Salvage Peanut Oral Immunotherapy Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peanut Allergy

Intervention / Treatment
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* Drug: Peanut OIT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have completed an immunotherapy trial for peanut allergy within the last 6 months and are unable to tolerate ≥ 300mg of peanut. Age 1-65 years of either sex, any race, any ethnicity. Written informed consent from patient or parent/guardian (if < 18 years) with participant's assent. Exclusion Criteria: Current participation in an interventional study for peanut allergy History of a severe anaphylactic reaction to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or SpO2 ≤ 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence) Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease Severe asthma (2007 NHLBI Criteria Steps 5 or 6 , Appendix 2) Use of B blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would put the subject at risk for induction of severe food reactions. Pregnancy or lactation.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peanut OIT/dietary peanut<br>Single arm study with all subjects receiving peanut OIT study drug for the initial 6 months. This is followed by daily ingestion of common dietary foods containing approximately 300 mg of peanut protein for an additional 6 months. | Drug: Peanut OIT<br>* 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.<br>* Other names: Peanut flour;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Experiencing Treatment-emergent Adverse Events During the 2-stage Study Sequence (Safety) | Percentage of participants experiencing an adverse event related to peanut oral immunotherapy (OIT) or dietary peanut ingestion | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Missed Doses During the 2-stage Study Sequence (Compliance) | Evaluation of patient compliance with a 2-stage peanut oral immunotherapy (OIT) and dietary peanut protocol as measured by the percentage of doses missed over the entire 2-stage study protocol sequence. | 12 months | 
| Percentage of Participants Experiencing Treatment-emergent Adverse Events During the Peanut Oral Immunotherapy Stage | Evaluation of peanut oral immunotherapy (OIT) safety measured by the percentage of participants experiencing an adverse event related to peanut OIT during the peanut oral immunotherapy (OIT) stage of the 2-stage Peanut Oral Immunotherapy/Dietary Peanut protocol. | 6 months | 
| Percentage of Missed Doses During the Peanut Oral Immunotherapy Stage | Evaluation of patient compliance measured by the percentage of doses missed during the peanut oral immunotherapy (OIT) stage of the 2-stage Peanut Oral Immunotherapy/Dietary Peanut protocol. | 6 months | 
| Percentage of Participants Utilizing Emergency Epinephrine Use During the 2-Stage Study Sequence (Safety) | Percentage of participants utilizing epinephrine for treatment of an adverse event related to peanut oral immunotherapy (OIT) or dietary peanut | 12 months | 
| Percentage of Participants Experiencing Gastrointestinal Adverse Events During the 2-stage Study Sequence (Safety) | Percentage of participants experiencing a gastrointestinal adverse event related to peanut oral immunotherapy (OIT) or dietary peanut | 12 months | 
| Percentage of Participants Withdrawing During the 2-stage Study Sequence Due to Gastrointestinal Adverse Events (Safety) | Percentage of participants withdrawing from the study due to a gastrointestinal adverse event related to peanut oral immunotherapy (OIT) or dietary peanut | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peanut