To Evaluate the Phase III Clinical Trial of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis
NCT Number: NCT06552520
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Atopic Dermatitis
Interventions: DRUG: TQH2722 injection|DRUG: Placebo of TQH2722 injection
Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-06
Locations: The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, 233004, China|Tongling People's Hospital, Tongling, Anhui, 244000, China|The Second Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, 241000, China|Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, 100050, China|The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400010, China|The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University, Chongqing, Chongqing, 400038, China|The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400072, China|Chongqing Three Gorges Medical College affiliated People's Hospital, Chongqing, Chongqing, 404100, China|The Second Affiliated Hospital of Xiamen Medical College, Xiamen, Fujian, 361021, China|Dermatology Hospital of Southern Medical UniversityDermatology Hospital of Southern Medical University, Guangzhou, Guangdong, 510000, China|The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510000, China|Peking University Shenzhen Hospital, Shenzhen, Guangdong, 518036, China|Liuzhou People's Hospital, Liuzhou, Guangxi, 545006, China|Cangzhou Central Hospital, Cangzhou, Hebei, 061012, China|The Affiliated Hospital of Chengde Medical College, Chengde, Hebei, 067000, China|Heilongjiang Provincial Hospital, Ha'erbin, Heilongjiang, 150036, China|The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 151100, China|Qiqihar Hospital of Traditional Chinese Medicine, Qiqihar, Heilongjiang, 161005, China|Anyang District Hospital, Puyang City, Anyang, Henan, 455001, China|The Second Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, 471000, China|Nanyang city first People's Hospital, Nanyang, Henan, 473000, China|Sanmenxia Central Hospital, Sanmenxia, Henan, 472000, China|Henan Provincial People's Hospital, Zhengzhou, Henan, 450000, China|The First Affiliated Hospital of Henan University of Science and Technology, Zhengzhou, Henan, 471000, China|Jingzhou Central Hospital, Jingzhou, Hubei, 434000, China|Wuhan University People's Hospital, Wuhan, Hubei, 430060, China|Yichang Central People's Hospital, Yichang, Hubei, 443003, China|The Second Xiangya Hospital, Central South University, Changsha, Hunan, 410011, China|Xiangya Third Hospital, Central South University, Changsha, Hunan, 410013, China|The First Affiliated Hospital of University of South China, Hengyang, Hunan, 421001, China|Hunan Medical University General Hospital, Huaihua, Hunan, 418000, China|The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, Inner Mongolia, 14017, China|Baotou Central Hospital, Baotou, Inner Mongolia, 14040, China|Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, 10000, China|Changzhou First People's Hospital, Changzhou, Jiangsu, 213000, China|The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215000, China|Suzhou Municipal Hospital, Suzhou, Jiangsu, Weiling, China|Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, 221132, China|Yancheng First People's Hospital, Yancheng, Jiangsu, 224005, China|Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, 210039, China|The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China|Second Hospital of Jilin University, Changchun, Jilin, 130041, China|Panjin Liao oil precious stone flower hospital, Panjin, Liaoning, 124120, China|Yinchuan First People's Hospital, Yinchuan, Ningxia, 750010, China|Affiliated Hospital of Qinghai University, Xining, Qinghai, 810000, China|Dezhou People's Hospital, Dezhou, Shandong, 277102, China|Shandong University Qilu Hospital, Jinan, Shandong, 250012, China|Liaocheng People's Hospital, Liaocheng, Shandong, 252000, China|Yantai Yuhuangding Hospital, Yantai, Shandong, 264000, China|Zaozhuang Municipal Hospital, Zaozhuang, Shandong, 277102, China|Shanghai Dermatology Hospital, Shanghai, Shanghai, 545006, China|Baoji Central Hospital, Baoji, Shanxi, 721008, China|Shanxi Provincial People's Hospital, Taiyuan, Shanxi, 030000, China|Peking University First Hospital Taiyuan Hospital, Taiyuan, Shanxi, 030009, China|The Second Affiliated Hospital of Xi 'an Jiaotong University, Xi'an, Shanxi, 710004, China|The First Affiliated Hospital of PLA Air Force Medical University, Xi'an, Shanxi, 710032, China|The First Affiliated Hospital of Xi 'an Medical College, Xi'an, Shanxi, 710032, China|The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University, Xi'an, Shanxi, 710032, China|Chengdu Second People's Hospital, Chengdu, Sichuan, 610000, China|Sichuan Provincial People's Hospital, Chengdu, Sichuan, 610000, China|Chengdu Second People's Hospital, Chengdu, Sichuan, 610072, China|Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China|Suining Central Hospital, Suining, Sichuan, 629000, China|Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, Tianjin, 300120, China|Tianjin First Central Hospital, Tianjin, Tianjin, 300190, China|People's Hospital of Xinjiang Uygur Autonomous Region, Ürümqi, Xinjiang, 830002, China|Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine, Ürümqi, Xinjiang, 830002, China|The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, 650032, China|Hangzhou First People's Hospital, Hangzhou, Zhejiang, 310006, China|Hangzhou Third People's Hospital, Hangzhou, Zhejiang, 310009, China|Jiaxing second Hospital, Jiaxing, Zhejiang, 545006, China|Jinhua Central Hospital, Jinhua, Zhejiang, 321000, China|The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, 315211, China

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.

Primary Outcome Measures: Participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI), 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, 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
Secondary Outcome Measures: The incidence of adverse events, Adverse events that occur during treatment, After medication to 60 weeks|Steady valley concentration of TQH2722, Relatively stable concentration levels of TQH2722, After medication to 60 weeks|The incidence and titer of drug-resistant antibodies (ADA) in subjects, The incidence and titer of drug-resistant antibodies (ADA) in subjects, After medication to 60 weeks|Incidence of neutralizing antibodies (Nab), Incidence of neutralizing antibodies (Nab), After medication to 60 weeks|Eczema area and severity score (EASI) change from baseline, 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), 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, 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, 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, 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, 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, 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