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This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 70 subjects with moderate to severe plaque psoriasis.
Successfully screened subjects will be randomized in a ratio of 2:2:2:1 and stratified to previous biologics use for psoriasis.
After a 4-week screening period (day -28-0), subjects will be randomly assigned to treatment for 12 weeks.
Clinical psoriasis area and severity index (PASI), Physician's Global Assessment (PGA), dermatological Quality of Life Index (DLQI), physical exams and Laboratory tests will be performed at baseline, the end of weeks 4, 8 and 12 respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | TLL018 tablets, 1piece,BID |
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| Cohort 2 | Experimental | TLL018 tablets, 2pieces, BID |
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| Cohort 3 | Experimental | TLL018 tablets, 3pieces, BID |
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| Cohort 4 | Placebo Comparator | TLL018 placeboes, 3pieces, BID |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLL018 tablets | Drug | Oral tablets administered at different doses BID daily for 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs | Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs | From day 1 to Weeks 12 |
| adverse events (AEs) according to severity | Number of adverse events (AEs) according to severity | From day 1 to Weeks 12 |
| blood pressure from baseline | Change of blood pressure from baseline | From day 1 to Weeks 12 |
| pulse rate from baseline | Change of pulse rate from baseline | From day 1 to Weeks 12 |
| respiratory rate from baseline | Change of respiratory rate from baseline | From day 1 to Weeks 12 |
| temperature from baseline | Change of oral temperature from baseline | From day 1 to Weeks 12 |
| clinical laboratory abnormalities compared to baseline | Number of participants with clinical laboratory abnormalities compared to baseline | From day 1 to Weeks 12 |
| ECG parameters from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| PASI score decreased from baseline at week 4 | The percentage of subjects whose PASI score decreased by at least 50%(PASI 50) 75%(PASI 75) 90%(PASI 90) and 100%(PASI 100) from baseline at week 4 when comparing TLL-018 with placebo | Baseline to Week 4 |
| PASI score decreased from baseline at week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 88 Jiefang Road, Shangcheng District, Hangzhou City, Zhejiang Province | Hangzhou | Zhejiang | 310009 | China |
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Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline
| From day 1 to Weeks 12 |
| physical examination findings from baseline | Number of participants with changes in physical examination findings from baseline | From day 1 to Weeks 12 |
| Cmax of TLL018 | Maximum observed plasma concentration (Cmax) of TLL018 | 0 hour (pre-dose - within 30 minutes prior to dosing), and at 0.5, 1, 2, 4 and 12 hours post-dose |
The percentage of subjects whose PASI score decreased by at least 50%(PASI 50) 75%(PASI 75) 90%(PASI 90) and 100%(PASI 100) from baseline at week 8 when comparing TLL-018 with placebo |
| Baseline to Week 8 |
| PASI score decreased from baseline at week 12 | The percentage of subjects whose PASI score decreased by at least 50%(PASI 50) 75%(PASI 75) 90%(PASI 90) and 100%(PASI 100) from baseline at week 12 when comparing TLL-018 with placebo | Baseline to Week 12 |
| (sPGA) 0/1 response at week 4 | static Physician Global Assessment (sPGA) 0/1 response | Baseline to Weeks 4 |
| (sPGA) 0/1 response at week 8 | static Physician Global Assessment (sPGA) 0/1 response | Baseline to Weeks 8 |
| (sPGA) 0/1 response at week 12 | static Physician Global Assessment (sPGA) 0/1 response | Baseline to Weeks 12 |