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

NCT ID: NCT01897077

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-02-03

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.

Conditions

Peanut Allergy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peanut Allergic

Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film.

Group Type: EXPERIMENTAL

Peanut Dissolving Film

Intervention Type: DRUG

Healthy Volunteers

Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films.

Group Type: ACTIVE_COMPARATOR

Peanut Dissolving Film

Intervention Type: DRUG

Interventions

Peanut Dissolving Film

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Wood, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Corinne Keet, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Hugh Sampson, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Mount Sinai School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

NA_00042409

Identifier Type: -

Identifier Source: org_study_id