Peanut Allergic SubjectsPhase 1PeanutFlourNCT02203799
Peanut Oral Immunotherapy in Children With Peanut Allergy (Peanut Flour)
A Phase 1 study testing Peanut Oral Immunotherapy (POIT) in people with Peanut Allergic Subjects, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Many children who are allergic to peanuts do not outgrow their allergy and have very severe allergic reactions called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing, decreased blood pressure, hives, and lip or throat swelling after exposure to an allergen. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Peanut Allergic Subjects
- What is being tested?
- Peanut Oral Immunotherapy (POIT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2014to 11 Feb 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 5-16 years of either sex, any race, any ethnicity, weighing at least 18.3 kg at the time of the initial visit.
- The presence of Immunoglobulin E (IgE) specific to peanuts (a positive skin prick test to peanuts (diameter of wheal > 3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 7 kUA/L) measured within the past year.
- Significant clinical symptoms occurring within 120 minutes after ingesting peanuts during an observed DBPCFC. Patients who have not had previous oral exposure to peanut will be observed for a longer duration of 150 minutes because they may demonstrate a delayed immune response, given the lack of prior peanut exposure. Also, patients with a history of prior anaphylaxis will be observed for 150 minutes.
- Provide signed informed consent.
- Ability to follow-up regularly for scheduled appointments.
- Subjects will not be excluded if they are primarily Spanish speaking.
- Females of childbearing potential must be willing to practice an acceptable form of birth control throughout the protocol.
- Epinephrine injection training provided. Participant has current in-date epinephrine injector and parent/guardian demonstrates proper use
Who cannot join
- History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or SpO2 < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)
- Currently participating in a study using an investigational new drug.
- Participation in any interventional study for the treatment of food allergy in the past 12 months or while participating in this study.
- Poor control or persistent activation of atopic dermatitis.
- Diagnosis of persistent asthma as defined by NHLBI criteria and currently being treated with daily doses of inhaled corticosteroids or requiring a rescue inhaler more than 2 days per week.
- Inability to discontinue antihistamines for skin testing and Oral Food Challenges (OFCs).
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- Pregnant female.
- Chronic medical condition requiring frequent use of oral steroids, chronic psychiatric illness or history of substance abuse.
- Active eosinophilic esophagitis requiring medication therapy during the past 12 months.
- Subjects with known oat or wheat allergy
- Subjects currently on the build-up phase of environmental allergy immunotherapy injections
- Live more than 175 miles away from Texas Children's Hospital located in the Medical Center.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune Responses in Peanut Allergic Subjects Undergoing Peanut Oral Immunotherapy
Many children who are allergic to peanuts do not outgrow their allergy and have very severe allergic reactions called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing, decreased blood pressure, hives, and lip or throat swelling after exposure to an allergen. A severe allergic reaction can lead to death if not treated appropriately.
The purpose of this study is to find out if there is a way to treat children with peanut allergy to help lower the risk of severe allergic reactions and also cause them to lose their allergy to peanuts. The approach that will used for this study is a process called "desensitization".
Oral immunotherapy involves eating gradually increasing amounts of a food over several months. This is a research study because at this time peanut oral immunotherapy (OIT) is investigational. Peanut OIT (study drug) is investigational because it is not currently approved for clinical use by the Food and Drug Administration. There are no alternative safe and effective treatments for peanut induced allergic reactions other than peanut avoidance and treatment with medications.
Read the detailed description
This is a phase I, open label study for the initial 12 month desensitization phase of peanut oral immunotherapy and a 2 year maintenance phase. Subjects will be recruited to determine the immune response during the administration of peanut OIT after the development of disease. Cohort will include children age 5-16 years who have peanut allergy. The study will require approximately 36 visits with 3 phases: screening phase (~ 2 months); build-up phase (weeks 1 year), followed by the maintenance phase (2 years).
The primary objective of the OIT protocol is to desensitize subjects to peanut and this occurs over the first 12 months of the study (build-up phase). The first dose will be based on the amount at which the subject reacted during a double blind placebo controlled food challenge (DBPCFC). Thereafter, dose escalation would continue as outlined in the protocol for approximately 50 weeks until the maintenance dose of peanut protein (3900 mg) is reached.
