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.
The vunakizumab is a humanized IL-17A inhibitor with innovative binding epitopes, which accurately binds to IL-17A, the core pathogenic factor of psoriasis. However, there is still a lack of efficacy and safety data in a large sample size of the Chinese population after marketing. Therefore, this study is intended to observe the efficacy and safety of vunachizumab in a larger population. The clinical efficacy of vunakizumab on special sites and the influence of comorbidity on the treatment of psoriasis are also paid attention to. At the same time, the improvement effect of vunakizumab on the quality of life and mental health of psoriasis patients is explored through patient-reported outcome (PRO) and patient satisfaction survey, so as to develop a clinical program that can benefit psoriasis patients physically and mentally.
Study Type
OBSERVATIONAL
Enrollment
1,516
The recommended dose of vunakizumab was 240 mg, administered subcutaneously at weeks 0, 2, and 4, then every 4 weeks, with a final injection at 48 weeks
The First Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGThe overall clinical clearance rate of skin lesions
1. The proportion of subjects who achieved at least a 90% improvement from baseline in PASI scores by week 12 (PASI 90). (PASI: Psoriasis Area and Severity Index, 0 ≤ PASI ≤ 72, where a higher score indicates a greater extent of the disease and more severe skin lesion severity.) 2. Proportion of subjects achieving sPGA 0/1 response at week 12. (sPGA 0/1 response is defined as an sPGA score of 0 (clear) or 1 (almost clear))
Time frame: Three months
The overall clinical clearance rate of skin lesions
Proportion of subjects with PASI 75, PASI 90, PASI 100, sPGA 0/1, and sPGA 0 at week 4, 12, and 52.
Time frame: One month， Three months，Twelve months
The time when subjects reached PASI 75 and PASI 90 within 12 weeks
Time frame: Three months
The time when subjects reached PASI 75, PASI 90, PASI 100 at 52 weeks.
Time frame: Twelve months
Changes in PASI scores relative to baseline at each visit point during 52 weeks.
Time frame: Twelve months
Response rates of ACR (American College of Rheumatology) 20, ACR50 and ACR70 at week 4, 12, 24 and 52.
ACR20 refers to the improvement of at least 20% in the number of swollen and tender joints in rheumatoid arthritis treatment, along with improvement of at least 20% in at least three of the other five assessment criteria. ACR50 and ACR70 are defined using the same criteria, representing a 50% and 70% improvement, respectively.
Time frame: One month， Three months， Six months，Twelve months
Weeks 12 and 52 Treatment Satisfaction Questionnaire for Medication (TSQM) survey questionnaire.
0 ≤ TSQM ≤ 100, where a higher score indicates greater patient satisfaction with the medication
Time frame: Three months，Twelve months
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