Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy
RecruitingPhase 4
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
Who can join
Ages 4 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Neffy (drug)
- Adrenaline (drug)
Sponsor: ARS Pharmaceuticals, Inc. · Participants: 600 · Started: May 20, 2025
Contact the study team
- Osnat Ehrman, MSc. · Phone: 952.334.5797
Official record on ClinicalTrials.gov — NCT06834165
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.