[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575269":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":31,"slug":20,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":36,"eligibilityCriteria":37,"healthyVolunteers":32,"sex":38,"minAge":39,"maxAge":20,"enrollmentInfo":40,"targetDuration":20,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":20,"overallStatus":49,"whyStopped":20,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":55,"leadSponsor":57,"locationsCount":20},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"single arm","ACTIVE_COMPARATOR","Vunakizumab",[13],"Drug: vnacicizumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","vnacicizumab","Vunakizumab 120 mg subcutaneous injection at baseline and week2, week4, then every other 4 weeks.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Jieruo Gu","CONTACT","+86 13922280820","gujieruo@163.com",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Gu Jieruo","Professor","100575269",false,"NCT06770088","Vunakizumab in Adults with Spondyloarthritis","A Prospective, Single-arm, Multicenter Study to Explore the Efficacy and Safety of Vunakizumab in Adults with Active Spondyloarthritis","V SPA","Inclusion Criteria:\n\n1. Patients older than 18 years when signing the informed consent;\n2. Patients diagnosed with spondyloarthritis (excluding psoriatic arthritis) and are eligible for biologic therapy;\n3. 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.\n\nExclusion Criteria:\n\n1. Patients with severe hypersensitivity reaction to the active ingredient or any excipient of Vunakizumab;\n2. 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;\n3. active infection with important clinical significance;\n4. patients with moderate to severe heart failure (NYHA class Ⅲ\u002FⅣ);\n5. patients with malignant tumors who were receiving treatment or were not receiving treatment;\n6. concomitant with other inflammatory diseases or severe autoimmune diseases, including but not limited to inflammatory bowel disease, which may affect the efficacy and safety evaluation according to the investigator's judgment;\n7. any other condition that the investigator considers would prevent the subject from adhering to and completing the study protocol.","ALL","18 Years",{"count":41,"type":42},880,"ESTIMATED","INTERVENTIONAL",[45],"PHASE4","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.",[48],"Spondyloarthritis (SpA)","NOT_YET_RECRUITING","2025-01-10",{"date":52,"type":53},"2025-01-13","ACTUAL",{"date":50,"type":42},{"date":56,"type":42},"2027-12-31",{"name":5,"class":6}]