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The Grown Up Peanut Immunotherapy Study (GUPI)

Primary Purpose

Peanut Allergy

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Peanut oral immunotherapy
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring IgE mediated peanut allergy, Oral immunotherapy, Desensitisation, GUPI

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

For peanut OIT patients:

Adults aged 18-40 years with:

  1. A positive skin prick test to peanut extract.
  2. Elevated (>0.35) serum specific Immunoglobulin E (IgE) to Ara h 2 major peanut allergen within 2 years of date of initial screening visit.
  3. Positive DBPCFC to 300mg or less of peanut protein.
  4. Where appropriate, use of effective form of birth control by females for the duration of participation in the study (i.e. up to exit DBPCFC).
  5. Participants with asthma may be included if well controlled:

    • Asthma control questionnaire (ACQ) score <1
    • Maximum permitted asthma treatment: moderate dose of inhaled corticosteroid (ICS) and long-acting beta agonists (LABA) as treatment
    • Pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) >80% of predicted value at screening visit
    • For asthmatic participants with intermittent mild symptoms (induced by exercise, animals or pollens) using as required salbutamol only, treatment will be given with regular low dose inhaled corticosteroids (ICS) prior to challenges and for the duration of updosing as an additional measure.

For mechanistic sub-study subjects:

Adults aged 18-40 years with:

  1. A positive skin prick test to peanut extract within previous 12 months
  2. Elevated serum specific IgE (>0.35) to Ara h 2 major peanut allergen within 2 years of date of initial screening visit.
  3. Clinical diagnosis of peanut allergy made by an experienced allergy specialist.

Exclusion Criteria:

For peanut OIT patients:

  1. Anaphylaxis to a food other than peanut - despite attempted avoidance - within the last 2 years.
  2. History of life-threatening anaphylaxis or angioedema, including previous intensive care unit (ITU) admission attributable peanut allergy.
  3. Asthmatic treated with higher than moderate dose of ICS (>800 mcg equivalent of beclomethasone dipropionate (BDP) per day).
  4. Any asthmatic if uncontrolled or difficult to control as evidenced by any following: ACQ>1; FEV1 <80% predicted; FEV1/ forced vital capacity (FVC) <0.7 irrespective of treatment; hospital attendance (A&E or admission) for asthma in the past 2 years; treatment of asthma with oral steroids within last 2 years.
  5. Evidence of non-adherence with asthma treatment from General PRactitioner (GP) repeat prescription records.
  6. Participants who react to less than 1 mg of peanut protein on DBPCFC, or who cannot tolerate at least an initial dose of 1.5 mg peanut protein on OIT initiation day.
  7. Participants who react to placebo during DBPCFC.
  8. Ongoing treatment with beta-blockers, biologics (such as omalizumab or mepolizumab) or systemic immunosuppressive treatment.
  9. Regular ongoing use of NSAIDs for a chronic condition (NSAIDs may act as a co-factor for allergic reactions)
  10. For females a positive serum or urine pregnancy test with sensitivity of less than 50 mIU/mL within 72 hours of first administration of study therapy.
  11. Lactating females.
  12. The use of any investigational drug within 30 days of the screening visit.
  13. Past history of eosinophilic oesophagitis or chronic gastro-oesophageal reflux symptoms requiring regular treatment with anti-acids.
  14. Inability to discontinue antihistamines for a minimum of 4 days prior to DBPCFC visits
  15. The presence of any medical condition that the investigator deems incompatible with participation in the trial.
  16. Individuals with insufficient understanding of the trial.

For mechanistic sub-study subjects:

  1. Ongoing treatment with biologic or systemic immunosuppressive treatment.
  2. Known current pregnancy
  3. Lactating females.
  4. The use of any investigational drug within 30 days of the screening visit.
  5. Inability to discontinue antihistamines for a minimum of 4 days prior to venesection.
  6. The presence of any medical condition that the investigator deems incompatible with participation in the study.
  7. Individuals with insufficient understanding of the study.

