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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Xinghua Gao, professor
• Email: gaobarry@hotmail.com
• Phone: +86 24 83282116

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• HS-20137: a treatment option for adults with moderate-to-severe plaque psoriasis

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• Vunakizumab for mild to moderate lupus

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• Evaluating the safety and effectiveness of Sotyktu for plaque psoriasis in Korea

  This study is testing if a new medication called Sotyktu is safe and effective for adults in Korea with moderate-to-severe plaque psoriasis who need treatment.

  Recruiting Bristol-Myers Squibb · Seoul and 1 other locations · NCT06258668

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.