The goal of this clinical trial is to learn if different doses of TLL-018 works to treat in moderate-to-severe chronic spontaneous urticaria (CSU) participants . It will also learn about the safety of TLL-018. The main questions it aims to answer are:
Which is the best regimen of TLL-018 administration in reducing or eliminating symptoms (hives, itch, and/or angioedema) ? What medical problems do participants have when taking TLL-018? Researchers will compare different doses of TLL-018, and placebo (a look-alike substance that contains no drug).
Participants will:
Take TLL-018 or a placebo every day for 12 weeks Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms
Aged between 18 and 75.
Diagnosis of CSU refractory to second-generation H1-AH.
CSU diagnosis for ≥ 6 months.
The presence of itch and hives despite current use of an approved dose of H1-AH prior to randomization.
Progressive or uncontrolled signs or symptoms of renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiovascular, neurologic, psychiatric, or cerebral disease, as judged by the investigator to place the subject at unacceptable risk by study participation.
Clearly defined underlying etiology for chronic urticarias other than CSU. E.g. induced urticaria, including but not limited to artificial urticaria.
Any disease, which may have symptoms of urticaria and/or angioedema, including but not limited to urticaria and vasculitis.
Suffering from other chronic pruritic diseases that may affect the assessment of efficacy, such as psoriasis, atopic dermatitis, etc.
Parallel
TLL-018 tablets
DrugTLL-018 tablets taken orally 10 mg (1 tablet) twice daily
TLL-018 tablets
DrugTLL-018 tablets taken orally 20 mg (2 tablets) twice daily
Placebo
DrugPlacebo taken orally (2 tablets) twice daily for 12 weeks
Change from baseline in weekly Itch Severity Score at Week 12
The weekly Itch Severity Score (ISS7) is the itch severity score for 7 days, and it ranges from 0 to 21 (higher = worse itch).
Change from baseline in weekly Urticaria Activity Score at Week 12
The weekly Urticaria Activity Score (UAS7) is a scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
Change from baseline in weekly Hive Severity Score
Change from baseline in weekly hive severity score (HSS7) at week 1, 2, 4, 8, and 12. The weekly hive severity score (HSS7) ranges from 0 to 21 (higher = worse).
Proportion of Participants With weekly Urticaria Activity Score ≤ 6
Proportion of participants achieve disease activity control (weekly Urticaria Activity Score≤6) at Week 1, 2, 4, 8, and 12. The weekly Urticaria Activity Score is a scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
Proportion of Participants With weekly Urticaria Activity Score = 0
Proportion of participants achieve achieve complete absence of hives and itch (weekly Urticaria Activity Score=0) at Week 1, 2, 4, 8, and 12. The weekly Urticaria Activity Score is a scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
Change from baseline in Dermatology Life Quality Index score
Change from baseline in Dermatology Life Quality Index score at week 4, 8,and 12. The Dermatology Life Quality Index (DLQI) is a widely used patient-reported outcome (PRO) instrument with a range of 0-30, higher scores indicate greater impairment of quality of life.
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