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

Launched by ARS PHARMACEUTICALS, INC. · Feb 18, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to evaluate the safety and effectiveness of two treatments, Neffy and intramuscular (IM) Adrenalin, for patients who experience allergic reactions after undergoing an oral food challenge (OFC) or allergen immunotherapy (AIT). Essentially, the study aims to find out which of these treatments works best for managing allergic responses that may require immediate intervention with epinephrine, a medication that can quickly reverse severe allergic reactions.

To participate in this trial, individuals must be at least 4 years old and weigh 15 kg or more. They should be scheduled for an OFC, AIT, or another relevant allergy challenge and must be experiencing an allergic reaction that requires treatment with epinephrine, as determined by a doctor. Participants will need to give consent to take part in the study, and if they are minors, permission will also be obtained from a parent or guardian. This study is not yet recruiting participants, but it aims to help improve the care of patients dealing with severe allergies.

Gender

ALL

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.