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A Study to Evaluate the Safety and Effectiveness of Upadacitinib in Pediatric Participants With Alopecia Areata

2026年9月15日 更新者：AbbVie

A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of Upadacitinib in Pediatric Subjects With Severe Alopecia Areata

Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the scalp and face, but hair loss can happen on any hair-bearing part of the body. Some treatment options are available for adults and adolescents with AA, however there is still high unmet need for systemic treatments (treatment that moves throughout the bloodstream) approved for young patients with AA. Treatments may not work for all patients or may stop working over time. Because of this, researchers are developing new AA treatments, like upadacitinib. Upadacitinib is a type of medicine called a Janus- Kinase (JAK) inhibitor and works with the body to fight the inflammation that can cause AA. In this study, different doses (amounts) of upadacitinib are being compared to treatment with placebo (looks like the study treatment but contains no medicine).

Upadacitinib is an investigational JAK inhibitor being developed for the treatment of severe alopecia areata in pediatric patients. This is a randomized, double-blind, placebo-controlled study. Participants are placed in 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. Pediatric participants with a diagnosis of severe alopecia areata with SALT score ≥ 50 scalp hair loss will be enrolled. Participants will be at least 6 years old at Screening and less than 18 years old at Baseline. Approximately 300 participants will be enrolled in the study at approximately 120 sites worldwide.

Participants will receive oral doses of upadacitinib or matching placebo daily, or twice daily, for approximately 160 weeks. The study comprises a 35-day Screening Period, a 24-week placebo-controlled double-blinded treatment period (Period A), a 28-week blinded extension treatment period (Period B), a 108-week blinded long-term extension period (Period C), and a 30-day follow-up period.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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)

300

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

  • 美国
    • California
      • Los Angeles、California、美国、90045
        • 招聘中
        • Dermatology Research Associates - Los Angeles /ID# 282821
    • Florida
      • Miami、Florida、美国、33156
        • 招聘中
        • Pediatric Skin Research - Miami /ID# 283281
    • Idaho
      • Meridian、Idaho、美国、83646
        • 招聘中
        • Ada West Research /ID# 283063
    • Indiana
      • Indianapolis、Indiana、美国、46250
        • 招聘中
        • Dawes Fretzin- Indianapolis /ID# 283498
    • Nebraska
      • Omaha、Nebraska、美国、68144
        • 招聘中
        • Skin Specialists /ID# 283358
    • Ohio
      • Fairborn、Ohio、美国、45324
        • 招聘中
        • Dermatologists of Southwestern Ohio (DSWO) /ID# 282818
    • Texas
      • El Paso、Texas、美国、79925
        • 招聘中
        • 3A Research - East location /ID# 283404
      • San Antonio、Texas、美国、78218
        • 招聘中
        • Texas Dermatology and Laser Specialists /ID# 282813

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

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • Participants must have a diagnosis of severe alopecia areata with SALT score >= 50 scalp hair loss at Screening and Baseline
  • No spontaneous scalp hair regrowth over the past 6 months
  • Participants will have current episode of alopecia areata of less than 8 years

Exclusion Criteria:

  • Participants must not have a current diagnosis of primarily diffuse type of alopecia areata
  • Participants must not have a diagnosis of other types of alopecia that would interfere with evaluation of alopecia areata, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater, traction alopecia, lichen planopilaris, discoid lupus, frontal fibrosing alopecia, central centrifugal cicatricial alopecia, folliculitis decalvans, trichotillomania, and telogen effluvium
  • Participants must not have a diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of alopecia areata, including but not limited to seborrheic dermatitis, scalp psoriasis, AD, and tinea capitis

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：Group 1A: Upadacitinib Dose 1
Participants will receive upadacitinib Dose 1 during Period A (Baseline to Week 24) and continue the same treatment through Period B (Week 24 to Week 52) and Period C (Week 52 to Week 160).
药品：乌帕替尼
口服
实验性的：Group 2A: Upadacitinib Dose 2
Participants will receive upadacitinib Dose 2 during Period A (Baseline to Week 24) and continue the same treatment through Period B (Week 24 to Week 52) and Period C (Week 52 to Week 160).
药品：乌帕替尼
口服
安慰剂比较：Group 3A: Matching Placebo
Participants will receive matching placebo during Period A (Baseline to Week 24). Participants achieving SALT score ≤ 20 at Week 24 will remain on placebo until SALT score > 20, then switch to blinded upadacitinib. Participants with SALT score > 20 at Week 24 will be re-randomized to upadacitinib Dose 1 or Dose 2.
药品：安慰剂
口服
实验性的：Group 1B: Upadacitinib Dose 1
Participants initially randomized to placebo in Period A with SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose 1 during Period B and continue through Period C.
药品：乌帕替尼
口服
实验性的：Group 2B: Upadacitinib Dose 2
Participants initially randomized to placebo in Period A with SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose 2 during Period B and continue through Period C.
药品：乌帕替尼
口服

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
Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20, defined as less than or equal to 20% scalp hair loss.
大体时间：At Week 24
The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
At Week 24
Number of Participants with Adverse Events (AEs)
大体时间：Up to Week 160
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to Week 160

