Food HypersensitivityPhase 2DEVILNCT00932828
Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study
A Phase 2 study testing Peanut oral immunotherapy in people with Food Hypersensitivity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit young subjects who have recently been diagnosed with peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune… Read more about this study
- Who is it for?
- Ages 9 to 36 months
- Conditions the study is for
- Food Hypersensitivity
- What is being tested?
- Peanut oral immunotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2009to 1 Feb 2017
- Phase
- Phase 2
- 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 9 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 9-36 months of either sex, any race, any ethnicity at the time of the initial visit
- EITHER a positive skin prick test to peanuts or in vitro [CAP-FEIA] peanut immunoglobin E (IgE) level in the blood > 0.35 kU/L PLUS a history of a clinical allergic reaction (defined as significant clinical symptoms occurring within 60 minutes after ingesting peanuts) within 6 months of screening
- OR a positive prick skin test to peanuts and in vitro [CAP-FEIA] peanut IgE level > 5 kU/L when there is no history of allergic reaction and no known peanut exposure
- Provision of signed informed consent
- Development of symptoms characteristic of IgE-mediated food allergy (urticaria, angioedema, respiratory distress/wheeze/cough, vomiting/diarrhea, anaphylaxis) during initial oral food challenge
Who cannot join
- History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise
- 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
- Subjects with a known wheat food allergy will be excluded because of cross contamination of oat with wheat
- Severe atopic dermatitis
- Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI) guidelines
- Inability to discontinue antihistamines for skin testing and OFCs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study; Grant "Optimizing Tolerance Induction in Peanut Allergy: The DEVIL Study"
Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit young subjects who have recently been diagnosed with peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).
Read the detailed description
Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies, it tends to be more persistent and 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 mucosal immunotherapy (PMIT) more commonly called oral immunotherapy (OIT). We are also studying the effect of PMIT on the peanut-specific immune response to determine if tolerance to peanut protein will develop. Based on our preliminary work and recent studies supporting the importance of early oral exposure in tolerance induction, we propose that early treatment of peanut allergy with PMIT will be safe and effective. Children ages 9 to 36 months with peanut allergy will be randomized to receive high or low dose PMIT using peanut flour. Subjects will undergo desensitization on the first day and then increase the doses gradually to a maintenance dose. Doses will be taken daily at home except for dose increases which will be done on the research unit. Subjects will undergo a double-blinded, placebo-controlled food challenge (DBPCFC) if challenge criteria are met. Subjects passing the first challenge will stop PMIT and repeat the DBPCFC to assess tolerance. Outcome variables of interest include response to oral food challenges (OFC), skin prick testing, peanut specific serum immunoglobin E (IgE), immunoglobin G (IgG), and immunoglobin G4 (IgG4) and stool immunoglobin A (IgA), T and B cell responses, quality of life, and adverse events. As secondary and exploratory outcomes, these longitudinal results will be compared between high and low dose PMIT groups and controls using appropriate statistical analysis.
- Conditions
- Food Hypersensitivity
- Being tested
- Peanut oral immunotherapy
- Keywords
- Peanut allergy
- Medical subject headings
- Food Hypersensitivity, Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut oral immunotherapyDrug
Also called Peanut mucosal immunotherapy, Peanut OIT
Defatted peanut in flour form to be used as treatment for peanut allergy
| Study group | Role | What they receive |
|---|---|---|
| Peanut oral immunotherapy | Experimental | Newly diagnosed allergic children receiving peanut flour as oral immunotherapy for the treatment of peanut allergy. Receives: Drug: Peanut oral immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Percentage of Subjects Who Demonstrate Sustained Unresponsiveness (SU) by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC).
The goal of the study is to treat peanut-allergic subjects with peanut OIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes SU. We expect to demonstrate the effectiveness of peanut OIT in inducing SU by showing that subjects will have a negative DBPCFC to 5 grams of peanut following completion of a 36-month course of peanut OIT followed by avoidance of therapy for 4 weeks.
Measured: After 36 months of OIT dosing followed by 1 month of avoidance
Secondary outcomes (2)
Determine the Percentage of Subjects Who Demonstrate Desensitization by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC).
We expect to demonstrate the effectiveness of peanut OIT in inducing desensitization by showing that subjects will have a negative DBPCFC to 5 grams of peanut following completion of a 36-month course of peanut OIT .
Measured: After 36 months of OIT dosing
Determine the Frequency of Treatment-related Adverse Effects (TAE) From Peanut OIT.
In addition to studying the effectiveness of peanut OIT, we will also determine the safety of peanut OIT by reporting the average rate of TAEs per person per dose.
Measured: After 36 months of OIT dosing followed by 1 month of avoidance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study start22 Jun 2009
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food HypersensitivityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- For the purposes of the primary outcome, all subjects will receive peanut OIT and represent a single group. For exploratory analysis, subjects will be randomized to high and low dose OIT to potentially look for a dose response.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arvil W Burks, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932828
- Sponsor's protocol ID
- 11-2307
- Acronym
- DEVIL
- Status last verified
- Feb 2018
- First submitted
- 2 Jul 2009
- Last updated
- 24 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Vickery BP, Berglund JP, Burk CM, Fine JP, Kim EH, Kim JI, Keet CA, Kulis M, Orgel KG, Guo R, Steele PH, Virkud YV, Ye P, Wright BL, Wood RA, Burks AW. Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective. J Allergy Clin Immunol. 2017 Jan;139(1):173-181.e8. doi: 10.1016/j.jaci.2016.05.027. Epub 2016 Aug 10.
PubMed 27522159
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study; Grant "Optimizing Tolerance Induction in Peanut Allergy: The DEVIL Study"
- ClinicalTrials.gov ID
- NCT00932828
- Acronym / sponsor ID
- DEVIL / 11-2307
- Conditions
- Food Hypersensitivity
- Keywords
- Peanut allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 22 Jun 2009 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 3 Jul 2009 (estimated)
- Results
- Posted 24 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit young subjects who have recently been diagnosed with peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).
Detailed description
Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies, it tends to be more persistent and 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 mucosal immunotherapy (PMIT) more commonly called oral immunotherapy (OIT). We are also studying the effect of PMIT on the peanut-specific immune response to determine if tolerance to peanut protein will develop. Based on our preliminary work and recent studies supporting the importance of early oral exposure in tolerance induction, we propose that early treatment of peanut allergy with PMIT will be safe and effective. Children ages 9 to 36 months with peanut allergy will be randomized to receive high or low dose PMIT using peanut flour. Subjects will undergo desensitization on the first day and then increase the doses gradually to a maintenance dose. Doses will be taken daily at home except for dose increases which will be done on the research unit. Subjects will undergo a double-blinded, placebo-controlled food challenge (DBPCFC) if challenge criteria are met. Subjects passing the first challenge will stop PMIT and repeat the DBPCFC to assess tolerance. Outcome variables of interest include response to oral food challenges (OFC), skin prick testing, peanut specific serum immunoglobin E (IgE), immunoglobin G (IgG), and immunoglobin G4 (IgG4) and stool immunoglobin A (IgA), T and B cell responses, quality of life, and adverse events. As secondary and exploratory outcomes, these longitudinal results will be compared between high and low dose PMIT groups and controls using appropriate statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- For the purposes of the primary outcome, all subjects will receive peanut OIT and represent a single group. For exploratory analysis, subjects will be randomized to high and low dose OIT to potentially look for a dose response.
| Arm | Type | Receives |
|---|---|---|
| Peanut oral immunotherapy | Experimental | Drug: Peanut oral immunotherapyNewly diagnosed allergic children receiving peanut flour as oral immunotherapy for the treatment of peanut allergy. |
Who may qualify
- Ages
- 9 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 9-36 months of either sex, any race, any ethnicity at the time of the initial visit
- EITHER a positive skin prick test to peanuts or in vitro [CAP-FEIA] peanut immunoglobin E (IgE) level in the blood > 0.35 kU/L PLUS a history of a clinical allergic reaction (defined as significant clinical symptoms occurring within 60 minutes after ingesting peanuts) within 6 months of screening
- OR a positive prick skin test to peanuts and in vitro [CAP-FEIA] peanut IgE level > 5 kU/L when there is no history of allergic reaction and no known peanut exposure
- Provision of signed informed consent
- Development of symptoms characteristic of IgE-mediated food allergy (urticaria, angioedema, respiratory distress/wheeze/cough, vomiting/diarrhea, anaphylaxis) during initial oral food challenge
Key exclusion criteria (7 listed)
- History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise
- 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
- Subjects with a known wheat food allergy will be excluded because of cross contamination of oat with wheat
- Severe atopic dermatitis
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 immunotherapyAlso: Peanut mucosal immunotherapy, Peanut OITDefatted peanut in flour form to be used as treatment for peanut allergy | Drug | Peanut oral immunotherapy |
Primary outcome
Determine the Percentage of Subjects Who Demonstrate Sustained Unresponsiveness (SU) by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC).
Time frame: After 36 months of OIT dosing followed by 1 month of avoidance
The goal of the study is to treat peanut-allergic subjects with peanut OIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes SU. We expect to demonstrate the effectiveness of peanut OIT in inducing SU by showing that subjects will have a negative DBPCFC to 5 grams of peanut following completion of a 36-month course of peanut OIT followed by avoidance of therapy for 4 weeks.
2 secondary outcomes
Determine the Percentage of Subjects Who Demonstrate Desensitization by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC).
Time frame: After 36 months of OIT dosing
Determine the Frequency of Treatment-related Adverse Effects (TAE) From Peanut OIT.
Time frame: After 36 months of OIT dosing followed by 1 month of avoidance
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27522159Vickery BP, Berglund JP, Burk CM, Fine JP, Kim EH, Kim JI, Keet CA, Kulis M, Orgel KG, Guo R, Steele PH, Virkud YV, Ye P, Wright BL, Wood RA, Burks AW. Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective. J Allergy Clin Immunol. 2017 Jan;139(1):173-181.e8. doi: 10.1016/j.jaci.2016.05.027. Epub 2016 Aug 10.
- Individual participant dataSharing planned: No
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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.
Arvil W Burks, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peanut oral immunotherapy in people with Food Hypersensitivity, run by University of North Carolina, Chapel Hill 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 5 inclusion and 7 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 24 May 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 24 May 2018). 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 Subjects Who Demonstrate Sustained Unresponsiveness (SU) by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC). (time frame: After 36 months of OIT dosing followed by 1 month of avoidance). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00932828, which also lists 1 linked publication.
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 24 May 2018.