NCT07013838

The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis

Comparison of Deucravacitinib and Adalimumab for the Treatment of Relapsed Takayasu's Arteritis: The TYK-TAK Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Chinese SLE Treatment And Research Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 24-week, single-center, randomized, open-label trial conducted by Peking Union Medical College Hospital. The aim of this study is to assess the efficacy and safety of deucravacitinib in adult patients with relapsing TAK in comparison to patients treated with TNF inhibitor (TNFi), the most well-recognized therapeutic choice of non-glucocorticoid immunosuppressive for patients with relapsed or refractory TAK.

Detailed description

Background: The majority of patients with TAK experience relapses, and some patients fail to respond adequately to current medications used for treatment of TAK. There is an urgent unmet need to identify novel therapies to effectively treat TAK. Th-17 and Th-1 cells, and their related cytokines IL-12, IL-23, IL-17, and type I interferon have all been reported to play a role in the pathogenesis of TAK. Tyrosine kinase 2 (TYK2) mediates signaling transduction between these key cytokines and immune cells. Therefore, blocking TYK2 signaling may downregulate potential pathogenic pathways in TAK, and may be a therapeutic alternative. No study has investigated the effectiveness of agents targeting TYK2 in the treatment of TAK so far. In the present study, we aim to investigate whether deucravacitinib, an oral, selective, allosteric inhibitor of TYK2, is effective and safe for patients with relapsed TAK. Objectives: To assess the efficacy and safety of deucravacitinib in adult patients with relapsing TAK in comparison to patients treated with TNF inhibitor (TNFi), the most well-recognized therapeutic choice of non-glucocorticoid immunosuppressive for patients with relapsed or refractory TAK. Overall Design: This is a 24-week, single-center, randomized, open-label trial conducted by Peking Union Medical College Hospital. Patients enrolled into the study are randomly assigned (in a 1:1 ratio, 25 patients in each group) to receive deucravacitinib or adalimumab (a TNFi). Patients are followed for efficacy and safety at month 1, month 3, and month 6. Adverse events/Serious adverse events are assessed and recorded at each visit.

Conditions

• Takayasu Arteritis (TAK)

Interventions

Type	Name	Description
DRUG	Deucravacitinib	Deucravacitinib is a new, oral, selective, allosteric inhibitor of TYK2. It was first approved in the United States on 09-Sep-2022 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
DRUG	Adalimumab	TNFα inhibitors have already been used in TAK treatment. Several retrospective studies have demonstrated the treatment effects of these agents in patients with TAK, including disease remission, GC tapering and vascular inflammation control. According to the ACR and EULAR guidelines, TNFis are recommended to be considered in cases of relapsing or refractory TAK. These agents (including adalimumab) are the most frequently analyzed therapeutic modalities in recent studies of TAK.

Timeline

• Start date: 2025-06-15
• Primary completion: 2027-12-31
• Completion: 2028-03-31
• First posted: 2025-06-10
• Last updated: 2025-06-10

Locations

1 site across 1 country: China