Sites / Locations

  • Guy's and St Thomas' NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peanut oral immunotherapy

Arm Description

Desensitisation using peanut flour

Outcomes

Primary Outcome Measures

Desensitisation to 1.4g peanut
Tolerance of cumulative dose of 1.4g peanut protein without reaction on DBPCFC post OIT after minimum of 1 month maintenance dosing on peanut OIT

Secondary Outcome Measures

Desensitisation to 4.4g peanut
Tolerance of cumulative dose of 4.4 g peanut protein without reaction on DBPCFC post OIT
Incidence of adverse events related to treatment (safety)
Incidence of local and systemic reactions during peanut OIT updosing and maintenance
Reactions with ara h 8 sensitisation
Comparison of local and systemic reactions in Ara h 8 sensitised vs. non-sensitised subjects.
Skin prick test reactivity
Change in size of wheal diameter to peanut extract following OIT
Immunoglobulin G (IgG) levels
Change in peanut-specific IgG following OIT
Quality of life measure
Change measured using Food Allergy Quality of Life Questionnaire- Adult Form (FAQLQ-AF) and the Food Allergy Independent Measure Adult Form (FAIM-AF). These are validated questionnaires consisting of 29 (FAQLQ-AF) and 6 (FAIM-AF) questions each scored on a 7 point likert scale. The total scores are the mean score of all items with a range of 1 'no impairment' to 7 'maximal impairment'.
Food Neophobia score
Change measured using validated Food Neophobia Scale (FNS) questionnaire. This consists of 8 questions with answers on a 7 point likert scale ranging from 1 ("disagree strongly") to 7 ("agree strongly"). The total score is the mean score of all questions with lower score signifying increased food neophobia.
Food Situations score
Change using Food Situations Questionnaire, validated in children and amended to be appropriate for adults. 10 different scenarios related to food are rated from 1 (very unhappy) to 5 (very happy), giving a total possible score of 50. Higher scores are indicative of lower food neophobia.
Study compliance
Compliance with OIT measured using monthly diaries.

