Food Allergy Clinical Trial
Official title:
The Persistence of Oral Tolerance Induction to Peanut and Its Immunological Basis (ITN049AD)
ITN049AD (LEAP-On) Study is a continuation of the ITN032AD LEAP Study (NCT00329784).
Peanut Allergy, a recognized public health concern, is a common and potentially
life-threatening food allergy for which there is no treatment. ITN032AD (LEAP) Study
evaluated whether early exposure to peanut promotes tolerance and provides protection from
developing peanut allergy in children who are allergic to eggs or who have severe eczema.
ITN049AD (LEAP-On) Study will evaluate persistent tolerance to peanut by assessing the
effect of twelve months of cessation of peanut consumption in LEAP Study participants who
consumed peanut and those who avoided peanut over the previous five years.
This is a two-sample comparison employing all available study participants in both arms of
the LEAP (NCT00329784) study at visit 72. After obtaining informed consent, LEAP
participants who are evaluable for peanut allergy at age 60 months (V60) will be enrolled
into this study, the LEAP-On (NCT01366846) Study. All LEAP-On participants will avoid peanut
for an additional 12 months regardless of their previous allocation to the LEAP Study
consumption arm (Group A) or the LEAP Study avoidance arm (Group B).
At V72, after 12 months of this new intervention, all participants will have skin prick
testing (SPT), specific IgE and a repeat oral challenge to peanut to determine the frequency
of peanut allergy in both groups. The LEAP Study decision table will be used to determine
the presence of peanut allergy. Briefly, peanut allergy will be based on the presence of a
positive oral peanut challenge with objective signs of allergy. Tolerance will be
established on the basis of a negative oral peanut challenge (tolerating 5 g of peanut
protein in the absence of symptoms). For participants who do not have an oral challenge or
an oral challenge at V72 with a determinate outcome, the following criteria will be used to
determine their outcome at V72:
- If the participant is tolerant and has an IgE > 0.1 and/or SPT > 0 mm at V60, the
participant will be considered non-evaluable and will not be included in the analysis.
- For all other participants, the V60 outcome will be applied to the V72 outcome (last
observation carried forward).
Predictive values of peanut-specific IgE and/or SPT will not be used in the LEAP-On study
because participants in the peanut consumption arm in the LEAP study are tolerating peanuts
despite having high IgE and/or SPT.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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