A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCalixis Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Chronic urticaria with an identified cause other than chronic spontaneous urticaria.
Another active skin condition associated with chronic itching that could interfere with the study assessments.
Recent treatment with prohibited immunosuppressive therapy, biologic therapy, a Bruton's tyrosine kinase inhibitor, an investigational drug, or another therapy that inhibits the c-KIT receptor.
Clinically significant hepatic, hematologic, or renal disease or laboratory abnormalities.
Trial design
Treatments tested in this trial
- THB335 Lower Dose
- THB335 Higher Dose
- Placebo
Treatment groups
81 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov