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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: TQH2722 injection; Drug: Placebo of TQH2722 injection

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • The First Affiliated Hospital Of Bengbu Medical College
    • Tongling, Anhui, China, 244000
      • Tongling People's Hospital
    • Wuhu, Anhui, China, 241000
      • The Second Affiliated Hospital of Wannan Medical College
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400010
      • The First Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing Municipality, China, 400038
      • The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
    • Chongqing, Chongqing Municipality, China, 400072
      • The Second Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing Municipality, China, 404100
      • Chongqing Three Gorges Medical College affiliated People's Hospital
  • Fujian
    • Xiamen, Fujian, China, 361021
      • The Second Affiliated Hospital of Xiamen Medical College
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • The Second Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China, 510000
      • Dermatology Hospital of Southern Medical UniversityDermatology Hospital of Southern Medical University
    • Shenzhen, Guangdong, China, 518036
      • Peking University Shenzhen Hospital
  • Guangxi
    • Liuchow, Guangxi, China, 545006
      • Liuzhou People's Hospital
  • Hebei
    • Cangzhou, Hebei, China, 061012
      • Cangzhou Central Hospital
    • Chengde, Hebei, China, 067000
      • The Affiliated Hospital of Chengde Medical College
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150036
      • Heilongjiang Provincial Hospital
    • Harbin, Heilongjiang, China, 151100
      • The Second Affiliated Hospital of Harbin Medical University
    • Qiqihar, Heilongjiang, China, 161005
      • Qiqihar Hospital of Traditional Chinese Medicine
  • Henan
    • Anyang, Henan, China, 455001
      • Anyang District Hospital, Puyang City
    • Luoyang, Henan, China, 471000
      • The Second Affiliated Hospital of Henan University of Science and Technology
    • Nanyang, Henan, China, 473000
      • Nanyang city first People's Hospital
    • Sanmenxia, Henan, China, 472000
      • Sanmenxia Central Hospital
    • Zhengzhou, Henan, China, 450000
      • Henan Provincial People's Hospital
    • Zhengzhou, Henan, China, 471000
      • The First Affiliated Hospital of Henan University of Science and Technology
  • Hubei
    • Jingzhou, Hubei, China, 434000
      • Jingzhou Central Hospital
    • Wuhan, Hubei, China, 430060
      • Wuhan University People's Hospital
    • Yichang, Hubei, China, 443003
      • Yichang Central People's Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • Xiangya Third Hospital, Central South University
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital, Central South University
    • Hengyang, Hunan, China, 421001
      • The First Affiliated Hospital of University of South China
    • Huaihua, Hunan, China, 418000
      • Hunan Medical University General Hospital
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 14017
      • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
    • Baotou, Inner Mongolia, China, 14040
      • Baotou Central Hospital
    • Hohhot, Inner Mongolia, China, 10000
      • Affiliated Hospital of Inner Mongolia Medical University
  • Jiangsu
    • Changzhou, Jiangsu, China, 213000
      • Changzhou First People's Hospital
    • Suzhou, Jiangsu, China, 215000
      • The Second Affiliated Hospital of Soochow University
    • Suzhou, Jiangsu, China, Weiling
      • Suzhou Municipal Hospital
    • Xuzhou, Jiangsu, China, 221132
      • Affiliated Hospital of Xuzhou Medical University
    • Yancheng, Jiangsu, China, 224005
      • Yancheng First People's Hospital
    • Zhenjiang, Jiangsu, China, 210039
      • Affiliated Hospital of Jiangsu University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The Second Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China, 130041
      • Second Hospital of Jilin University
  • Liaoning
    • Panjin, Liaoning, China, 124120
      • Panjin Liao oil precious stone flower hospital
  • Ningxia
    • Yinchuan, Ningxia, China, 750010
      • Yinchuan First People's Hospital
  • Qinghai
    • Xining, Qinghai, China, 810000
      • Affiliated Hospital of Qinghai University
  • Shandong
    • Dezhou, Shandong, China, 277102
      • Dezhou People's Hospital
    • Jinan, Shandong, China, 250012
      • Shandong University Qilu Hospital
    • Liaocheng, Shandong, China, 252000
      • Liaocheng People's Hospital
    • Yantai, Shandong, China, 264000
      • Yantai Yuhuangding Hospital
    • Zaozhuang, Shandong, China, 277102
      • Zaozhuang Municipal Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 545006
      • Shanghai Dermatology Hospital
  • Shanxi
    • Baoji, Shanxi, China, 721008
      • Baoji Central Hospital
    • Taiyuan, Shanxi, China, 030000
      • Shanxi Provincial People's Hospital
    • Taiyuan, Shanxi, China, 030009
      • Peking University First Hospital Taiyuan Hospital
    • Xi’an, Shanxi, China, 710004
      • The Second Affiliated Hospital of Xi 'an Jiaotong University
    • Xi’an, Shanxi, China, 710032
      • The First Affiliated Hospital of PLA Air Force Medical University
    • Xi’an, Shanxi, China, 710032
      • The First Affiliated Hospital of Xi 'an Medical College
    • Xi’an, Shanxi, China, 710032
      • The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Sichuan Provincial People's Hospital
    • Chengdu, Sichuan, China, 610000
      • Chengdu Second People's Hospital
    • Chengdu, Sichuan, China, 610072
      • Chengdu Second People's Hospital
    • Luzhou, Sichuan, China, 646000
      • Affiliated Hospital of Southwest Medical University
    • Suining, Sichuan, China, 629000
      • Suining Central Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300120
      • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
    • Tianjin, Tianjin Municipality, China, 300190
      • Tianjin First Central Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830002
      • People's Hospital of Xinjiang Uygur Autonomous Region
    • Ürümqi, Xinjiang, China, 830002
      • Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • The First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Hangzhou First People's Hospital
    • Hangzhou, Zhejiang, China, 310009
      • Hangzhou Third People's Hospital
    • Jiaxing, Zhejiang, China, 545006
      • Jiaxing Second Hospital
    • Jinhua, Zhejiang, China, 321000
      • Jinhua Central Hospital
    • Ningbo, Zhejiang, China, 315211
      • The First Affiliated Hospital of Ningbo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQH2722 injection; TQH2722 injection, 14 days for a treatment cycle	Drug: TQH2722 injection; Humanized interleukin-4 receptor alpha (4Rα) monoclonal antibody
Placebo Comparator: Placebo of TQH2722 injection; Placebo of TQH2722 injection, 14 days for a treatment cycle	Drug: Placebo of TQH2722 injection; Placebo without drug substance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2024
• Primary Completion (Actual): September 11, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: TQH2722-III-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes