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

Phase 1

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Peanut Dissolving Film	Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films.
Peanut Allergic	Peanut Dissolving Film	Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film.

Primary Outcome Measures

Name	Time	Method
The Proportion of Subjects That Discontinue the Study for Treatment Related Reasons	18 months	No healthy volunteers discontinued the study for treatment related reasons. No active participants enrolled.

Secondary Outcome Measures

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