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

NCT05496465 | Completed Phase 2 FDA Drug

• 1 other identifier: RELIEF-CSU1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Urticaria

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessment will start from 1 hour pre-dose to 120 (± 10 min) minutes after dosing.

Study Arms (3)

ARS-1 1mg

ACTIVE COMPARATOR

1 mg per 100 µL dose of ARS-1

Drug: ARS-1

ARS-1 2mg

ACTIVE COMPARATOR

2 mg per 100 µL dose of ARS-1

Drug: ARS-1

Placebo

PLACEBO COMPARATOR

Placebo (100 µL)

Drug: Placebo

Interventions

ARS-1 DRUG

A single treatment of ARS-1.

ARS-1 1mg; ARS-1 2mg

Placebo DRUG

A single treatment of placebo nasal spray

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female subject between the ages of 18 and 65 years.
• \. Clinically diagnosed urticaria with acute symptom flares at least two (2) times a week while on a chronic treatment.
• \. Body weight more than 30 kg and body mass index between 18 and 34 kg/m².
• \. Has no medical history of hypertension and cardiovascular disease in the last 10 years.
• \. At screening, has stable vital signs.
• \. If female, is not pregnant or breastfeeding.
• \. 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.
• \. Is able to communicate clearly with the Investigator and staff. 9. Provide written informed consent prior to participating in the study.

You may not qualify if:

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

Sponsors & Collaborators

• ARS Pharmaceuticals, Inc.: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45236, United States

Location

MeSH Terms

Conditions

Urticaria

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sarina Tanimoto, MD, PhD

  ARS Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: August 11, 2022
• Study Start: July 28, 2022
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: October 27, 2025

Record last verified: 2025-10

Locations

US (2)