[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583819":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":20,"responsibleParty":40,"collaborators":11,"id":42,"slug":11,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":11,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":11,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":23,"whyStopped":11,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"Chinese SLE Treatment And Research Group","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Vunakizumab","EXPERIMENTAL",null,[13],"Drug: Vunakizumab (IL-17A inhibitor)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Vunakizumab (IL-17A inhibitor)","Vunakizumab combined with glucocorticoid therapy: Vunakizumab is administered subcutaneously at 240 mg at weeks 0, 2, and 4, followed by maintenance dosing every 4 weeks at 240 mg per dose.",[9],[21],{"facility":22,"status":23,"city":24,"state":25,"zip":26,"country":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Peking Union Medical College Hospital","RECRUITING","Beijing","Beijing Municipality","100730","China",{"type":29,"coordinates":30},"Point",[31,32],116.39723,39.9075,{"lat":32,"lon":31},[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Mengtao Li, Doctor","CONTACT","China 6915-9958","mengtao.li@cstar.org.cn",{"type":41,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100583819",false,"NCT06881290","Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus","Pilot Study on the Treatment of Vunakizumab in Mild to Moderate Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Patients aged 18-65 years meeting the 2019 EULAR\u002FACR classification criteria for SLE.\n2. SLEDAI score was within 2-12 scores (with clinical SLEDAI \\[cSLEDAI\\] ≠ 0).\n3. Occurence of new or recurrent mucocutaneous or joint involvement.\n4. Stable standard treatment regimen prior to study entry but not effect: Prednisone or equivalent corticosteroid dose ≤ 20 mg per day for more than 4 weeks; Immunosuppressant less than 1 type for more than 12 weeks, including methotrexate ≤15 mg per week, azathioprine ≤100mg per day, mycophenolate mofetil ≤1.5 g per day, tacrolimus ≤2 mg per day, cyclosporine ≤150 mg per day). Antimalarials was permitted.\n5. Body mass index (BMI) 18-35 kg\u002Fm² at screening.\n6. Clinically eligible for Vunakizumab combination therapy with corticosteroids after investigator assessment.\n7. Willing to provide written informed consent with demonstrated compliance.\n\nExclusion Criteria:\n\n1. SLE with major organ dysfunction including Encephalopathy\u002Fcognitive impairment, Renal insufficiency, Cardiac insufficiency (NYHA class III-IV), Pulmonary hypertension\u002Finterstitial lung disease\n2. Active SLE-related organ involvement: Lupus cerebritis, Active lupus nephritis (proteinuria ≥1g\u002F24h), Myocardial involvement, Gastrointestinal vasculitis, Diffuse alveolar hemorrhage, Thrombocytopenic purpura, Hemophagocytic syndrome, Retinopathy\n3. Concurrent autoimmune diseases affecting efficacy assessment (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis).\n4. Liver dysfunction: ALT\u002FAST \\>1.5×ULN or total bilirubin \\>1×ULN.\n5. Active malignancy within 5 years or history of malignancy.\n6. Comorbidities requiring corticosteroids (e.g., asthma, Crohn's disease).\n7. Active infections requiring treatment:Tuberculosis, HBV\u002FHCV\u002FHIV\u002FCMV infections\n8. Major surgery within 3 months prior to screening.\n9. Hypersensitivity or intolerance to funakizumab.\n10. Pregnancy, lactation, or planned pregnancy.\n11. Biologic therapy within 3 months (anti-CD20 agents, belimumab, TNF-α inhibitors).\n12. Recent intensive therapies: Systemic corticosteroids within 3 months\u002F Plasmapheresis\u002FIVIG\u002Fcyclophosphamide within 3 months\n13. Any condition deemed by investigators to compromise study completion or patient safety.","ALL","18 Years","65 Years",{"count":52,"type":53},20,"ESTIMATED","INTERVENTIONAL",[56],"PHASE1","Systemic lupus erythematosus (SLE) is a systemic autoimmune disease characterized by heterogeneous clinical manifestations ranging from mild cutaneous involvement to severe multi-organ damage. While its pathogenesis involves complex cytokine dysregulation, emerging evidence implicates IL-17 as a potential contributor. Elevated serum IL-17 levels have been observed in SLE patients compared to healthy controls, with heightened expression detected in renal and cutaneous lesions. Ustekinumab, a monoclonal antibody targeting IL-23\u002FIL-12 that indirectly modulates IL-17 signaling, demonstrated superior efficacy and safety to placebo in an SLE clinical trial, particularly in glucocorticoid dose reduction. Notably, no clinical trials have directly evaluated IL-17-targeted therapies for SLE, though case reports suggest secukinumab (an anti-IL-17A agent) may improve cutaneous manifestations in psoriasis-SLE overlap patients.\n\nVunakizumab, a humanized anti-IL-17A monoclonal antibody (IgG1\u002Fκ) with a unique epitope-binding profile, selectively inhibits IL-17A-mediated inflammatory signaling. Its established safety profile and infrequent dosing regimen in IL-17-mediated diseases (e.g., psoriasis, psoriatic arthritis) warrant investigation in SLE. The investigators aim to provide new treatment options for SLE patients",[59],"Lupus Erythematosus, Systemic",[9,61],"Systemic lupus erythematosus","2025-07-07",{"date":64,"type":65},"2025-07-10","ACTUAL",{"date":67,"type":65},"2025-05-19",{"date":69,"type":53},"2027-12-01",{"name":5,"class":6},1]