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NCT06552520

PHASE3

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

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

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis in Subjects

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2024-09

Completion Date

2026-06

Last Updated

2024-08-14

Healthy Volunteers

Conditions

Atopic Dermatitis

Interventions

DRUG

TQH2722 injection

Humanized interleukin-4 receptor alpha (4Rα) monoclonal antibody

DRUG

Placebo of TQH2722 injection

Placebo without drug substance

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 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.

Locations (73)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Tongling People's Hospital

Tongling, Anhui, China

The Second Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

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

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Chongqing Three Gorges Medical College affiliated People's Hospital

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital of Xiamen Medical College

Xiamen, Fujian, China

Dermatology Hospital of Southern Medical UniversityDermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Liuzhou People's Hospital

Liuchow, Guangxi, China

Cangzhou Central Hospital

Cangzhou, Hebei, China

The Affiliated Hospital of Chengde Medical College

Chengde, Hebei, China

Heilongjiang Provincial Hospital

Harbin, Heilongjiang, China

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Qiqihar Hospital of Traditional Chinese Medicine

Qiqihar, Heilongjiang, China

Anyang District Hospital, Puyang City

Anyang, Henan, China

The Second Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Nanyang city first People's Hospital

Nanyang, Henan, China

Sanmenxia Central Hospital

Sanmenxia, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Zhengzhou, Henan, China

Jingzhou Central Hospital

Jingzhou, Hubei, China

Wuhan University People's Hospital

Wuhan, Hubei, China

Yichang Central People's Hospital

Yichang, Hubei, China

The Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Xiangya Third Hospital, Central South University

Changsha, Hunan, China

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

Hunan Medical University General Hospital

Huaihua, Hunan, China

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

Baotou, Inner Mongolia, China

Baotou Central Hospital

Baotou, Inner Mongolia, China

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Changzhou First People's Hospital

Changzhou, Jiangsu, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Yancheng First People's Hospital

Yancheng, Jiangsu, China

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Second Hospital of Jilin University

Changchun, Jilin, China

Panjin Liao oil precious stone flower hospital

Panjin, Liaoning, China

Yinchuan First People's Hospital

Yinchuan, Ningxia, China

Affiliated Hospital of Qinghai University

Xining, Qinghai, China

Dezhou People's Hospital

Dezhou, Shandong, China

Shandong University Qilu Hospital

Jinan, Shandong, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Zaozhuang Municipal Hospital

Zaozhuang, Shandong, China

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, China

Baoji Central Hospital

Baoji, Shanxi, China

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Peking University First Hospital Taiyuan Hospital

Taiyuan, Shanxi, China

The Second Affiliated Hospital of Xi 'an Jiaotong University

Xi’an, Shanxi, China

The First Affiliated Hospital of PLA Air Force Medical University

Xi’an, Shanxi, China

The First Affiliated Hospital of Xi 'an Medical College

Xi’an, Shanxi, China

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

Xi’an, Shanxi, China

Chengdu Second People's Hospital

Chengdu, Sichuan, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Chengdu Second People's Hospital

Chengdu, Sichuan, China

Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Suining Central Hospital

Suining, Sichuan, China

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, Tianjin Municipality, China

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

Ürümqi, Xinjiang, China

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, China

Jiaxing second Hospital

Jiaxing, Zhejiang, China

Jinhua Central Hospital

Jinhua, Zhejiang, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (73)