Phase IV Study: Vunakizumab Efficacy and Safety in Moderate-to-severe Plaque Psoriasis
Recruiting · NCT06696417 · Observational (researchers observe without assigning treatment) · Lead sponsor: First Hospital of China Medical University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a multicenter, prospective, observational study of 1516 patients with moderate-to-severe chronic plaque psoriasis to evaluate the efficacy and safety of vunakizumab in patients with moderate-to-severe chronic plaque psoriasis. Approximately 50-100 clinical trial centers are planned to participate in the study. The study consisted of a 7-day screening period, a 52-week treatment period and an 8-week safety follow-up period. The recommended dose of vunakizumab is 240 mg (120 mg in two injections), with subcutaneous injection at week 0, 2, and 4, followed by a dose every 4 weeks and a final injection at week 48 (the actual treatment regimen is based on the clinician's recommendation). After the corresponding assessment at 52 weeks, an 8-week safety follow-up period was entered until the end of the study.
Who can take part
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 is running
1 location listed.
- The First Hospital of China Medical University - Shenyang, Liaoning, China