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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy and Safety of THB335 in Adult Participants With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Standard-of-Care Treatment

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Trial Profile

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy and Safety of THB335 in Adult Participants With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Standard-of-Care Treatment

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Aug 2026

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At a glance

  • Drugs THB 335 (Primary)
  • Indications Chronic urticaria
  • Focus Adverse reactions; Therapeutic Use

Most Recent Events

  • 17 Aug 2026 Status changed from planning to not yet recruiting.
  • 12 Jun 2025 According to a Third Harmonic Bio media release, the company has now completed all clinical, toxicology and manufacturing activities to support this Phase 2 clinical trial of THB335 for the treatment of chronic spontaneous urticaria, and it plans to submit imminently a regulatory filing with the US Food and Drug Administration (FDA) to seek clearance for trial initiation
  • 11 Feb 2025 According to a Third Harmonic Bio media release, The Company intends to continue THB335 development activities through the first half of 2025 to prepare for the initiation of a 12-week, placebo-controlled Phase 2 study in CSU by mid-year 2025.

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