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.
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 for ≥ 6 weeks prior to screening visit.
Progressive or uncontrolled symptoms of renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric or cerebral disorders that, in the investigator's judgment, would expose the patient to unacceptable risk from study participation.
A well-defined underlying etiology of chronic urticaria other than CSU, such as inducible urticaria, including but not limited to dermatographism, cold contact urticaria, heat contact urticaria, delayed pressure urticaria, solar urticaria, vibratory angioedema, cholinergic urticaria, aquagenic urticaria, and contact urticaria.
Other diseases presenting with urticaria or angioedema symptoms, including but not limited to urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, drug-induced urticaria, and hereditary or acquired angioedema.
Other chronic pruritic diseases that may interfere with efficacy outcome assessment, such as psoriasis, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, and senile pruritus.
Parallel
TLL-018
DrugParticipants will receive TLL-018 10 mg (1 tablet) and placebo (1 tablet) orally after meals, with a dosing interval of 12 hours (±15 minutes)
TLL-018
DrugParticipants will receive TLL-018 20 mg (2 tablets) orally after meals, with a dosing interval of 12 hours (±15 minutes)
Placebo
DrugParticipants will receive placebo (2 tablets) orally after meals, with a dosing interval of 12 hours (±15 minutes)
Time to first achievement of ≥1-point reduction from baseline in in-clinic Itch Severity Scale after first dose
Time from first dose until the first clinic assessment where a ≥1-point reduction from baseline in Itch Severity Scale (ISS, range 0-3; higher = worse itch) at in-clinic evaluation.
Time to first ≥1-point reduction from baseline in in-clinic Hive Severity Scale after first dose
Time from first dose to the first in-clinic assessment with ≥1-point reduction from baseline on Hive Severity Scale (HSS, 0-3).
Change from baseline in in-clinic Itch Severity Scale post first dose
Mean change from baseline of in-clinic ISS (0-3) at scheduled timepoints after first dose.
Change from baseline in in-clinic Hive Severity Scale post first dose
Mean change from baseline of in-clinic Hive Severity Scale (0-3) at scheduled timepoints after first dosing.
Change from baseline in in-clinic Itch Severity Scale within 1 hour prior to third dose and at 2 hours post third dose
Itch Severity Scale (ISS, range 0-3; higher = worse itch)
Change from baseline in in-clinic Hive Severity Scale within 1 hour prior to third dose and at 2 hours post third dose
Hive Severity Scale (HSS, range 0-3; higher = worse hive)
Change from baseline in in-clinic Numeric Rating Scale within 1 hour prior to third dose and at 2 hours post third dose
Itch Numeric Rating Scale (NRS): from 0 (no itch) to 10 (worst imaginable itch)
Proportion of participants with ≥1-point reduction from baseline in in-clinic Itch Severity Scale within 1 hour prior to third dose and at 2 hours post third dose
Itch Severity Scale (ISS, range 0-3; higher = worse itch)
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
To demonstrate the safety and tolerability of TLL-018 by assessing occurrence of treatment emergent adverse events and serious adverse events during the study.
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