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

ConditionTakayasu Arteritis (TAK)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChinese SLE Treatment And Research Group

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vanakizumab

    Drug

    Vanakizumab 240mg each 4 weeks taken subcutaneously with an additional injection at day 15

  • Ivarmacitinib

    Drug

    Ivarmacitinib 8mg daily taken orally

  • Prednisone

    Drug

    Prednisone taken daily according to preset tapering protocol

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Vunakizumab group (Group Vuna I)Experimental treatment 2 interventions
Group B: Ivarmacitinib group (Group Iva I)Experimental treatment 2 interventions
Group C: Prednisone group (Group Pred)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Complete response rate at week 52

Percentage of patients with complete response at week 52

Time frame
week 52

Secondary outcomes

1

Complete response at week 26

Percentage of patients with complete response at week 26

Time frame
week 26
2

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

Time frame
week 26 and week 52
3

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

Time frame
week 26 and week 52
4

Time to relapse

Time to relapse in each treatment group

Time frame
week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese SLE Treatment And Research Group

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: