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The Grown Up Peanut Immunotherapy Study (GUPI)

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ClinicalTrials.gov Identifier: NCT03648320
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
King's College London
Imperial College London
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:
To determine efficacy and safety of peanut oral immunotherapy in adults with peanut allergy.

Condition or disease Intervention/treatment Phase
Peanut Allergy Other: Peanut oral immunotherapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm Phase II Efficacy Study of Peanut Oral Immunotherapy in Adults
Actual Study Start Date : May 18, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Peanut oral immunotherapy
Desensitisation using peanut flour
Other: Peanut oral immunotherapy
Daily doses of peanut flour (with 2-weekly incremental interval)




Primary Outcome Measures :
  1. Desensitisation to 1.4g peanut [ Time Frame: 7-8 months ]
    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 :
  1. Desensitisation to 4.4g peanut [ Time Frame: 7-8 months ]
    Tolerance of cumulative dose of 4.4 g peanut protein without reaction on DBPCFC post OIT

  2. Incidence of adverse events related to treatment (safety) [ Time Frame: 7-8 months ]
    Incidence of local and systemic reactions during peanut OIT updosing and maintenance

  3. Reactions with ara h 8 sensitisation [ Time Frame: 7-8 months ]
    Comparison of local and systemic reactions in Ara h 8 sensitised vs. non-sensitised subjects.

  4. Skin prick test reactivity [ Time Frame: 9 months ]
    Change in size of wheal diameter to peanut extract following OIT

  5. Immunoglobulin G (IgG) levels [ Time Frame: 9 months ]
    Change in peanut-specific IgG following OIT

  6. Quality of life measure [ Time Frame: 7-8 months ]
    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'.

  7. Food Neophobia score [ Time Frame: 7-8 months ]
    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.

  8. Food Situations score [ Time Frame: 7-8 months ]
    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.

  9. Study compliance [ Time Frame: 7-8 months ]
    Compliance with OIT measured using monthly diaries.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03648320


Contacts
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Contact: Hannah Hunter, RD MSc 020 7188 0599 GUPI@gstt.nhs.uk
Contact: Kok Loong Ue, MBChB MRCP 020 7188 5846 GUPI@gstt.nhs.uk

Locations
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United Kingdom
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 9RT
Contact: Hannah Hunter    020 7188 0599    GUPI@gstt.nhs.uk   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
National Institute for Health Research, United Kingdom
King's College London
Imperial College London
Investigators
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Principal Investigator: Stephen J Till, MA FRCP PhD Guy's and St Thomas' NHS Foundation Trust / King's College London

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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03648320     History of Changes
Other Study ID Numbers: 225583
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

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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 Guy's and St Thomas' NHS Foundation Trust:
IgE mediated peanut allergy
Oral immunotherapy
Desensitisation
GUPI
Additional relevant MeSH terms:
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Peanut Hypersensitivity
Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Immunologic Factors
Physiological Effects of Drugs