site Not Available

  • Suining Central Hospital

    Suining, Sichuan 629000
    China

    Site Not Available

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    Tianjin, Tianjin 300120
    China

    Site Not Available

  • Tianjin First Central Hospital

    Tianjin, Tianjin 300190
    China

    Site Not Available

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang 830002
    China

    Site Not Available

  • Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

    Ürümqi, Xinjiang 830002
    China

    Site Not Available

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Site Not Available

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang 310006
    China

    Site Not Available

  • Hangzhou Third People's Hospital

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Jiaxing second Hospital

    Jiaxing, Zhejiang 545006
    China

    Site Not Available

  • Jinhua Central Hospital

    Jinhua, Zhejiang 321000
    China

    Site Not Available

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang 315211
    China

    Site Not Available

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