IgE Mediated Peanut AllergyBOPI-2NCT03937726
Boiled Peanut Immunotherapy for the Treatment of Peanut Allergy
A study testing Boiled peanut and Defatted roasted peanut flour in people with IgE Mediated Peanut Allergy and Peanut Hypersensitivity, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Peanut allergy is the most common cause of severe allergic reactions to food. Onset is common in childhood, but in contrast to other food allergies such as cow's milk and egg, peanut allergy tends to persist into adulthood. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- IgE Mediated Peanut Allergy, Peanut Hypersensitivity
- What is being tested?
- Boiled peanut and Defatted roasted peanut flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Apr 2019to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 7-18 years (enrolment up to a participant's 19th birthday).
- Past history consistent with IgE-mediated peanut allergy
- Allergic to ≤1.44 g peanut protein (approx. 6 peanuts) at baseline double-blind placebo-controlled food challenge, prior to treatment allocation
- Tolerates at least 1/8 boiled peanut (boiled for 4 hours) at open food challenge at screening.
- Written informed consent of parent/legal guardian and patient assent.
Who cannot join
- Required previous admission to an intensive care unit for management of an allergic reaction to peanut.
- Clinically significant chronic illness (other than asthma, rhinitis or eczema).
- Undergoing subcutaneous or sublingual immunotherapy to respiratory allergens, and not yet established on maintenance dosing for at least 3 months.
- Undergoing oral immunotherapy for food allergy and within the first year of treatment.
- Subjects receiving anti-IgE therapy, oral immunosuppressants, beta-blocker or ACE inhibitor.
- Tolerance to ≥1.44 g peanut protein (approx. 6 peanuts) at initial DBPCFC during screening.
Show all 10Show fewer
- Dose-limiting symptoms to 1/8 boiled peanut (boiled for 4 hours) at screening.
- Poorly controlled asthma within the previous 3 months (as defined by clinician judgement with reference to the ICON consensus ), or asthma requiring treatment with >5 days oral corticosteroids within the previous 3 months.
- Pregnancy
- Unwilling or unable to fulfil study requirements
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust (St. Mary's Hospital)
London
About this study
Official title: Boiled Peanut Immunotherapy for the Treatment of Peanut Allergy: A Non-inferiority Study
Peanut allergy is the most common cause of severe allergic reactions to food. Onset is common in childhood, but in contrast to other food allergies such as cow's milk and egg, peanut allergy tends to persist into adulthood. It is associated with a significant impact on quality of life, both for the affected individual and their family.
There is no current cure for peanut allergy. Oral peanut immunotherapy (OIT) using defatted, roasted peanut flour has been demonstrated to offer potential in this regard, but is associated with significant and frequent reactions and can cause life-threatening allergic symptoms.
Read more
The investigators have previously demonstrated that the processing of peanuts through boiling results in a relatively hypoallergenic product due to the loss of key allergenic components from peanut into the water. This has been tested in a recently-completed Phase 2b/3 trial (The BOPI Study, Clinicaltrials.gov NCT02149719; HRA reference 15/LO/0287): 47 children/ young people with peanut allergy confirmed at double-blind, placebo-controlled food challenge (DBPCFC) were randomised (2:1) to receive either oral immunotherapy (updosing using boiled peanut for ~6 months, followed by maintenance with roasted peanut) or standard treatment (allergen avoidance). Participants underwent repeat DBPCFC at 12 months to assess response, following which peanut OIT was stopped and sustained unresponsiveness assessed after 4 weeks (4SU). 24/32 participants (100% per protocol) achieved the primary outcome of desensitisation to >1.44g peanut protein (approximately 6-8 peanuts, p<0.0001); of those 14 tolerated >4.4g peanut protein. 13/24 participants achieved 4SU. There was no significant change in threshold in the control group (p>0.05). Boiled peanut OIT had a favourable safety profile, with under 2% of doses associated with gastrointestinal symptoms.
The BOPI-2 study is a non-inferiority study to demonstrate that boiled peanut is at least as effective as peanut flour in treating children with peanut allergy. The study will compare the rate of adverse events and other safety outcomes between these two interventions, and assess the immunological mechanisms involved, a secondary aim being to develop clinically-useful predictors for identifying individuals likely to undergo successful desensitisation.
- Being tested
- Boiled peanut, Defatted roasted peanut flour
- Keywords
- Peanut allergy, Desensitisation, Safety
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boiled peanutOther
Desensitisation using boiled peanut for induction and initial updosing
Defatted roasted peanut flourOther
Desensitisation using defatted peanut flour for induction and initial updosing
| Study group | Role | What they receive |
|---|---|---|
| Boiled peanut Oral Immunotherapy | Experimental | Desensitisation using boiled peanut Receives: Other: Boiled peanut |
| Conventional Oral immunotherapy | Active comparator | Desensitisation using defatted peanut flour Receives: Other: Defatted roasted peanut flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desensitisation to >1.4g (roasted) peanut protein at food challenge
The proportion of participants who tolerate 1.44g (or more) roasted peanut protein (equivalent to ≥ 6 roasted peanuts) after 12 months of OIT, as assessed by DBPCFC, in each treatment group.
Measured: 12 months
Secondary outcomes (9)
Adverse events
The proportion of participants experiencing adverse events classified as mild non-transient symptoms or more severe during updosing and maintenance in each treatment group.
Measured: 12 months
Other safety outcomes
Rates of adverse events by type / organ involved in each treatment group
Measured: 12 months
Change in Health-related quality of life (HRQL) from baseline - assessed using FAQLQ
Change in HRQL measures at 6, 12 and 13 months from baseline, as assessed in study participants and their parent/carer using the following validated questionnaire:
- Food Allergy Quality of Life Questionnaire (FAQLQ) (reference Muraro et al, 2014)
Measured: 6,12 and 13+ months
Change in Health-related quality of life (HRQL) from baseline - assessed using FAIM
Change in HRQL measures at 6, 12 and 13 months from baseline, as assessed in study participants and their parent/carer using the following validated questionnaire:
- Food Allergy Independent Measure (FAIM) (see Muraro et al, 2014)
Measured: 6,12 and 13+ months
Change in Health-related quality of life (HRQL) from baseline - assessed using standardized instrument (EQ-5D)
Change in HRQL measures at 6, 12 and 13 months from baseline, as assessed using the following validated questionnaire:
- EQ-5D - a standardized instrument for use as a measure of health outcome. (Further details at https://euroqol.org/)
Measured: 6,12 and 13+ months
Change in Health-related quality of life (HRQL) from baseline - assessed using standardized instrument (CHU-9D)
Change in HRQL measures at 6, 12 and 13 months from baseline, as assessed using the following validated questionnaire:
- CHU-9D (The Child Health Utility 9D) - also a standardized instrument for use as a measure of health outcome. (Further details at https://www.sheffield.ac.uk/scharr/sections/heds/mvh/paediatric)
Measured: 6,12 and 13+ months
Change in self-efficacy after each phase of immunotherapy
Change in self-efficacy at 6, 12 and 13 months from baseline, as assessed in study participants and their parent/carer using validated questionnaire.
Measured: 6,12 and 13+ months
Immunological outcome: skin prick test
Change in skin prick test wheal (mm) and end-point titration skin prick test between baseline and post immunotherapy
Measured: 12 months
Immunological outcome: Allergen-specific IgE
Change in allergen-specific IgE (kUa/l) between baseline and post immunotherapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start29 Apr 2019
- Primary completionMay 2024 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IgE Mediated Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- University College Cork
- Responsible party
- Sponsor
- Investigators
- Paul J Turner, FRACP PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937726
- Sponsor's protocol ID
- 19SM5033
- Acronym
- BOPI-2
- Status last verified
- Oct 2023
- First submitted
- 29 Apr 2019
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muraro A, Dubois AE, DunnGalvin A, Hourihane JO, de Jong NW, Meyer R, Panesar SS, Roberts G, Salvilla S, Sheikh A, Worth A, Flokstra-de Blok BM; European Academy of Allergy and Clinical Immunology. EAACI Food Allergy and Anaphylaxis Guidelines. Food allergy health-related quality of life measures. Allergy. 2014 Jul;69(7):845-53. doi: 10.1111/all.12405. Epub 2014 May 2.
PubMed 24785644
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boiled Peanut Immunotherapy for the Treatment of Peanut Allergy: A Non-inferiority Study
- ClinicalTrials.gov ID
- NCT03937726
- Acronym / sponsor ID
- BOPI-2 / 19SM5033
- Keywords
- Peanut allergy, Desensitisation, Safety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- University College Cork
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
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 the most common cause of severe allergic reactions to food. Onset is common in childhood, but in contrast to other food allergies such as cow's milk and egg, peanut allergy tends to persist into adulthood. It is associated with a significant impact on quality of life, both for the affected individual and their family.
There is no current cure for peanut allergy. Oral peanut immunotherapy (OIT) using defatted, roasted peanut flour has been demonstrated to offer potential in this regard, but is associated with significant and frequent reactions and can cause life-threatening allergic symptoms.
