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中等度から重度のアトピー性皮膚炎の治療におけるTQH2722注射の第III相臨床試験を評価するには

2026年11月5日 更新者：Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

被験者の中等度から重度のアトピー性皮膚炎の治療におけるTQH2722注射の有効性と安全性を評価する多施設共同無作為化二重盲検プラセボ対照第III相臨床試験

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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

500

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：TQH2722 injection

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

Humanized interleukin-4 receptor alpha (4Rα) monoclonal antibody
プラセボコンパレーター：Placebo of TQH2722 injection

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

Placebo without drug substance

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI)
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
The incidence of adverse events
時間枠：After medication to 60 weeks

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

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

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

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年10月8日

一次修了 (実際)

2025年9月11日

研究の完了 (実際)

2026年7月18日

試験登録日

最初に提出

2024年8月8日

QC基準を満たした最初の提出物

2024年8月12日

最初の投稿 (実際)

2024年8月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月9日

QC基準を満たした最後の更新が送信されました

2026年11月5日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • TQH2722-III-01

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

はい

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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