CompletedNot Applicable

The Grown Up Peanut Immunotherapy Study

United Kingdom33 participantsStarted 2018-10-15

Plain-language summary

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

Age range18 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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.

✕. 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.

Desensitisation to 1.4g peanut

Timeframe: 7-8 months

NCT IDNCT03648320

SponsorGuy's and St Thomas' NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-21

Who can participate

Age range18 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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.

✕. 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.