Actively Recruiting

Phase 4
Age: 4Years +
All Genders
NCT06834165

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

Led by ARS Pharmaceuticals, Inc. · Updated on 2026-04-21

600

Participants Needed

6

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study is to assess the safety of neffy or IM Adrenalin in patients who are experiencing allergic reactions after an OFC, allergen Immunotherapy (AIT), or other allergy challenge that may require epinephrine intervention.

CONDITIONS

Official Title

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

Who Can Participate

Age: 4Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is 4 years old or older and scheduled for oral food challenge, allergen immunotherapy, or other allergy challenge
  • Patient weighs 15 kg or more at the time of allergy challenge
  • Patient or legal representative can provide written informed consent; minors to provide assent when possible
  • Patient experiences an allergic reaction judged by the Investigator to require epinephrine treatment via Neffy or IM Adrenalin
Not Eligible

You will not qualify if you...

  • Presence of any clinically significant medical condition that prevents treatment with epinephrine as assessed by the Investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Orso Health, Inc.

La Jolla, California, United States, 92037

Actively Recruiting

2

Children's National Hospital

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

3

Endeavor Health

Glenview, Illinois, United States, 60026

Actively Recruiting

4

University Of Michigan

Ann Arbor, Michigan, United States, 48105

Actively Recruiting

5

Weill Cornell Medicine/NewYork Presbyterian Hospital

New York, New York, United States, 10021

Actively Recruiting

6

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

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Research Team

O

Osnat Ehrman, MSc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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