The maintenance phase will continue from the end of the build-up phase until approximately 24 months. During this phase, the subject will switch to a peanut equivalent dose for the maintenance phase. At the conclusion of the maintenance phase a DBPCFC will be done. Negative challenges will be confirmed by open challenge. DBPCFC will be done.
- Conditions
- Peanut Allergic Subjects
- Being tested
- Peanut Oral Immunotherapy (POIT)
- Keywords
- Peanut Allergy, Anaphylaxis, Desensitization, Food Allergy, Oral Immunotherapy
- Medical subject headings
- Peanut Hypersensitivity, Anaphylaxis, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut Oral Immunotherapy (POIT)Biological
Also called Peanut Flour, Peanut Oral Immunotherapy
The peanut protein is ingested in the form of peanut flour. Peanut flour will be given in small pre-measured soufflé cups containing the amount of peanut flour that needs to be eaten for one dose. One dose will be taken per day. Dosage of the peanut flour will begin with 1.8 mg of peanut protein during the initial visit or the lowest tolerated dose on initial challenge and increased every 2 during the build-up phase until the maintenance dose of peanut protein (3900 mg) is reached.
| Study group | Role | What they receive |
|---|---|---|
| Peanut Oral Immunotherapy (POIT) | Experimental | The peanut OIT is taken in the form of peanut flour. It will be given in small cups containing the amount of flour that needs to be eaten for one dose. One dose should be taken per day. Receives: Biological: Peanut Oral Immunotherapy (POIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Percentage of Patients Tolerating the 12-month DBPCFC
Patients underwent a build-up phase (month 0-12). The patients returned every 2 weeks during the build-up phase until the maintenance dose of 3900 mg was achieved. The 12-month double blind placebo controlled food challenge (DBPFC) was performed on achieving the maintenance dose. The primary objective was to determine the percentage of subjects tolerating a cumulative dose of 26255 mg of peanut flour with absence of clinical symptoms during the 12-month DBPCFC.
Measured: Month 12 after first dose of peanut flour
Secondary outcomes (1)
Sustained Unresponsiveness After 1 Month of Treatment Discontinuation
To compare the change in dose tolerated after one month of abstaining from peanut to determine sustained unresponsiveness. The subjects underwent a DBPCFC at month 36 and month 37. The mean of the highest dose tolerated by the subjects was assessed at these two timepoints.
Measured: Month 36 and 37 after first dose of peanut flour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study start31 Jul 2014
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peanut Allergic SubjectsStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla McGuire Davis, Baylor College of Medicine
- Investigators
- Carla M Davis, MD, Principal investigator, Texas Children's Hospital/Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203799
- Sponsor's protocol ID
- 26819
- Acronym
- PeanutFlour
- Status last verified
- Apr 2023
- First submitted
- 28 Jul 2014
- Last updated
- 19 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Responses in Peanut Allergic Subjects Undergoing Peanut Oral Immunotherapy
- ClinicalTrials.gov ID
- NCT02203799
- Acronym / sponsor ID
- PeanutFlour / 26819
- Conditions
- Peanut Allergic Subjects
- Keywords
- Peanut Allergy, Anaphylaxis, Desensitization, Food Allergy, Oral Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 31 Jul 2014 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Posted 19 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many children who are allergic to peanuts do not outgrow their allergy and have very severe allergic reactions called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing, decreased blood pressure, hives, and lip or throat swelling after exposure to an allergen. A severe allergic reaction can lead to death if not treated appropriately.
The purpose of this study is to find out if there is a way to treat children with peanut allergy to help lower the risk of severe allergic reactions and also cause them to lose their allergy to peanuts. The approach that will used for this study is a process called "desensitization".
Oral immunotherapy involves eating gradually increasing amounts of a food over several months. This is a research study because at this time peanut oral immunotherapy (OIT) is investigational. Peanut OIT (study drug) is investigational because it is not currently approved for clinical use by the Food and Drug Administration. There are no alternative safe and effective treatments for peanut induced allergic reactions other than peanut avoidance and treatment with medications.
