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

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Boiled peanut Oral Immunotherapy
Desensitisation using boiled peanut
Other: Boiled peanut
Desensitisation using boiled peanut for induction and initial updosing
Active Comparator: Conventional Oral immunotherapy
Desensitisation using defatted peanut flour
Other: Defatted roasted peanut flour
Desensitisation using defatted peanut flour for induction and initial updosing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University College Cork

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19SM5033

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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