Takayasu Arteritis (TAK)Phase 4VIVA-TAKNCT07451665
Efficacy and Safety of Vunakizumab and Ivarmacitinib in the Treatment of Active Takayasu's Arteritis
A Phase 4 study testing Vanakizumab, Ivarmacitinib and Prednisone in people with Takayasu Arteritis (TAK), run by Chinese SLE Treatment And Research Group at 20 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Takayasu Arteritis (TAK)
- What is being tested?
- Vanakizumab, Ivarmacitinib and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 20 sitesChina
- Study dates
- 1 Apr 2026to 31 Mar 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 14Show fewer
- 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)
- 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
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
China20 sites
The First Affiliated Hospital of Baotou Medical College
Baotou, Neimenggu
Yongfu WANG, M.D., +86-18686198868, wyf18686198868@163.com
Yongfu WANG, M.D.
Beijing Anzhen Hospital Capital Medical University
Beijing, Beijing Municipality
Lili PAN, M.D., +86-13720021786, lilypansxmu@sina.com
Lili PAN, M.D.
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality
Yi ZHAO, M.D., +86-13811038669, zy85070@xwhosp.org
Yi ZHAO, M.D.
The First Hospital of Jilin University
Ch’ang-ch’un, Jilin
Zhenyu JIANG, M.D., +86-15843079623, jlujzy@aliyun.com
Zhenyu JIANG, M.D.
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Jing ZHU, M.D., +86-18981838317, zhujingys@sina.com
Jing ZHU, M.D.
The First Affiliated Hospital of Sun Yat-sen University
Guanzhou, Guangdong
Yujin YE, M.D., +86-13600490868, yeyujin@mail.sysu.edu.cn
Yunjin YE, M.D.
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jing XUE, M.D., +86-13858121751, jingxue@zju.edu.cn
Jing XUE, M.D.
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Neimenggu
Hongbin LI, M.D., +86-13948536552, lhbwb73@gmail.com
Hongbin LI, M.D.
Jiaozuo People's Hospital
Jiaozuo, Henan
Dongyun YAO, M.D., +86-13939199823, yaodongyun88@163.com
Dongyun YAO, M.D.
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Xiaofei SHI, M.D., +86-13663884080, sxf0379@126.com
Xiaofei SHI, M.D.
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Xinwang DUAN, M.D., +86-13970085678, 13970085678@163.com
Xinwang DUAN, M.D.
Jiangsu Province Hospital
Nanjing, Jiangsu
Yanyan WANG, M.D., +86-13813892892, yongchy@sina.com
Yanyan WANG, M.D.
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
Hanyou MO, M.D., +86-13707730655, 419459292@qq.com
Hanyou MO, M.D.
The First Hospital of China Medical University
Shenyang, Liaoning
Chunling WU, M.D., +86-13889116542, wuhuaguo7712@aliyun.com
Chunling WU, M.D.
Shenzhen People's Hospital
Shenzhen, Guangdong
Dongzhou LIU, M.D., +86-13802257360, liu_dz2001@sina.com
Dongzhou LIU, M.D.
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang
Kuerbanjiang Yimaiti, M.D., +86-13999832117, kuerbanjiang211@qq.com
Kuerbanjiang Yimaiti, M.D.
The First Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Li LU, M.D., +86-13999868690, luoli.6@163.com
Li LU, M.D.
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
Xiaojing LIU, M.D., +86-13072799445, xiaojing6163@163.com
Xiaojing LIU, M.D.
