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

Stopped early · Phase 1/Phase 2

Conditions studied: Peanut Allergy

In brief

The purpose of this study is to determine if a new method of administration of peanut sublingual immunotherapy, a dissolving peanut film, is effective.

Key facts

Study ID

NCT01897077

Run by

Johns Hopkins University

People needed

5

Starts

2012-11-01

Expected to finish

2013-02-03

Last updated by the study team

2018-07-03

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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:
• Life-threatening anaphylaxis, or
• Reaction requiring hospitalization
• Healthy Volunteers Only
• History of any allergy to peanut

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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