Phase IV Study: Vunakizumab Efficacy and Safety in Moderate-to-severe Plaque Psoriasis

Launched by FIRST HOSPITAL OF CHINA MEDICAL UNIVERSITY · Nov 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called vunakizumab for people with moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches on the skin. The trial will take place at around 50-100 medical centers and will involve 1,516 participants. It aims to see how well vunakizumab works and how safe it is over a year. Participants will receive an injection under the skin at specific times during the study and will be monitored for their health and safety.

To be eligible for this trial, participants must be at least 18 years old and have a diagnosis of moderate to severe plaque psoriasis. They should be planning to receive treatment with vunakizumab, and they need to agree to follow the study's requirements. However, individuals who have had certain previous treatments or have specific health issues, like severe allergic reactions or active infections, may not be able to participate. Overall, this study is designed to gather important information about a new treatment option for psoriasis patients.

Gender

ALL

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.