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

• ClinicalTrials.gov Identifier: NCT01897077
• Recruitment Status: Terminated
• First Posted: July 11, 2013
• Results First Posted: July 3, 2018
• Last Update Posted: July 3, 2018
• Sponsor: Johns Hopkins University
• Collaborator: Icahn School of Medicine at Mount Sinai
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Peanut Allergy	Drug: Peanut Dissolving Film	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Safety and Efficacy of a Peanut Immunotherapy Dissolving Film for Peanut Allergy
• Actual Study Start Date: November 2012
• Actual Primary Completion Date: February 3, 2013
• Actual Study Completion Date: February 3, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. The Proportion of Subjects That Discontinue the Study for Treatment Related Reasons [ Time Frame: 18 months ]
   No healthy volunteers discontinued the study for treatment related reasons. No active participants enrolled.

Secondary Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

United States, New York

Mount Sinai School of Medicine

New York, New York, United States, 10029

Sponsors and Collaborators

Johns Hopkins University

Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Robert Wood, MD; Johns Hopkins University
• Principal Investigator: Corinne Keet, MD, MS; Johns Hopkins University
• Principal Investigator: Hugh Sampson, MD; Icahn School of Medicine at Mount Sinai

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01897077
• Other Study ID Numbers: NA_00042409
• First Posted: July 11, 2013
• Results First Posted: July 3, 2018
• Last Update Posted: July 3, 2018
• Last Verified: July 2018

Keywords provided by Johns Hopkins University:

Food Allergy; Peanut; Sublingual Immunotherapy

Additional relevant MeSH terms:

Hypersensitivity; Peanut Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate