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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Takayasu Arteritis (TAK)

Intervention / Treatment
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* Drug: Upadacitinib
* Drug: Placebo for Upadacitinib
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Upadacitinib<br>Participants will be administered updadacitinib once daily (QD) along with prednisolone. | Drug: Upadacitinib<br>* Upadacitinib will be administered as oral tablet<br>* Other names: RINVOQ;Drug: Prednisolone<br>* Prednisolone will be administered as oral tablet<br>|
| Experimental: Arm 2: Placebo for Upadacitinib<br>Participants will be administered placebo once daily (QD) along with prednisolone. | Drug: Upadacitinib<br>* Upadacitinib will be administered as oral tablet<br>* Other names: RINVOQ;Drug: Placebo for Upadacitinib<br>* Placebo for upadacitinib will be administered as oral tablet<br>Drug: Prednisolone<br>* Prednisolone will be administered as oral tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to occurrence of 40 events (approximately 52 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | Up to occurrence of 40 events (approximately 52 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Takayasu Arteritis (TAK), Upadacitinib, Placebo, Corticosteroid, Prednisolone