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

Phase 4

Not yet recruiting

• Conditions: Allergic Reactions
• Interventions: Drug: Neffy; Drug: Adrenaline

• Registration Number: NCT06834165
• Lead Sponsor: ARS Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Study Start: 2025-04-30
• Primary Completion: 2026-04
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neffy	Neffy	-
IM adrenaline	Adrenaline	-

Primary Outcome Measures

Name	Time	Method
AEs after epinephrine treatment within 2 hours	2 hours