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This is study designed to investigate the efficacy and safety of Jaktinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jaktinib 50mg Bid | Experimental | Jaktinib 50mg Bid+ Placebo 50mg Bid+ Placebo 75mg Bid |
|
| Jaktinib 75mg Bid | Experimental | Jaktinib 75mg Bid+ Placebo 50mg*2 Bid |
|
| Jaktinib 100mg Bid | Experimental | Jaktinib 50mg*2 Bid+ Placebo 75mg Bid |
|
| Placebo | Placebo Comparator | Placebo 50mg*2 Bid+ Placebo 75mg Bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jaktinib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Jaktinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI]) | The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema (redness), and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Jaktinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA]) | The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xinghua Gao, PhD | First Hospital of China Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of China Medical University | Shenyang | Liaoning | 110000 | China |
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| Placebo | Drug | Administered orally |
|
| Week 8、12、16、20、24 |