Trial Outcomes & Findings for Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares (NCT NCT05496465)
NCT ID: NCT05496465
Last Updated: 2026-04-07
Results Overview
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
COMPLETED
PHASE2
21 participants
UAS score at 120 (± 10 min) minutes after dosing.
2026-04-07
Participant Flow
Cross-over study. All participants received at least one treatment.
Participant milestones
| Measure |
Sequence 1
1 mg ARS-1 IN: placebo: 2 mg ARS-1 IN
|
Sequence 2
2 mg ARS-1 IN: placebo: 1 mg ARS-1 IN
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares
Baseline characteristics by cohort
| Measure |
Interventional Treatment
n=21 Participants
Each subject received the following treatments in a randomized sequence:
ARS-1 1 mg ARS-1 2 mg placebo
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=527 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=527 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=527 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=527 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=527 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=527 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=527 Participants
|
PRIMARY outcome
Timeframe: UAS score at 120 (± 10 min) minutes after dosing.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
Outcome measures
| Measure |
2 mg
n=18 Participants
2 mg ARS-1 IN
|
Placebo
n=18 Participants
Placebo
|
1 mg
n=18 Participants
1 mg ARS-1 IN
|
|---|---|---|---|
|
Effect of ARS-1 Versus Placebo Based on a Patient Reported Pruritus/Hive Score
Hives
|
0.8 UAS score 0 to 3
Standard Error 0.3
|
1.8 UAS score 0 to 3
Standard Error 0.3
|
1.1 UAS score 0 to 3
Standard Error 0.3
|
|
Effect of ARS-1 Versus Placebo Based on a Patient Reported Pruritus/Hive Score
Itch
|
0.3 UAS score 0 to 3
Standard Error 0.1
|
1.5 UAS score 0 to 3
Standard Error 0.2
|
0.4 UAS score 0 to 3
Standard Error 0.1
|
Adverse Events
ARS-1 1mg
ARS-1 2mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ARS-1 1mg
n=21 participants at risk
1 mg ARS-1 IN
|
ARS-1 2mg
n=21 participants at risk
2 mg ARS-1 IN
|
Placebo
n=21 participants at risk
Placebo
|
|---|---|---|---|
|
General disorders
Nasal discomfort
|
28.6%
6/21 • Number of events 10 • AEs were collected for two hours after dosing.
There are no known risks anticipated for ARS-1.
|
33.3%
7/21 • Number of events 12 • AEs were collected for two hours after dosing.
There are no known risks anticipated for ARS-1.
|
0.00%
0/21 • AEs were collected for two hours after dosing.
There are no known risks anticipated for ARS-1.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60