Detailed description
This is a phase I, open label study for the initial 12 month desensitization phase of peanut oral immunotherapy and a 2 year maintenance phase. Subjects will be recruited to determine the immune response during the administration of peanut OIT after the development of disease. Cohort will include children age 5-16 years who have peanut allergy. The study will require approximately 36 visits with 3 phases: screening phase (~ 2 months); build-up phase (weeks 1 year), followed by the maintenance phase (2 years).
The primary objective of the OIT protocol is to desensitize subjects to peanut and this occurs over the first 12 months of the study (build-up phase). The first dose will be based on the amount at which the subject reacted during a double blind placebo controlled food challenge (DBPCFC). Thereafter, dose escalation would continue as outlined in the protocol for approximately 50 weeks until the maintenance dose of peanut protein (3900 mg) is reached.
The maintenance phase will continue from the end of the build-up phase until approximately 24 months. During this phase, the subject will switch to a peanut equivalent dose for the maintenance phase. At the conclusion of the maintenance phase a DBPCFC will be done. Negative challenges will be confirmed by open challenge. DBPCFC will be done.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peanut Oral Immunotherapy (POIT) | Experimental | Biological: Peanut Oral Immunotherapy (POIT)The peanut OIT is taken in the form of peanut flour. It will be given in small cups containing the amount of flour that needs to be eaten for one dose. One dose should be taken per day. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 5-16 years of either sex, any race, any ethnicity, weighing at least 18.3 kg at the time of the initial visit.
- The presence of Immunoglobulin E (IgE) specific to peanuts (a positive skin prick test to peanuts (diameter of wheal > 3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 7 kUA/L) measured within the past year.
- Significant clinical symptoms occurring within 120 minutes after ingesting peanuts during an observed DBPCFC. Patients who have not had previous oral exposure to peanut will be observed for a longer duration of 150 minutes because they may demonstrate a delayed immune response, given the lack of prior peanut exposure. Also, patients with a history of prior anaphylaxis will be observed for 150 minutes.
- Provide signed informed consent.
- Ability to follow-up regularly for scheduled appointments.
Key exclusion criteria (12 listed)
- History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or SpO2 < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)
- Currently participating in a study using an investigational new drug.
- Participation in any interventional study for the treatment of food allergy in the past 12 months or while participating in this study.
- Poor control or persistent activation of atopic dermatitis.
- Diagnosis of persistent asthma as defined by NHLBI criteria and currently being treated with daily doses of inhaled corticosteroids or requiring a rescue inhaler more than 2 days per week.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peanut Oral Immunotherapy (POIT)Also: Peanut Flour, Peanut Oral ImmunotherapyThe peanut protein is ingested in the form of peanut flour. Peanut flour will be given in small pre-measured soufflé cups containing the amount of peanut flour that needs to be eaten for one dose. One dose will be taken per day. Dosage of the peanut flour will begin with 1.8 mg of peanut protein during the initial visit or the lowest tolerated dose on initial challenge and increased every 2 during the build-up phase until the maintenance dose of peanut protein (3900 mg) is reached. | Biological | Peanut Oral Immunotherapy (POIT) |
Primary outcome
Determine the Percentage of Patients Tolerating the 12-month DBPCFC
Time frame: Month 12 after first dose of peanut flour
Patients underwent a build-up phase (month 0-12). The patients returned every 2 weeks during the build-up phase until the maintenance dose of 3900 mg was achieved. The 12-month double blind placebo controlled food challenge (DBPFC) was performed on achieving the maintenance dose. The primary objective was to determine the percentage of subjects tolerating a cumulative dose of 26255 mg of peanut flour with absence of clinical symptoms during the 12-month DBPCFC.
1 secondary outcome
Sustained Unresponsiveness After 1 Month of Treatment Discontinuation
Time frame: Month 36 and 37 after first dose of peanut flour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Peanut Allergic Subjects
Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
Active, not recruitingPhase 1
Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects
Peanut Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla M Davis, MD principal investigator
Texas Children's Hospital/Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Peanut Oral Immunotherapy (POIT) in people with Peanut Allergic Subjects, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the Percentage of Patients Tolerating the 12-month DBPCFC (time frame: Month 12 after first dose of peanut flour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.