An Outpatient, Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria
ARS Pharmaceuticals, Inc.
Summary
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).
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugPlacebo
Placebo solution nasal spray containing no active drug
- Drug0.5 mg epinephrine
0.5 mg epinephrine per spray
- Drug1 mg epinephrine
1 mg epinephrine per spray
Locations (3)
- Endeavor Health Clinical Trials CenterGlenview, Illinois
- Bernstein Clinical Research Center, LLCCincinnati, Ohio
- Institute of Allergology IFA Charité - Campus Benjamin Franklin | Hindenburgdamm 30Berlin