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RECRUITING
NCT06834165
PHASE4

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

Sponsor: ARS Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase IV Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy

Key Details

Gender

All

Age Range

4 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2025-05-20

Completion Date

2027-06

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

Neffy

Epinephrine nasal spray

DRUG

Adrenaline

Epinephrine injection

Locations (6)

Orso Health, Inc.

La Jolla, California, United States

Children's National Hospital

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

Endeavor Health

Glenview, Illinois, United States

University Of Michigan

Ann Arbor, Michigan, United States

Weill Cornell Medicine/NewYork Presbyterian Hospital

New York, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States