Psoriasis drug combo aims to tackle skin and cholesterol in one shot
NCT ID NCT07373847
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 4 trial tests whether adding recaticimab to vunakizumab works better than vunakizumab alone for adults with moderate-to-severe plaque psoriasis and high cholesterol. Forty participants will be randomly assigned to receive either the drug combo or vunakizumab plus a placebo. The main goal is to see how many achieve completely clear skin by week 16.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vunakizumab and recaticimab
- What this could lead to
- If successful, this combination could offer a new treatment option that controls both psoriasis and high cholesterol at the same time.
- What could go wrong
- This is a small, early-phase trial with only 40 people. The combination may not work better than vunakizumab alone, and side effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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