88 Jiefang Road, Shangcheng District, Hangzhou City, Zhejiang Province
Hangzhou, Zhejiang, 310009, China
NCT Number: NCT05342428
This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 70 subjects with moderate to severe plaque psoriasis.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Hangzhou, Zhejiang, 310009, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral tablets administered at different doses BID daily for 12 weeks.
Other names: TLL018 Placeboes
Time frame: 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
Time frame: From day 1 to Weeks 12
Number of adverse events (AEs) according to severity
Time frame: From day 1 to Weeks 12
Change of blood pressure from baseline
Time frame: From day 1 to Weeks 12
Change of pulse rate from baseline
Time frame: From day 1 to Weeks 12
Change of respiratory rate from baseline
Time frame: From day 1 to Weeks 12
Change of oral temperature from baseline
Time frame: From day 1 to Weeks 12
Number of participants with clinical laboratory abnormalities compared to baseline
Time frame: From day 1 to Weeks 12
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
Number of participants with changes in physical examination findings from baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Weeks 4
static Physician Global Assessment (sPGA) 0/1 response
Time frame: Baseline to Weeks 8
static Physician Global Assessment (sPGA) 0/1 response
Time frame: Baseline to Weeks 12
static Physician Global Assessment (sPGA) 0/1 response
Hangzhou Highlightll Pharmaceutical Co., Ltd
Industry
A Phase Ⅰb, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of TLL-018 in Subjects With Moderate to Severe Plaque Psoriasis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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