Evaluating the effects of vunakizumab on moderate-to-severe plaque psoriasis

A Prospective, Single-arm, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Vunakizumab in Adults With Moderate-to-severe Plaque Psoriasis Who Have Not Previously Received Biologics

This study is testing if a new medication called vunakizumab can help people with moderate-to-severe plaque psoriasis feel better and improve their quality of life over a year.

Quick facts

• Study type: Observational
• Enrollment: 1516 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Hospital of China Medical University (Academic / other)
• Drugs / interventions: vunakizumab, vunachizumab
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT06696417 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective observational study aims to assess the efficacy and safety of vunakizumab, an IL-17A inhibitor, in 1516 patients diagnosed with moderate-to-severe chronic plaque psoriasis. Participants will undergo a 7-day screening period followed by a 52-week treatment phase, receiving subcutaneous injections of vunakizumab at specified intervals. The study will also explore the impact of treatment on quality of life and mental health through patient-reported outcomes and satisfaction surveys. The goal is to gather comprehensive data on the drug's performance in a large Chinese population post-marketing.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of moderate to severe plaque psoriasis who are planning to receive vunakizumab therapy.

Not a fit: Patients who have previously been treated with biological agents or have severe hypersensitivity to vunakizumab will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the efficacy and safety of vunakizumab, potentially improving treatment options for patients with moderate-to-severe plaque psoriasis.

How similar studies have performed: Other studies involving IL-17A inhibitors have shown promising results, indicating that this approach is supported by previous successes in similar treatments.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years old at the time of signing the informed consent, regardless of gender;
* Moderate to severe plaque psoriasis was diagnosed;
* Plan to receive vunakizumab therapy as assessed by the investigator;
* The subject voluntarily signs informed consent before the start of any procedures related to the study, can communicate with the researcher smoothly, understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study; Patients voluntarily sign informed consent forms.

Exclusion Criteria:

* Previous treatment with biological agents: including but not limited to anti-tumor necrosis factor-α (TNF-α), anti-IL-17, anti-IL-17 receptor, anti-IL-12 /IL-23 or IL-23p19 antibody drugs;
* Severe hypersensitivity to vunakizumab active ingredient or any excipients;
* Patients with clinically important active diseases, such as active tuberculosis, active hepatitis, and active malignant tumors;
* Fertile women (defined as all women with physical conditions necessary for pregnancy) and men who are pregnant or unwilling or unable to use highly effective birth control during the study period and within 20 weeks after last receiving the study drug;
* Any other circumstances that the investigator believes will prevent the subject from following and completing the study protocol.

Where this trial is running

Shenyang, Liaoning

• The First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)

Study contacts

• Study coordinator: Xinghua Gao, professor

Conditions Moderate to Severe Plaque Psoriasis