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

Status and phase

Enrolling

Phase 4

Conditions

Allergic Reactions

Treatments

Drug: Adrenaline

Drug: Neffy

Study type

Interventional

Funder types

Industry

Identifiers

NCT06834165

EPI R01

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Ages

4+ years old

Volunteers

No Healthy Volunteers

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.