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Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).
Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies it tends to be more persistent and also its prevalence seems to be rising. Currently there is no proven treatment other than strict avoidance. We are attempting to decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut using peanut oral immunotherapy (OIT). We are also studying the effect of peanut OIT on the peanut specific immune response to determine if tolerance to peanut protein will develop. Children ages one to six years of age with peanut allergy will be randomized to peanut OIT or placebo (active subjects). Thirty subjects will also be recruited as controls. These subjects will not receive any peanut or placebo but only have skin prick testing and lab work in addition to a history and physical exam. Active subjects will undergo a modified rush immunotherapy on the first day and then increase the doses at least every two weeks up to a maintenance dose of 4 grams (equivalent to about 13 peanuts). Doses will be taken daily at home except for dose increases which will be done on the research unit. Outcome variables of interest include response to double-blind placebo controlled food challenge, skin prick testing, peanut specific IgE, and adverse events. These results will be compared between the start and end of peanut OIT using appropriate statistical analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peanut OIT | Active Comparator | Subjects randomized to receive active treatment with peanut protein flour. |
|
| Placebo | Placebo Comparator | Subjects randomized to receive placebo in the form of oat flour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peanut OIT | Drug | Peanut flour that is orally ingested in a graded fashion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving Tolerance as Defined by a Negative DBPCFC 4 Weeks After Discontinuation of Peanut OIT Therapy. | Upon completion of 60 months of peanut OIT treatment, subjects discontinued peanut OIT for 4 weeks. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms 4 weeks after discontinuing peanut OIT. | 61 months for those randomized to active treatment and 73 months for those randomized to placebo for the initial 12 months of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Subjects Achieving Full Desensitization as Defined by a Negative DBPCFC After 60 Months of Peanut OIT Therapy. | Upon completion of 60 months of peanut OIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCPFC) to assess desensitization. The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms after completing peanut OIT therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wesley Burks, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12562461 | Background | Patriarca G, Nucera E, Roncallo C, Pollastrini E, Bartolozzi F, De Pasquale T, Buonomo A, Gasbarrini G, Di Campli C, Schiavino D. Oral desensitizing treatment in food allergy: clinical and immunological results. Aliment Pharmacol Ther. 2003 Feb;17(3):459-65. doi: 10.1046/j.1365-2036.2003.01468.x. | |
| 17208602 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Blinded Phase-Peanut OIT | Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT. Peanut OIT: Peanut flour that is orally ingested in a graded fashion. |
| FG001 | Blinded Phase-Placebo | Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour. Placebo: Oat flour used as a placebo that is orally ingested a graded fashion |
| FG002 | Open Label Phase-Peanut OIT | Subjects receiving open-label peanut OIT treatment after unblinding through the end of study. Peanut OIT: Peanut flour that is orally ingested in a graded fashion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Blinded Phase |
| |||||||||||||
| Open Label Extension Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Blinded Phase-Peanut OIT | Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT. Peanut OIT: Peanut flour that is orally ingested in a graded fashion. |
| BG001 | Blinded Phase-Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Achieving Tolerance as Defined by a Negative DBPCFC 4 Weeks After Discontinuation of Peanut OIT Therapy. | Upon completion of 60 months of peanut OIT treatment, subjects discontinued peanut OIT for 4 weeks. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms 4 weeks after discontinuing peanut OIT. | Subjects completing 60 months of OIT treatment, then passing the DBPCFC on the last day of treatment, then completing the DBPCFC after 1 month off of treatment were analyzed. | Posted | Number | percentage of participants | 61 months for those randomized to active treatment and 73 months for those randomized to placebo for the initial 12 months of therapy |
|
Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blinded Phase-Peanut OIT | Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT. Peanut OIT: Peanut flour that is orally ingested in a graded fashion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edwin Kim, Director UNC Food Allergy Initiative | University of North Carolina at Chapel Hill | 919-843-9087 | edwinkim@email.unc.edu |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| Placebo | Drug | Oat flour used as a placebo that is orally ingested a graded fashion |
|
|
| 60 months for those randomized to active treatment and 72 months for those randomized to placebo for the initial 12 months of therapy |
| The Percentage of Subjects Who Tolerated the Initial-day Escalation to 6 mg of Peanut | The first day of peanut OIT dosing involved multiple increasing doses of peanut flour in what was called an initial escalation day up to a maximum dose of 6 mg of peanut protein. The secondary outcome measure assessed the percentage of subjects were successfully able to reach this 6 mg dose. | first day of peanut OIT dosing |
| The Percentage of Subjects Who Are Successfully Able to Escalate up to the 4000 mg Maximum Maintenance Dose of Peanut Protein OIT During the 60 Month Desensitization Phase of the Study | During the desensitization phase of the study, subjects under go an initial day escalation up to a maximum of 6 mg of peanut protein. They then undergo biweekly dose escalation over approximately 10 months up to a maximum dose of 4000 mg of peanut protein. This outcome reports the percentage of subjects that achieve this. | approximately 40 weeks (10 months) |
| Incidence of All Serious Adverse Events During the Study | All serious adverse events during the blinded and open-label phases of the study were recorded and reported as a safety outcome. | 61 months for those randomized to active peanut OIT and 73 months for those randomized to placebo for the initial 12 months of the study. |
| Buchanan AD, Green TD, Jones SM, Scurlock AM, Christie L, Althage KA, Steele PH, Pons L, Helm RM, Lee LA, Burks AW. Egg oral immunotherapy in nonanaphylactic children with egg allergy. J Allergy Clin Immunol. 2007 Jan;119(1):199-205. doi: 10.1016/j.jaci.2006.09.016. Epub 2006 Oct 27. |
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| NOT COMPLETED |
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Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.
