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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
Placebo solution nasal spray containing no active drug
0.5 mg epinephrine per spray
1 mg epinephrine per spray
Endeavor Health Clinical Trials Center
Glenview, Illinois, United States
RECRUITINGBernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States
RECRUITINGInstitute of Allergology IFA Charité - Campus Benjamin Franklin | Hindenburgdamm 30
Berlin, Germany
NOT_YET_RECRUITINGDetermine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on itch
Change in itch scores (Uniform Assessment System) - Range is a scale of 0-3. Zero is none and 3 is severe. \[UAS\] as compared to placebo at each timepoint on exacerbation days
Time frame: 12 months
Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on hive
Change in hive scores (Uniform Assessment System) - Range is a scale of 0-3. Zero is none and 3 is severe. \[UAS\] as compared to placebo at each timepoint on exacerbation days
Time frame: 12 months
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