Efficacy and Safety of Vunakizumab and Ivarmacitinib in the Treatment of Active Takayasu's Arteritis (VIVA-TAK)

February 28, 2026 updated by: Chinese SLE Treatment And Research Group

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xinping TIAN, M.D.
  • Phone Number: +86-13691165939
  • Email: tianxp6@126.com

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Peking Union Medical College Hospital
      • Beijing, Beijing Municipality, China
        • Xuanwu Hospital Capital Medical University
        • Contact:
        • Principal Investigator:
          • Yi ZHAO, M.D.
      • Beijing, Beijing Municipality, China
        • Beijing Anzhen Hospital Capital Medical University
        • Contact:
        • Principal Investigator:
          • Lili PAN, M.D.
    • Guangdong
      • Guanzhou, Guangdong, China
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Yunjin YE, M.D.
      • Shenzhen, Guangdong, China
        • Shenzhen People's Hospital
        • Principal Investigator:
          • Dongzhou LIU, M.D.
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China
        • People's Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
        • Principal Investigator:
          • Hanyou MO, M.D.
    • Henan
      • Jiaozuo, Henan, China
        • Jiaozuo People's Hospital
        • Contact:
        • Principal Investigator:
          • Dongyun YAO, M.D.
      • Luoyang, Henan, China
        • The First Affiliated Hospital of Henan University of Science And Technology
        • Contact:
        • Principal Investigator:
          • Xiaofei SHI, M.D.
    • Hubei
      • Wuhan, Hubei, China
        • Union Hospital Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Xiaojing LIU, M.D.
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
        • Contact:
        • Principal Investigator:
          • Yanyan WANG, M.D.
    • Jiangxi
      • Nanchang, Jiangxi, China
        • The Second Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Xinwang DUAN, M.D.
        • Contact:
    • Jilin
      • Ch’ang-ch’un, Jilin, China
        • The First Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • Zhenyu JIANG, M.D.
    • Liaoning
      • Shenyang, Liaoning, China
        • The First Hospital of China Medical University
        • Contact:
        • Principal Investigator:
          • Chunling WU, M.D.
    • Neimenggu
      • Baotou, Neimenggu, China
        • The First Affiliated Hospital of Baotou Medical College
        • Contact:
        • Principal Investigator:
          • Yongfu WANG, M.D.
      • Hohhot, Neimenggu, China
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Principal Investigator:
          • Hongbin LI, M.D.
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China
        • People's Hospital of Ningxia Hui Autonomous Region
        • Contact:
        • Principal Investigator:
          • Donggeng GUO, M.D.
    • Sichuan
      • Chengdu, Sichuan, China
        • Sichuan Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Jing ZHU, M.D.
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • The First Hospital of Xinjiang Medical University
        • Contact:
        • Principal Investigator:
          • Li LU, M.D.
      • Ürümqi, Xinjiang, China
        • People's Hospital of Xinjiang Uygur Autonomous Region
        • Contact:
        • Principal Investigator:
          • Kuerbanjiang Yimaiti, M.D.
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Principal Investigator:
          • Jing XUE, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Participants are excluded from the study if any of the following criteria apply:

    1. Medical Conditions

      1. Severe disease from TAK for which urgent treatment with interventional vascular procedures or bypass surgery is considered necessary
      2. Critical organ involvement of TAK, such as myocardial or coronary artery involvement, or cerebral ischemia, that is anticipated to need treatment during the study
      3. Active hepatitis B or C virus infection
      4. Active tuberculosis (Patients with latent tuberculosis infection could be enrolled with preventive therapy for tuberculosis flare)
      5. Malignancy in the past 5 years (with the exception of fully excised non-melanoma skin cancer or cervical carcinoma in situ)
      6. Poorly controlled diabetes
      7. Patients with history of venous thrombosis
      8. Upper GI bleeding within 3 months prior to enrollment
      9. Uncontrolled heart failure
      10. Refractory hypertension
    2. 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)
    3. Other Exclusion Criteria m. Females who are pregnant or intend to be pregnant during the time frame of the study n. History of treatment with JAKi or IL-17i. o. Any other medical, psychiatric, and/or social reason as determined by the investigator to be a contraindication for study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vunakizumab group (Group Vuna I)
Vanakizumab 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
Drug: Vanakizumab
Vanakizumab 240mg each 4 weeks taken subcutaneously with an additional injection at day 15
Drug: Prednisone
Prednisone taken daily according to preset tapering protocol
Experimental: Ivarmacitinib group (Group Iva I)
Ivarmacitinib 8mg daily taken orally for 52 weeks combined with glucocorticoid taken daily according to preset tapering protocol during same period
Drug: Prednisone
Prednisone taken daily according to preset tapering protocol
Drug: Ivarmacitinib
Ivarmacitinib 8mg daily taken orally
Active Comparator: Prednisone group (Group Pred)
Prednisone taken daily according to preset tapering protocol for 52 weeks
Drug: Prednisone
Prednisone taken daily according to preset tapering protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate at week 52
Time Frame: week 52
Percentage of patients with complete response at week 52
week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response at week 26
Time Frame: week 26
Percentage of patients with complete response at week 26
week 26
Combined response rate of vunakizumab at week 26 and week 52
Time Frame: week 26 and week 52
Percentage of patients with response treated with vunakizumab at week 26 and week 52
week 26 and week 52
Combined response rate of ivarmacitinib at week 26 and week 52
Time Frame: week 26 and week 52
Percentage of patients with response treated with ivarmacitinib at week 26 and week 52
week 26 and week 52
Time to relapse
Time Frame: week 52
Time to relapse in each treatment group
week 52
Time to event
Time Frame: week 52
Time to event (including relapse, discontinuation due to AE/SAE, treatment failure)
week 52
Patient-Reported Outcomes
Time Frame: week 52
The comparison of PtGA and PhGA in each individual during the treatment in each group
week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese SLE Treatment And Research Group

Investigators

  • Principal Investigator: Xinping TIAN, M.D., Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

February 28, 2026

First Submitted That Met QC Criteria

February 28, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIVA-TAK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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