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

Primary Purpose

Peanut Allergy

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Peanut Dissolving Film
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring Food Allergy, Peanut, Sublingual Immunotherapy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins Hospital
  • Mount Sinai School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peanut Allergic

Healthy Volunteers

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Number of Participants With Serious and Non-serious Adverse Effects With Therapy
The Rate of Medication Use With Therapy
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
Only in peanut allergic subjects
Number of Participants With Serious Adverse Events With Dosing

Full Information

First Posted
July 8, 2013
Last Updated
July 2, 2018
Sponsor
Johns Hopkins University
Collaborators
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT01897077
Brief Title
The Safety and Efficacy of a Peanut Immunotherapy Dissolving Film for Peanut Allergy
Official Title
The Safety and Efficacy of a Peanut Immunotherapy Dissolving Film for Peanut Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Study product manufacturing suspended due to manufacturing problems, before initiation of study intervention.
Study Start Date
November 2012 (Actual)
Primary Completion Date
February 3, 2013 (Actual)
Study Completion Date
February 3, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
Food Allergy, Peanut, Sublingual Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peanut Allergic
Arm Type
Experimental
Arm Description
Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film.
Arm Title
Healthy Volunteers
Arm Type
Active Comparator
Arm Description
Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films.
Intervention Type
Drug
Intervention Name(s)
Peanut Dissolving Film
Primary Outcome Measure Information:
Title
The Proportion of Subjects That Discontinue the Study for Treatment Related Reasons
Description
No healthy volunteers discontinued the study for treatment related reasons. No active participants enrolled.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
The Proportion of Subjects Who Are Able to Tolerate the Full 10 Gram Peanut Protein Challenge at the Completion of the Study
Description
For peanut allergic subjects only
Time Frame
18 months
Title
Number of Participants With Serious and Non-serious Adverse Effects With Therapy
Time Frame
18 months
Title
The Rate of Medication Use With Therapy
Description
For peanut allergic subjects only.
Time Frame
18 months
Title
Changes in Biomarkers (Peanut Specific Immunoglobulin E (IgE) and Immunoglobulin G (IgG), Basophil Reactivity, and Salivary Biomarkers) From Baseline to the End of Therapy
Description
Only in peanut allergic subjects
Time Frame
18 months
Title
Number of Participants With Serious Adverse Events With Dosing
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Wood, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Corinne Keet, MD, MS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hugh Sampson, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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

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