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

15. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

300

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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).
Lék: Upadacitinib
Perorální
Experimentální: 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).
Lék: Upadacitinib
Perorální
Komparátor placeba: 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.
Lék: Placebo
Ústní
Experimentální: 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.
Lék: Upadacitinib
Perorální
Experimentální: 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.
Lék: Upadacitinib
Perorální

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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.
Časové okno: 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)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants Achieving SALT Score <= 10
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

AbbVie

Vyšetřovatelé

  • Ředitel studie: ABBVIE INC., AbbVie

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

24. srpna 2026

Primární dokončení (Odhadovaný)

1. března 2032

Dokončení studie (Odhadovaný)

1. března 2032

Termíny zápisu do studia

První předloženo

11. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

13. srpna 2026

První zveřejněno (Aktuální)

19. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • M24-725
  • 2025 (Grant/smlouva NIH USA: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-525048-16-00 (Ctis)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Časový rámec sdílení IPD

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

Kritéria přístupu pro sdílení IPD

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

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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