CompletedNCT05496465Updated Apr 7, 2026Results posted

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

A Phase 2 interventional study of ARS-1 in Urticaria, sponsored by ARS Pharmaceuticals, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by ARS Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 21
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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

Conditions studied

Urticaria

Browse trials for

Urticaria 237

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 21 participants (actual)

Study arms

Experimental
Sequence 1
1 mg ARS-1 IN: placebo: 2 mg ARS-1 IN
Drug: ARS-1
Experimental
Sequence 2
2 mg ARS-1 IN: placebo: 1 mg ARS-1
Drug: ARS-1

Interventions

DrugARS-1
A single treatment of ARS-1 1mg, 2 mg or placebo

What researchers measure

Primary outcomes

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 1. Mild Easily tolerated 2. Moderate Bothersome but tolerable 3. Intense Difficult to tolerate Hive Severity Score Number of Hives 0 None 1. 1-6 2. 7-12 3. \>12
Time frame: UAS score at 120 (± 10 min) minutes after dosing.

Results

Posted Apr 7, 2026

Participant flow

Participant flow — Overall Study
Milestone	Sequence 1	Sequence 2
Started	10	11
Completed	8	10
Not completed	2	1

Outcome measures

PrimaryEffect 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 1. Mild Easily tolerated 2. Moderate Bothersome but tolerable 3. Intense Difficult to tolerate Hive Severity Score Number of Hives 0 None 1. 1-6 2. 7-12 3. \>12

Time frame:: UAS score at 120 (± 10 min) minutes after dosing.
Reported as:: Mean · UAS score 0 to 3

Effect of ARS-1 Versus Placebo Based on a Patient Reported Pruritus/Hive Score
UAS score 0 to 3	1 mg	2 mg	Placebo
Hives	1.1 ± 0.3	0.8 ± 0.3	1.8 ± 0.3
Itch	0.4 ± 0.1	0.3 ± 0.1	1.5 ± 0.2

Adverse events

Collected over AEs were collected for two hours after dosing.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
ARS-1 1mg	0/21 (0%)	0/21 (0%)	6/21 (28.6%)
ARS-1 2mg	0/21 (0%)	0/21 (0%)	7/21 (33.3%)
Placebo	0/21 (0%)	0/21 (0%)	0/21 (0%)

Most frequent other events

Most frequent other events
Event	ARS-1 1mg	ARS-1 2mg	Placebo
Nasal discomfortGeneral disorders	6/21	7/21	0/21

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Interventional Treatment
<=18 years	0
Between 18 and 65 years	21
>=65 years	0

Sex: Female, Male
Sex: Female, Male(Participants)	Interventional Treatment
Female	17
Male	4

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Interventional Treatment
Hispanic or Latino	0
Not Hispanic or Latino	0
Unknown or Not Reported	21

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Interventional Treatment
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	0
More than one race	0
Unknown or Not Reported	21

Region of Enrollment
Region of Enrollment(participants)	Interventional Treatment
United States	21

Study locations

2 sites

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

References and documents

Study documents

Protocol and statistical analysis plan · Aug 24, 2022

Documents are hosted by the registry — open the source record to download them.

Registry details

Key details

Study ID: NCT05496465
Lead sponsor: ARS Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Aug 11, 2022
Start date: Jul 28, 2022
Primary completion: Feb 29, 2024
Completion: Feb 29, 2024
Results posted: Apr 7, 2026
Last update: Apr 7, 2026

Study contacts

Sarina Tanimoto, MD, PhD

study director · ARS Pharmaceuticals, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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