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

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

Study Overview

• Status: Terminated
• Conditions: Peanut Allergy
• Intervention / Treatment: Drug: Peanut Dissolving Film

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Hugh Sampson, MD, ICAHN School of Medicine at Mount Sinai; Principal Investigator: Corinne Keet, MD, MS, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): February 3, 2013
• Study Completion (Actual): February 3, 2013

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: July 8, 2013
• First Posted (Estimate): July 11, 2013

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Peanut; Food Allergy; Sublingual Immunotherapy
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: NA_00042409