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Vunakizumab in Adults with Spondyloarthritis

ConditionSpondyloarthritis (SpA)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

This prospective, single-arm, multicenter study is aimed to explore the efficacy and safety of Vunakizumab in adults with spondyloarthritis. The primary endpoint is the proportion of adults with spondyloarthritis achieving ankylosing spondylitis assessment score (ASAS) 40 at week 16 in the treatment of Vunakizumab.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients older than 18 years when signing the informed consent;

Patients diagnosed with spondyloarthritis (excluding psoriatic arthritis) and are eligible for biologic therapy;

The subjects voluntarily signed informed consent before the start of any procedures related to the study, were able to communicate with the investigators smoothly, understood and were willing to strictly abide by the requirements of the clinical research protocol to complete the study.

Disqualifiers

Patients with severe hypersensitivity reaction to the active ingredient or any excipient of Vunakizumab;

fertile women (defined as all women with the physical requirements for pregnancy) and men who are pregnant or who are unwilling or unable to use highly effective birth control during the study and within 20 weeks after last receiving the study drug;

active infection with important clinical significance;

patients with moderate to severe heart failure (NYHA class Ⅲ/Ⅳ);

Trial design

Design model

Single group

Treatments tested in this trial

  • vnacicizumab

    Drug

    Vunakizumab 120 mg subcutaneous injection at baseline and week2, week4, then every other 4 weeks.

Treatment groups

880 Participants
are divided into 1 treatment group
Group A: single armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with spondyloarthritis who achieved ASAS40 response

Proportion of patients with spondyloarthritis who achieved ASAS40 response

Time frame
week 16

Secondary outcomes

1

The proportion of patients achieving ASAS20

The proportion of patients achieving ASAS20

Time frame
Week 16
2

Proportion of patients with spondyloarthritis who achieved ASAS20 response

Proportion of patients with spondyloarthritis who achieved ASAS20 response

Time frame
Week 52

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

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