NCT06834165PHASE4Recruiting
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, Inc.
Start Date
5/20/2025
Completion Date
6/1/2027
Summary
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
Age Range: 4 years to No maximum
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.
Interventions
DRUG
Neffy
DRUG
Adrenaline
Conditions
Allergic Reactions
Locations
Orso Health, Inc.
La Jolla, California 92037
United States
Children's National Hospital
Washington D.C., District of Columbia 20010
United States
Endeavor Health
Glenview, Illinois 60026
United States
University Of Michigan
Ann Arbor, Michigan 48105
United States
Weill Cornell Medicine/NewYork Presbyterian Hospital
New York, New York 10021
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States