A Phase 1/2 interventional study of Peanut Immunotherapy in Food Allergy and Peanut Allergy, sponsored by University Hospital, Geneva. Terminated at 1 site in Switzerland. Open to participants aged 12 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-08-28.
Sponsored by University Hospital, Geneva · Phase 1/2, Interventional, and Treatment
The purpose of this trial is to assess the safety and efficacy of peanut immunotherapy in children and adults with peanut allergy. Participants will receive immunotherapy with peanut every 2 weeks for a period of 3 months.
344 studies on the registry are indexed under Food Hypersensitivity; 87 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 215 interventional studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →University Hospital, Geneva is the lead sponsor of 378 studies on the registry; 69 are open to participants now.
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Patients with convincing history of IgE-mediated systemic allergic reaction after consumption of peanut, and specific IgE above 95% positive predictive value:
a. Peanut ≥ 15kU/L or Ara h 2 ≥ 5U/L
Exclusion Criteria:
injected peanut extract.
Drug: Peanut Immunotherapy
Treatment will be injected peanut extract every 2 weeks for a period of 3 months.
Result (positive or negative) and cumulative reaction threshold at 3 months peanut oral food challenge (OFC).
An unblinded evaluation of peanut OFC cumulative reaction threshold after 3 months of peanut immunotherapy.
Time frame: 3 months
Change in serum levels of allergen specific IgE and IgG4 after 6 weeks and 3 months of treatment compared to baseline peanut specific IgE and IgG4 after 3 months of treatment with peanut extract.
An evaluation of changes in serum levels of allergen specific IgE and IgG4 after 6 weeks and 3 months of treatment compared to baseline peanut specific IgE and IgG4 after 3 months of treatment with peanut extract.
Time frame: 3 months
Change in titrated skin prick test after 6 weeks and 3 months of treatment with peanut extract compared to baseline.
An evaluation of changes in titrated skin prick tests after 6 weeks and 3 months of treatment with peanut extract compared to baseline.
Time frame: 3 months
Incidence rate of treatment emergent adverse events during peanut immunotherapy
An unblinded evaluation of the safety of peanut immunotherapy as measured by the incidence of treatment-emergent adverse events (AEs and SAEs).
Time frame: 3 months
Ran from Apr 2019 to primary completion in Apr 2022, 36 months.
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This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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