이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

중등도~중증 아토피성 피부염 치료에 TQH2722 주사에 대한 제3상 임상시험을 평가합니다.

2026년 11월 5일 업데이트: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

피험자의 중등도 및 중증 아토피성 피부염 치료에서 TQH2722 주사의 효능 및 안전성을 평가하기 위한 다기관, 무작위, 이중 맹검, 위약 대조 3상 임상 시험

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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

500

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: TQH2722 injection

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

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

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

Placebo without drug substance

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI)
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
The incidence of adverse events
기간: After medication to 60 weeks

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

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 10월 8일

기본 완료 (실제)

2025년 9월 11일

연구 완료 (실제)

2026년 7월 18일

연구 등록 날짜

최초 제출

2024년 8월 8일

QC 기준을 충족하는 최초 제출

2024년 8월 12일

처음 게시됨 (실제)

2024년 8월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 5일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TQH2722-III-01

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다