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Vunakizumab Combined With Recaticimab in Subjects With Moderate to Severe Plaque Psoriasis and Dyslipidemia | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE4

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

NCT07373847•Xiangya Hospital of Central South University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+23 more criteria

Key Dates

Start Date

January 20, 2026

Primary Completion Date

June 30, 2027

Completion Date

August 30, 2027

Last Updated

January 28, 2026

Enrollment

ESTIMATED participants

Conditions

Plaque Psoriasis

Interventions

vunakizumab and recaticimab.

DRUG

vunakizumab and placebo

DRUG

Contacts

Yehong Kuang, professor

CONTACT

13574171102 yh_927@126.com

Yi Xiao, professor

CONTACT

186 7482 3326

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis