Efficacy and Safety of Vunakizumab and Ivarmacitinib in the Treatment of Active Takayasu's Arteritis
VIVA-TAK
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
1 other identifier
interventional
180
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2026
Typical duration for phase_4
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2026
CompletedFirst Posted
Study publicly available on registry
March 5, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
March 5, 2026
February 1, 2026
3 years
February 28, 2026
February 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete response rate at week 52
Percentage of patients with complete response at week 52
week 52
Secondary Outcomes (6)
Complete response at week 26
week 26
Combined response rate of vunakizumab at week 26 and week 52
week 26 and week 52
Combined response rate of ivarmacitinib at week 26 and week 52
week 26 and week 52
Time to relapse
week 52
Time to event
week 52
- +1 more secondary outcomes
Study Arms (3)
Vunakizumab group (Group Vuna I)
EXPERIMENTALVanakizumab 240mg each 4 weeks subcutaneously (with an additional infection at day 15) for 52 weeks combined with glucocorticoid taken daily according to preset tapering protocol during same period
Ivarmacitinib group (Group Iva I)
EXPERIMENTALIvarmacitinib 8mg daily taken orally for 52 weeks combined with glucocorticoid taken daily according to preset tapering protocol during same period
Prednisone group (Group Pred)
ACTIVE COMPARATORPrednisone taken daily according to preset tapering protocol for 52 weeks
Interventions
Vanakizumab 240mg each 4 weeks taken subcutaneously with an additional injection at day 15
Prednisone taken daily according to preset tapering protocol
Eligibility Criteria
You may qualify if:
- 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.
- Patient is considered to have active disease by the investigator is the patients meets at least two of the following three criteria: i) one or more clinical manifestations determined by the investigator to be due to active TAK; ii) one or more findings on imaging of progressive disease; or iii) elevated erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). Clinical criteria included constitutional symptoms (fever, fatigue, and weight loss), musculoskeletal symptoms, vascular pain, neurological or visual symptoms, abdominal pain or angina, new or worsening limb claudication, loss of pulses, and worsening hypertension. Imaging criteria includes new vascular stenosis or aneurysms detected by ultrasound, computed tomography angiography (CTA), or magnetic resonance angiography.
You may not qualify if:
- Participants are excluded from the study if any of the following criteria apply:
- 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
- Active tuberculosis (Patients with latent tuberculosis infection could be enrolled with preventive therapy for tuberculosis flare)
- Malignancy in the past 5 years (with the exception of fully excised non-melanoma skin cancer or cervical carcinoma in situ)
- Poorly controlled diabetes
- Patients with history of venous thrombosis
- Upper GI bleeding within 3 months prior to enrollment
- Uncontrolled heart failure
- Refractory hypertension
- Abnormal Laboratory Test Findings k. Serum liver enzyme elevation 3 times higher than the upper limits of normal range l. Severe renal function impairment with estimated glomerular filtration rate ≤ 30 ml/minute/1.73 m2, calculated using the Modification of Diet in Renal Disease equation (doi:10.1056/NEJMoa2102953)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Beijing Anzhen Hospital Capital Medical University
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Sun Yat-sen University
Guanzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Jiaozuo People's Hospital
Jiaozuo, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Ch’ang-ch’un, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Neimenggu, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Neimenggu, China
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
The First Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xinping TIAN, M.D.
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2026
First Posted
March 5, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
March 31, 2029
Study Completion (Estimated)
March 31, 2029
Last Updated
March 5, 2026
Record last verified: 2026-02