Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria.
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- Drug: TLL018 tablets
- Registration Number
- NCT05373355
- Lead Sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 TLL018 tablets TLL018 tablets 3pieces, BID Cohort 3 TLL018 tablets TLL018 placeboes 3pieces, BID Cohort 1 TLL018 tablets TLL018 tablets 1piece,BID
- Primary Outcome Measures
Name Time Method 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
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
respiratory rate from baseline From day 1 to Weeks 4 Change of respiratory rate 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
temperature from baseline From day 1 to Weeks 4 Change of oral temperature from 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
clinical laboratory abnormalities compared to baseline From day 1 to Weeks 4 Number of participants with clinical laboratory abnormalities compared to baseline
physical examination findings from baseline From day 1 to Weeks 4 Number of participants with changes in physical examination findings from baseline
- Secondary Outcome Measures
Name Time Method 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
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
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
respiratory rate from baseline From week 4 to Weeks 12 Change of respiratory rate from baseline
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
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
blood pressure from baseline From week 4 to Weeks 12 Change of blood pressure from baseline
temperature from baseline From week 4 to Weeks 12 Change of oral temperature from baseline
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
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
adverse events (AEs) according to severity From week 4 to Weeks 12 Number of adverse events (AEs) according to severity
clinical laboratory abnormalities compared to baseline From week 4 to Weeks 12 Number of participants with clinical laboratory abnormalities compared to baseline
physical examination findings from baseline From week 4 to Weeks 12 Number of participants with changes in physical examination findings from baseline
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
pulse rate from baseline From week 4 to Weeks 12 Change of pulse rate from baseline
Trial Locations
- Locations (1)
Hospital For Skin Diseases,Institute of Dermatology Chinese Academy of Medical Sciences, Peking Union Medical College
🇨🇳Nanjing, Jiangsu, China