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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

StatusNot Yet Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Start date: Jul 15, 2026 to Aug 15, 2026v4
  2. Secondary endpoints: details revised at 4 of 7 entriesv3
  3. Secondary endpoints: details revised at 7 of 7 entries
    • Study title shortened, about 1 word
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07665996
Lead Sponsor Hangzhou Highlightll Pharmaceutical Co., Ltd
Conditions
(from sponsor)		 Chronic Spontaneous Urticaria (CSU)
Related terms Chronic Urticaria
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov