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

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Johns Hopkins University

Current Primary Outcome: The proportion of subjects that discontinue the study for treatment related reasons [ Time Frame: 1 month or 18 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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
• The rate of serious and non-serious adverse effects with therapy [ Time Frame: 18 months ]
  For peanut allergic subjects only.
• The rate of medication use with therapy [ Time Frame: 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 [ Time Frame: 18 months ]
• Characterization of safety of the peanut film by determination of the incidence of serious adverse events with dosing [ Time Frame: 18 months ]

Original Secondary Outcome:

• 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
• The rate of serious and non-serious adverse effects with therapy [ Time Frame: 18 months ]
  For peanut allergic subjects only.
• The rate of medication use with therapy [ Time Frame: 18 months ]
• Changes in biomarkers (peanut specific IgE and IgG, basophil reactivity, and salivary biomarkers) from baseline to the end of therapy [ Time Frame: 18 months ]
• Characterization of safety of the peanut film by determination of the incidence of serious adverse events with dosing [ Time Frame: 18 months ]

Information By: Johns Hopkins University

Dates:
Date Received: July 8, 2013
Date Started: November 2012
Date Completion: March 31, 2018
Last Updated: March 21, 2017
Last Verified: March 2017