Chronic Spontaneous Urticaria
Conditions
Brief summary
This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 36 subjects with moderate to severe Chronic Spontaneous Urticaria.
Detailed description
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.
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 70 Years
Healthy volunteers
No
Inclusion criteria
* Have had a diagnosis of moderate to severe Chronic Spontaneous Urticaria for at least 6 months prior to Baseline; * Subjects with moderate to severe Chronic Spontaneous Urticaria UAS7 score ≥16 at Baseline; * Able and willing to give written informed consent.
Exclusion criteria
* Other types of Chronic Urticaria (such as Artificial urticaria, cold-contact urticaria, heat-contact urticaria etc); * Other disease with symptoms of urticaria or angioedema, e.g., Urticaria vasculitis, color Vegetarian urticaria, erythema multiforme; * 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 4 | 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 4 | Number of adverse events (AEs) according to severity |
| blood pressure from baseline | From day 1 to Weeks 4 | Change of blood pressure from baseline |
| pulse rate from baseline | From day 1 to Weeks 4 | Change of pulse rate from baseline |
| respiratory rate from baseline | From day 1 to Weeks 4 | Change of respiratory rate from baseline |
| temperature from baseline | From day 1 to Weeks 4 | Change of oral temperature from baseline |
| clinical laboratory abnormalities compared to baseline | From day 1 to Weeks 4 | Number of participants with clinical laboratory abnormalities compared to baseline |
| ECG parameters from baseline | From day 1 to Weeks 4 | 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 4 | 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 8 hours post-dose | Maximum observed plasma concentration (Cmax) of TLL018 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UAS7 score decreased from baseline at week 8 | Time Frame: Baseline to Week 8 | Change in mean value of UAS7 score from baseline at week 8 when comparing TLL-018 with placebo |
| UAS7 score decreased from baseline at week 12 | Baseline to Week 12 | Change in mean value of UAS7 score from baseline at week 12 when comparing TLL-018 with placebo |
| treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs | From week 4 to Weeks 12 | Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs |
| DLQI score decreased from baseline at week 8 | Baseline to Weeks 8 | Change in mean value of DLQI score from baseline at week 8 when comparing TLL-018 with placebo |
| DLQI score decreased from baseline at week 12 | Baseline to Weeks 12 | Change in mean value of DLQI score from baseline at week 12 when comparing TLL-018 with placebo |
| DLQI score decreased from baseline at week 4 | Baseline to Weeks 4 | Change in mean value of DLQI score from baseline at week 4 when comparing TLL-018 with placebo |
| adverse events (AEs) according to severity | From week 4 to Weeks 12 | Number of adverse events (AEs) according to severity |
| blood pressure from baseline | From week 4 to Weeks 12 | Change of blood pressure from baseline |
| pulse rate from baseline | From week 4 to Weeks 12 | Change of pulse rate from baseline |
| respiratory rate from baseline | From week 4 to Weeks 12 | Change of respiratory rate from baseline |
| temperature from baseline | From week 4 to Weeks 12 | Change of oral temperature from baseline |
| clinical laboratory abnormalities compared to baseline | From week 4 to Weeks 12 | Number of participants with clinical laboratory abnormalities compared to baseline |
| ECG parameters from baseline | From week 4 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 week 4 to Weeks 12 | Number of participants with changes in physical examination findings from baseline |
| UAS7 score decreased from baseline at week 4 | Baseline to Week 4 | Change in mean value of UAS7 score from baseline at week 4 when comparing TLL-018 with placebo |
Countries
China
Outcome results
None listed