To Evaluate the Phase III Clinical Trial of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: Placebo of TQH2722 injection
- Registration Number
- NCT06552520
- Lead Sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TQH2722 injection TQH2722 injection TQH2722 injection, 14 days for a treatment cycle Placebo of TQH2722 injection Placebo of TQH2722 injection Placebo of TQH2722 injection, 14 days for a treatment cycle
- Primary Outcome Measures
Name Time Method Participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI) 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)
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 Percentage of subjects with an Investigator's Overall Rating (IGA) score (5-scale) of 0 or 1 and ≥2 points decline from baseline.
- Secondary Outcome Measures
Name Time Method Eczema area and severity score (EASI) change from baseline 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.
Rate of change from baseline in the Investigator's overall Score (IGA) 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.
Change rate of atopic dermatitis score (SCORAD) from baseline 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.
Incidence of neutralizing antibodies (Nab) After medication to 60 weeks Incidence of neutralizing antibodies (Nab)
Rate of change in dermatological quality of life (DLQI) score from baseline After medication to 60 weeks Assess how much the skin problems of the last week have affected the subjects' lives
Change in patients' self-assessment of eczema (POEM) from baseline 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.
The incidence of adverse events After medication to 60 weeks Adverse events that occur during treatment
The incidence and titer of drug-resistant antibodies (ADA) in subjects After medication to 60 weeks The incidence and titer of drug-resistant antibodies (ADA) in subjects
Change of body surface area from baseline in moderate to severe atopic dermatitis 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.
Steady valley concentration of TQH2722 After medication to 60 weeks Relatively stable concentration levels of TQH2722
Change in daily Peak Itch Digital Rating Scale (NRS) score from baseline 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.
Trial Locations
- Locations (72)
Chengdu Second People's Hospital
🇨🇳Chengdu, Sichuan, China
The Second Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
The Second Affiliated Hospital of Xiamen Medical College
🇨🇳Xiamen, Fujian, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Liuzhou People's Hospital
🇨🇳Liuzhou, Guangxi, China
Heilongjiang Provincial Hospital
🇨🇳Ha'erbin, Heilongjiang, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Liaocheng People's Hospital
🇨🇳Liaocheng, Shandong, 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 Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University
🇨🇳Xi'an, Shanxi, 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, China
Tianjin First Central Hospital
🇨🇳Tianjin, Tianjin, China
People's Hospital of Xinjiang Uygur Autonomous Region
🇨🇳Ürümqi, Xinjiang, China
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
🇨🇳Ürümqi, Xinjiang, China
Jinhua Central Hospital
🇨🇳Jinhua, Zhejiang, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Tongling People's Hospital
🇨🇳Tongling, Anhui, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Chongqing Three Gorges Medical College affiliated People's Hospital
🇨🇳Chongqing, Chongqing, 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
Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
The Affiliated Hospital of Chengde Medical College
🇨🇳Chengde, Hebei, China
Qiqihar Hospital of Traditional Chinese Medicine
🇨🇳Qiqihar, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The Second Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
Anyang District Hospital, Puyang City
🇨🇳Anyang, 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
Jingzhou Central Hospital
🇨🇳Jingzhou, Hubei, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Zhengzhou, Henan, China
Wuhan University People's Hospital
🇨🇳Wuhan, Hubei, China
Yichang Central People's Hospital
🇨🇳Yichang, Hubei, China
Xiangya Third Hospital, Central South University
🇨🇳Changsha, Hunan, China
The Second Xiangya Hospital, Central South University
🇨🇳Changsha, Hunan, China
Baoji Central Hospital
🇨🇳Baoji, Shanxi, China
The First Affiliated Hospital of University of South China
🇨🇳Hengyang, Hunan, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
🇨🇳Baotou, Inner Mongolia, China
Hunan Medical University General Hospital
🇨🇳Huaihua, Hunan, 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
Suzhou Municipal Hospital
🇨🇳Suzhou, Jiangsu, China
The Second Affiliated Hospital of Soochow University
🇨🇳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
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
Yantai Yuhuangding Hospital
🇨🇳Yantai, Shandong, China
Zaozhuang Municipal Hospital
🇨🇳Zaozhuang, Shandong, China
Shanghai Dermatology Hospital
🇨🇳Shanghai, Shanghai, China
Shanxi Provincial People's Hospital
🇨🇳Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi 'an Medical College
🇨🇳Xi'an, Shanxi, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Hangzhou First People's Hospital
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Hangzhou Third People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Jiaxing second Hospital
🇨🇳Jiaxing, Zhejiang, China
The First Affiliated Hospital of Ningbo University
🇨🇳Ningbo, Zhejiang, China