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Долгосрочное исследование лекарства, называемого абитинибом у детей в возрасте 2 лет и старше с умеренной или тяжелой экземой

12 октября 2026 г. обновлено: Pfizer

Фаза 3, многоцентровое, долгосрочное, открытое исследование на этикетке, оценивающее безопасность и эффективность абрацитиниба, с или без актуальных лекарств, вводимых участникам педиатрии в возрасте от 2 лет и старше среднего с атопическим дерматитом от средней до тяжелой степени.

This 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

Phase 3, open-label study to assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children ≥2 years of age with moderate-to-severe atopic dermatitis (AD). This study will enroll participants in two cohorts: an extension cohort of participants who previously completed prior abrocitinib studies, and a de novo cohort of participants (6 to <12 years of age) who have not participated in previous abrocitinib studies. Study duration will be up to 2 years (or commercial availability, whichever occurs earlier). The study will enroll a maximum of approximately 500 participants with moderate-to-severe Atopic Dermatitis from study sites globally (extension cohort will enroll up to 320 participants; de novo cohort will enroll approximately 180 participants). All participants will receive the study intervention abrocitinib oral suspension.

Тип исследования

Интервенционный

Регистрация (Оцененный)

450

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Места учебы

  • Венгрия
    • Baranya
      • Pécs, Baranya, Венгрия, 7632
        • Рекрутинг
        • Pécsi Tudományegyetem Klinikai Központ
    • Bekes County
      • Békéscsaba, Bekes County, Венгрия, 5600
        • Рекрутинг
        • Trial Pharma Kft.
    • Pest County
      • Budapest, Pest County, Венгрия, 1033
        • Рекрутинг
        • Clinexpert Kft.
  • Испания
      • Zaragoza, Испания, 50009
        • Рекрутинг
        • Hospital Universitario Miguel Servet
    • A Coruña [LA Coruña]
      • Santiago de Compostela, A Coruña [LA Coruña], Испания, 15706
        • Рекрутинг
        • CHUS - Hospital Clinico Universitario
    • Barcelona
      • Granollers, Barcelona, Испания, 08402
        • Рекрутинг
        • Hospital General de Granollers
  • Китай
      • Shanghai, Китай, 200062
        • Рекрутинг
        • Shanghai Children's Hospital
      • Shanghai, Китай, 200092
        • Рекрутинг
        • Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Китай, 100045
        • Рекрутинг
        • Beijing Children's hospital, Capital Medical University
    • Guangdong
      • Shenzhen, Guangdong, Китай, 518026
        • Рекрутинг
        • Shenzhen Children's Hospital
    • Hunan
      • Changsha, Hunan, Китай, 410007
        • Рекрутинг
        • Hunan Children's Hospital
    • Jiangxi
      • Nanchang, Jiangxi, Китай, 330000
        • Еще не набирают
        • Dermatology Hospital of Jiangxi Province
    • Zhejiang
      • Hangzhou, Zhejiang, Китай, 310009
        • Рекрутинг
        • Hangzhou Third People's Hospital
  • Мексика
      • Chihuahua City, Мексика, 31238
        • Еще не набирают
        • Servicios Hospitalarios de Mexico S.A. DE C.V.
    • Mexico City
      • Mexico City, Mexico City, Мексика, 06720
        • Еще не набирают
        • Hospital Infantil de Mexico Federico Gomez
    • Nuevo León
      • Monterrey, Nuevo León, Мексика, 64718
        • Еще не набирают
        • Eukarya Pharmasite S.C.
    • Veracruz Ignacio de LA Llave
      • Veracruz, Veracruz Ignacio de LA Llave, Мексика, 91900
        • Еще не набирают
        • Arké SMO S.A de C.V
  • Польша
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Польша, 20-573
        • Рекрутинг
        • LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Польша, 02-625
        • Рекрутинг
        • Centrum Medyczne Evimed
    • Silesian Voivodeship
      • Chorzów, Silesian Voivodeship, Польша, 41-500
        • Рекрутинг
        • DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska
      • Katowice, Silesian Voivodeship, Польша, 40-611
        • Еще не набирают
        • Centrum Medyczne Angelius Provita
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Польша, 90-436
        • Рекрутинг
        • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
    • Świętokrzyskie Voivodeship
      • Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Польша, 27-400
        • Рекрутинг
        • Dermedic Jacek Zdybski
  • Соединенные Штаты
    • Alabama
      • Birmingham, Alabama, Соединенные Штаты, 35244
        • Рекрутинг
        • Cahaba Dermatology & Skin Health Center
    • Arkansas
      • North Little Rock, Arkansas, Соединенные Штаты, 72117
        • Рекрутинг
        • Arkansas Research Trials
    • California
      • San Diego, California, Соединенные Штаты, 92123
        • Еще не набирают
        • Investigational Drug Service - Rady Childrens Hospital-San Diego
      • San Diego, California, Соединенные Штаты, 92123
        • Еще не набирают
        • University of California, San Diego/ Rady Children's Hospital - San Diego
    • Florida
      • Jacksonville, Florida, Соединенные Штаты, 32256
        • Рекрутинг
        • Solutions Through Advanced Research
    • Idaho
      • Meridian, Idaho, Соединенные Штаты, 83646
        • Еще не набирают
        • Ada West Research - Meridian
    • Indiana
      • Indianapolis, Indiana, Соединенные Штаты, 46250
        • Рекрутинг
        • Dawes Fretzin Clinical Research Group, LLC
    • Missouri
      • St Louis, Missouri, Соединенные Штаты, 63104
        • Рекрутинг
        • Saint Louis University
    • South Carolina
      • Charleston, South Carolina, Соединенные Штаты, 29425
        • Рекрутинг
        • Medical University of South Carolina - South Carolina Translational Research Nexus Clinic
      • Greenville, South Carolina, Соединенные Штаты, 29607
        • Рекрутинг
        • Tribe Clinical Research, LLC
    • Texas
      • San Antonio, Texas, Соединенные Штаты, 78235
        • Еще не набирают
        • Texas Dermatology and Laser Specialists
  • Япония
      • Fukuoka, Япония, 811-1394
        • Рекрутинг
        • Fukuoka National Hospital
      • Fukuoka, Япония, 819-0042
        • Рекрутинг
        • Saruta Dermatology Clinic
    • Kanagawa
      • Yokohama, Kanagawa, Япония, 220-6208
        • Рекрутинг
        • Queen's square Medical Facilities Queen's square Dermatology and Allergology
    • Osaka
      • Sakai, Osaka, Япония, 593-8324
        • Рекрутинг
        • Dermatology and Ophthalmology Kume Clinic
    • Tokyo
      • Setagaya-ku, Tokyo, Япония, 157-0066
        • Рекрутинг
        • Sasamoto Children's Clinic

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 2 года до 11 лет (Ребенок)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria for the Extension Cohort:

1. Participants who have completed the treatment phase of the qualifying parent study (age 2 to <12 years old).

• No contraception methods are required for male participants. Female participants must not be pregnant or breastfeeding and, if the participant is of child-bearing potential, must use a highly effective form of contraception (i.e., abstinence) during the study intervention period and for at least 28 days after the last dose of study intervention.

Inclusion Criteria for the De Novo Cohort:

Age

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

    • No contraception methods are required for male participants.

    Disease Characteristics:

  2. Participants who meet all of the following AD criteria:

    • A documented diagnosis of chronic AD for at least 6 months prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria; 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:

  3. Body weight ≥15 kg

Exclusion Criteria for the Extension Cohort:

Medical Conditions:

  1. 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 the child or refer them 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.

    Prior/Concomitant Therapy:

  2. Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol.

  3. Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment.

    Diagnostic Assessments:

  4. Ongoing adverse event in the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern OR the participant is currently triggering safety monitoring criteria.

  5. Discontinued from treatment early in the parent studies OR triggered a discontinuation criterion at any point during the parent studies OR meets exclusion criteria from the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern.

Exclusion Criteria for the De Novo Cohort

Medical Conditions:

  1. 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.

  2. 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:

  3. Prior treatment with a systemic JAK inhibitor for AD.

  4. 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.

  5. Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes and strong inducers of CYP2C9 enzymes is not allowed in the study.

    Prior/Concurrent Clinical Study Experience:

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

    Diagnostic Assessments:

  7. Hepatic and/or renal and/or hematological abnormalities defined as:

    • AST >2 x ULN
    • Hemoglobin <10 g/dL
    • ALT >2 x ULN
    • ANC <1000/mm3
    • Total bilirubin ≥1.5 x ULN
    • ALC <500/mm3
    • eGFR <60 mL/min/1.73 m2
    • Platelets <150,000 /mm3

    Other Exclusion Criteria:

  8. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Нерандомизированный
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Extension

Patients who have completed other abrocitinib studies
Лекарство: Abrocitinib

Abrocitinib administered as liquid oral suspension.

Другие имена:
  • PF-04965842
Экспериментальный: De novo

Patients who have not participated other abrocitinib studies
Лекарство: Abrocitinib

Abrocitinib administered as liquid oral suspension.

Другие имена:
  • PF-04965842

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events (AEs) that lead to study discontinuation
Временное ограничение: 0-24 months

The number of the treatment emergent adverse events, serious adverse events and adverse events leading to discontinuation among patients with moderate-to-severe disease treated with abrocitinib regardless of discontinuation from study treatment.
0-24 months

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Participants With Clinically Significant Laboratory Abnormalities
Временное ограничение: 0-24 months

The number of clinically significant laboratory abnormalities among participants with moderate-to-severe disease treated with abrocitinib.
0-24 months
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 2 -point reduction from baseline at all scheduled time points
Временное ограничение: Baseline, 24 months

Proportion of responders based on vIGA at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib
Baseline, 24 months
Percentage of Response based on achieving a ≥4 point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at all scheduled time points in participants aged ≥2 to <6 years
Временное ограничение: 0-24 months

Percentage of responders based on achieving an improvement ≥4 points from baseline at all scheduled time points in the WI-NRS (in patients aged ≥2 to <6 years) with moderate-to-severe disease treated with abrocitinib.
0-24 months
Percentage of Response based on achieving a ≥4-point improvement from baseline in the WSI-NRS at all scheduled time points in participants aged ≥6 to 12 years
Временное ограничение: 0-24 months

Percentage of responders based on achieving an improvement ≥4 points from baseline at all scheduled time points in the WSI-NRS (in patients aged ≥6 to 12 years) with moderate-to-severe disease treated with abrocitinib.
0-24 months
Percentage of Responders based on achieving Eczema Area and Severity Index (EASI)-50, EASI-90 and EASI-100 at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib
Временное ограничение: 0-24 months

Percentage of response based on achieving ≥50%, ≥90%, 100% improvement from parent study baseline in the EASI total score (EASI-50, EASI-90, EASI-100) at all scheduled time points.
0-24 months
Percent Change from Baseline (CFB) in EASI total score at all scheduled time points.
Временное ограничение: 0-24 months

Mean percent CFB in EASI total score at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib
0-24 months
Percentage of Participants with Flares
Временное ограничение: 0-24 months

Percentage of participants reporting flares in patients with moderate-to-severe disease treated with abrocitinib.
0-24 months
CFB in the percentage Body Surface Area (BSA) affected at all scheduled time points
Временное ограничение: 0-24 months

Mean CFB in BSA affected at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib.
0-24 months
CFB in Children's Dermatology Life Quality Index (CDLQI) at all scheduled time points.
Временное ограничение: 0-24 months

Mean CFB in CDLQI at all scheduled time points in participants aged ≥4 to <16 years with moderate-to-severe disease treated with abrocitinib.
0-24 months
CFB in in Infants' Dermatitis Quality of Life (IDQOL) Index at all scheduled time points
Временное ограничение: 0-24 months

Mean CFB in IDQOL Index or CDQLI depending on age at all scheduled time points in participants aged <4 years with moderate-to-severe disease treated with abrocitinib
0-24 months
CFB in Patient-Oriented Eczema Measure (POEM) at all scheduled time points
Временное ограничение: 0-24 months

Mean CFB in POEM at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib.
0-24 months
CFB in Dermatitis Family Impact (DFI) at all scheduled time points
Временное ограничение: 0-24 months

Mean CFB in DFI at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib.
0-24 months
CFB in Patient Global Impression of Severity (PGIS) at all scheduled time points
Временное ограничение: 0-24 months

Mean CFB in PGIS (in patients aged 6 to <12 years) at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib.
0-24 months
CFB in Observer Reported Global Impression of Severity (OGIS) at all scheduled time points
Временное ограничение: 0-24 months

Mean CFB in OGIS (in patients aged 2 to <6 years) at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib
0-24 months
CFB in the the EuroQol- 5 Dimension Youth (EQ-5D-Y)
Временное ограничение: 0-24 months

Mean CFB in EQ-5D-Y at all scheduled time points in patients with moderate-tosevere AD treated with abrocitinib versus placebo.
0-24 months
Number of topical corticosteroid and /or topical calcineurin inhibitor free days
Временное ограничение: 0-24 months

Mean number of days free from topical corticosteroids and /or topical calcineurin inhibitor use in patients with moderate-to-severe disease treated with abrocitinib.
0-24 months
Percentage of Participants Achieving satisfactory response in Tdap/DTaP and/or pneumococcal antibody titers as appropriate in participants who receive Tdap/DTaP and/or pneumococcal vaccinations
Временное ограничение: 0-24 months

For patients that receive Tdap/ DTap and/or pneumococcal vaccinations during the study, the proportion of patients treated with abrocitinib who achieve satisfactory immunogenicity at 4 weeks after receiving the vaccinations.
0-24 months

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Pfizer

Следователи

  • Директор по исследованиям: Pfizer CT.gov Call Center, Pfizer

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

2 декабря 2025 г.

Первичное завершение (Оцененный)

22 февраля 2032 г.

Завершение исследования (Оцененный)

22 февраля 2032 г.

Даты регистрации исследования

Первый отправленный

29 января 2025 г.

Впервые представлено, что соответствует критериям контроля качества

29 января 2025 г.

Первый опубликованный (Действительный)

4 февраля 2025 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

13 октября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

12 октября 2026 г.

Последняя проверка

1 октября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • B7451031
  • 2023-509124-18-00 (Идентификатор реестра: CTIS (EU))
  • 2023 (Грант/контракт NIH США)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

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.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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