Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients with Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy

ARS Pharmaceuticals

Status and phase: Not yet enrolling; Phase 4

Conditions: Allergic Reactions

Treatments: Drug: Adrenaline; Drug: Neffy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06834165

EPI R01

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Neffy

Active Comparator group

Treatment:

Drug: Neffy

IM adrenaline

Active Comparator group

Treatment:

Drug: Adrenaline