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Recruiting

NCT Number: NCT06834165

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

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.

Recruiting

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Key information

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Orso Health, Inc., La Jolla, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neffy

Drug

Epinephrine nasal spray

Adrenaline

Drug

Epinephrine injection

Primary outcomes

  1. AEs after epinephrine treatment within 2 hours

    Time frame: 2 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Osnat Ehrman, MSc.

CONTACT

[email protected]

952.334.5797

Sponsors and collaborators

Lead sponsor

ARS Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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