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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChinese SLE Treatment And Research Group

About this trial

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.

Eligibility criteria

Qualifiers

a. Adult patients (aged between 18-70 years) fulfilling the 2022 ACR/EULAR classification criteria for TAK with new-onset or relapsing disease.

b. Presence of active disease despite treatment with gluccorticoids combined with a conventional synthetic or biologic immunosuppressive agent other than JAK inhibitors and IL-17 inhibitors, including new-onset patients and relapsed patients.

Disqualifiers

Medical Conditions

Severe disease from TAK for which urgent treatment with interventional vascular procedures or bypass surgery is considered necessary

Critical organ involvement of TAK, such as myocardial or coronary artery involvement, or cerebral ischemia, that is anticipated to need treatment during the study

Active hepatitis B or C virus infection

Trial design

Treatments tested in this trial

  • Vanakizumab
  • Ivarmacitinib
  • Prednisone

Treatment groups

180 Participants
are divided into 3 treatment groups

Locations

20
Beijing Anzhen Hospital Capital Medical University BeijingBeijing Municipality, China
Peking Union Medical College Hospital BeijingBeijing Municipality, China
Xuanwu Hospital Capital Medical University BeijingBeijing Municipality, China
The First Affiliated Hospital of Sun Yat-sen University GuanzhouGuangdong, China

Sponsors and collaborators

Chinese SLE Treatment And Research Group

Lead sponsor