Full Information

First Posted
August 6, 2018
Last Updated
August 24, 2018
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom, King's College London, Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT03648320
Brief Title
The Grown Up Peanut Immunotherapy Study
Acronym
GUPI
Official Title
A Single Arm Phase II Efficacy Study of Peanut Oral Immunotherapy in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 18, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom, King's College London, Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine efficacy and safety of peanut oral immunotherapy in adults with peanut allergy.
Detailed Description
25 adults with peanut allergy, as confirmed by double blind placebo controlled food challenge (DBPCFC), will undergo peanut oral immunotherapy (OIT) with peanut flour. An additional 15 untreated peanut allergic adults will be recruited as comparator group for skin prick tests and mechanistic studies/immunological assays.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
IgE mediated peanut allergy, Oral immunotherapy, Desensitisation, GUPI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peanut oral immunotherapy
Arm Type
Experimental
Arm Description
Desensitisation using peanut flour
Intervention Type
Other
Intervention Name(s)
Peanut oral immunotherapy
Intervention Description
Daily doses of peanut flour (with 2-weekly incremental interval)
Primary Outcome Measure Information:
Title
Desensitisation to 1.4g peanut
Description
Tolerance of cumulative dose of 1.4g peanut protein without reaction on DBPCFC post OIT after minimum of 1 month maintenance dosing on peanut OIT
Time Frame
7-8 months
Secondary Outcome Measure Information:
Title
Desensitisation to 4.4g peanut
Description
Tolerance of cumulative dose of 4.4 g peanut protein without reaction on DBPCFC post OIT
Time Frame
7-8 months
Title
Incidence of adverse events related to treatment (safety)
Description
Incidence of local and systemic reactions during peanut OIT updosing and maintenance
Time Frame
7-8 months
Title
Reactions with ara h 8 sensitisation
Description
Comparison of local and systemic reactions in Ara h 8 sensitised vs. non-sensitised subjects.
Time Frame
7-8 months
Title
Skin prick test reactivity
Description
Change in size of wheal diameter to peanut extract following OIT
Time Frame
9 months
Title
Immunoglobulin G (IgG) levels
Description
Change in peanut-specific IgG following OIT
Time Frame
9 months
Title
Quality of life measure
Description
Change measured using Food Allergy Quality of Life Questionnaire- Adult Form (FAQLQ-AF) and the Food Allergy Independent Measure Adult Form (FAIM-AF). These are validated questionnaires consisting of 29 (FAQLQ-AF) and 6 (FAIM-AF) questions each scored on a 7 point likert scale. The total scores are the mean score of all items with a range of 1 'no impairment' to 7 'maximal impairment'.
Time Frame
7-8 months
Title
Food Neophobia score
Description
Change measured using validated Food Neophobia Scale (FNS) questionnaire. This consists of 8 questions with answers on a 7 point likert scale ranging from 1 ("disagree strongly") to 7 ("agree strongly"). The total score is the mean score of all questions with lower score signifying increased food neophobia.
Time Frame
7-8 months
Title
Food Situations score
Description
Change using Food Situations Questionnaire, validated in children and amended to be appropriate for adults. 10 different scenarios related to food are rated from 1 (very unhappy) to 5 (very happy), giving a total possible score of 50. Higher scores are indicative of lower food neophobia.
Time Frame
7-8 months
Title
Study compliance
Description
Compliance with OIT measured using monthly diaries.
Time Frame
7-8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For peanut OIT patients: Adults aged 18-40 years with: A positive skin prick test to peanut extract. Elevated (>0.35) serum specific Immunoglobulin E (IgE) to Ara h 2 major peanut allergen within 2 years of date of initial screening visit. Positive DBPCFC to 300mg or less of peanut protein. Where appropriate, use of effective form of birth control by females for the duration of participation in the study (i.e. up to exit DBPCFC). Participants with asthma may be included if well controlled: Asthma control questionnaire (ACQ) score <1 Maximum permitted asthma treatment: moderate dose of inhaled corticosteroid (ICS) and long-acting beta agonists (LABA) as treatment Pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) >80% of predicted value at screening visit For asthmatic participants with intermittent mild symptoms (induced by exercise, animals or pollens) using as required salbutamol only, treatment will be given with regular low dose inhaled corticosteroids (ICS) prior to challenges and for the duration of updosing as an additional measure. For mechanistic sub-study subjects: Adults aged 18-40 years with: A positive skin prick test to peanut extract within previous 12 months Elevated serum specific IgE (>0.35) to Ara h 2 major peanut allergen within 2 years of date of initial screening visit. Clinical diagnosis of peanut allergy made by an experienced allergy specialist. Exclusion Criteria: For peanut OIT patients: Anaphylaxis to a food other than peanut - despite attempted avoidance - within the last 2 years. History of life-threatening anaphylaxis or angioedema, including previous intensive care unit (ITU) admission attributable peanut allergy. Asthmatic treated with higher than moderate dose of ICS (>800 mcg equivalent of beclomethasone dipropionate (BDP) per day). Any asthmatic if uncontrolled or difficult to control as evidenced by any following: ACQ>1; FEV1 <80% predicted; FEV1/ forced vital capacity (FVC) <0.7 irrespective of treatment; hospital attendance (A&E or admission) for asthma in the past 2 years; treatment of asthma with oral steroids within last 2 years. Evidence of non-adherence with asthma treatment from General PRactitioner (GP) repeat prescription records. Participants who react to less than 1 mg of peanut protein on DBPCFC, or who cannot tolerate at least an initial dose of 1.5 mg peanut protein on OIT initiation day. Participants who react to placebo during DBPCFC. Ongoing treatment with beta-blockers, biologics (such as omalizumab or mepolizumab) or systemic immunosuppressive treatment. Regular ongoing use of NSAIDs for a chronic condition (NSAIDs may act as a co-factor for allergic reactions) For females a positive serum or urine pregnancy test with sensitivity of less than 50 mIU/mL within 72 hours of first administration of study therapy. Lactating females. The use of any investigational drug within 30 days of the screening visit. Past history of eosinophilic oesophagitis or chronic gastro-oesophageal reflux symptoms requiring regular treatment with anti-acids. Inability to discontinue antihistamines for a minimum of 4 days prior to DBPCFC visits The presence of any medical condition that the investigator deems incompatible with participation in the trial. Individuals with insufficient understanding of the trial. For mechanistic sub-study subjects: Ongoing treatment with biologic or systemic immunosuppressive treatment. Known current pregnancy Lactating females. The use of any investigational drug within 30 days of the screening visit. Inability to discontinue antihistamines for a minimum of 4 days prior to venesection. The presence of any medical condition that the investigator deems incompatible with participation in the study. Individuals with insufficient understanding of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Hunter, RD MSc
Phone
020 7188 0599
Email
GUPI@gstt.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Kok Loong Ue, MBChB MRCP
Phone
020 7188 5846
Email
GUPI@gstt.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Till, MA FRCP PhD
Organizational Affiliation
Guy's and St Thomas' NHS Foundation Trust / King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Hunter
Phone
020 7188 0599
Email
GUPI@gstt.nhs.uk

12. IPD Sharing Statement

Learn more about this trial

The Grown Up Peanut Immunotherapy Study

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