NCT06834165

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: ARS Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Reactions

Interventions

Type	Name	Description
DRUG	Neffy	Epinephrine nasal spray
DRUG	Adrenaline	Epinephrine injection

Timeline

• Start date: 2025-05-20
• Primary completion: 2027-04-01
• Completion: 2027-06-01
• First posted: 2025-02-19
• Last updated: 2026-04-09

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study