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

NCT06927999 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-10-02

No results posted yet for this study

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).

Conditions

  • Urticaria Chronic

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

Sponsors & Collaborators

  • ARS Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-09
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06927999 on ClinicalTrials.gov