NCT03251508

Salvage Peanut Oral Immunotherapy Study

Salvage Peanut Oral Immunotherapy Study: A Single-arm, Open Label Trial of Peanut Flour With 6 Month Active Treatment and 6 Month Follow-up

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 1 Year – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to study the safety of rescue peanut oral immunotherapy followed by the introduction of dietary peanut for patients with peanut allergy who have lost desensitization during a peanut immunotherapy trial.

Detailed description

Salvage Peanut Oral Immunotherapy Study is a single-arm, open label trial of peanut flour oral immunotherapy (OIT) administered for 6 months followed by introduction of dietary peanut for an additional 6 months. The peanut OIT phase will involve approximately 3 months of dose escalation up to a maintenance dose of 300 mg peanut protein. This is followed by 3 months of daily maintenance dosing with 300 mg of peanut protein. Patients are then transitioned to the dietary peanut phase ingesting common foods containing approximately 300 mg of peanut protein daily. Safety will be assessed during both peanut OIT and dietary peanut phases with adverse events recorded including gastrointestinal side effects. They will also be monitored for any anaphylaxis or injectable epinephrine administration. Data regarding compliance with peanut OIT will be collected as well.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
DRUG	Peanut OIT	Participants will be given increasing doses of the peanut flour as peanut oral immunotherapy (OIT) with increasing doses every 2 weeks over a period of 3 months up to a 300 mg target dose. This 300 mg peanut OIT maintenance dose is then continued daily for 3 months. Participants will then introduce dietary peanut of approximately 300 mg of peanut protein and continue daily ingestion for an additional 6 months.

Timeline

• Start date: 2018-01-03
• Primary completion: 2021-11-23
• Completion: 2021-11-23
• First posted: 2017-08-16
• Last updated: 2023-01-30
• Results posted: 2023-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study