Allergic ReactionsPhase 4NCT06834165
Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy
A Phase 4 study testing Neffy and Adrenaline in people with Allergic Reactions, run by ARS Pharmaceuticals, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Allergic Reactions
- What is being tested?
- Neffy and Adrenaline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 May 2025to Jun 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Has any clinically significant medical condition that precludes treatment with epinephrine as assessed by the Investigator.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University Of Michigan
Ann Arbor, Michigan, 48105
Ian Slack, MD
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Investigator, MD, 513-517-1179, Yasmin.hassoun@cchmc.org
Yasmin Hassoun, MD
- Recruiting
Endeavor Health
Glenview, Illinois, 60026
Giselle Mosnaim, MD
- Recruiting
Orso Health, Inc.
La Jolla, California, 92037
Investigator, MD
Ali Doroudchi, MD
- Recruiting
Weill Cornell Medicine/NewYork Presbyterian Hospital
New York, New York, 10021
Miriam Samstein, M.D, Ph.D., 347-834-3746, mb.eichenbaum@gmail.com
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Ammara Ahmed, DO
About this study
Official title: 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
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.
- Conditions
- Allergic Reactions
- Being tested
- Neffy, Adrenaline
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeffyDrug
Epinephrine nasal spray
AdrenalineDrug
Epinephrine injection
| Study group | Role | What they receive |
|---|---|---|
| Neffy | Active comparator | Not described Receives: Drug: Neffy |
| IM adrenaline | Active comparator | Not described Receives: Drug: Adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs after epinephrine treatment within 2 hours
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start20 May 2025
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ReactionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARS Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834165
- Sponsor's protocol ID
- EPI R01
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No