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

NCT01897077 | Terminated Phase 1 Results DMC

• 1 other identifier: NA_00042409
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Peanut Allergy

Keywords

Food Allergy; Peanut; Sublingual Immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The Proportion of Subjects Who Are Able to Tolerate the Full 10 Gram Peanut Protein Challenge at the Completion of the Study

  18 months

• Number of Participants With Serious and Non-serious Adverse Effects With Therapy

  18 months

• The Rate of Medication Use With Therapy

  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

  18 months

• Number of Participants With Serious Adverse Events With Dosing

  18 months

Study Arms (2)

Peanut Allergic

EXPERIMENTAL

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

Drug: Peanut Dissolving Film

Healthy Volunteers

ACTIVE COMPARATOR

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

Drug: Peanut Dissolving Film

Interventions

Peanut Dissolving Film DRUG

Healthy Volunteers; Peanut Allergic

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Johns Hopkins University: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Corinne Keet
• Organization: Johns Hopkins School of Medicine

ckeet1@jhmi.edu

410-955-5883

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Study Start: November 1, 2012
• Primary Completion: February 3, 2013
• Study Completion: February 3, 2013
• Last Updated: July 3, 2018
• Results First Posted: July 3, 2018

Record last verified: 2018-07

Locations

US (2)