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Para avaliar o ensaio clínico de fase III da injeção de TQH2722 no tratamento da dermatite atópica moderada a grave

5 de novembro de 2026 atualizado por: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Um ensaio clínico de fase III multicêntrico, randomizado, duplo-cego e controlado por placebo para avaliar a eficácia e segurança da injeção de TQH2722 no tratamento de dermatite atópica moderada a grave em indivíduos

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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

500

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • 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
        • Dermatology Hospital of Southern Medical UniversityDermatology Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 510000
        • The Second Affiliated Hospital of Guangzhou Medical University
      • Shenzhen, Guangdong, China, 518036
        • Peking University Shenzhen Hospital
    • Guangxi
      • Liuzhou, 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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: TQH2722 injection

TQH2722 injection, 14 days for a treatment cycle
Medicamento: TQH2722 injection

Humanized interleukin-4 receptor alpha (4Rα) monoclonal antibody
Comparador de Placebo: Placebo of TQH2722 injection

Placebo of TQH2722 injection, 14 days for a treatment cycle
Medicamento: Placebo of TQH2722 injection

Placebo without drug substance

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI)
Prazo: 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)
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
Prazo: 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.
Baseline to 16 weeks after treatment

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
The incidence of adverse events
Prazo: After medication to 60 weeks

Adverse events that occur during treatment
After medication to 60 weeks
Steady valley concentration of TQH2722
Prazo: After medication to 60 weeks

Relatively stable concentration levels of TQH2722
After medication to 60 weeks
The incidence and titer of drug-resistant antibodies (ADA) in subjects
Prazo: 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)
Prazo: After medication to 60 weeks

Incidence of neutralizing antibodies (Nab)
After medication to 60 weeks
Eczema area and severity score (EASI) change from baseline
Prazo: 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.
From baseline to week 60
Rate of change from baseline in the Investigator's overall Score (IGA)
Prazo: 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.
After medication to 60 weeks
Change of body surface area from baseline in moderate to severe atopic dermatitis
Prazo: 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.
After medication to 60 weeks
Change rate of atopic dermatitis score (SCORAD) from baseline
Prazo: 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.
After medication to 60 weeks
Change in daily Peak Itch Digital Rating Scale (NRS) score from baseline
Prazo: 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.
After medication to 60 weeks
Rate of change in dermatological quality of life (DLQI) score from baseline
Prazo: After medication to 60 weeks

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
Prazo: 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.
After medication to 60 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

8 de outubro de 2024

Conclusão Primária (Real)

11 de setembro de 2025

Conclusão do estudo (Real)

18 de julho de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

8 de agosto de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de agosto de 2024

Primeira postagem (Real)

14 de agosto de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • TQH2722-III-01

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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