Takayasu Arteritis (TAK)
Conditions
Keywords
Takayasu Arteritis (TAK), Upadacitinib, Placebo, Corticosteroid, Prednisolone
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.
Interventions
DRUGUpadacitinib
Upadacitinib will be administered as oral tablet
Placebo for upadacitinib will be administered as oral tablet
DRUGPrednisolone
Prednisolone will be administered as oral tablet
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of Participants with Adverse Events (AEs) | Up to approximately 58 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Argentina, Brazil, China, Japan, South Korea, Turkey (Türkiye)
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed