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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
73
Oral tablets administered at different doses BID daily for 12 weeks.
88 Jiefang Road, Shangcheng District, Hangzhou City, Zhejiang Province
Hangzhou, Zhejiang, China
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
Time frame: From day 1 to Weeks 12
adverse events (AEs) according to severity
Number of adverse events (AEs) according to severity
Time frame: From day 1 to Weeks 12
blood pressure from baseline
Change of blood pressure from baseline
Time frame: From day 1 to Weeks 12
pulse rate from baseline
Change of pulse rate from baseline
Time frame: From day 1 to Weeks 12
respiratory rate from baseline
Change of respiratory rate from baseline
Time frame: From day 1 to Weeks 12
temperature from baseline
Change of oral temperature from baseline
Time frame: From day 1 to Weeks 12
clinical laboratory abnormalities compared to baseline
Number of participants with clinical laboratory abnormalities compared to baseline
Time frame: From day 1 to Weeks 12
ECG parameters from baseline
Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline
Time frame: From day 1 to Weeks 12
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physical examination findings from baseline
Number of participants with changes in physical examination findings from baseline
Time frame: From day 1 to Weeks 12
Cmax of TLL018
Maximum observed plasma concentration (Cmax) of TLL018
Time frame: 0 hour (pre-dose - within 30 minutes prior to dosing), and at 0.5, 1, 2, 4 and 12 hours post-dose
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
Time frame: Baseline to Week 4
PASI score decreased from baseline at 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
Time frame: 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
Time frame: Baseline to Week 12
(sPGA) 0/1 response at week 4
static Physician Global Assessment (sPGA) 0/1 response
Time frame: Baseline to Weeks 4
(sPGA) 0/1 response at week 8
static Physician Global Assessment (sPGA) 0/1 response
Time frame: Baseline to Weeks 8
(sPGA) 0/1 response at week 12
static Physician Global Assessment (sPGA) 0/1 response
Time frame: Baseline to Weeks 12