Placebo: Oat flour used as a placebo that is orally ingested a graded fashion
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Secondary | The Percentage of Subjects Achieving Full Desensitization as Defined by a Negative DBPCFC After 60 Months of Peanut OIT Therapy. | Upon completion of 60 months of peanut OIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCPFC) to assess desensitization. The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms after completing peanut OIT therapy. | Subjects completing 60 months of OIT treatment and completing the DBPCFC on the last day of treatment were analyzed. | Posted | Number | percentage of participants | 60 months for those randomized to active treatment and 72 months for those randomized to placebo for the initial 12 months of therapy |
|
|
|
| Secondary | The Percentage of Subjects Who Tolerated the Initial-day Escalation to 6 mg of Peanut | The first day of peanut OIT dosing involved multiple increasing doses of peanut flour in what was called an initial escalation day up to a maximum dose of 6 mg of peanut protein. The secondary outcome measure assessed the percentage of subjects were successfully able to reach this 6 mg dose. | Open label phase includes subjects initially randomized to placebo and then subsequently crossed over to open label treatment. Subjects initially randomized to Peanut OIT maintained their dose and did not repeat this 6 mg initial-day escalation. | Posted | Number | percentage of participants | first day of peanut OIT dosing |
|
|
|
| Secondary | The Percentage of Subjects Who Are Successfully Able to Escalate up to the 4000 mg Maximum Maintenance Dose of Peanut Protein OIT During the 60 Month Desensitization Phase of the Study | During the desensitization phase of the study, subjects under go an initial day escalation up to a maximum of 6 mg of peanut protein. They then undergo biweekly dose escalation over approximately 10 months up to a maximum dose of 4000 mg of peanut protein. This outcome reports the percentage of subjects that achieve this. | Open label phase includes subjects initially randomized to placebo and then subsequently crossed over to open label treatment. Subjects initially randomized to Peanut OIT maintained their dose and did not re-escalate for the purposes of this outcome. | Posted | Number | percentage of patients | approximately 40 weeks (10 months) |
|
|
|
| Secondary | Incidence of All Serious Adverse Events During the Study | All serious adverse events during the blinded and open-label phases of the study were recorded and reported as a safety outcome. | The initial 10-11 months of the study were blinded. After unblinding, subjects completing the blinded phase continued on open label peanut OIT for the duration of the study. | Posted | Number | number of discrete SAE events | 61 months for those randomized to active peanut OIT and 73 months for those randomized to placebo for the initial 12 months of the study. |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 10 |
| 10 |
| EG001 | Blinded Phase-Placebo | Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour. Placebo: Oat flour used as a placebo that is orally ingested a graded fashion | 0 | 6 | 0 | 6 | 4 | 6 |
| EG002 | Open Label Phase-Peanut OIT | Subjects receiving open-label peanut OIT treatment after unblinding through the end of study. Peanut OIT: Peanut flour that is orally ingested in a graded fashion. | 0 | 15 | 0 | 15 | 15 | 15 |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Erythematous rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Oropharyngeal itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Itchy nose | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin itch | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Lip or eye swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Eye itch | Eye disorders | Systematic Assessment |
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| Eye tearing | Eye disorders | Systematic Assessment |
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| Hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| D007154 | Immune System Diseases |