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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Urticaria Chronic
• Intervention / Treatment: Drug: Placebo; Drug: 0.5 mg epinephrine; Drug: 1 mg epinephrine

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Osnat Ehrman, MSc; Phone Number: 952.334.5797; Email: osnate@pacificlinkconsulting.com

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Not yet recruiting
    • Institute of Allergology IFA Charité - Campus Benjamin Franklin | Hindenburgdamm 30
• United States
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Recruiting
      • Endeavor Health Clinical Trials Center
      • Contact: Giselle Mosnaim, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Recruiting
      • Bernstein Clinical Research Center, LLC
      • Principal Investigator: Jonathan A. Bernstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Is a male or female between the ages of 18 and 65 years, inclusive.
• Has been clinically diagnosed with CSU and experiences an acute flare of moderate to severe urticaria symptoms (itch and hive severity UAS score ≥ 2) approximately 1-2 times a month or every other month consistently during the past year while on a chronic treatment.
• Has been on a daily chronic treatment for ≥ 6 weeks.
• Is willing to use a smartphone study application to record study assessments and AEs.
• Has body weight more than 15 kilogram (kg).
• Has no medical history of clinically significant hypertension and cardiovascular disease in the last 10 years
• If female, is not pregnant or breastfeeding based on a negative urine pregnancy test at baseline.
• Is able to communicate clearly with the Investigator and staff; able to read, complete questionnaires, and perform study procedures on the smartphone study application.
• Is willing and able to provide written informed consent prior to participating in the study.
• Controlled hypertension without beta blocker confirmed by the Investigator is acceptable.

• At screening, has stable vital signs in the following ranges (after 5 minutes of rest):

  • Systolic blood pressure (SBP) ≥90 and ≤140 milliliters of mercury (mmHg)
  • Diastolic blood pressure (DBP) ≥50 and ≤90 mmHg
  • Heart rate (HR) ≥45 and ≤100 beats per minute (bpm)

Exclusion Criteria:

• Has a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• Has any clinically significant medical condition or PE finding as deemed inappropriate by the Investigator.
• Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram (ECG)
• Has had significant traumatic injury or major surgery within 30 days prior to study screening.
• Known hypersensitivity to any compound in the test product, or any other closely related compound (e.g., dihydropyridine-derived molecules).
• Has participated in a clinical trial within 30 days prior to the first dose of study drug.
• Has an immediate family member of the Investigator, or an employee of the study center, with direct involvement in the proposed study, or other studies under the direction of the Investigator or study center or is in a dependent relationship with a study center employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo solution nasal spray containing no active drug will be administered using the commercial sprayer device.	Drug: Placebo; Placebo solution nasal spray containing no active drug
Active Comparator: 0.5 mg; 0.5 mg epinephrine per spray	Drug: 0.5 mg epinephrine; 0.5 mg epinephrine per spray
Active Comparator: 1 mg; 1 mg epinephrine per spray	Drug: 1 mg epinephrine; 1 mg epinephrine per spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on itch	Change in itch scores (Uniform Assessment System) - Range is a scale of 0-3. Zero is none and 3 is severe. [UAS] as compared to placebo at each timepoint on exacerbation days	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on hive	Change in hive scores (Uniform Assessment System) - Range is a scale of 0-3. Zero is none and 3 is severe. [UAS] as compared to placebo at each timepoint on exacerbation days	12 months

Collaborators and Investigators

• Sponsor: ARS Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Urticaria; Skin Diseases, Vascular; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Chronic Urticaria; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amines; Catechols; Phenols; Benzene Derivatives; Alcohols; Amino Alcohols; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Epinephrine
• Other Study ID Numbers: EPI U02

Drug and device information, study documents

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