The goal of this clinical trial is to evaluate the rapid onset characteristics of TLL-018 in moderate-to-severe CSU with inadequate response to second-generation H1 antihistamines. The main objectives are: To evaluate the rapid onset characteristics of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria. To evaluate the safety profile of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria. To evaluate the pharmacokinetic (PK) profile of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria. Participants will be randomly allocated at a 1:1:1 ratio to receive TLL-018 10 mg, TLL-018 20 mg, or placebo orally after meals.
Age range
18 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Time to first achievement of ≥1-point reduction from baseline in in-clinic Itch Severity Scale after first dose
Timeframe: First dose up to day 2
Time to first ≥1-point reduction from baseline in in-clinic Hive Severity Scale after first dose
Timeframe: First dose up to day 2
Change from baseline in in-clinic Itch Severity Scale post first dose
Timeframe: First dose up to 8 hours post first dose
Change from baseline in in-clinic Hive Severity Scale post first dose
Timeframe: First dose up to 8 hours post first dose
Change from baseline in in-clinic Numeric Rating Scale post first dose
Timeframe: First dose up to 8 hours post first dose
Proportion of participants with ≥1-point reduction from baseline in in-clinic Itch Severity Scale post first dose
Timeframe: First dose up to 8 hours post first dose
Proportion of participants with ≥1-point reduction from baseline in in-clinic Hive Severity Scale post first dose
Timeframe: First dose up to 8 hours post first dose
Proportion of participants with ≥3-point reduction from baseline in in-clinic Numeric Rating Scale post first dose (baseline clinic Numeric Rating Scale ≥3)
Timeframe: First dose up to 8 hours post first dose
Proportion of participants with ≥4-point reduction from baseline in in-clinic Numeric Rating Scale post first dose (baseline clinic Numeric Rating Scale ≥4)
Timeframe: First dose up to 8 hours post first dose
Change from baseline in Itch Severity Scale at Day 0.5, Day 1, Day 1.5 post first dose
Timeframe: First dose up to 1.5 days post first dose
Change from baseline in Hive Severity Scale at Day 0.5, Day 1, Day 1.5 post first dose
Timeframe: First dose up to 1.5 days post first dose
Change from baseline in Worst Itch Numeric Rating Scale at Day 0.5, Day 1, Day 1.5 post first dose
Timeframe: First dose up to 1.5 days post first dose
Change from baseline in in-clinic Itch Severity Scale at 2 hours post second dose
Timeframe: 2 hours post second dose
Change from baseline in in-clinic Hive Severity Scale at 2 hours post second dose
Timeframe: 2 hours post second dose
Change from baseline in in-clinic Numeric Rating Scale at 2 hours post second dose
Timeframe: 2 hours post second dose
Proportion of participants with ≥1-point reduction from baseline in in-clinic Itch Severity Scale at 2 hours post second dose
Timeframe: 2 hours post second dose
Proportion of participants with ≥1-point reduction from baseline in in-clinic Hive Severity Scale at 2 hours post second dose
Timeframe: 2 hours post second dose
Proportion of participants with ≥3-point reduction from baseline in in-clinic Numeric Rating Scale at 2 hours post second dose (baseline clinic Numeric Rating Scale ≥3)
Timeframe: 2 hours post second dose
Proportion of participants with ≥4-point reduction from baseline in in-clinic Numeric Rating Scale at 2 hours post second dose (baseline clinic Numeric Rating Scale ≥4)
Timeframe: 2 hours post second dose