Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares

A Single-Dose, Randomized, Placebo-Controlled, Cross-Over Study of the Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares

Determine the effect of ARS-1 on a patient reported pruritus/hive score

Study Overview

• Status: Completed
• Conditions: Urticaria
• Intervention / Treatment: Drug: ARS-1

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Bernstein Clinical Research Center, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Male or female subject between the ages of 18 and 65 years.
• 2. Clinically diagnosed urticaria with acute symptom flares at least two (2) times a week while on a chronic treatment.
• 3. Body weight more than 30 kg and body mass index between 18 and 34 kg/m².
• 4. Has no medical history of hypertension and cardiovascular disease in the last 10 years.
• 5. At screening, has stable vital signs.
• 6. If female, is not pregnant or breastfeeding.

• 7. If male (with or without vasectomy), agree to the use of highly effective contraceptive methods at screening until 7 days after the last day of study drug.

  8. Is able to communicate clearly with the Investigator and staff. 9. Provide written informed consent prior to participating in the study.

Exclusion Criteria:

• 1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease.
• 2. Patients receiving beta blocker due to potential interaction with the study drug.
• 3. Prior nasal fractures, severe nasal injuries or history of nasal disorders.
• 4. Clinically significant medical condition or physical exam finding.
• 5. Abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal ECG.
• 6. Mucosal inflammatory disorders.
• 7. Significant traumatic injury or major surgery within 30 days prior to study screening.
• 8. Has donated blood or had an acute loss of blood (>50 mL) during the 30 days before study drug administration.
• 9. Known hypersensitivity to any compound in the test product.
• 10. Participated in a clinical trial within 30 days prior to the first dose of study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; 1 mg ARS-1 IN: placebo: 2 mg ARS-1 IN	Drug: ARS-1; A single treatment of ARS-1 1mg, 2 mg or placebo
Experimental: Sequence 2; 2 mg ARS-1 IN: placebo: 1 mg ARS-1	Drug: ARS-1; A single treatment of ARS-1 1mg, 2 mg or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of ARS-1 Versus Placebo Based on a Patient Reported Pruritus/Hive Score	Assess time to effect and duration of effect on acute flares associated with urticaria based on a patient reported pruritus/hive score, from 0 (none) to 3 (severe) for itch and hive using Uniform Assessment System (UAS) as below: Severity Score Amount of Itch Itch Severity 0 None None; Mild Easily tolerated; Moderate Bothersome but tolerable; Intense Difficult to tolerate Hive Severity Score Number of Hives 0 None; 1-6; 7-12; >12	UAS score at 120 (± 10 min) minutes after dosing.

Collaborators and Investigators

• Sponsor: ARS Pharmaceuticals, Inc.
• Investigators: Study Director: Sarina Tanimoto, MD, PhD, ARS Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2022
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Vascular; Skin and Connective Tissue Diseases; Urticaria
• Other Study ID Numbers: RELIEF-CSU1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No