Vanakizumab: Vanakizumab 240mg each 4 weeks taken subcutaneously with an additional injection at day 15
Ivarmacitinib: Ivarmacitinib 8mg daily taken orally
Prednisone: Prednisone taken daily according to preset tapering protocol
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Complete response rate at week 52 — week 52 Percentage of patients with complete response at week 52
Trial sites (20)
Facility
City
Region
Status
Beijing Anzhen Hospital Capital Medical University
Beijing
Beijing Municipality
Peking Union Medical College Hospital
Beijing
Beijing Municipality
Xuanwu Hospital Capital Medical University
Beijing
Beijing Municipality
The First Affiliated Hospital of Sun Yat-sen University
Guanzhou
Guangdong
Shenzhen People's Hospital
Shenzhen
Guangdong
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning
Guangxi
Jiaozuo People's Hospital
Jiaozuo
Henan
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang
Henan
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan
Hubei
Jiangsu Province Hospital
Nanjing
Jiangsu
The Second Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
The First Hospital of Jilin University
Ch’ang-ch’un
Jilin
The First Hospital of China Medical University
Shenyang
Liaoning
The First Affiliated Hospital of Baotou Medical College
Baotou
Neimenggu
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot
Neimenggu
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan
Ningxia
Sichuan Provincial People's Hospital
Chengdu
Sichuan
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi
Xinjiang
The First Hospital of Xinjiang Medical University
Ürümqi
Xinjiang
The Second Affiliated Hospital of Zhejiang University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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