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia
Donggeng GUO, M.D., +86-15769509687, guodonggeng@126.com
Donggeng GUO, M.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Takayasu Arteritis (TAK)
- Being tested
- Vanakizumab, Ivarmacitinib, Prednisone
- Keywords
- Vunakizumab, Ivarmacitinib, randomized controlled trial
- Medical subject headings
- Takayasu Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VanakizumabDrug
Vanakizumab 240mg each 4 weeks taken subcutaneously with an additional injection at day 15
IvarmacitinibDrug
Ivarmacitinib 8mg daily taken orally
PrednisoneDrug
Prednisone taken daily according to preset tapering protocol
| Study group | Role | What they receive |
|---|---|---|
| Vunakizumab group (Group Vuna I) | Experimental | 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 Receives: Drug: Vanakizumab; Drug: Prednisone |
| Ivarmacitinib group (Group Iva I) | Experimental | Ivarmacitinib 8mg daily taken orally for 52 weeks combined with glucocorticoid taken daily according to preset tapering protocol during same period Receives: Drug: Ivarmacitinib; Drug: Prednisone |
| Prednisone group (Group Pred) | Active comparator | Prednisone taken daily according to preset tapering protocol for 52 weeks Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate at week 52
Percentage of patients with complete response at week 52
Measured: week 52
Secondary outcomes (6)
Complete response at week 26
Percentage of patients with complete response at week 26
Measured: week 26
Combined response rate of vunakizumab at week 26 and week 52
Percentage of patients with response treated with vunakizumab at week 26 and week 52
Measured: week 26 and week 52
Combined response rate of ivarmacitinib at week 26 and week 52
Percentage of patients with response treated with ivarmacitinib at week 26 and week 52
Measured: week 26 and week 52
Time to relapse
Time to relapse in each treatment group
Measured: week 52
Time to event
Time to event (including relapse, discontinuation due to AE/SAE, treatment failure)
Measured: week 52
Patient-Reported Outcomes
The comparison of PtGA and PhGA in each individual during the treatment in each group
Measured: week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takayasu Arteritis (TAK)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinping TIAN, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451665
- Sponsor's protocol ID
- VIVA-TAK
- Acronym
- VIVA-TAK
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07451665
- Acronym / sponsor ID
- VIVA-TAK / VIVA-TAK
- Conditions
- Takayasu Arteritis (TAK)
- Keywords
- Vunakizumab, Ivarmacitinib, randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chinese SLE Treatment And Research GroupUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vunakizumab group (Group Vuna I) | Experimental | Drug: Vanakizumab, Drug: PrednisoneVanakizumab 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) | Experimental | Drug: Ivarmacitinib, Drug: PrednisoneIvarmacitinib 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 comparator | Drug: PrednisonePrednisone taken daily according to preset tapering protocol for 52 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- Participants are excluded from the study if any of the following criteria apply:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VanakizumabVanakizumab 240mg each 4 weeks taken subcutaneously with an additional injection at day 15 | Drug | Vunakizumab group (Group Vuna I) |
| IvarmacitinibIvarmacitinib 8mg daily taken orally | Drug | Ivarmacitinib group (Group Iva I) |
| PrednisonePrednisone taken daily according to preset tapering protocol | Drug | Ivarmacitinib group (Group Iva I), Prednisone group (Group Pred), Vunakizumab group (Group Vuna I) |
Primary outcome
Complete response rate at week 52
Time frame: week 52
Percentage of patients with complete response at week 52
6 secondary outcomes
Complete response at week 26
Time frame: week 26
Combined response rate of vunakizumab at week 26 and week 52
Time frame: week 26 and week 52
Combined response rate of ivarmacitinib at week 26 and week 52
Time frame: week 26 and week 52
Time to relapse
Time frame: week 52
Time to event
Time frame: week 52
Patient-Reported Outcomes
Time frame: week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Takayasu Arteritis (TAK)
Not yet recruitingObservational study
Monitoring Disease Activity in Patients With Takayasu Arteritis With the OMERACT Takayasu Ultrasound Score (OTUS)
Takayasu Arteritis (TAK)
RecruitingObservational study
Global Initiative on Takayasu Arteritis (GITA)
Takayasu Arteritis (TAK), Takayasu's Arteritis
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)
Takayasu Arteritis (TAK)
RecruitingObservational study
Vasculitis Pregnancy Registry
Vasculitis, Behcet's Disease
RecruitingObservational study
VCRC Tissue Repository
Aortitis, Cutaneous Vasculitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinping TIAN, M.D. principal investigator
Peking Union Medical College Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vanakizumab, Ivarmacitinib and Prednisone in people with Takayasu Arteritis (TAK), run by Chinese SLE Treatment And Research Group at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinping TIAN, M.D. (+86-13691165939, tianxp6@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate at week 52 (time frame: week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.