Vunakizumab Combined With Recaticimab in Subjects With Moderate to Severe Plaque Psoriasis and Dyslipidemia

Starting soon · Phase 4 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT07373847

Run by

Xiangya Hospital of Central South University

People needed

40

Starts

2026-01-20

Expected to finish

2027-08-30

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who meet all of the following criteria may be enrolled in this study:
• Adults aged 18 to 75 years, inclusive.
• Clinically confirmed diagnosis of psoriasis.
• At screening or on Day 1 of study treatment, a PASI score ≥10, BSA involvement ≥10%, and PGA score ≥3.
• Presence of dyslipidemia at screening or on Day 1 of study treatment, defined as fasting LDL-C ≥2.6 mmol/L and <4.9 mmol/L in subjects without concomitant atherosclerotic cardiovascular disease (ASCVD).
• Fasting triglycerides (TG) <5.6 mmol/L and 10-year ASCVD risk score <10%.
• Women 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.
• Subjects must voluntarily participate in the study and provide written informed consent.

You may not qualify if…

• Subjects meeting any of the following criteria will be excluded from the study:
• Presence of non-plaque psoriasis at screening or on Day 1 of the study, including guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis.
• Fever or active infection within 7 days prior to study initiation.
• History 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.
• History of chronic infection, such as chronic pyelonephritis or chronic osteomyelitis.
• Positive hepatitis B virus (HBV) DNA with abnormal liver function, or HBV DNA >1 × 10⁵ copies/mL, indicating active infection.
• Positive test results for human immunodeficiency virus (HIV) or Treponema pallidum (syphilis) antibodies.
• Clinical 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.
• New York Heart Association (NYHA) class III or IV heart failure, or left ventricular ejection fraction <30%.
• Diagnosis within 3 months prior to randomization of new-onset myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, or stroke.
• Type 1 diabetes mellitus, poorly controlled type 2 diabetes mellitus (HbA1c ≥10%), or diabetes with multiple organ comorbidities.
• SCORE (Systematic Coronary Risk Evaluation) ≥10%.
• During 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 <30 mL/min/1.73 m².
• Ongoing active liver disease or liver function abnormalities, defined as ALT and/or AST ≥3× the upper limit of normal (ULN).
• Presence of malignancy.
• History of severe drug allergy, or known hypersensitivity to funakinzumab, ricazinumab, or any of their excipients.
• Pregnant or breastfeeding women, women planning pregnancy during the study period, or male or female subjects unwilling to use contraception.
• Receipt of systemic oral or intravenous treatment prior to screening without completion of the required washout period, as defined below:
• Use of TNF-α, IL-12/23, IL-17, or IL-23 monoclonal antibodies (e.g., adalimumab, ustekinumab, ixekizumab, secukinumab, guselkumab) within 3 months prior to screening;
• 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;
• Use of topical psoriasis treatments (including but not limited to corticosteroids, vitamin D₃ analogues, calcineurin inhibitors, tapinarof) within 2 weeks prior to screening;
• Receipt of phototherapy (including oral or topical PUVA, UVB, tanning beds, or therapeutic sun exposure) within 4 weeks prior to screening;
• Use of statins, cholesterol absorption inhibitors, or fibrates within 4 weeks prior to screening.
• Laboratory abnormalities at screening meeting any of the following criteria:
• Absolute white blood cell count <3,000/mm³;

Full record on ClinicalTrials.gov

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