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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age4+
SponsorARS Pharmaceuticals, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Neffy
  • Adrenaline

Treatment groups

600 Participants
are divided into 2 treatment groups

Sponsors and collaborators