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)

THB335-201 is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adults with CSU who remain symptomatic despite standard-of-care treatment. The study includes a Screening Period of up to 4 weeks, a 12-week Treatment Period, and a 4-week Follow-Up Period, for a total participant duration of approximately 20 weeks.

NCT Number	NCT07766499
Lead Sponsor	Calixis Inc.
Conditions	Chronic Spontaneous Urticaria (CSU), Chronic Idiopathic Urticaria
Enrollment	81 participants
Start Date	2026-09-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-01-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-14