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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
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Currently, the main systemic drug therapies in China include methotrexate (MTX), cyclosporine A, retinoids, and biologics. In recent years, monoclonal antibody biologics targeting cellular inflammatory factors have been used in the treatment of severe psoriasis, which is poorly treated with conventional systemic medications, severely affects the quality of life, and is accompanied by significant arthritic symptoms, including tumor necrosis factor-alpha (TNF-alpha) antagonists (etanercept, infliximab, adalimumab); IL-12/23 antagonists (ursodiol, ibuprofen); and IL-12/23 antagonists (ubuntu, ubiquinone). IL-12/23 antagonists (ustekinumab) and IL-17A antagonists (skutecimab). Among them, ezekizumab and stuccizumab are more widely used at present. However, the efficacy, safety, and tolerability of ezekizumab and stuclizumab in the treatment of plaque psoriasis in elderly patients over 70 years of age are not known.
Primary objective:
To evaluate the efficacy of ezekizumab versus secukizumab in patients over 70 years of age with plaque psoriasis.
Secondary objectives:
Currently, the main systemic drug therapies in China include methotrexate (MTX), cyclosporine A, retinoids, and biologics. In recent years, monoclonal antibody biologics targeting cellular inflammatory factors have been used in the treatment of severe psoriasis, which is poorly treated with conventional systemic medications, severely affects the quality of life, and is accompanied by significant arthritic symptoms, including tumor necrosis factor-alpha (TNF-alpha) antagonists (etanercept, infliximab, adalimumab); IL-12/23 antagonists (ursodiol, ibuprofen); and IL-12/23 antagonists (ubuntu, ubiquinone). IL-12/23 antagonists (ustekinumab) and IL-17A antagonists (skutecimab). Among them, ezekizumab and stuccizumab are more widely used at present. However, the efficacy, safety, and tolerability of ezekizumab and stuclizumab in the treatment of plaque psoriasis in elderly patients over 70 years of age are not known.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixe. group | Active Comparator |
| |
| Sec. group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixekizumab | Biological | injected with ixekizumab |
| |
| Secukizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who improved their PASI score by 90% (PASI 90) or more from baseline or achieved an sPGA score of 0 or 1 at Week 16. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with 100% improvement in PASI score from baseline at Week 16 | Week 16 | |
| At Week 16, the proportion of subjects with an sPGA score of 0 | Week 16 | |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C549079 | ixekizumab |
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| Biological |
injected with secukizumab |
|
| Absolute value of change from baseline in subjects' PASI, sPGA, BSA, DLQI, and NRS at Week 16 |
| Week 16 |
| atients who achieved a PASI of 90 at week 16. | Week 16 |
| patients who achieved PASI 75 at week 16 | Week 16 |