Recruiting
Phase 2

Observational Study

Sponsor:

ARS Pharmaceuticals, Inc.

Code:

NCT06927999

Conditions

Urticaria Chronic

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Placebo

0.5 mg epinephrine

1 mg epinephrine

Study Details

Brief 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

Study ID

NCT06927999

Start date

Jul 9, 2025

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo solution nasal spray containing no active drug will be administered using the commercial sprayer device.

active comparator: 0.5 mg

0.5 mg epinephrine per spray

active comparator: 1 mg

1 mg epinephrine per spray

Interventions

Placebo

Placebo solution nasal spray containing no active drug

0.5 mg epinephrine

0.5 mg epinephrine per spray

1 mg epinephrine

1 mg epinephrine per spray

Primary outcome measure

  • Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on itch and hive [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Osnat Ehrman, MSc

952.334.5797osnate@pacificlinkconsulting.com

Locations

Endeavor Health Clinical Trials Center

Recruiting

Glenview, Illinois, United States, 60026

Bernstein Clinical Research Center, LLC

Recruiting

Cincinnati, Ohio, United States, 45236

Principal Investigator:

Jonathan A. Bernstein

More Information

Sponsor

ARS Pharmaceuticals, Inc.

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ARS Pharmaceuticals, Inc. on 2026-07-22.