Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy
Part of paid clinical trials in La Jolla, California.
- Sponsor
- ARS Pharmaceuticals, Inc.
- Study ID
- NCT06834165
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Allergic Reactions
Eligibility Criteria
- Sex
- ALL
- Age
- 4 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Neffy — DRUGEpinephrine nasal spray
- Adrenaline — DRUGEpinephrine injection
Study Details
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 Dates
- Start date
- May 20, 2025
- Status verified
- Apr 2026
- Primary completion
- Apr 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 600 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Neffy
- Active Comparator: IM adrenaline
Primary Outcome Measure
AEs after epinephrine treatment within 2 hours [ Time Frame: 2 hours ]
Central Contacts
- Osnat Ehrman, MSc.952.334.5797
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Orso Health, Inc. | La Jolla | California | 92037 | Investigator, MD Ali Doroudchi, MD (PRINCIPAL_INVESTIGATOR) |
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | Ammara Ahmed, DO |
| Endeavor Health | Glenview | Illinois | 60026 | Giselle Mosnaim, MD |
| University Of Michigan | Ann Arbor | Michigan | 48105 | Ian Slack, MD |
| Weill Cornell Medicine/NewYork Presbyterian Hospital | New York | New York | 10021 | |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | Yasmin Hassoun, MD (PRINCIPAL_INVESTIGATOR) |