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RECRUITING
NCT06927999
PHASE2

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

Sponsor: ARS Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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).

Official title: An Outpatient, Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2025-07-09

Completion Date

2026-06

Last Updated

2025-10-02

Healthy Volunteers

No

Interventions

DRUG

Placebo

Placebo solution nasal spray containing no active drug

DRUG

0.5 mg epinephrine

0.5 mg epinephrine per spray

DRUG

1 mg epinephrine

1 mg epinephrine per spray

Locations (3)

Endeavor Health Clinical Trials Center

Glenview, Illinois, United States

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, United States

Institute of Allergology IFA Charité - Campus Benjamin Franklin | Hindenburgdamm 30

Berlin, Germany