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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug group:vunakizumab (IL-17A inhibitor) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The overall clinical clearance rate of skin lesions |
| Three months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One month, Three months,Twelve months |
| The time when subjects reached PASI 75 and PASI 90 within 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Moderate and severe plaque psoriasis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinghua Gao, professor | Contact | +86 24 83282116 | gaobarry@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | China |
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This study only collects routine testing data and does not specifically collect biospecimens.
| Three months |
| The time when subjects reached PASI 75, PASI 90, PASI 100 at 52 weeks. | Twelve months |
| Changes in PASI scores relative to baseline at each visit point during 52 weeks. | 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. | 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 | Three months,Twelve months |