NCT07451665

Efficacy and Safety of Vunakizumab and Ivarmacitinib in the Treatment of Active Takayasu's Arteritis

A Prospective, Open-label, Controlled, Multiple Centers Clinical Study of the Efficacy and Safety for Vunakizumab and Ivarmacitinib in the Treatment of Active Takayasu's Arteritis (TAK): The VIVA-TAK Ttrial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Chinese SLE Treatment And Research Group · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label, controlled, multiple centers, randonmized clinical trial. It compares the clinical efficacy and safety of vunakizumab ivarmacitinib and glucocorticoids in the treatment of active Takayasu's arteritis.

Detailed description

In this study, 180 Takayasu's arteritis patients with active disease will be enrolled. Patients are randomized in to the vunakizumab treatment group, ivarmacitinib treatment group and glucocorticoid treatment group. Patients will follow the same reduction steps for glucocorticoids. The primary endpoint is the percentage of patients who are in complete response at week 52. The efficacy will be evaluated at week 4, 12, 26, 38 and 52. Safety is also monitored during the study.

Conditions

• Takayasu Arteritis (TAK)

Interventions

Type	Name	Description
DRUG	Vanakizumab	Vanakizumab 240mg each 4 weeks taken subcutaneously with an additional injection at day 15
DRUG	Ivarmacitinib	Ivarmacitinib 8mg daily taken orally
DRUG	Prednisone	Prednisone taken daily according to preset tapering protocol

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-03-31
• Completion: 2029-03-31
• First posted: 2026-03-05
• Last updated: 2026-03-05

Locations

20 sites across 1 country: China