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Apremilast 对活动性幼年型银屑病关节炎患儿的儿科研究 (PEAPOD)

2026年10月16日 更新者：Amgen

一项 3 期、多中心、双盲、随机、安慰剂对照、平行组研究，以评估阿普司特在 5 岁至 18 岁以下患有活动性青少年银屑病关节炎 (PEAPOD) 儿童中的疗效、安全性和药代动力学

The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

60

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

学习地点

  • 南非
      • Cape Town、南非、7935
        • 终止
        • Groote Schuur Hospital
    • Western Cape
      • Panorama、Western Cape、南非、7500
        • 招聘中
        • Panorama Medical Centre
  • 土耳其（türkiye）
      • Ankara、土耳其（türkiye）、06100
        • 招聘中
        • Hacettepe Universitesi Tip Fakultesi Hastanesi
      • Istanbul、土耳其（türkiye）、34098
        • 招聘中
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi
      • Istanbul、土耳其（türkiye）、34093
        • 招聘中
        • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
      • Istanbul、土耳其（türkiye）、34764
        • 招聘中
        • Umraniye Egitim ve Arastirma Hastanesi
  • 希腊
      • Athens、希腊、12462
        • 终止
        • Attikon University General Hospital
      • Athens、希腊、11527
        • 终止
        • Agia Sofia Children Hospital
      • Thessaloniki、希腊、54642
        • 招聘中
        • General Hospital of Thessaloniki Ippokrateio
  • 德国
      • Berlin、德国、13353
        • 招聘中
        • Charite - Universitaetsmedizin Berlin, Campus Virchow
      • Dresden、德国、01307
        • 终止
        • Universitaetsklinikum Dresden
      • Hamburg、德国、22081
        • 终止
        • An der Schoen Klinik Hamburg Eilbek
      • Sankt Augustin、德国、53757
        • 终止
        • Asklepios Kinderklinik Sankt Augustin GmbH
  • 意大利
      • Chieti、意大利、66100
        • 终止
        • Ospedale Santissima Annunziata
      • Genova、意大利、16147
        • 终止
        • IRCCS Istituto Giannina Gaslini
      • Milan、意大利、20122
        • 招聘中
        • Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini
      • Roma、意大利、00165
        • 终止
        • IRCCS Ospedale Pediatrico Bambino Gesu
  • 比利时
      • Ghent、比利时、9000
        • 终止
        • Universitair Ziekenhuis Gent
      • Liège、比利时、4000
        • 终止
        • Centre Hospitalier Regional de la Citadelle
      • Merksem、比利时、2170
        • 终止
        • Ziekenhuis Netwerk Antwerpen Jan Palfijn
  • 法国
      • Bron、法国、69677
        • 招聘中
        • Hospices Civils de Lyon Hopital Femme Mere Enfant
      • Lille、法国、59037
        • 招聘中
        • Hopital Jeanne de Flandre
  • 波兰
      • Krakow、波兰、31-503
        • 终止
        • Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie
      • Lodz、波兰、91-738
        • 终止
        • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
      • Warsaw、波兰、02-637
        • 终止
        • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
  • 立陶宛
      • Vilnius、立陶宛、08406
        • 招聘中
        • Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine
  • 罗马尼亚
      • Cluj-Napoca、罗马尼亚、400124
        • 终止
        • Spitalul Clinic de Urgenta pentru Copii Cluj
      • Timișoara、罗马尼亚、300011
        • 招聘中
        • Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara
  • 英国
      • Birmingham、英国、B4 6NH
        • 终止
        • Birmingham Childrens Hospital
      • Liverpool、英国、L12 2AP
        • 终止
        • Alder Hey Childrens Hospital
      • Nottingham、英国、NG7 2UH
        • 招聘中
        • Nottingham Childrens Hospital
      • Oxford、英国、OX3 7LD
        • 招聘中
        • John Radcliffe Hospital
  • 荷兰
      • Utrecht、荷兰、3584 EA
        • 招聘中
        • Universitair Medisch Centrum Utrecht
  • 葡萄牙
      • Lisbon、葡萄牙、1649-035
        • 招聘中
        • Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
      • Lisbon、葡萄牙、1349-019
        • 终止
        • Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Egas Moniz
      • Ponte de Lima、葡萄牙、4990-041
        • 招聘中
        • Unidade Local de Saude do Alto Minho EPE - Hospital do Conde de Bertiandos
      • Porto、葡萄牙、4200-319
        • 终止
        • Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
      • Vila Nova de Gaia、葡萄牙、4430-502
        • 招聘中
        • Unidade Local de Saude de Gaia-Espinho, EPE
  • 西班牙
      • Madrid、西班牙、28034
        • 招聘中
        • Hospital Universitario Ramon y Cajal
      • Madrid、西班牙、28046
        • 终止
        • Hospital Universitario La Paz
    • Canary Islands
      • San Cristóbal de La Laguna、Canary Islands、西班牙、38320
        • 招聘中
        • Hospital Universitario de Canarias
    • Catalonia
      • Barcelona、Catalonia、西班牙、08035
        • 招聘中
        • Hospital Universitari Vall d Hebron
      • Esplugues de Llobregat、Catalonia、西班牙、08950
        • 招聘中
        • Hospital Sant Joan de Deu
    • Valencia
      • Valencia、Valencia、西班牙、46026
        • 招聘中
        • Hospital Universitari i Politecnic La Fe

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

5年 至 17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:

  • Male or Female participants 5 to < 18 years of age at the time of randomization.

  • Participant must have a confirmed diagnosis of juvenile psoriatic arthritis (JPsA) according to the International League of Associations for Rheumatology (ILAR) Edmonton Revision (Petty, 2001) classification criteria of at least 6 months duration:

    • Arthritis and psoriasis, OR
    • Arthritis with at least 2 of the following:
    • Dactylitis
    • Nail pitting or onycholysis
    • Psoriasis in a first-degree relative

  • Active disease: at least 3 active joints.

  • Inadequate response (at least 2 months) or intolerance to ≥ 1 disease-modifying anti-rheumatic drugs (DMARD), (which may include methotrexate [MTX] or biologic agents).

Exclusion Criteria:

  • Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include:

    • Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age
    • Ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative
    • History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart
    • Presence of systemic juvenile idiopathic arthritis (JIA).

  • Rheumatic autoimmune disease other than psoriatic arthritis (PsA), including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.

  • Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).

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：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Apremilast

Participants will receive apremilast in the double-blind 16 week treatment phase. Then the participants will continue to receive apremilast in the active 36 weeks treatment phase.
药品：Apremilast

Participants will receive apremilast orally.

其他名称：
  • 奥特兹拉®
安慰剂比较：Placebo to Apremilast

Participants will receive the matching placebo in the double-blind 16 week treatment phase. Then the participants will receive apremilast in the active 36 weeks treatment phase.
药品：Apremilast

Participants will receive apremilast orally.

其他名称：
  • 奥特兹拉®
药品：Placebo

Participants will receive the matching placebo orally.

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
Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16
大体时间：Baseline to Week 16

The ACR Pedi 30 is defined as a minimum of 30 percent improvement from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by >30 percent.

The ACR Pedi consists of 6 core criteria:

  1. physician global assessment (PGA) of disease activity (visual analog scale [VAS]) where 0 represents no disease activity and 100 represents the most disease activity
  2. assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being
  3. functional ability (assessed using the Childhood Health Assessment Questionnaire [CHAQ]);
  4. number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both)
  5. number of joints with limited range of motion
  6. laboratory marker of inflammation (C-reactive protein [CRP]).
Baseline to Week 16

次要结果测量

结果测量
措施说明
大体时间
第 16 周运动范围受限的关节数量相对于基线的变化
大体时间：第 16 周的基线
第 16 周的基线
第 16 周炎症实验室标记物（C 反应蛋白）相对于基线的变化
大体时间：第 16 周的基线
第 16 周的基线
经历一种或多种治疗紧急不良事件 (TEAE) 的参与者人数
大体时间：直到第 56 周
直到第 56 周
第 56 周时体重相对于基线的变化
大体时间：第 56 周的基线
第 56 周的基线
第 56 周时身高相对于基线的变化
大体时间：第 56 周的基线
第 56 周的基线
第 56 周时身体质量指数 (BMI) 相对于基线的变化
大体时间：第 56 周的基线
第 56 周的基线
阿普司特的血浆浓度
大体时间：第 2 周：给药后 0-5 小时；第 8 周：给药后 2 小时；第 16 周：给药后 4 小时；第 28 周：给药前；第 40 周：给药前；第 52 周：给药前
第 2 周：给药后 0-5 小时；第 8 周：给药后 2 小时；第 16 周：给药后 4 小时；第 28 周：给药前；第 40 周：给药前；第 52 周：给药前
Change from Baseline in Participants Assessment of Pain at Week 16
大体时间：Baseline to Week 16

The participants assessment of pain will be assessed using a visual analogue scale (VAS). Participants will be asked to place a vertical line on a 100-mm VAS where the left-hand boundary represents "no pain" and the right-hand boundary represents "worst possible pain".
Baseline to Week 16
Number of Participants who Achieve ACR Pedi 20, ACR Pedi 50, ACR Pedi 70 and ACR Pedi 90 Response at Week 16
大体时间：Baseline to Week 16

The ACR Pedi 20, 50, 70 and 90 is defined as a minimum of either 20 percent, 50 percent. 70 percent or 90 percent improvement respectively from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by >20 percent, >50 percent, >70 percent or >90 percent respectively.

The ACR Pedi consists of 6 core criteria:

  1. PGA of disease activity (VAS) where 0 represents no disease activity and 100 represents the most disease activity
  2. assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being
  3. functional ability (assessed using the CHAQ)
  4. number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both) 5. number of joints with limited range of motion

6. laboratory marker of inflammation (CRP).
Baseline to Week 16
Change from Baseline in the Physician Global Assessment (PGA) of Disease Activity at Week 16
大体时间：Baseline to Week 16

PGA of disease activity is assessed using a visual analog scale (VAS), where 0 represents no disease activity and 100 represents the most disease activity.
Baseline to Week 16
Change from Baseline in the Assessment of Overall Well-being at Week 16
大体时间：Baseline to Week 16

Assessment of overall well-being is assessed using a visual analog scale (VAS), where 0 represents very well and 100 represents very poor for overall well-being. This assessment can be completed by either the participant or the parent/caregiver.
Baseline to Week 16
Change from Baseline in the Number of Joints with Active Arthritis at Week 16
大体时间：Baseline to Week 16

Active arthritis is defined as joints with swelling not caused by deformity of joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both.
Baseline to Week 16
Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) at Week 16
大体时间：Baseline to Week 16

The CHAQ will be used to assess physical ability and functional status of participants as well as their quality of life.

The CHAQ consists of 20 items concerning difficulty in performing the following 8 activities of daily living: dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping, and activities. Subjects will choose from 4 responses ranging from 0 (without any difficulty) to 3 (unable to do). A lower score indicates a better outcome. The subject's/parent's/caregiver's assessment of arthritis-related pain will also be assessed on a VAS that is part of the CHAQ.
Baseline to Week 16
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS) at Week 16
大体时间：Baseline to Week 16

JADAS is a composite score of participant well-being visual analog scale (VAS) score, physician global assessment (PGA) VAS score, active joint count, and laboratory marker of inflammation (C-reactive protein [CRP]).

There are 4 components of the JADAS:

  1. Active joint count (71 joints)
  2. PGA (0 to 100) measured on a VAS
  3. Patient/parent global assessment of well-being (0 to 100) measured on a VAS
  4. CRP (normalized to a 0 to 10 scale)

The active joint count is taken from 71 joints: Temporomandibular joints, cervical spine, glenohumeral joints, acromioclavicular joints, sternoclavicular joints, elbows, wrists, metacarpophalangeal joints, interphalangeal joints, proximal interphalangeal joints, distal interphalangeal joints, hips, subtalar joints, midfoot joints, knees and ankles .

The total score is calculated by adding all 4 components of the JADAS. The score for the JADAS ranges from 0 to 101 where a lower score indicates a better outcome.
Baseline to Week 16
Number of Participants who Experience Psoriatic Arthritis (PsA) Flares at Week 16
大体时间：Baseline to Week 16

PsA flares are defined as more than or equal to 30 percent worsening in at least 3 of 6 American College of Rheumatology Pediatric (ACR Pedi) core set variables with a more than or equal to 30 percent improvement in not more than 1 of 6 ACR Pedi core set variables.
Baseline to Week 16
Psoriasis Area Severity Index (PASI)-75 Response at Week 16 for Participants With a Baseline Psoriasis Body Surface Area (BSA) ≥ 3 percent
大体时间：Baseline to Week 16

PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.

The PASI score is determined only for subjects whose BSA involved by psoriasis is

≥3 percent. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on the 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90 percent < 100 percent involvement). The sum of scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region, and then multiplied by a constant corresponding to the region's percentage of BSA. The resultant values for each anatomic region are then summed to yield the PASI score.
Baseline to Week 16
Number of Participants With Suicidal Ideation or Behaviour Assessed Via the Columbia Suicide Severity Rating Scale (C-SSRS)
大体时间：Up to Week 56

The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Number of participants with suicidal ideation or behavior is defined as the number of participants who answer "yes" at any time during the study (up to end of safety follow-up, Week 56) to one of the 10 categories:

Category 1: Wish to be dead Category 2: Non-specific active suicidal thoughts Category 3: Active suicidal ideation with any methods (not plan) without intent to act Category 4: Active suicidal ideation with some intent to act, without specific plan Category 5: Active suicidal ideation with specific plan and intent Category 6: Preparatory acts or behavior Category 7: Aborted attempt Category 8: Interrupted attempt Category 9: Actual attempt (non-fatal) Category 10: Completed suicide
Up to Week 56
Change from Baseline in Tanner Staging at Week 52
大体时间：Baseline to Week 52

Tanner Staging of sexual development assessment will be used to assess sexual maturity. Tanner Staging assessment consists of 3 domains (pubic hair, breast development, and other changes) for girls and 4 domains (pubic hair, penis development, testes development, and other changes) for boys. Stages range from 1-5, with 1 indicating preadolescent and 5 adult.
Baseline to Week 52
Taste and Acceptability of Apremilast
大体时间：Baseline and Week 2

Taste and acceptability will be assessed using a questionnaire with a 7-point faces Likert Scale, with 1 ranging from "super bad" to 7 "super good" and questions to determine whether the participants are able to take the treatment medication.
Baseline and Week 2

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

Amgen

调查人员

  • 研究主任：MD、Amgen

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)

2022年3月17日

初级完成 (估计的)

2028年3月21日

研究完成 (估计的)

2028年12月29日

研究注册日期

首次提交

2021年3月16日

首先提交符合 QC 标准的

2021年3月16日

首次发布 (实际的)

2021年3月18日

研究记录更新

最后更新发布 (实际的)

2026年10月20日

上次提交的符合 QC 标准的更新

2026年10月16日

最后验证

2026年10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

  • 20190529

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

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD 共享时间框架

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD 共享访问标准

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

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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