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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937726
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
University College Cork
Information provided by (Responsible Party):
Imperial College London

Brief 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. 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.


Condition or disease Intervention/treatment Phase
IgE Mediated Peanut Allergy Peanut Hypersensitivity Other: Boiled peanut Other: Defatted roasted peanut flour Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Primary outcome will be assessed by double-blind, placebo-controlled food challenge
Primary Purpose: Treatment
Official Title: Boiled Peanut Immunotherapy for the Treatment of Peanut Allergy: A Non-inferiority Study
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Other safety outcomes [ Time Frame: 12 months ]
    Rates of adverse events by type / organ involved in each treatment group

  3. 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)


  4. 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)


  5. 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. 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)


  7. 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.

  8. 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

  9. Immunological outcome: Allergen-specific IgE [ Time Frame: 12 months ]
    Change in allergen-specific IgE (kUa/l) between baseline and post immunotherapy


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937726


Contacts
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Contact: Paul J Turner, FRACP PhD +44 20 3312 7754 p.turner@imperial.ac.uk

Locations
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United Kingdom
Imperial College Healthcare NHS Trust (St. Mary's Hospital) Recruiting
London, United Kingdom
Contact: Paul J Turner       p.turner@imperial.ac.uk   
Principal Investigator: Paul J Turner         
Sponsors and Collaborators
Imperial College London
University College Cork
Investigators
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Principal Investigator: Paul J Turner, FRACP PhD Imperial College London
Additional Information:
Publications:
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03937726    
Other Study ID Numbers: 19SM5033
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Peanut allergy
Desensitisation
Safety
Additional relevant MeSH terms:
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Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate