Peanut Allergy
Conditions
Keywords
Food Allergy, Peanut, Sublingual Immunotherapy
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.
Interventions
DRUGPeanut Dissolving Film
Sponsors
Icahn School of Medicine at Mount Sinai
Johns Hopkins University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Subjects That Discontinue the Study for Treatment Related Reasons | 18 months | No healthy volunteers discontinued the study for treatment related reasons. No active participants enrolled. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events With Dosing | 18 months | — |
| The Proportion of Subjects Who Are Able to Tolerate the Full 10 Gram Peanut Protein Challenge at the Completion of the Study | 18 months | For peanut allergic subjects only |
| Number of Participants With Serious and Non-serious Adverse Effects With Therapy | 18 months | — |
| The Rate of Medication Use With Therapy | 18 months | 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 | 18 months | Only in peanut allergic subjects |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peanut Allergic Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film.
Peanut Dissolving Film | 0 |
| Healthy Volunteers Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films.
Peanut Dissolving Film | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Healthy Volunteers | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants |
| Region of Enrollment United States | 5 participants | 5 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 5 |
| other Total, other adverse events | 0 / 0 | 0 / 5 |
| serious Total, serious adverse events | 0 / 0 | 0 / 5 |
Outcome results
Primary
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.
Time frame: 18 months
Population: There were no peanut allergic subjects enrolled because the study ended prematurely due to manufacturing issues with the study product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Volunteers | The Proportion of Subjects That Discontinue the Study for Treatment Related Reasons | 0 Participants |
Secondary
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
Time frame: 18 months
Population: No participants were analyzed for this secondary outcome because data was not collected due to early termination of the study
Secondary
Number of Participants With Serious Adverse Events With Dosing
Time frame: 18 months
Population: No participants were analyzed for this secondary outcome in the peanut allergic group because no data was collected due to early termination of the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Volunteers | Number of Participants With Serious Adverse Events With Dosing | 0 participants |
Secondary
Number of Participants With Serious and Non-serious Adverse Effects With Therapy
Time frame: 18 months
Population: No participants were analyzed for this secondary outcome in the peanut allergic group because data was not collected due to early termination of the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peanut Allergic | Number of Participants With Serious and Non-serious Adverse Effects With Therapy | 0 Participants |
| Healthy Volunteers | Number of Participants With Serious and Non-serious Adverse Effects With Therapy | 0 Participants |
Secondary
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
Time frame: 18 months
Population: No participants were analyzed for this secondary outcome because data was not collected due to early termination of the study
Secondary
The Rate of Medication Use With Therapy
For peanut allergic subjects only.
Time frame: 18 months
Population: No participants were analyzed for this secondary outcome because no data for the outcome was collected due to early termination of the study