FARE - Food Allergy Research & Education Logo

The Grown Up Peanut Immunotherapy Study

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 40 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03648320
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Guy's and St Thomas' NHS Foundation Trust
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Stephen J Till, MA FRCP PhD
Principal Investigator Affiliation Guy's and St Thomas' NHS Foundation Trust / King's College London
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOther
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Peanut Allergy
Additional Details

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.

Arms & Interventions

Arms

Experimental: Peanut oral immunotherapy

Desensitisation using peanut flour

Interventions

Other: - Peanut oral immunotherapy

Daily doses of peanut flour (with 2-weekly incremental interval)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

London, United Kingdom

Status

Recruiting

Address

Guy's and St Thomas' NHS Foundation Trust

London, , SE1 9RT

Site Contact

Hannah Hunter

GUPI@gstt.nhs.uk

020 7188 0599

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.