Clinical trial NCT06552520: To Evaluate the Phase III Clinical Trial of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI)
timeFrame: Baseline to 16 weeks after treatment
measure: Subjects with an Investigator's Overall Rating (IGA) score (5-scale) of 0 or 1 and ≥2 points decline from baseline
timeFrame: Baseline to 16 weeks after treatment
Secondary outcomes:
measure: The incidence of adverse events
timeFrame: After medication to 60 weeks
measure: Steady valley concentration of TQH2722
timeFrame: After medication to 60 weeks
measure: The incidence and titer of drug-resistant antibodies (ADA) in subjects
timeFrame: After medication to 60 weeks
measure: Incidence of neutralizing antibodies (Nab)
timeFrame: After medication to 60 weeks
measure: Eczema area and severity score (EASI) change from baseline
timeFrame: From baseline to week 60
measure: Rate of change from baseline in the Investigator's overall Score (IGA)
timeFrame: After medication to 60 weeks
measure: Change of body surface area from baseline in moderate to severe atopic dermatitis
timeFrame: After medication to 60 weeks
measure: Change rate of atopic dermatitis score (SCORAD) from baseline
timeFrame: After medication to 60 weeks
measure: Change in daily Peak Itch Digital Rating Scale (NRS) score from baseline
timeFrame: After medication to 60 weeks
measure: Rate of change in dermatological quality of life (DLQI) score from baseline
timeFrame: After medication to 60 weeks
measure: Change in patients' self-assessment of eczema (POEM) from baseline
timeFrame: After medication to 60 weeks
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Tongling
country: China
facility: Tongling People's Hospital
state: Anhui
city: Wuhu
country: China
facility: The Second Affiliated Hospital of Wannan Medical College
state: Anhui
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
state: Chongqing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Three Gorges Medical College affiliated People's Hospital
state: Chongqing
city: Xiamen
country: China
facility: The Second Affiliated Hospital of Xiamen Medical College
state: Fujian
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical UniversityDermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Guangxi
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Chengde
country: China
facility: The Affiliated Hospital of Chengde Medical College
state: Hebei
city: Ha'erbin
country: China
facility: Heilongjiang Provincial Hospital
state: Heilongjiang
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Qiqihar
country: China
facility: Qiqihar Hospital of Traditional Chinese Medicine
state: Heilongjiang
city: Anyang
country: China
facility: Anyang District Hospital, Puyang City
state: Henan
city: Luoyang
country: China
facility: The Second Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Nanyang
country: China
facility: Nanyang city first People's Hospital
state: Henan
city: Sanmenxia
country: China
facility: Sanmenxia Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Jingzhou
country: China
facility: Jingzhou Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan University People's Hospital
state: Hubei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital, Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Third Hospital, Central South University
state: Hunan
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
city: Huaihua
country: China
facility: Hunan Medical University General Hospital
state: Hunan
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
state: Inner Mongolia
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia
city: Hohhot
country: China
facility: Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Changzhou
country: China
facility: Changzhou First People's Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Yancheng
country: China
facility: Yancheng First People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Second Hospital of Jilin University
state: Jilin
city: Panjin
country: China
facility: Panjin Liao oil precious stone flower hospital
state: Liaoning
city: Yinchuan
country: China
facility: Yinchuan First People's Hospital
state: Ningxia
city: Xining
country: China
facility: Affiliated Hospital of Qinghai University
state: Qinghai
city: Dezhou
country: China
facility: Dezhou People's Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong University Qilu Hospital
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Zaozhuang
country: China
facility: Zaozhuang Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
state: Shanghai
city: Baoji
country: China
facility: Baoji Central Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Peking University First Hospital Taiyuan Hospital
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi 'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of PLA Air Force Medical University
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi 'an Medical College
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Second People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Second People's Hospital
state: Sichuan
city: Luzhou
country: China
facility: Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Suining
country: China
facility: Suining Central Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
city: Ürümqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Ürümqi
country: China
facility: Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
state: Xinjiang
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou Third People's Hospital
state: Zhejiang
city: Jiaxing
country: China
facility: Jiaxing second Hospital
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Central Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
Study officials:
References: