Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy
Recruiting now · Phase 4
Conditions studied: Allergic Reactions
In brief
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.
Key facts
- Study ID
- NCT06834165
- Run by
- ARS Pharmaceuticals, Inc.
- People needed
- 600
- Starts
- 2025-05-20
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-04-21
Who can join
Age: 4 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Has any clinically significant medical condition that precludes treatment with epinephrine as assessed by the Investigator.
Where it is running
- Orso Health, Inc. — La Jolla, California, United States (enrolling)
- Children's National Hospital — Washington D.C., District of Columbia, United States (enrolling)
- Endeavor Health — Glenview, Illinois, United States (enrolling)
- University Of Michigan — Ann Arbor, Michigan, United States (enrolling)
- Weill Cornell Medicine/NewYork Presbyterian Hospital — New York, New York, United States (enrolling)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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