Boiled Peanut Immunotherapy for the Treatment of Peanut Allergy (BOPI-2)

October 18, 2023 updated by: Imperial College London

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

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • London, United Kingdom
        • Imperial College Healthcare NHS Trust (St. Mary's Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
6,12 and 13+ months
Immunological outcome: skin prick test
Time Frame: 12 months
Change in skin prick test wheal (mm) and end-point titration skin prick test between baseline and post immunotherapy
12 months
Immunological outcome: Allergen-specific IgE
Time Frame: 12 months
Change in allergen-specific IgE (kUa/l) between baseline and post immunotherapy
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.
After 1 year of OIT
Sustained unresponsiveness after 12+ weeks cessation of maintenance OIT
Time Frame: After 1 year of OIT
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.
After 1 year of OIT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Paul J Turner, FRACP PhD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2019

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 29, 2019

First Submitted That Met QC Criteria

May 2, 2019

First Posted (Actual)

May 6, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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