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Valutare la sperimentazione clinica di fase III dell'iniezione TQH2722 nel trattamento della dermatite atopica da moderata a grave

5 novembre 2026 aggiornato da: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Uno studio clinico di fase III multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza dell'iniezione TQH2722 nel trattamento della dermatite atopica da moderata a grave nei soggetti

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

500

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: TQH2722 injection

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

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

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

Placebo without drug substance

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The incidence of adverse events
Lasso di tempo: After medication to 60 weeks

Adverse events that occur during treatment
After medication to 60 weeks
Steady valley concentration of TQH2722
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: After medication to 60 weeks

Incidence of neutralizing antibodies (Nab)
After medication to 60 weeks
Eczema area and severity score (EASI) change from baseline
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

8 ottobre 2024

Completamento primario (Effettivo)

11 settembre 2025

Completamento dello studio (Effettivo)

18 luglio 2026

Date di iscrizione allo studio

Primo inviato

8 agosto 2024

Primo inviato che soddisfa i criteri di controllo qualità

12 agosto 2024

Primo Inserito (Effettivo)

14 agosto 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TQH2722-III-01

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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