A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-Takayasu)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04161898Tipo: INTERVENTIONALInicio: 4 de feb de 2020Fin estimado: 1 de ago de 2028

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 15 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Upadacitinib

Upadacitinib will be administered as oral tablet

drug

Placebo for Upadacitinib

Placebo for upadacitinib will be administered as oral tablet

drug

Prednisolone

Prednisolone will be administered as oral tablet

Ubicaciones

Fundación Sanatorio Guemes /ID# 249675

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Hospital Italiano La Plata /ID# 249269

La Plata, Buenos Aires, Argentina

Patrocinadores

PrincipalAbbVie

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