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

Phase 3Active Not RecruitingNCT04161898

AbbVie56 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Takayasu Arteritis (TAK)

Interventions

UpadacitinibDRUG

Upadacitinib will be administered as oral tablet

Placebo for UpadacitinibDRUG

Placebo for upadacitinib will be administered as oral tablet

PrednisoloneDRUG

Prednisolone will be administered as oral tablet

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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.

Locations (48)

Outcomes

Primary Outcomes

Time to First Relapse of Takayasu Arteritis (TAK) From Baseline through End of the Double-Blind (DB) Period

Relapse of TAK is defined as the presence of signs or symptoms as judged by the investigator for at least 2 of the following categories: objective systemic symptoms, subjective systemic symptoms, elevated inflammation markers, vascular signs and symptoms, or ischemic symptoms OR where the criteria are met based on one category per protocol definition of relapse of TAK.

Time frame: Up to occurrence of 40 events (approximately 52 months)

Secondary Outcomes

Time to First Relapse of Takayasu Arteritis (TAK) by Kerr Criteria From Baseline through End of the DB Period

Kerr criteria for relapse are defined as the presence of signs or symptoms as judged by the investigator for at least 2 of the following categories: objective or subjective systemic symptoms, elevated inflammation markers, vascular or ischemic signs and symptoms, or worsening in imaging assessment due to TAK.

Time frame: Up to occurrence of 40 events (approximately 52 months)

Time to Worsening of Imaging Assessment Due to Takayasu Arteritis (TAK) From Baseline through End of the DB Period

Imaging with computed tomography angiogram (CTA).

Time frame: Up to occurrence of 40 events (approximately 52 months)

Data from ClinicalTrials.gov

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Fundación Sanatorio Guemes /ID# 249675

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Hospital Italiano La Plata /ID# 249269

La Plata, Buenos Aires, Argentina

SER - Servicos Especializados em Reumatologia da Bahia /ID# 243125

Salvador, Estado de Bahia, Brazil

CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 242517

Juiz de Fora, Minas Gerais, Brazil

CETI - Centro de Estudos em Terapias Inovadoras /ID# 242502

Curitiba, Paraná, Brazil

LMK Sevicos Medicos S/S /ID# 240645

Porto Alegre, Rio Grande do Sul, Brazil

Hospital do Rim /ID# 240380

São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 241175

São Paulo, Brazil

Xuanwu Hospital Capital Medical University /ID# 248104

Beijing, Beijing Municipality, China

Guangdong Provincial People's Hospital /ID# 248350

Guangzhou, Guangdong, China

...and 38 more locations