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 IV Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy
1 other identifier
interventional
600
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2025
Typical duration for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2025
CompletedFirst Posted
Study publicly available on registry
February 19, 2025
CompletedStudy Start
First participant enrolled
May 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
April 21, 2026
April 1, 2026
1.9 years
February 18, 2025
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
AEs after epinephrine treatment within 2 hours
2 hours
Study Arms (2)
Neffy
ACTIVE COMPARATORIM adrenaline
ACTIVE COMPARATORInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Orso Health, Inc.
La Jolla, California, 92037, United States
Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
Endeavor Health
Glenview, Illinois, 60026, United States
University Of Michigan
Ann Arbor, Michigan, 48105, United States
Weill Cornell Medicine/NewYork Presbyterian Hospital
New York, New York, 10021, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2025
First Posted
February 19, 2025
Study Start
May 20, 2025
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share