Calixis Inc.
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.
This study will evaluate the efficacy and safety of THB335 in adults with chronic spontaneous urticaria (CSU) who continue to have hives and itching despite treatment with a second-generation H1 antihistamine. Approximately 81 participants will be randomly assigned to receive 1 of 2 doses of THB335 or matching placebo orally once daily for 12 weeks, in addition to their stable antihistamine treatment. Neither participants nor study personnel will know the assigned treatment. Participants will then be followed for 4 weeks. The main assessment is the change in weekly Urticaria Activity Score (UA…
Key Inclusion Criteria: * Males and females 18 through 85 years. * Diagnosis of chronic spontaneous urticaria (CSU) ≥ 6 months. * Active CSU despite treatment with a second-generation H1 antihistamine. * Weekly Urticaria Activity Score (UAS7) ≥ 16 and ISS7 ≥ 8 during the 7 days before randomization, with sufficient electronic diary entries to calculate the baseline scores. * Body mass index of 18 to 38 kg/m² and minimum body weight of 50 kg for male participants or 45 kg for female participants. * Willing and able to complete the daily electronic diary, attend scheduled study visits, and comp…
THB335 is an orally administered capsule added to a stable background regimen of a second generation H1 antihistamine.
THB335 is an orally administered capsule added to a stable background regimen of a second generation H1 antihistamine.
Placebo is an orally administered capsule added to a stable background regimen of a second generation H1 antihistamine.