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

Starting soon · Phase 4

Conditions studied: Takayasu Arteritis (TAK)

In brief

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.

Key facts

Study ID

NCT07451665

Run by

Chinese SLE Treatment And Research Group

People needed

180

Starts

2026-04-01

Expected to finish

2029-03-31

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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)
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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