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Study of Neffy or Adrenaline for Allergic Reactions

This study is looking at the safety of two treatments, Neffy (an epinephrine nasal spray) and Adrenaline (an epinephrine injection), for people who have allergic reactions. These reactions happen after an oral food challenge (OFC), allergen immunotherapy (AIT), or other allergy tests that might need epinephrine. The study aims to see if there are any side effects from these treatments within two hours. You could be eligible if you are at least 4 years old, weigh 15 kg (about 33 pounds) or more, and are scheduled for an allergy challenge. The study is currently unclear about its recruitment status and plans to enroll about 600 participants.

Study design
This interventional study plans to enroll 600 participants to compare Neffy (epinephrine nasal spray) and Adrenaline (epinephrine injection). The study phase is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events (side effects) for 2 hours after receiving epinephrine treatment.

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NCT06834165

Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy

Recruiting
PHASE4Ages 4+InterventionalTreatment
ARS Pharmaceuticals, Inc.
~600 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:NeffyAdrenaline

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
AEs after epinephrine treatment within 2 hours
Measured over 2 hours

Conditions

Allergic Reactions

Explore related trials

Allergic Reaction

Where it's being run

6 sites across 6 states
California1
District of Columbia1
Illinois1
Michigan1
New York1
Ohio1

Who to contact

Osnat Ehrman, MSc.
[email protected]
952.334.5797
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Is a patient 4 years old or greater, inclusive, who are scheduled to undergo OFC, AIT, or other relevant allergy challenge.
Has body weight 15 kg or greater at the time of allergy challenge.
Is willing and able to provide written informed consent prior to participating in the study. In the case of minors (\<18 years old), assent can be obtained from his/her legal representative, and as much possible from the patient himself/herself.
Patient experiences an allergic reaction that, in the opinion of the Investigator, requires treatment with epinephrine via neffy or IM Adrenalin.

What this trial measures

  • AEs after epinephrine treatment within 2 hours2 hours