The investigators have previously demonstrated that the processing of peanuts through boiling results in a relatively hypoallergenic product due to the loss of key allergenic components from peanut into the water. This has been tested in a recently-completed Phase 2b/3 trial (The BOPI Study, Clinicaltrials.gov NCT02149719; HRA reference 15/LO/0287): 47 children/ young people with peanut allergy confirmed at double-blind, placebo-controlled food challenge (DBPCFC) were randomised (2:1) to receive either oral immunotherapy (updosing using boiled peanut for ~6 months, followed by maintenance with roasted peanut) or standard treatment (allergen avoidance). Participants underwent repeat DBPCFC at 12 months to assess response, following which peanut OIT was stopped and sustained unresponsiveness assessed after 4 weeks (4SU). 24/32 participants (100% per protocol) achieved the primary outcome of desensitisation to >1.44g peanut protein (approximately 6-8 peanuts, p<0.0001); of those 14 tolerated >4.4g peanut protein. 13/24 participants achieved 4SU. There was no significant change in threshold in the control group (p>0.05). Boiled peanut OIT had a favourable safety profile, with under 2% of doses associated with gastrointestinal symptoms.
The BOPI-2 study is a non-inferiority study to demonstrate that boiled peanut is at least as effective as peanut flour in treating children with peanut allergy. The study will compare the rate of adverse events and other safety outcomes between these two interventions, and assess the immunological mechanisms involved, a secondary aim being to develop clinically-useful predictors for identifying individuals likely to undergo successful desensitisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boiled peanut Oral Immunotherapy | Experimental | Other: Boiled peanutDesensitisation using boiled peanut |
| Conventional Oral immunotherapy | Active comparator | Other: Defatted roasted peanut flourDesensitisation using defatted peanut flour |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 7-18 years (enrolment up to a participant's 19th birthday).
- Past history consistent with IgE-mediated peanut allergy
- Allergic to ≤1.44 g peanut protein (approx. 6 peanuts) at baseline double-blind placebo-controlled food challenge, prior to treatment allocation
- Tolerates at least 1/8 boiled peanut (boiled for 4 hours) at open food challenge at screening.
- Written informed consent of parent/legal guardian and patient assent.
Key exclusion criteria (10 listed)
- Required previous admission to an intensive care unit for management of an allergic reaction to peanut.
- Clinically significant chronic illness (other than asthma, rhinitis or eczema).
- Undergoing subcutaneous or sublingual immunotherapy to respiratory allergens, and not yet established on maintenance dosing for at least 3 months.
- Undergoing oral immunotherapy for food allergy and within the first year of treatment.
- Subjects receiving anti-IgE therapy, oral immunosuppressants, beta-blocker or ACE inhibitor.
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 |
|---|---|---|
| Boiled peanutDesensitisation using boiled peanut for induction and initial updosing | Other | Boiled peanut Oral Immunotherapy |
| Defatted roasted peanut flourDesensitisation using defatted peanut flour for induction and initial updosing | Other | Conventional Oral immunotherapy |
Primary outcome
Desensitisation to >1.4g (roasted) peanut protein at food challenge
Time frame: 12 months
The proportion of participants who tolerate 1.44g (or more) roasted peanut protein (equivalent to ≥ 6 roasted peanuts) after 12 months of OIT, as assessed by DBPCFC, in each treatment group.
9 secondary outcomes
Adverse events
Time frame: 12 months
Other safety outcomes
Time frame: 12 months
Change in Health-related quality of life (HRQL) from baseline - assessed using FAQLQ
Time frame: 6,12 and 13+ months
Change in Health-related quality of life (HRQL) from baseline - assessed using FAIM
Time frame: 6,12 and 13+ months
Change in Health-related quality of life (HRQL) from baseline - assessed using standardized instrument (EQ-5D)
Time frame: 6,12 and 13+ months
Change in Health-related quality of life (HRQL) from baseline - assessed using standardized instrument (CHU-9D)
Time frame: 6,12 and 13+ months
Change in self-efficacy after each phase of immunotherapy
Time frame: 6,12 and 13+ months
Immunological outcome: skin prick test
Time frame: 12 months
Immunological outcome: Allergen-specific IgE
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Background: PubMed 24785644Muraro A, Dubois AE, DunnGalvin A, Hourihane JO, de Jong NW, Meyer R, Panesar SS, Roberts G, Salvilla S, Sheikh A, Worth A, Flokstra-de Blok BM; European Academy of Allergy and Clinical Immunology. EAACI Food Allergy and Anaphylaxis Guidelines. Food allergy health-related quality of life measures. Allergy. 2014 Jul;69(7):845-53. doi: 10.1111/all.12405. Epub 2014 May 2.
- Related InfoLink provided by the sponsor.
- 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.
Paul J Turner, FRACP PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boiled peanut and Defatted roasted peanut flour in people with IgE Mediated Peanut Allergy and Peanut Hypersensitivity, run by Imperial College London at 1 site in United Kingdom.
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 10 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2023. 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 Kingdom. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Desensitisation to >1.4g (roasted) peanut protein at food challenge (time frame: 12 months). 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 NCT03937726, 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 19 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.