NCT06834165 Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy
| NCT ID | NCT06834165 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | ARS Pharmaceuticals, Inc. |
| Condition | Allergic Reactions |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 600 participants in total. It began in 2025-05-20 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06834165 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, studying Allergic Reactions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06834165 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06834165 currently recruiting?
Yes, NCT06834165 is actively recruiting participants. Contact the research team at osnate@pacificlinkconsulting.com for enrollment information.
Where is the NCT06834165 trial being conducted?
This trial is being conducted at La Jolla, United States, Washington D.C., United States, Glenview, United States, Ann Arbor, United States and 2 additional locations.
Who is sponsoring the NCT06834165 clinical trial?
NCT06834165 is sponsored by ARS Pharmaceuticals, Inc.. The trial plans to enroll 600 participants.