Moderate to Severe Plaque Psoriasis
Conditions
Brief summary
This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 70 subjects with moderate to severe plaque psoriasis.
Detailed description
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.
Interventions
DRUGTLL018 tablets
Oral tablets administered at different doses BID daily for 12 weeks.
Sponsors
Hangzhou Highlightll Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Have had a diagnosis of moderate to severe plaque psoriasis for at least 6 months prior to Baseline; * Subjects with moderate to severe plaque psoriasis covering ≥10% BSA, with a PASI ≥12 and sPGA score ≥3 at Baseline; * Able and willing to give written informed consent.
Exclusion criteria
* Other types of psoriasis (such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, etc.); * Current drug-induced psoriasis, e.g., a new onset of psoriasis or an exacerbation of psoriasis induced by beta blockers, calcium channel blockers, antimalarial drugs or lithium; * History or symptoms of malignancy in any organ system regardless of treatment, and regardless of evidence of recurrence or metastasis; * Any uncontrolled clinically significant laboratory abnormality that would affect interpretation of study data or the subject's participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs | From day 1 to Weeks 12 | Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs |
| adverse events (AEs) according to severity | From day 1 to Weeks 12 | Number of adverse events (AEs) according to severity |
| blood pressure from baseline | From day 1 to Weeks 12 | Change of blood pressure from baseline |
| pulse rate from baseline | From day 1 to Weeks 12 | Change of pulse rate from baseline |
| respiratory rate from baseline | From day 1 to Weeks 12 | Change of respiratory rate from baseline |
| temperature from baseline | From day 1 to Weeks 12 | Change of oral temperature from baseline |
| clinical laboratory abnormalities compared to baseline | From day 1 to Weeks 12 | Number of participants with clinical laboratory abnormalities compared to baseline |
| ECG parameters from baseline | From day 1 to Weeks 12 | Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline |
| physical examination findings from baseline | From day 1 to Weeks 12 | Number of participants with changes in physical examination findings from baseline |
| 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 | Maximum observed plasma concentration (Cmax) of TLL018 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PASI score decreased from baseline at week 4 | Baseline to 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 |
| PASI score decreased from baseline at week 8 | Baseline to Week 8 | 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 |
| PASI score decreased from baseline at week 12 | Baseline to 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 |
| (sPGA) 0/1 response at week 4 | Baseline to Weeks 4 | static Physician Global Assessment (sPGA) 0/1 response |
| (sPGA) 0/1 response at week 8 | Baseline to Weeks 8 | static Physician Global Assessment (sPGA) 0/1 response |
| (sPGA) 0/1 response at week 12 | Baseline to Weeks 12 | static Physician Global Assessment (sPGA) 0/1 response |
Countries
China
Outcome results
None listed