The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis

Sponsor
Chinese SLE Treatment And Research Group
Study ID
NCT07013838
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Takayasu Arteritis (TAK)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Deucravacitinib — DRUG
    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.
  • Adalimumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 15, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Deucravacitinib treatment group
    Patients randomly assigned to the deucravacitinib treatment group are required to take the deucravacitinib tablets 6mg orally once daily on an empty stomach or after a meal during D1-D168, and orally take the study drug deucravacitinib with warm water. It is forbidden to drink water from 1 h before administration to 1 h after administration (except for administration of water) and fasting within 1 h after administration. Continuous treatment for 168 days or subject discontinuation criteria were met. The time of dose administration is called "0" hour. Subjects who miss a study medication on one day are not allowed to take a supplement to compensate but should take the next dose.
  • Active Comparator: Adalimumab treatment group
    Participants assigned to the adalimumab treatment group receive adalimumab 40mg by subcutaneous injection every 2 weeks during D1-D168. Adalimumab is administered for 24 weeks unless the discontinuation criteria are met.

Primary Outcome Measure

Overall response rate at week 24 [ Time Frame: Week 24 ]

Central Contacts

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