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NCT05496465 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by ARS Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
21
Enrollment target

NCT05496465: Completed Phase 2 study, sponsored by ARS Pharmaceuticals.

NCT05496465 is a Phase 2 study that has completed, run by ARS Pharmaceuticals. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05496465, a Phase 2 study, has completed, sponsored by ARS Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
21 participants
Enrollment target

Study Summary

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

Primary Outcome

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

Interventions

  • DRUG ARS-1

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2022-07-28
Est. Completion 2024-02-29
Phase Phase 2
ARS Pharmaceuticals

4 total trials

What the finished NCT05496465 record still lists

NCT05496465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 1 intervention - of which ARS-1 is the first listed.

NCT05496465 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05496465 about?

NCT05496465 is a clinical study titled "Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares". Determine the effect of ARS-1 on a patient reported pruritus/hive score

What is the current status of trial NCT05496465?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2022-07-28. Estimated completion is 2024-02-29.

What interventions are being tested in trial NCT05496465?

The interventions under investigation include: ARS-1 (DRUG).

Who is sponsoring clinical trial NCT05496465?

This trial is sponsored by ARS Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05496465's enrollment target sits among peer trials

21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05496465, the US trial registry maintained by the National Library of Medicine. NCT05496465 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.