Takayasu Arteritis (TAK)
Conditions
Keywords
Vunakizumab, Ivarmacitinib, randomized controlled trial
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.
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.
Interventions
DRUGVanakizumab
Vanakizumab 240mg each 4 weeks taken subcutaneously with an additional injection at day 15
DRUGIvarmacitinib
Ivarmacitinib 8mg daily taken orally
DRUGPrednisone
Prednisone taken daily according to preset tapering protocol
Sponsors
Chinese SLE Treatment And Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate at week 52 | week 52 | Percentage of patients with complete response at week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete response at week 26 | week 26 | Percentage of patients with complete response at week 26 |
| Combined response rate of vunakizumab at week 26 and week 52 | week 26 and week 52 | Percentage of patients with response treated with vunakizumab at week 26 and week 52 |
| Combined response rate of ivarmacitinib at week 26 and week 52 | week 26 and week 52 | Percentage of patients with response treated with ivarmacitinib at week 26 and week 52 |
| Time to relapse | week 52 | Time to relapse in each treatment group |
| Time to event | week 52 | Time to event (including relapse, discontinuation due to AE/SAE, treatment failure) |
| Patient-Reported Outcomes | week 52 | The comparison of PtGA and PhGA in each individual during the treatment in each group |
Countries
China
Contacts
CONTACTXinping TIAN, M.D.
CONTACTJing LI, M.D.
PRINCIPAL_INVESTIGATORXinping TIAN, M.D.
Peking Union Medical College Hospital
Outcome results
None listed