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RecruitingPhase 4

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, Inc. · NCT06834165

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 4+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 4
Target enrollment
600
US sites recruiting
6
Study start
May 20, 2025
Record last updated
April 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is 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.

Being studied: Neffy; Adrenaline

Conditions: Allergic Reactions

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Orso Health, Inc.

    La Jolla, CA 92037

    Site contact: Investigator, MD

  • Children's National Hospital

    Washington D.C., DC 20010

    Site contact: Ammara Ahmed, DO

  • Endeavor Health

    Glenview, IL 60026

    Site contact: Giselle Mosnaim, MD

  • University Of Michigan

    Ann Arbor, MI 48105

    Site contact: Ian Slack, MD

  • Weill Cornell Medicine/NewYork Presbyterian Hospital

    New York, NY 10021

    Site contact: Miriam Samstein, M.D, Ph.D. · 347-834-3746 · mb.eichenbaum@gmail.com

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, OH 45229

    Site contact: Investigator, MD · 513-517-1179 · Yasmin.hassoun@cchmc.org

Study contacts (from the official record)

  • Osnat Ehrman, MSc. · 952.334.5797 · osnate@pacificlinkconsulting.com
Study Evaluating the Safety and Efficacy of Neffy or Intramuscular… (NCT06834165) | Bored Studies