A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)

Study Identifier
M19-052
CT.gov Identifier
NCT04161898
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Takayasu arteritis
    • Study Drug
  • Upadacitinib
  • Placebo for Upadacitinib
  • Prednisolone
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    15+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants must be at least 18 years of age (at least 15 years of age in Japan) * Clinical diagnosis of TAK and fulfilling the Japanese Guidelines for Management of Vasculitis Syndrome 2017 criteria. * Participant must have experienced a relapse of TAK within 12 weeks of Baseline despite being on treatment with oral corticosteroid. * Participants must be in remission and on a stable corticosteroid dose prior to Baseline.
    Exclusion Criteria:
    * Treatment with an interleukin-6 (IL-6) inhibitor or Janus Kinase (JAK) inhibitor (including but not limited to tocilizumab, sirukumab, sarilumab, upadacitinib, tofacitinib, baricitinib, ruxolitinib, peficitinib, and filgotinib) within 4 weeks of Baseline. * Current use of immunomodulators other than corticosteroids.

    Protocol Summary

    The main objective of this study is to evaluate the efficacy of upadacitinib in combination with a corticosteroid taper regimen compared to placebo in combination with a corticosteroid taper regimen.

    Study Locations

    Location
    Status
    Location
    Fundación Sanatorio Guemes /ID# 249675
    Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1180
    Status
    Not applicable
    Location
    Hospital Italiano La Plata /ID# 249269
    La Plata, Buenos Aires, Argentina, 1900
    Status
    Not applicable
    Location
    SER - Servicos Especializados em Reumatologia da Bahia /ID# 243125
    Salvador, Estado de Bahia, Brazil, 40150-150
    Status
    Not applicable
    Location
    CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 242517
    Juiz de Fora, Minas Gerais, Brazil, 36010-570
    Status
    Not applicable
    Location
    CETI - Centro de Estudos em Terapias Inovadoras /ID# 242502
    Curitiba, Paraná, Brazil, 80030-110
    Status
    Not applicable
    Location
    LMK Sevicos Medicos S/S /ID# 240645
    Porto Alegre, Rio Grande Do Sul, Brazil, 90480-000
    Status
    Not applicable
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