Actively Recruiting
Phase IV Study: Vunakizumab Efficacy and Safety in Moderate-to-severe Plaque Psoriasis
Led by First Hospital of China Medical University · Updated on 2025-05-14
1516
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Phase IV Study: Vunakizumab Efficacy and Safety in Moderate-to-severe Plaque Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent, any gender
- Diagnosed with moderate to severe plaque psoriasis
- Planned to receive vunakizumab therapy as determined by the investigator
- Able and willing to provide informed consent and comply with study requirements
You will not qualify if you...
- Previous treatment with biological agents including anti-TNF-α, anti-IL-17, anti-IL-17 receptor, anti-IL-12/IL-23, or IL-23p19 antibodies
- Severe allergic reactions to vunakizumab or any of its ingredients
- Presence of active significant diseases such as active tuberculosis, hepatitis, or malignant tumors
- Women who are fertile and men who are pregnant or unwilling/unable to use highly effective birth control during the study and 20 weeks after last dose
- Any other condition that the investigator believes would prevent study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
Research Team
X
Xinghua Gao, professor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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