An Outpatient, Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria
This is a Phase 2b, outpatient, single-dose, randomized, double blind, placebo-controlled, three period crossover study that will consist of a screening period and three blinded treatment periods. Subjects enrolled will have CSU with a history of moderate to severe acute exacerbations (or flares).
• Is a male or female between the ages of 18 and 65 years, inclusive.
• Has been clinically diagnosed with CSU and experiences an acute flare of moderate to severe urticaria symptoms (itch and hive severity UAS score ≥ 2) approximately 1-2 times a month or every other month consistently during the past year while on a chronic treatment.
• Has been on a daily chronic treatment for ≥ 6 weeks.
• Is willing to use a smartphone study application to record study assessments and AEs.
• Has body weight more than 15 kilogram (kg).
• Has no medical history of clinically significant hypertension and cardiovascular disease in the last 10 years
• If female, is not pregnant or breastfeeding based on a negative urine pregnancy test at baseline.
• Is able to communicate clearly with the Investigator and staff; able to read, complete questionnaires, and perform study procedures on the smartphone study application.
• Is willing and able to provide written informed consent prior to participating in the study.
• Controlled hypertension without beta blocker confirmed by the Investigator is acceptable.
• At screening, has stable vital signs in the following ranges (after 5 minutes of rest):
‣ Systolic blood pressure (SBP) ≥90 and ≤140 milliliters of mercury (mmHg)
⁃ Diastolic blood pressure (DBP) ≥50 and ≤90 mmHg
⁃ Heart rate (HR) ≥45 and ≤100 beats per minute (bpm)