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对6至12岁的儿童中的名为Abrocitinib的药物研究中等至重度湿疹

2026年9月24日 更新者：Pfizer

一项为期16周的多中心，介入，第3阶段，随机，双盲，安慰剂对照，平行组研究，以研究6至12岁以下儿童的呼吸核酸蛋白毒素的疗效和安全性，中度至不足

This research study is being conducted to find out if the test medicine, abrocitinib, improves eczema and is safe for children 6 to <12 years of age who have moderate-to-severe eczema. Research study participants who meet the study criteria will be assigned by chance (like the flip of a coin) to receive either abrocitinib test medicine or placebo (pretend medicine that looks just like the test medicine) for 16 weeks. The study will last for about 24 weeks in total.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Different questionnaires will be used to find out how the participant's eczema is doing during the research study. An electronic diary, which looks like a cellular phone, will be used to collect the questionnaire information and other research study-related information. It will also be used to remind participants to take the test medicine each day and to fill out the questionnaires. Participants will also be asked to wear something on their wrist that looks like a children's wristwatch so we can know when they are scratching their skin because of their atopic dermatitis. Laboratory tests, physical examinations and vital signs (height, weight, temperature, blood pressure and heart rate) will be conducted before and during the research study to monitor your child's health. Participants will need to come to the clinic for research study visits and at other times during the research study, the research study doctor or nurse will call the participants to find out the participant is doing.

研究类型

介入性

注册 (估计的)

150

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
      • Shanghai、中国、200062
        • 招聘中
        • Shanghai Children's Hospital
      • Shanghai、中国、200092
        • 招聘中
        • Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100045
        • 招聘中
        • Beijing Children's hospital, Capital Medical University
    • Guangdong
      • Shenzhen、Guangdong、中国、518026
        • 招聘中
        • Shenzhen Children's Hospital
    • Hunan
      • Changsha、Hunan、中国、410007
        • 招聘中
        • Hunan Children's Hospital
    • Jiangxi
      • Nanchang、Jiangxi、中国、330000
        • 招聘中
        • Dermatology Hospital of Jiangxi Province
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200040
        • 招聘中
        • Shanghai Children's Hospital
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310009
        • 招聘中
        • Hangzhou Third People's Hospital
  • 匈牙利
      • Pécs、匈牙利、7622
        • 招聘中
        • University of Pecs
    • Baranya
      • Pécs、Baranya、匈牙利、7632
        • 招聘中
        • Pécsi Tudományegyetem Klinikai Központ
    • Bekes County
      • Békéscsaba、Bekes County、匈牙利、5600
        • 招聘中
        • Trial Pharma Kft.
    • Csongrád-csanád
      • Szeged、Csongrád-csanád、匈牙利、6720
        • 招聘中
        • Szegedi Tudományegyetem Bőrgyógyászati és Allergológiai Klinika
    • Pest County
      • Budapest、Pest County、匈牙利、1033
        • 招聘中
        • Clinexpert Kft.
  • 墨西哥
      • Chihuahua City、墨西哥、31238
        • 招聘中
        • Servicios Hospitalarios de México S.A. de C.V. (Hospital Angeles Chihuahua)
    • Mexico City
      • Mexico City、Mexico City、墨西哥、06720
        • 招聘中
        • Hospital Infantil de México Federico Gómez
    • Nuevo León
      • Monterrey、Nuevo León、墨西哥、64718
        • 招聘中
        • Eukarya Pharmasite S.C.
    • Veracruz
      • Veracruz、Veracruz、墨西哥、91900
        • 招聘中
        • Arke SMO S.A. de C.V.
  • 德国
    • North Rhine-Westphalia
      • Münster、North Rhine-Westphalia、德国、48149
        • 招聘中
        • Universitätsklinikum Münster
    • Saxony
      • Dresden、Saxony、德国、01307
        • 招聘中
        • Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
  • 日本
      • Fukuoka、日本、811-1394
        • 招聘中
        • Fukuoka National Hospital
      • Fukuoka、日本、819-0042
        • 招聘中
        • Saruta Dermatology Clinic
    • Kanagawa
      • Yokohama、Kanagawa、日本、220-6208
        • 招聘中
        • Queen's square Medical Facilities Queen's square Dermatology and Allergology
    • Osaka
      • Sakai、Osaka、日本、593-8324
        • 招聘中
        • Dermatology and Ophthalmology Kume Clinic
    • Tokyo
      • Setagaya-ku、Tokyo、日本、157-0066
        • 招聘中
        • Sasamoto Children's Clinic
  • 波兰
    • Lesser Poland Voivodeship
      • Krakow、Lesser Poland Voivodeship、波兰、30-002
        • 招聘中
        • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka cywilna
    • Lublin Voivodeship
      • Lublin、Lublin Voivodeship、波兰、20-573
        • 招聘中
        • LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska
    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、波兰、02-625
        • 招聘中
        • Centrum Medyczne Evimed
    • Silesian Voivodeship
      • Chorzów、Silesian Voivodeship、波兰、41-500
        • 招聘中
        • DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska
      • Katowice、Silesian Voivodeship、波兰、40-611
        • 招聘中
        • Centrum Medyczne Angelius Provita
    • Łódź Voivodeship
      • Lodz、Łódź Voivodeship、波兰、90-436
        • 招聘中
        • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
    • Świętokrzyskie Voivodeship
      • Ostrowiec Świętokrzyski、Świętokrzyskie Voivodeship、波兰、27-400
        • 招聘中
        • Dermedic Jacek Zdybski
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35244
        • 招聘中
        • Cahaba Dermatology & Skin Health Center, LLC
    • Arkansas
      • North Little Rock、Arkansas、美国、72117
        • 招聘中
        • Arkansas Research Trials
    • California
      • San Diego、California、美国、92123
        • 招聘中
        • Investigational Drug Service - Rady Childrens Hospital-San Diego
      • San Diego、California、美国、92123
        • 招聘中
        • University of California, San Diego/Rady Children's Hospital-San Diego; Pediatric & Adolescent Derm
    • Florida
      • Jacksonville、Florida、美国、32256
        • 招聘中
        • Solutions Through Advanced Research
    • Idaho
      • Meridian、Idaho、美国、83646
        • 招聘中
        • Ada West Research
    • Indiana
      • Indianapolis、Indiana、美国、46250
        • 招聘中
        • Dawes Fretzin Clinical Research Group, LLC
    • Missouri
      • St Louis、Missouri、美国、63104
        • 招聘中
        • Saint Louis University - Department of Dermatology
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • 招聘中
        • Medical University of South Carolina - South Carolina Translational Research Nexus Clinic
      • Charleston、South Carolina、美国、29425
        • 招聘中
        • Medical University of South Carolina - Department of Dermatology
      • Charleston、South Carolina、美国、29425
        • 招聘中
        • Medical University of South Carolina - Walton Research Building
      • Greenville、South Carolina、美国、29607
        • 招聘中
        • Tribe Clinical Research, LLC
    • Texas
      • San Antonio、Texas、美国、78235
        • 招聘中
        • Texas Dermatology and Laser Specialists
  • 西班牙
      • Zaragoza、西班牙、50009
        • 招聘中
        • Hospital Universitario Miguel Servet
    • A Coruña [LA Coruña]
      • Santiago de Compostela、A Coruña [LA Coruña]、西班牙、15706
        • 招聘中
        • CHUS - Hospital Clinico Universitario
    • Barcelona [barcelona]
      • Granollers、Barcelona [barcelona]、西班牙、08402
        • 招聘中
        • Hospital General de Granollers

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 至 11年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria Children aged 6 to <12 years at the time of informed consent/assent.

• No contraception methods are required for male participants. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.

Disease Characteristics:

Participants who meet all of the following AD criteria:

  • A documented diagnosis of chronic AD for at least 1 year prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria[19]; and
  • A diagnosis of moderate-to-severe AD at the baseline visit (must fulfill all of the following criteria: BSA ≥10%, vIGA ≥3, EASI ≥16, and WI-NRS ≥4); and
  • Documented history (within 6 months of the screening visit) of inadequate response to treatment with topical medical therapy for AD (eg, TCS and TCI), for at least 4 weeks and are candidates for systemic therapy

Other Inclusion Criteria:

Body weight ≥15 kg

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

Medical Conditions:

Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

If the participant has SDQ total score ≥17, the investigator should exclude them or refer the child to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents.

Have any of the following medical conditions:

  • Infections:

    • Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (Baseline) or have superficial skin infections within 1 week of Day 1.
    • History of systemic infection requiring hospitalization or parenteral antimicrobial therapy or as otherwise judged clinically significant by the investigator within 1 month prior to Day 1.
    • Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.
    • Infection with HIV, hepatitis B, and/or hepatitis C
    • Evidence of active TB or inadequately treated latent TB.

  • Skin Conditions:

    - Including but not limited to psoriasis, seborrheic dermatitis or lupus on Day 1 that would interfere with evaluation of AD or response to treatment.

  • Other Conditions:

    • Documented history of skeletal dysplasia.
    • Documented history of retinal detachment.
    • History of or conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.
    • Prior history of leukemia, lymphoma, sarcoma or any other malignancy.
    • Immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.
    • Any other medical conditions that in the investigator's judgment make the participant inappropriate for the study.

Prior/Concomitant Therapy:

Prior treatment with a systemic JAK inhibitor for AD. Live attenuated vaccination within 6 weeks prior to Day 1 or require vaccination with live attenuated vaccines during treatment or within 6 weeks after the last dose of study intervention.

Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes, strong inducers of CYP2C9 enzymes, P-gp substrates with narrow therapeutic index and sensitive CYP2C19 substrates is not allowed in the study.

Prior/Concurrent Clinical Study Experience:

Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Abrocitinib

Abrocitinib administered as liquid oral suspension.
药品：Abrocitinib

Abrocitinib administered as liquid oral suspension.

其他名称：
  • PF-04965842
安慰剂比较：Matching Placebo

Placebo administered as liquid oral suspension.
其他：Placebo

Placebo administered as liquid oral suspension.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Response based on achieving Validated Investigator's Global Assessment (vIGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at Week 12
大体时间：At week 12

The difference in proportion of responders based on vIGA at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo
At week 12
Response based on achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI)-75 at Week 12
大体时间：At week 12

The difference in proportion of responders based on EASI-75 at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo
At week 12

次要结果测量

结果测量
措施说明
大体时间
Change from Baseline (CFB) in the Worst Itch Numerical Rating Scale (WI-NRS) at Week 2
大体时间：At week 2

The difference in mean CFB in WI-NRS total score at Week 2 in patients with moderate-to-severe AD treated with abrocitinib versus placebo
At week 2
Response based on achieving at least a 4-point improvement from baseline in the WI-NRS at Week 12
大体时间：At week 12

The difference in proportion of responders based on achieving at least a 4-point improvement from baseline in the WI-NRS at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo
At week 12
Response based on achieving WI-NRS <2 at Week 12
大体时间：At week 12

The difference in proportion of responders based on achieving WI-NRS <2 at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo
At week 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pfizer

调查人员

  • 研究主任：Pfizer CT.gov Call Center、Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年7月24日

初级完成 (估计的)

2027年5月2日

研究完成 (估计的)

2027年5月2日

研究注册日期

首次提交

2025年1月29日

首先提交符合 QC 标准的

2025年1月29日

首次发布 (实际的)

2025年2月4日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • B7451023
  • 2023-509121-51-00 (注册表标识符：CTIS (EU))
  • 2023 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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