The Safety and Efficacy of a Peanut Immunotherapy Dissolving Film for Peanut Allergy

Study Overview
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Brief Summary
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The purpose of this study is to determine if a new method of administration of peanut sublingual immunotherapy, a dissolving peanut film, is effective.

Detailed Description
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Peanut allergy is a common problem with no current treatment. Recent studies have shown some success with oral or sublingual immunotherapy for the treatment of food allergy. Oral treatment, which requires very high doses, is associated with a small but appreciable risk of systemic reactions. Sublingual immunotherapy, which utilizes much smaller doses, is safer but constraints inherent in the available methods of sublingual administration have limited the utility of this method. Typically sublingual immunotherapy for food allergy has used either fresh foods or a simple liquid extract. These methods are not optimized for practicality or dwell duration in the mouth, and, thus far, dosing has been limited by the ability to make concentrated extracts and by the volume of extract that can be applied to the sublingual space. This study is being conducted to determine if a dissolving peanut extract film, will improve efficacy for immunotherapy for peanut allergy.

Official Title
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The Safety and Efficacy of a Peanut Immunotherapy Dissolving Film for Peanut Allergy

Conditions
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Peanut Allergy

Intervention / Treatment
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* Drug: Peanut Dissolving Film


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 50 years Provide signed informed consent Using appropriate birth control if subject is female and of child bearing age Are available for the study duration Healthy Volunteers Only Regularly consume a meal sized portion (5 grams) of peanut at least twice per month during the proceeding 6 months Peanut Allergic Subjects Only Have a history of symptomatic reactivity to peanut Have a positive skin prick test Have a positive oral food challenge to peanut at a cumulative dose of less than 1 grams of peanut protein Have self-injectable epinephrine available at home Exclusion Criteria: Have a history of severe anaphylaxis to peanut, defined as hypoxia, hypotension or neurological compromise as a result of ingestion of peanut. Have a history of intubation related to asthma Are pregnant or lactating Have a viral Upper Respiratory Infection (URI) or gastroenteritis within 7 days of Oral food challenge Have pulmonary function tests <80% of predicted (FEV1) or clinical history consistent with more than moderate persistent asthma Are currently taking greater than medium dose inhaled corticosteroid (>500 mcg/day fluticasone or fluticasone equivalent) Are unable to discontinue antihistamines for 5 days for long acting and 3 days for short acting prior to skin testing or food challenges Have used systemic corticosteroids within 4 weeks prior to baseline visit Are receiving omalizumab, beta-blocker, Angiotensin Converting Enzyme (ACE) inhibitor or tricyclic antidepressant therapy. Subjects need to be off omalizumab for 6 months. Have history of oral cancer. Use oral tobacco (i.e., chew tobacco) Have a chronic disease (other than asthma, atopic dermatitis or rhinitis) requiring therapy (e.g., heart disease, diabetes) Have participated in any interventional study for treatment of a food allergy in the past 12 months Have a history of eosinophilic esophagitis Have a severe reaction at initial double blind placebo-controlled food challenge, defined as either: Life-threatening anaphylaxis, or Reaction requiring hospitalization Healthy Volunteers Only History of any allergy to peanut

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peanut Allergic<br>Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film. | Drug: Peanut Dissolving Film<br> <br> |
| Active Comparator: Healthy Volunteers<br>Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films. | Drug: Peanut Dissolving Film<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Subjects That Discontinue the Study for Treatment Related Reasons | No healthy volunteers discontinued the study for treatment related reasons. No active participants enrolled. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Subjects Who Are Able to Tolerate the Full 10 Gram Peanut Protein Challenge at the Completion of the Study | For peanut allergic subjects only | 18 months | 
| Number of Participants With Serious and Non-serious Adverse Effects With Therapy |  | 18 months | 
| The Rate of Medication Use With Therapy | For peanut allergic subjects only. | 18 months | 
| Changes in Biomarkers (Peanut Specific Immunoglobulin E (IgE) and Immunoglobulin G (IgG), Basophil Reactivity, and Salivary Biomarkers) From Baseline to the End of Therapy | Only in peanut allergic subjects | 18 months | 
| Number of Participants With Serious Adverse Events With Dosing |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Allergy, Peanut, Sublingual Immunotherapy