A Study to Evaluate the Safety and Effectiveness of Upadacitinib in Pediatric Participants With Alopecia Areata
15 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
300
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: ABBVIE CALL CENTER
- Número de telefone: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 90045
- Recrutamento
- Dermatology Research Associates - Los Angeles /ID# 282821
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Florida
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Miami, Florida, Estados Unidos, 33156
- Recrutamento
- Pediatric Skin Research - Miami /ID# 283281
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Idaho
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Meridian, Idaho, Estados Unidos, 83646
- Recrutamento
- Ada West Research /ID# 283063
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46250
- Recrutamento
- Dawes Fretzin- Indianapolis /ID# 283498
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68144
- Recrutamento
- Skin Specialists /ID# 283358
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Ohio
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Fairborn, Ohio, Estados Unidos, 45324
- Recrutamento
- Dermatologists of Southwestern Ohio (DSWO) /ID# 282818
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Texas
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El Paso, Texas, Estados Unidos, 79925
- Recrutamento
- 3A Research - East location /ID# 283404
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San Antonio, Texas, Estados Unidos, 78218
- Recrutamento
- Texas Dermatology and Laser Specialists /ID# 282813
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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).
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Oral
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Experimental: 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).
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Oral
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Comparador de Placebo: 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.
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Oral
|
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Experimental: 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.
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Oral
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Experimental: 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.
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Oral
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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.
Prazo: 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%.
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At Week 24
|
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Number of Participants with Adverse Events (AEs)
Prazo: 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.
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Up to Week 160
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants Achieving SALT Score <= 10
Prazo: 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%.
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At Week 24
|
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Percentage of Participants Achieving SALT Score <= 20
Prazo: 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%.
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At Week 12
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Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1
Prazo: 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.
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At Week 24
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Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyelash Hair Loss of 0 or 1
Prazo: 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.
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At Week 24
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Percentage of Participants Achieving SALT Score 0
Prazo: 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%.
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AT Week 24
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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)
Prazo: 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."
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At Week 24
|
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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)
Prazo: 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."
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At Week 24
|
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Percentage of Participants with a Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score (In Participants 12 Years and Older)
Prazo: 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
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Percentage of Participants with a Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score
Prazo: 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.
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Baseline (Week 0) through Week 24
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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)
Prazo: 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.
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Baseline (Week 0) through Week 24
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Percentage of Participants with a Change From Baseline in PROMIS Pediatric Depressive Symptoms Short Form 8a Score (In Participants 12 Years and Older)
Prazo: 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
|
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Percentage of Participants with a Change From Baseline in PROMIS Parent Proxy Anxiety Short Form 8a Score (In Participants 6-11 Years Old)
Prazo: 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
|
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Percentage of Participants with a Change From Baseline in PROMIS Pediatric Anxiety Short Form 8a Score (In Participants 12 Years and Older)
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: ABBVIE INC., AbbVie
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
24 de agosto de 2026
Conclusão Primária (Estimado)
1 de março de 2032
Conclusão do estudo (Estimado)
1 de março de 2032
Datas de inscrição no estudo
Enviado pela primeira vez
11 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de agosto de 2026
Primeira postagem (Real)
19 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- M24-725
- 2025 (Concessão/Contrato do NIH dos EUA: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-525048-16-00 (Ctis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
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.
Prazo de Compartilhamento de IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Critérios de acesso de compartilhamento IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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