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NCT06834165 | NOT YET RECRUITING | Allergic Reactions

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

ARS Pharmaceuticals, Inc.

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.

Condition or disease

Allergic Reactions

Intervention/treatment

Neffy

Adrenaline

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 600 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-04-30
Estimated Primary Completion Date : 2026-04
Estimated Study Completion Date : 2026-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 4 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients with Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy

Location Details

NCT06834165

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How to Participate

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Locations

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