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

NCT07373847 | Not Yet Recruiting Phase 4

• 1 other identifier: MA-DER-IV-015
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Drug: vunakizumab and recaticimab.

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.

Drug: vunakizumab and placebo

Interventions

vunakizumab and recaticimab. DRUG

Adult patients (\>18 years) with moderate-to-severe psoriasis who will start treatment with either vunakizumab and recaticimab.

Active Comparator: adults with moderate-to-severe psoriasis treated by vunakizumab and recaticimab.

vunakizumab and placebo DRUG

Adult patients (\>18 years) with moderate-to-severe psoriasis who will start treatment with either vunakizumab and placebo.

Active Comparator: adults with moderate-to-severe psoriasis treated by vunakizumab and placebo.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Related Publications (2)

• Yan K, Li F, Bi X, Han L, Zhang Z, Chen R, Li Y, Zhang L, Wang X, Li L, Lu J, Xu A, Yang S, Lu Y, Sun J, Li Z, Zhu X, Jiang M, Zhang S, Wang W, Li Y, Meng Z, Li H, Mou K, Han X, Li S, Chen A, Li X, Liu D, Zhang C, Ji C, Wang Y, Cheng H, Cui X, Yao X, Bai X, Dong G, Xu J. Efficacy and safety of vunakizumab in moderate-to-severe chronic plaque psoriasis: A randomized, double-blind, placebo-controlled phase 3 trial. J Am Acad Dermatol. 2025 Jan;92(1):92-99. doi: 10.1016/j.jaad.2024.09.031. Epub 2024 Sep 26.

  PMID: 39332633 RESULT

• Zimerman A, Kunzler ALF, Weber BN, Ran X, Murphy SA, Wang H, Honarpour N, Keech AC, Sever PS, Sabatine MS, Giugliano RP. Intensive Lowering of LDL Cholesterol Levels With Evolocumab in Autoimmune or Inflammatory Diseases: An Analysis of the FOURIER Trial. Circulation. 2025 May 20;151(20):1467-1476. doi: 10.1161/CIRCULATIONAHA.124.072756. Epub 2025 Apr 21.

  PMID: 40255182 RESULT

Central Study Contacts

Yehong Kuang, professor

CONTACT

13574171102; yh_927@126.com

Yi Xiao, professor

CONTACT

186 7482 3326

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 28, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: January 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share