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants Achieving SALT Score <= 10
大体时间：At Week 24
The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
At Week 24
Percentage of Participants Achieving SALT Score <= 20
大体时间：At Week 12
The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
At Week 12
Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1
大体时间：At Week 24
The ClinRO for Eyebrow Hair Loss is a 4-point response scale where 0 = The eyebrows have full coverage and no areas of hair loss and 3 = No notable eyebrows. Responses should have a ≥ 2-point improvement from Baseline among participants with Baseline score ≥ 2.
At Week 24
Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyelash Hair Loss of 0 or 1
大体时间：At Week 24
The ClinRO for Eyelash Hair Loss is a 4-point response scale where 0 = The eyelashes form a continuous line along the eyelids on both eyes and 3 = No notable eyelashes. Responses should have a ≥ 2-point improvement from Baseline among participants with Baseline score ≥ 2.
At Week 24
Percentage of Participants Achieving SALT Score 0
大体时间：AT Week 24
The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
AT Week 24
Percentage of Participants with the Achievement of Patients' Global Impression of Change of Alopecia Areata (PaGIC-AA) Score of 1 "Much Better" or 2 "Moderately Better" (in participants who are 12 years and older at the time of baseline visit)
大体时间：At Week 24
The PaGIC-AA is a single-item measure that asks participants to rate how their alopecia condition has changed overall since the start of the study using a 7-point scale. Responses range from "much better" to "much worse."
At Week 24
Percentage of Participants with the Achievement of Patients' Caregiver Global Impression of Change (CaGIC-AA) Score of 1 "Much Better" or 2 "Moderately Better" (In Participants 6-11 Years Old at the time of baseline visit)
大体时间：At Week 24
The CaGIC-AA is a single-item measure that asks care givers of participants to rate how their alopecia condition has changed overall since the start of the study using a 7-point scale. Responses range from "much better" to "much worse."
At Week 24
Percentage of Participants with a Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score (In Participants 12 Years and Older)
大体时间：Baseline (Week 0) through Week 24
The HADS is a self-administered scale which measures anxiety and depression. It contains 14 items and is comprised of anxiety (7 items) and depression (7 items) subscales, which are scored separately and summed to give a total score. Item scores range from 0 (best) to 3 (worst), and total scores are categorized as normal (0 to 7), borderline abnormal (8 to 10), and abnormal (11 to 21).
Baseline (Week 0) through Week 24
Percentage of Participants with a Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score
大体时间：Baseline (Week 0) through Week 24
The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatological disease symptoms and treatment on quality of life. The CDLQI has been validated for use in Participants 4 to 16 years of age. It consists of 10 questions assessing impact of skin diseases on different aspects of quality of life over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of quality of life.
Baseline (Week 0) through Week 24
Percentage of Participants with a Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Depressive Symptoms Short Form 6a Score (In Participants 6-11 Years Old)
大体时间：Baseline (Week 0) through Week 24
The PROMIS Parent Proxy Depressive Symptoms - SF6a is a caregiver report questionnaire designed to assess depressive symptoms in pediatric populations. It consists of 6 items that measure core aspects of mood, thoughts, and behaviors related to depression, as observed by the caregiver over the past 7 days. Caregivers are asked to rate each item using a 5-point Likert scale ranging from 'Never' to 'Almost Always'. Higher scores reflect greater severity of depressive symptoms.
Baseline (Week 0) through Week 24
Percentage of Participants with a Change From Baseline in PROMIS Pediatric Depressive Symptoms Short Form 8a Score (In Participants 12 Years and Older)
大体时间：Baseline (Week 0) through Week 24
The PROMIS Pediatric Depressive Symptoms - SF8a is a self-report questionnaire designed to assess depressive symptoms in pediatric populations. It consists of 8 items focused on core aspects of mood, thoughts, and behaviors related to depression. Respondents rate each item based on their experiences over the past 7 days using a 5-point Likert scale ranging from 'Never' to 'Almost Always'. Higher scores indicate greater severity of depressive symptoms
Baseline (Week 0) through Week 24
Percentage of Participants with a Change From Baseline in PROMIS Parent Proxy Anxiety Short Form 8a Score (In Participants 6-11 Years Old)
大体时间：Baseline (Week 0) through Week 24
The PROMIS Pediatric Anxiety - SF8a is a caregiver report questionnaire designed to assess anxiety symptoms in pediatric populations. It consists of 8 items that measure core aspects of worry, fear, and other anxiety-related feelings and behaviors as observed by the parent or caregiver. Each item item rated based on experiences over the past 7 days using a 5-point Likert scale ranging from 'Never' to 'Almost Always'. Higher scores reflect greater severity of anxiety symptoms
Baseline (Week 0) through Week 24
Percentage of Participants with a Change From Baseline in PROMIS Pediatric Anxiety Short Form 8a Score (In Participants 12 Years and Older)
大体时间：Baseline (Week 0) through Week 24
The PROMIS Pediatric Anxiety - SF8a is a self-report questionnaire designed to assess anxiety symptoms in pediatric populations. It consists of 8 items that measure core aspects of worry, fear, and other anxiety-related feelings and behaviors. Respondents rate each item based on their experiences over the past 7 days using a 5-point Likert scale ranging from 'Never' to 'Almost Always'. Higher scores reflect greater severity of anxiety symptoms
Baseline (Week 0) through Week 24

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

AbbVie

调查人员

  • 研究主任：ABBVIE INC.、AbbVie

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)

2026年8月24日

初级完成 (估计的)

2032年3月1日

研究完成 (估计的)

2032年3月1日

研究注册日期

首次提交

2026年8月11日

首先提交符合 QC 标准的

2026年8月13日

首次发布 (实际的)

2026年8月19日

研究记录更新

最后更新发布 (实际的)

2026年9月17日

上次提交的符合 QC 标准的更新

2026年9月15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

  • M24-725
  • 2025 (美国 NIH 拨款/合同：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-525048-16-00 (克蒂斯)

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

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD 共享时间框架

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD 共享访问标准

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD 共享支持信息类型

  • 研究方案
  • 树液

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

不

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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