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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06834165
- Acronym / sponsor ID
- EPI R01
- Conditions
- Allergic Reactions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- ARS Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 May 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neffy | Active comparator | Drug: Neffy |
| IM adrenaline | Active comparator | Drug: Adrenaline |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Has any clinically significant medical condition that precludes treatment with epinephrine as assessed by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeffyEpinephrine nasal spray | Drug | Neffy |
| AdrenalineEpinephrine injection | Drug | IM adrenaline |
Primary outcome
AEs after epinephrine treatment within 2 hours
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neffy and Adrenaline in people with Allergic Reactions, run by ARS Pharmaceuticals, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osnat Ehrman, MSc. (952.334.5797, osnate@pacificlinkconsulting.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs after epinephrine treatment within 2 hours (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.