Plaque Psoriasis
Conditions
Brief summary
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.
Interventions
DRUGvunakizumab and recaticimab.
Adult patients (\>18 years) with moderate-to-severe psoriasis who will start treatment with either vunakizumab and recaticimab.
DRUGvunakizumab and placebo
Adult patients (\>18 years) with moderate-to-severe psoriasis who will start treatment with either vunakizumab and placebo.
Sponsors
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\- 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.
Exclusion criteria
* 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: 1. 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; 2. 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; 3. Use of topical psoriasis treatments (including but not limited to corticosteroids, vitamin D₃ analogues, calcineurin inhibitors, tapinarof) within 2 weeks prior to screening; 4. Receipt of phototherapy (including oral or topical PUVA, UVB, tanning beds, or therapeutic sun exposure) within 4 weeks prior to screening; 5. Use of statins, cholesterol absorption inhibitors, or fibrates within 4 weeks prior to screening. Laboratory abnormalities at screening meeting any of the following criteria: 1. Absolute white blood cell count \<3,000/mm³; 2. Absolute lymphocyte count \<500/mm³; 3. Absolute neutrophil count \<1,000/mm³; 4. Platelet count \<100,000/mm³; 5. Hemoglobin \<9 g/dL; 6. ALT and/or AST \>3× ULN; 7. Total unconjugated and/or conjugated bilirubin \>2× ULN; 8. Clinically significant electrocardiogram (ECG) abnormalities; 9. Any other laboratory abnormality deemed by the investigator to interfere with study completion or interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PASI 100 response rate at week 16 in the group treated with vunakizumab combined with recaticimab versus vunakizumab combined with placebo | From enrollment to the end of treatment at 16 weeks |
Contacts
CONTACTYehong Kuang, professor
CONTACTYi Xiao, professor
Outcome results
None listed