To Evaluate the Phase III Clinical Trial of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis
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
1 other identifier
interventional
500
1 country
73
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2024
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2024
CompletedFirst Posted
Study publicly available on registry
August 14, 2024
CompletedStudy Start
First participant enrolled
October 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedApril 20, 2026
April 1, 2026
11 months
August 8, 2024
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (11)
The incidence of adverse events
After medication to 60 weeks
Steady valley concentration of TQH2722
After medication to 60 weeks
The incidence and titer of drug-resistant antibodies (ADA) in subjects
After medication to 60 weeks
Incidence of neutralizing antibodies (Nab)
After medication to 60 weeks
Eczema area and severity score (EASI) change from baseline
From baseline to week 60
- +6 more secondary outcomes
Study Arms (2)
TQH2722 injection
EXPERIMENTALTQH2722 injection, 14 days for a treatment cycle
Placebo of TQH2722 injection
PLACEBO COMPARATORPlacebo of TQH2722 injection, 14 days for a treatment cycle
Interventions
Humanized interleukin-4 receptor alpha (4Rα) monoclonal antibody
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (73)
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 Municipality, 100050, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
Chongqing, Chongqing Municipality, 400038, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400072, China
Chongqing Three Gorges Medical College affiliated People's Hospital
Chongqing, Chongqing Municipality, 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
Liuchow, Guangxi, 545006, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061012, China
The Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 067000, China
Heilongjiang Provincial Hospital
Harbin, 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 Municipality, 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 Municipality, 300120, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2024
First Posted
August 14, 2024
Study Start
October 8, 2024
Primary Completion
September 11, 2025
Study Completion (Estimated)
June 1, 2026
Last Updated
April 20, 2026
Record last verified: 2026-04