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The goal of this clinical trial is to To evaluate the efficacy of subcutaneous (SC) Netakimab in adult Chinese patients with moderate to severe plaque psoriasis. Researchers will compare Netakimab to placebo to see if Netakimab works to treat plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Netakimab | Experimental | Netakimab administered by subcutaneous injection until Week 52 |
|
| Placebo | Placebo Comparator | Placebo administered by subcutaneous injection until Week 12 then Netakimab subcutaneous injection until 52 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Netakimab | Biological | Netakimab administered subcutaneously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving PASI75 | Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 75% (to achieve a PASI 75 response) relative to the baseline PASI score at Week 12 | at week 12 |
| Proportion of subjects achieving sPGA0/1 | Proportion of subjects with a sPGA(Static Physician Global Assessment) either 0 or 1 at Week 12 | at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving PASI75 | Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 75% (to achieve a PASI 75 response) relative to the baseline PASI score through out the study | through out the study(From baseline to Week 62) |
| Proportion of subjects achieving PASI90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| C000718740 | netakimab |
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| Placebo |
| Drug |
Placebo administered subcutaneously |
|
Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 90% (to achieve a PASI90 response) relative to the baseline PASI score through out the study |
| through out the study(From baseline to Week 62) |
| Proportion of subjects achieving PASI100 | Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least100% (to achieve a PASI100 response) relative to the baseline PASI score through out the study | through out the study(From baseline to Week 62) |
| Proportion of subjects achieving PGA | Proportion of subjects with a sPGA(Static Physician Global Assessment) either 0 or 1 through out the study | through out the study(From baseline to Week 62) |
| Changes from baseline in NAPSI score | Changes from baseline in NAPSI score through out the study | through out the study(From baseline to Week 52) |