The Grown Up Peanut Immunotherapy Study

NCT03648320 | Completed DMC

• 1 other identifier: 225583
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peanut Allergy

Keywords

IgE mediated peanut allergy; Oral immunotherapy; Desensitisation; GUPI

Outcome Measures

Primary Outcomes (1)

• 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

  7-8 months

Secondary Outcomes (9)

• Desensitisation to 4.4g peanut

  7-8 months

• Incidence of adverse events related to treatment (safety)

  7-8 months

• Reactions with ara h 8 sensitisation

  7-8 months

• Skin prick test reactivity

  9 months

• Immunoglobulin G (IgG) levels

  9 months

Study Arms (1)

Peanut oral immunotherapy

EXPERIMENTAL

Desensitisation using peanut flour

Other: Peanut oral immunotherapy

Interventions

Peanut oral immunotherapy OTHER

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

Peanut oral immunotherapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• King's College London: collaborator
• Imperial College London: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40268292 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Stephen J Till, MA FRCP PhD

  Guy's and St Thomas' NHS Foundation Trust / King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 27, 2018
• Study Start: October 15, 2018
• Primary Completion: May 21, 2021
• Study Completion: May 19, 2022
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

GB (1)