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A Study to evaluate efficacy and safety in subjects with moderate to severe Plaque Psoriasis treated with a TYK2 Inhibitor for 12 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose level 1 | Experimental |
| |
| dose level 2 | Experimental |
| |
| dose level 3 | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tyk2 inhibitor | Drug | Specific dose of Tyk2 inhibitor on specific days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Week 12 | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With PASI-90, PASI-100 on Week 12 | Baseline to Week 12 | |
| Percentage of Participants on Week 12 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate) | Baseline to Week 12 | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Zhang | Contact | +8613636393195 | yang_zhang@usynova.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Skin Disease Hospital | Recruiting | Shanghai | China |
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| Placebo | Drug | Specified dose of Placebo on specified days. |
|
| Change From Baseline in DLQI Scores to Week 12 |
| Baseline to Week 12 |
| Change From Baseline in BSA to Week 12 | Baseline to Week 12 |
| Number of Participants With Adverse Events | From enrollment to Day 112 |
| Mean steady-state plasma concentration of the drug (Cav,ss) | Day 1, Day 8, Day 15, Day 29, Day 57, Day 84 |
| Steady-state trough plasma concentration of the drug (Ctrough, ss) | Day 1, Day 8, Day 15, Day 29, Day 57, Day 84 |
| The area under the steady-state blood drug concentration-time curve (AUCss) | Day 1, Day 8, Day 15, Day 29, Day 57, Day 84 |