Plaque PsoriasisPhase 4NCT07373847
Vunakizumab Combined With Recaticimab in Subjects With Moderate to Severe Plaque Psoriasis and Dyslipidemia
A Phase 4 study testing vunakizumab and recaticimab. in people with Plaque Psoriasis, run by Xiangya Hospital of Central South University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- vunakizumab and recaticimab.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 30 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- 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).
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- 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.
Who cannot join
- 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.
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- 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;
- Absolute lymphocyte count <500/mm³;
- Absolute neutrophil count <1,000/mm³;
- Platelet count <100,000/mm³;
- Hemoglobin <9 g/dL;
- ALT and/or AST >3× ULN;
- Total unconjugated and/or conjugated bilirubin >2× ULN;
- Clinically significant electrocardiogram (ECG) abnormalities;
- Any other laboratory abnormality deemed by the investigator to interfere with study completion or interpretation of study results.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Yi Xiao, professor contact
About this study
Official title: 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
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
- Being tested
- vunakizumab and recaticimab., vunakizumab and placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vunakizumab and recaticimab.Drug
Adult patients (>18 years) with moderate-to-severe psoriasis who will start treatment with either vunakizumab and recaticimab.
vunakizumab and placeboDrug
Adult patients (>18 years) with moderate-to-severe psoriasis who will start treatment with either vunakizumab and placebo.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: vunakizumab and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI 100 response rate at week 16 in the group treated with vunakizumab combined with recaticimab versus vunakizumab combined with placebo
Measured: From enrollment to the end of treatment at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373847
- Sponsor's protocol ID
- MA-DER-IV-015
- Status last verified
- Dec 2025
- First submitted
- 12 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 39332633Zimerman 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.
PubMed 40255182
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07373847
- Acronym / sponsor ID
- MA-DER-IV-015
- Conditions
- Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: adults with moderate-to-severe psoriasis treated by vunakizumab and recaticimab. | Experimental | Drug: vunakizumab and recaticimab.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. |
| Active Comparator: adults with moderate-to-severe psoriasis treated by vunakizumab and placebo. | Placebo comparator | Drug: vunakizumab and placeboThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- -
- 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).
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vunakizumab and recaticimab.Adult patients (>18 years) with moderate-to-severe psoriasis who will start treatment with either vunakizumab and recaticimab. | Drug | Active Comparator: adults with moderate-to-severe psoriasis treated by vunakizumab and recaticimab. |
| vunakizumab and placeboAdult patients (>18 years) with moderate-to-severe psoriasis who will start treatment with either vunakizumab and placebo. | Drug | Active Comparator: adults with moderate-to-severe psoriasis treated by vunakizumab and placebo. |
Primary outcome
PASI 100 response rate at week 16 in the group treated with vunakizumab combined with recaticimab versus vunakizumab combined with placebo
Time frame: From enrollment to the end of treatment at 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Results publication: PubMed 39332633Yan 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.
- Results publication: PubMed 40255182Zimerman 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi Xiao, professor contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vunakizumab and recaticimab. in people with Plaque Psoriasis, run by Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yehong Kuang, professor (13574171102, yh_927@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PASI 100 response rate at week 16 in the group treated with vunakizumab combined with recaticimab versus vunakizumab combined with placebo (time frame: From enrollment to the end of treatment at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07373847, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.