An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria

Conditions

• Urticaria Chronic

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Placebo solution nasal spray containing no active drug
• 0.5 mg epinephrine — DRUG
  0.5 mg epinephrine per spray
• 1 mg epinephrine — DRUG
  1 mg epinephrine per spray

Study Details

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).

Key Dates

Start date

Jul 9, 2025

Status verified

Sep 2025

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

42 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Placebo solution nasal spray containing no active drug will be administered using the commercial sprayer device.
• Active Comparator: 0.5 mg
  0.5 mg epinephrine per spray
• Active Comparator: 1 mg
  1 mg epinephrine per spray

Primary Outcome Measure

Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on itch and hive [ Time Frame: 12 months ]

Central Contacts

• Osnat Ehrman, MSc
  952.334.5797
  [email protected]

Locations (2)

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