Peanut AllergyGUPINCT03648320
The Grown Up Peanut Immunotherapy Study
A study testing Peanut oral immunotherapy in people with Peanut Allergy, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To determine efficacy and safety of peanut oral immunotherapy in adults with peanut allergy. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Peanut oral immunotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2018to 19 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
About this study
Official title: A Single Arm Phase II Efficacy Study of Peanut Oral Immunotherapy in Adults
To determine efficacy and safety of peanut oral immunotherapy in adults with peanut allergy.
Read the 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.
- Conditions
- Peanut Allergy
- Being tested
- Peanut oral immunotherapy
- Keywords
- IgE mediated peanut allergy, Oral immunotherapy, Desensitisation, GUPI
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut oral immunotherapyOther
Daily doses of peanut flour (with 2-weekly incremental interval)
| Study group | Role | What they receive |
|---|---|---|
| Peanut oral immunotherapy | Experimental | Desensitisation using peanut flour Receives: Other: Peanut oral immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7-8 months
Secondary outcomes (9)
Desensitisation to 4.4g peanut
Tolerance of cumulative dose of 4.4 g peanut protein without reaction on DBPCFC post OIT
Measured: 7-8 months
Incidence of adverse events related to treatment (safety)
Incidence of local and systemic reactions during peanut OIT updosing and maintenance
Measured: 7-8 months
Reactions with ara h 8 sensitisation
Comparison of local and systemic reactions in Ara h 8 sensitised vs. non-sensitised subjects.
Measured: 7-8 months
Skin prick test reactivity
Change in size of wheal diameter to peanut extract following OIT
Measured: 9 months
Immunoglobulin G (IgG) levels
Change in peanut-specific IgG following OIT
Measured: 9 months
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'.
Measured: 7-8 months
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.
Measured: 7-8 months
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.
Measured: 7-8 months
Study compliance
Compliance with OIT measured using monthly diaries.
Measured: 7-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start15 Oct 2018
- Primary completion21 May 2021
- Study completion19 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, King's College London, Imperial College London
- Responsible party
- Sponsor
- Investigators
- Stephen J Till, MA FRCP PhD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust / King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648320
- Sponsor's protocol ID
- 225583
- Acronym
- GUPI
- Status last verified
- May 2024
- First submitted
- 6 Aug 2018
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hunter H, Ue KL, Cornelius V, Yung CC, Thomas I, Tsilochristou O, Layhadi J, Siew LQC, Venter C, Shamji MH, Till SJ. Oral Immunotherapy in Peanut-Allergic Adults Using Real-World Materials. Allergy. 2025 Aug;80(8):2310-2318. doi: 10.1111/all.16493. Epub 2025 Apr 23.
PubMed 40268292
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase II Efficacy Study of Peanut Oral Immunotherapy in Adults
- ClinicalTrials.gov ID
- NCT03648320
- Acronym / sponsor ID
- GUPI / 225583
- Conditions
- Peanut Allergy
- Keywords
- IgE mediated peanut allergy, Oral immunotherapy, Desensitisation, GUPI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, King's College London, Imperial College London
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peanut oral immunotherapy | Experimental | Other: Peanut oral immunotherapyDesensitisation using peanut flour |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peanut oral immunotherapyDaily doses of peanut flour (with 2-weekly incremental interval) | Other | Peanut oral immunotherapy |
Primary outcome
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
9 secondary outcomes
Desensitisation to 4.4g peanut
Time frame: 7-8 months
Incidence of adverse events related to treatment (safety)
Time frame: 7-8 months
Reactions with ara h 8 sensitisation
Time frame: 7-8 months
Skin prick test reactivity
Time frame: 9 months
Immunoglobulin G (IgG) levels
Time frame: 9 months
Quality of life measure
Time frame: 7-8 months
Food Neophobia score
Time frame: 7-8 months
Food Situations score
Time frame: 7-8 months
Study compliance
Time frame: 7-8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Derived from this study: PubMed 40268292Hunter H, Ue KL, Cornelius V, Yung CC, Thomas I, Tsilochristou O, Layhadi J, Siew LQC, Venter C, Shamji MH, Till SJ. Oral Immunotherapy in Peanut-Allergic Adults Using Real-World Materials. Allergy. 2025 Aug;80(8):2310-2318. doi: 10.1111/all.16493. Epub 2025 Apr 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J Till, MA FRCP PhD principal investigator
Guy's and St Thomas' NHS Foundation Trust / King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut oral immunotherapy in people with Peanut Allergy, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desensitisation to 1.4g peanut (time frame: 7-8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03648320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.