[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621686":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":40,"collaborators":26,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":26,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":26,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":26,"overallStatus":61,"whyStopped":26,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":26},{"fullName":5,"class":6},"Xiangya Hospital of Central South University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Comparator: adults with moderate-to-severe psoriasis treated by vunakizumab and recaticimab.","EXPERIMENTAL","The recommended dosage of vunakizumab is 240 mg (administered as two 120 mg injections), given subcutaneously at Weeks 0, 2, and 4, followed by maintenance dosing every 4 weeks. For recaticimab, the recommended dosages are 150 mg subcutaneously every 4 weeks or 300 mg every 8 weeks.",[13],"Drug: vunakizumab and recaticimab.",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Comparator: adults with moderate-to-severe psoriasis treated by vunakizumab and placebo.","PLACEBO_COMPARATOR","The recommended dosage of vunakizumab is 240 mg (administered as two 120 mg injections), given subcutaneously at Weeks 0, 2, and 4, followed by maintenance dosing every 4 weeks. For placebo, the recommended dosages are 150 mg subcutaneously every 4 weeks or 300 mg every 8 weeks.",[19],"Drug: vunakizumab and placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","vunakizumab and recaticimab.","Adult patients (\\>18 years) with moderate-to-severe psoriasis who will start treatment with either vunakizumab and recaticimab.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"vunakizumab and placebo","Adult patients (\\>18 years) with moderate-to-severe psoriasis who will start treatment with either vunakizumab and placebo.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Yehong Kuang, professor","CONTACT","13574171102","yh_927@126.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":26},"Yi Xiao, professor","186 7482 3326",{"type":41,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100621686","phase-4-vunakizumab-combined-with-recaticimab-in-subjects-with-moderate-to-severe-plaque-psoriasis-and-dyslipidemia-100621686",false,"NCT07373847","Vunakizumab Combined With Recaticimab in Subjects With Moderate to Severe Plaque Psoriasis and Dyslipidemia","A Single-center, Randomized, Placebo-controlled Trial Study to Compare Efficacy, Safety and Tolerability of Vunakizumab Combined With Recaticimab in Subjects With Moderate to Severe Plaque Psoriasis and Dyslipidemia","Inclusion Criteria:\n\n\\-\n\nSubjects who meet all of the following criteria may be enrolled in this study:\n\nAdults aged 18 to 75 years, inclusive.\n\nClinically confirmed diagnosis of psoriasis.\n\nAt screening or on Day 1 of study treatment, a PASI score ≥10, BSA involvement ≥10%, and PGA score ≥3.\n\nPresence of dyslipidemia at screening or on Day 1 of study treatment, defined as fasting LDL-C ≥2.6 mmol\u002FL and \\\u003C4.9 mmol\u002FL in subjects without concomitant atherosclerotic cardiovascular disease (ASCVD).\n\nFasting triglycerides (TG) \\\u003C5.6 mmol\u002FL and 10-year ASCVD risk score \\\u003C10%.\n\nWomen of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline, and must agree to use effective contraception throughout the study and for 30 days after the end of the study.\n\nSubjects must voluntarily participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria will be excluded from the study:\n\nPresence of non-plaque psoriasis at screening or on Day 1 of the study, including guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis.\n\nFever or active infection within 7 days prior to study initiation.\n\nHistory of serious infection within 60 days prior to study initiation (including but not limited to bacterial, viral, or fungal infections requiring hospitalization or intravenous antimicrobial therapy), or any untreated infection.\n\nHistory of chronic infection, such as chronic pyelonephritis or chronic osteomyelitis.\n\nPositive hepatitis B virus (HBV) DNA with abnormal liver function, or HBV DNA \\>1 × 10⁵ copies\u002FmL, indicating active infection.\n\nPositive test results for human immunodeficiency virus (HIV) or Treponema pallidum (syphilis) antibodies.\n\nClinical signs or symptoms suggestive of active tuberculosis (TB) during screening (e.g., fever, cough, night sweats, weight loss), or evidence of current or active pulmonary TB on chest imaging (X-ray or CT) during screening or within 6 months prior to screening.\n\nNew York Heart Association (NYHA) class III or IV heart failure, or left ventricular ejection fraction \\\u003C30%.\n\nDiagnosis within 3 months prior to randomization of new-onset myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, or stroke.\n\nType 1 diabetes mellitus, poorly controlled type 2 diabetes mellitus (HbA1c ≥10%), or diabetes with multiple organ comorbidities.\n\nSCORE (Systematic Coronary Risk Evaluation) ≥10%.\n\nDuring screening, uncontrolled hypertension (defined as systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg) or moderate to severe renal impairment, defined as estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m².\n\nOngoing active liver disease or liver function abnormalities, defined as ALT and\u002For AST ≥3× the upper limit of normal (ULN).\n\nPresence of malignancy.\n\nHistory of severe drug allergy, or known hypersensitivity to funakinzumab, ricazinumab, or any of their excipients.\n\nPregnant or breastfeeding women, women planning pregnancy during the study period, or male or female subjects unwilling to use contraception.\n\nReceipt of systemic oral or intravenous treatment prior to screening without completion of the required washout period, as defined below:\n\n1. Use of TNF-α, IL-12\u002F23, IL-17, or IL-23 monoclonal antibodies (e.g., adalimumab, ustekinumab, ixekizumab, secukinumab, guselkumab) within 3 months prior to screening;\n2. Use of systemic psoriasis treatments (including but not limited to methotrexate, JAK inhibitors, acitretin, cyclosporine, oral or injectable corticosteroids) within 4 weeks prior to screening;\n3. Use of topical psoriasis treatments (including but not limited to corticosteroids, vitamin D₃ analogues, calcineurin inhibitors, tapinarof) within 2 weeks prior to screening;\n4. Receipt of phototherapy (including oral or topical PUVA, UVB, tanning beds, or therapeutic sun exposure) within 4 weeks prior to screening;\n5. Use of statins, cholesterol absorption inhibitors, or fibrates within 4 weeks prior to screening.\n\nLaboratory abnormalities at screening meeting any of the following criteria:\n\n1. Absolute white blood cell count \\\u003C3,000\u002Fmm³;\n2. Absolute lymphocyte count \\\u003C500\u002Fmm³;\n3. Absolute neutrophil count \\\u003C1,000\u002Fmm³;\n4. Platelet count \\\u003C100,000\u002Fmm³;\n5. Hemoglobin \\\u003C9 g\u002FdL;\n6. ALT and\u002For AST \\>3× ULN;\n7. Total unconjugated and\u002For conjugated bilirubin \\>2× ULN;\n8. Clinically significant electrocardiogram (ECG) abnormalities;\n9. Any other laboratory abnormality deemed by the investigator to interfere with study completion or interpretation of study results.","ALL","18 Years","75 Years",{"count":53,"type":54},40,"ESTIMATED","INTERVENTIONAL",[57],"PHASE4","The aim is to evaluate the safety and efficacy of vunakizumab combined with recaticimab versus vunakizumab combined with placebo in the treatment of plaque psoriasis with dyslipidemia.",[60],"Plaque Psoriasis","NOT_YET_RECRUITING","2026-01-22",{"date":64,"type":65},"2026-01-28","ACTUAL",{"date":67,"type":54},"2026-01-20",{"date":69,"type":54},"2027-08-30",{"name":5,"class":6}]