A Phase Ib/IIa Study Assessing the Rapid Onset Characteristics of TLL-018 for Moderate-to-Severe CSU With Inadequate Response to Second-Generation H1 Antihistamines
brief summary
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.
official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ib/IIa Clinical Trial Assessing the Rapid Onset Characteristics of TLL-018 in Subjects With Moderate-to-Severe Chronic Spontaneous Urticaria Who Fail to Achieve Adequate Control With Second-Generation H1 Antihistamines