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Vyhodnotit fázi III klinického hodnocení injekčního podání TQH2722 při léčbě středně těžké až těžké atopické dermatitidy

5. listopadu 2026 aktualizováno: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Multicentrická, randomizovaná, dvojitě zaslepená, placebem kontrolovaná klinická studie fáze III k vyhodnocení účinnosti a bezpečnosti injekce TQH2722 při léčbě středně těžké až těžké atopické dermatitidy u subjektů

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

500

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 75 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: TQH2722 injection

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

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

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

Placebo without drug substance

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI)
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The incidence of adverse events
Časové okno: After medication to 60 weeks

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

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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

8. října 2024

Primární dokončení (Aktuální)

11. září 2025

Dokončení studie (Aktuální)

18. července 2026

Termíny zápisu do studia

První předloženo

8. srpna 2024

První předloženo, které splnilo kritéria kontroly kvality

12. srpna 2024

První zveřejněno (Aktuální)

14. srpna 2024

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • TQH2722-III-01

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ano

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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