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NCT06834165PHASE4Recruiting

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

ARS Pharmaceuticals, Inc.

Start Date

5/20/2025

Completion Date

6/1/2027

Summary

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.

Eligibility Criteria

Age Range: 4 years to No maximum

Inclusion Criteria: * 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. Exclusion Criteria: \- Has any clinically significant medical condition that precludes treatment with epinephrine as assessed by the Investigator.

Interventions

DRUG

Neffy

DRUG

Adrenaline

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Conditions

Allergic Reactions

Locations

Orso Health, Inc.

La Jolla, California 92037

United States

Children's National Hospital

Washington D.C., District of Columbia 20010

United States

Endeavor Health

Glenview, Illinois 60026

United States

University Of Michigan

Ann Arbor, Michigan 48105

United States

Weill Cornell Medicine/NewYork Presbyterian Hospital

New York, New York 10021

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States