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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXiangya Hospital of Central South University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • vunakizumab and recaticimab.

    Drug

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Active Comparator: adults with moderate-to-severe psoriasis treated by vunakizumab and recaticimab.Experimental treatment 1 intervention
Group B: Active Comparator: adults with moderate-to-severe psoriasis treated by vunakizumab and placebo.Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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