A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)
- Conditions
- Takayasu Arteritis (TAK)
- Interventions
- Registration Number
- NCT04161898
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 56
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2: Placebo for Upadacitinib Placebo for Upadacitinib Participants will be administered placebo once daily (QD) along with prednisolone. Arm 2: Placebo for Upadacitinib Prednisolone Participants will be administered placebo once daily (QD) along with prednisolone. Arm 1: Upadacitinib Upadacitinib Participants will be administered updadacitinib once daily (QD) along with prednisolone. Arm 1: Upadacitinib Prednisolone Participants will be administered updadacitinib once daily (QD) along with prednisolone. Arm 2: Placebo for Upadacitinib Upadacitinib Participants will be administered placebo once daily (QD) along with prednisolone.
- Primary Outcome Measures
Name Time Method Time to First Relapse of Takayasu Arteritis (TAK) From Baseline through End of the Double-Blind (DB) Period Up to occurrence of 40 events (approximately 52 months) 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.
- Secondary Outcome Measures
Name Time Method Time to First Relapse of Takayasu Arteritis (TAK) by Kerr Criteria From Baseline through End of the DB Period Up to occurrence of 40 events (approximately 52 months) 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 to Worsening of Imaging Assessment Due to Takayasu Arteritis (TAK) From Baseline through End of the DB Period Up to occurrence of 40 events (approximately 52 months) Imaging with computed tomography angiogram (CTA).
Trial Locations
- Locations (48)
Fundación Sanatorio Guemes /ID# 249675
🇦🇷Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Duplicate_Hokkaido University Hospital /ID# 215066
🇯🇵Sapporo-shi, Hokkaido, Japan
St Marianna University School Of Medicine /ID# 214535
🇯🇵Kawasaki-shi, Kanagawa, Japan
Duplicate_Kyoto University Hospital /ID# 215128
🇯🇵Kyoto-shi, Kyoto, Japan
Duplicate_Nagasaki University Hospital /ID# 215683
🇯🇵Nagasaki-shi, Nagasaki, Japan
Duplicate_Keio University Hospital /ID# 214905
🇯🇵Shinjuku-ku, Tokyo, Japan
Duplicate_Tokyo Women's Medical University Hospital /ID# 215129
🇯🇵Shinjuku-ku, Tokyo, Japan
Hospital Italiano La Plata /ID# 249269
🇦🇷La Plata, Buenos Aires, Argentina
SER - Servicos Especializados em Reumatologia da Bahia /ID# 243125
🇧🇷Salvador, Bahia, Brazil
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 242517
🇧🇷Juiz de Fora, Minas Gerais, Brazil
Scroll for more (38 remaining)Fundación Sanatorio Guemes /ID# 249675🇦🇷Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina