Neffy versus intramuscular epinephrine for allergic reactions after food challenge or immunotherapy

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

This trial will test whether Neffy or standard intramuscular epinephrine works and is safe for people aged 4 and up who have allergic reactions during oral food challenges or allergen immunotherapy.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 4 Years and up
• Sex: All
• Sponsor: ARS Pharmaceuticals, Inc. (Industry-sponsored)
• Drugs / interventions: Immunotherapy
• Locations: 6 sites (La Jolla, California and 5 other locations)
• Trial ID: NCT06834165 on ClinicalTrials.gov

What this trial studies

This is a Phase 4 interventional study conducted at multiple U.S. centers enrolling patients age 4 and older who are scheduled for oral food challenges, allergen immunotherapy, or similar allergy challenges. If a participant has an allergic reaction that, in the investigator's opinion, requires epinephrine, they will be treated with either Neffy or intramuscular adrenaline according to the study protocol and monitored closely. Study staff will record symptom resolution, need for additional doses, vital signs, and any adverse events, with follow-up safety assessments after the event. The main focus is to characterize the safety and clinical response of Neffy compared with intramuscular adrenaline in these real-world challenge situations.

Who should consider this trial

Good fit: Ideal candidates are patients aged 4 years or older, weighing at least 15 kg, who are scheduled for an oral food challenge, allergen immunotherapy, or other allergy challenge and who experience a reaction judged to require epinephrine.

Not a fit: Patients with medical conditions that make epinephrine unsafe, those not undergoing a qualifying challenge, or those who do not experience a reaction are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the trial could support a needle-free epinephrine option that works as well as intramuscular adrenaline for treating reactions during challenges.

How similar studies have performed: Needle-free and intranasal epinephrine approaches have shown promising results in prior studies but are not yet as established as standard intramuscular epinephrine.

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.

Where this trial is running

La Jolla, California and 5 other locations

• Orso Health, Inc. — La Jolla, California, United States (Recruiting)
• Children's National Hospital — Washington D.C., District of Columbia, United States (Recruiting)
• Endeavor Health — Glenview, Illinois, United States (Recruiting)
• University Of Michigan — Ann Arbor, Michigan, United States (Recruiting)
• Weill Cornell Medicine/NewYork Presbyterian Hospital — New York, New York, United States (Recruiting)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Osnat Ehrman, MSc.

Conditions Allergic Reactions