The Grown Up Peanut Immunotherapy Study

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.