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This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 36 subjects with moderate to severe Chronic Spontaneous Urticaria.
Successfully screened subjects will be randomized in a ratio of 1：1：1. After a 4-week screening period (day -28-0), subjects will be randomly assigned to treatment for 12 weeks.
Clinical Urticaria Activity Score (UAS), 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 |
|
| Cohort 2 | Experimental | TLL018 tablets 3pieces, BID |
|
| Cohort 3 | Placebo Comparator | TLL018 placeboes 3pieces, BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLL018 tablets | Drug | Oral tablets administered at different doses BID daily for 12 weeks. |
|
| 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 4 |
| adverse events (AEs) according to severity | Number of adverse events (AEs) according to severity | From day 1 to Weeks 4 |
| blood pressure from baseline | Change of blood pressure from baseline | From day 1 to Weeks 4 |
| pulse rate from baseline | Change of pulse rate from baseline | From day 1 to Weeks 4 |
| respiratory rate from baseline | Change of respiratory rate from baseline | From day 1 to Weeks 4 |
| temperature from baseline | Change of oral temperature from baseline | From day 1 to Weeks 4 |
| clinical laboratory abnormalities compared to baseline | Number of participants with clinical laboratory abnormalities compared to baseline | From day 1 to Weeks 4 |
| ECG parameters from baseline |
| 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 week 4 to Weeks 12 |
| adverse events (AEs) according to severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital For Skin Diseases,Institute of Dermatology Chinese Academy of Medical Sciences, Peking Union Medical College | Nanjing | Jiangsu | 210042 | China |
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| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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 4 |
| physical examination findings from baseline | Number of participants with changes in physical examination findings from baseline | From day 1 to Weeks 4 |
| 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 8 hours post-dose |
Number of adverse events (AEs) according to severity |
| From week 4 to Weeks 12 |
| blood pressure from baseline | Change of blood pressure from baseline | From week 4 to Weeks 12 |
| pulse rate from baseline | Change of pulse rate from baseline | From week 4 to Weeks 12 |
| respiratory rate from baseline | Change of respiratory rate from baseline | From week 4 to Weeks 12 |
| temperature from baseline | Change of oral temperature from baseline | From week 4 to Weeks 12 |
| clinical laboratory abnormalities compared to baseline | Number of participants with clinical laboratory abnormalities compared to baseline | From week 4 to Weeks 12 |
| ECG parameters from baseline | Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline | From week 4 to Weeks 12 |
| physical examination findings from baseline | Number of participants with changes in physical examination findings from baseline | From week 4 to Weeks 12 |
| UAS7 score decreased from baseline at week 4 | Change in mean value of UAS7 score from baseline at week 4 when comparing TLL-018 with placebo | Baseline to Week 4 |
| UAS7 score decreased from baseline at week 8 | Change in mean value of UAS7 score from baseline at week 8 when comparing TLL-018 with placebo | Time Frame: Baseline to Week 8 |
| UAS7 score decreased from baseline at week 12 | Change in mean value of UAS7 score from baseline at week 12 when comparing TLL-018 with placebo | Baseline to Week 12 |
| DLQI score decreased from baseline at week 4 | Change in mean value of DLQI score from baseline at week 4 when comparing TLL-018 with placebo | Baseline to Weeks 4 |
| DLQI score decreased from baseline at week 8 | Change in mean value of DLQI score from baseline at week 8 when comparing TLL-018 with placebo | Baseline to Weeks 8 |
| DLQI score decreased from baseline at week 12 | Change in mean value of DLQI score from baseline at week 12 when comparing TLL-018 with placebo | Baseline to Weeks 12 |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |