- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03937726
Boiled Peanut Immunotherapy for the Treatment of Peanut Allergy (BOPI-2)
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.
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paul J Turner, FRACP PhD
- Phone Number: +44 20 3312 7754
- Email: p.turner@imperial.ac.uk
Study Locations
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-
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London, United Kingdom
- Imperial College Healthcare NHS Trust (St. Mary's Hospital)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Boiled peanut Oral Immunotherapy
Desensitisation using boiled peanut
|
Desensitisation using boiled peanut for induction and initial updosing
|
Active Comparator: Conventional Oral immunotherapy
Desensitisation using defatted peanut flour
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Desensitisation using defatted peanut flour for induction and initial updosing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 12 months
|
The proportion of participants experiencing adverse events classified as mild non-transient symptoms or more severe during updosing and maintenance in each treatment group.
|
12 months
|
Other safety outcomes
Time Frame: 12 months
|
Rates of adverse events by type / organ involved in each treatment group
|
12 months
|
Change in Health-related quality of life (HRQL) from baseline - assessed using FAQLQ
Time Frame: 6,12 and 13+ months
|
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) |
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 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) |
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 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/) |
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 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) |
6,12 and 13+ months
|
Change in self-efficacy after each phase of immunotherapy
Time Frame: 6,12 and 13+ months
|
Change in self-efficacy at 6, 12 and 13 months from baseline, as assessed in study participants and their parent/carer using validated questionnaire.
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6,12 and 13+ months
|
Immunological outcome: skin prick test
Time Frame: 12 months
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Change in skin prick test wheal (mm) and end-point titration skin prick test between baseline and post immunotherapy
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12 months
|
Immunological outcome: Allergen-specific IgE
Time Frame: 12 months
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Change in allergen-specific IgE (kUa/l) between baseline and post immunotherapy
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12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustained unresponsiveness after 4 weeks cessation of maintenance OIT
Time Frame: After 1 year of OIT
|
Rate of sustained unresponsiveness after 4 weeks cessation of maintenance OIT at 1 year.
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After 1 year of OIT
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Sustained unresponsiveness after 12+ weeks cessation of maintenance OIT
Time Frame: After 1 year of OIT
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Rate of sustained unresponsiveness after 12+ weeks cessation of maintenance OIT at 1 year, in those participants who demonstrate sustained unresponsiveness at 4 weeks off maintenance OIT.
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After 1 year of OIT
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul J Turner, FRACP PhD, Imperial College London
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19SM5033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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