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A Study of Efficacy and Safety of TLL-018 in CSU Participants

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruitingv5 Show 5 more changesShow less
    • Enrollment target: estimated 436 to confirmed 440
    • Primary completion date changed from estimate of Mar 30, 2026 to Oct 23, 2025
    • Study completion date: Dec 30, 2027 to Dec 30, 2026
    • Start date: Dec 24, 2024 to Mar 27, 2024
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 30, 2024 to Dec 24, 2024
    v4
  3. Study title shortened, about 2 wordsv3
  4. Interventions: TLL-018 tablets；Placebo tablets (Drug) to Placebo tablets (Drug), TLL-018 tablets (Drug)
    • Study title shortened, about 7 words
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TLL-018 in Participants With Moderate-to-Severe Chronic Spontaneous Urticaria (CSU) With Inadequate Controll to Second Generation H1-antihistamines.
Trial Details
NCT Number NCT06396026
Lead Sponsor Hangzhou Highlightll Pharmaceutical Co., Ltd
Conditions
(from sponsor)		 Chronic Spontaneous Urticaria
Related terms Chronic Urticaria
Enrollment 440 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov