To Evaluate the Phase III Clinical Trial of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Atopic Dermatitis
Спонсор: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Налично на:
БГ
Обобщение
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.
Кой може да участва
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.
Интервенции
TQH2722 injection
DRUG
Placebo of TQH2722 injection
DRUG
Места на провеждане
73
Китай (73)
Anyang District Hospital, Puyang City
Anyang , Henan
Baoji Central Hospital
Baoji , Shanxi
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou , Inner Mongolia
Baotou Central Hospital
Baotou , Inner Mongolia
Beijing Friendship Hospital, Capital Medical University
Beijing , Beijing Municipality
The First Affiliated Hospital of Bengbu Medical College
Bengbu , Anhui
Cangzhou Central Hospital
Cangzhou , Hebei
Second Hospital of Jilin University
Changchun , Jilin
The Second Xiangya Hospital, Central South University
Changsha , Hunan
Xiangya Third Hospital, Central South University
Changsha , Hunan
Changzhou First People's Hospital
Changzhou , Jiangsu
The Affiliated Hospital of Chengde Medical College
Chengde , Hebei
Chengdu Second People's Hospital
Chengdu , Sichuan
Sichuan Provincial People's Hospital
Chengdu , Sichuan
Chengdu Second People's Hospital
Chengdu , Sichuan
The First Affiliated Hospital of Chongqing Medical University
Chongqing , Chongqing Municipality
The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
Chongqing , Chongqing Municipality
The Second Affiliated Hospital of Chongqing Medical University
Chongqing , Chongqing Municipality
Chongqing Three Gorges Medical College affiliated People's Hospital
Chongqing , Chongqing Municipality
Dezhou People's Hospital
Dezhou , Shandong
Dermatology Hospital of Southern Medical UniversityDermatology Hospital of Southern Medical University
Guangzhou , Guangdong
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou , Guangdong
Hangzhou First People's Hospital
Hangzhou , Zhejiang
Hangzhou Third People's Hospital
Hangzhou , Zhejiang
Heilongjiang Provincial Hospital
Harbin , Heilongjiang
The Second Affiliated Hospital of Harbin Medical University
Harbin , Heilongjiang
The First Affiliated Hospital of University of South China
Hengyang , Hunan
Affiliated Hospital of Inner Mongolia Medical University
Hohhot , Inner Mongolia
Hunan Medical University General Hospital
Huaihua , Hunan
Jiaxing second Hospital
Jiaxing , Zhejiang
Shandong University Qilu Hospital
Jinan , Shandong
Jingzhou Central Hospital
Jingzhou , Hubei
Jinhua Central Hospital
Jinhua , Zhejiang
The First Affiliated Hospital of Kunming Medical University
Kunming , Yunnan
Liaocheng People's Hospital
Liaocheng , Shandong
Liuzhou People's Hospital
Liuchow , Guangxi
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang , Henan
Affiliated Hospital of Southwest Medical University
Luzhou , Sichuan
The Second Affiliated Hospital of Nanchang University
Nanchang , Jiangxi
Nanyang city first People's Hospital
Nanyang , Henan
The First Affiliated Hospital of Ningbo University
Ningbo , Zhejiang
Panjin Liao oil precious stone flower hospital
Panjin , Liaoning
Qiqihar Hospital of Traditional Chinese Medicine
Qiqihar , Heilongjiang
Sanmenxia Central Hospital
Sanmenxia , Henan
Shanghai Dermatology Hospital
Shanghai , Shanghai Municipality
Peking University Shenzhen Hospital
Shenzhen , Guangdong
Suining Central Hospital
Suining , Sichuan
The Second Affiliated Hospital of Soochow University
Suzhou , Jiangsu
Suzhou Municipal Hospital
Suzhou , Jiangsu
Shanxi Provincial People's Hospital
Taiyuan , Shanxi
Peking University First Hospital Taiyuan Hospital
Taiyuan , Shanxi
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin , Tianjin Municipality
Tianjin First Central Hospital
Tianjin , Tianjin Municipality
Tongling People's Hospital
Tongling , Anhui
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi , Xinjiang
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
Ürümqi , Xinjiang
Wuhan University People's Hospital
Wuhan , Hubei
The Second Affiliated Hospital of Wannan Medical College
Wuhu , Anhui
The Second Affiliated Hospital of Xi 'an Jiaotong University
Xi’an , Shanxi
The First Affiliated Hospital of PLA Air Force Medical University
Xi’an , Shanxi
The First Affiliated Hospital of Xi 'an Medical College
Xi’an , Shanxi
The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University
Xi’an , Shanxi
The Second Affiliated Hospital of Xiamen Medical College
Xiamen , Fujian
Affiliated Hospital of Qinghai University
Xining , Qinghai
Affiliated Hospital of Xuzhou Medical University
Xuzhou , Jiangsu
Yancheng First People's Hospital
Yancheng , Jiangsu
Yantai Yuhuangding Hospital
Yantai , Shandong
Yichang Central People's Hospital
Yichang , Hubei
Yinchuan First People's Hospital
Yinchuan , Ningxia
Zaozhuang Municipal Hospital
Zaozhuang , Shandong
Henan Provincial People's Hospital
Zhengzhou , Henan
The First Affiliated Hospital of Henan University of Science and Technology