Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study
Condition: Treatment Efficacy
Study type: Interventional
Phase: Phase 2

Summary: 
      This application is being submitted as a follow-up to Protocol "Oral Immunotherapy for
      Induction of Tolerance in Peanut Allergic Children-The IMPACT Study." The IMPACT study was a
      double-blind, placebo-controlled study of peanut oral immunotherapy in children 12-48 months
      of age. As part this protocol, all participants who received placebo treatment were promised
      the opportunity to receive open label treatment at the conclusion of the double-blind phase
      and initial follow-up. At the time of submitting that protocol, the investigator did not
      specify any detailed protocol for the open label crossover treatment, as this is an evolving
      field, but the investigator is now ready to offer this open label treatment as promised.
    

Detailed description: 
      This study will enroll up to 20 subjects aged 4-9 years old who were enrolled in the placebo
      arm of the IMPACT study.

      Once subjects have completed participation in the IMPACT study, subjects will be offered the
      option of participating in this open label, peanut oral immunotherapy study.

      After the informed consent has been signed, subjects will undergo an initial dose escalation
      to peanut protein to establish the starting dose for the build-up phase. The starting dose of
      peanut protein for the build-up phase will be the highest tolerated dose during the initial
      dose escalation. The subject will return to the study site and the first starting dose of
      peanut protein will be given under observation. Subjects will be sent home with doses of
      peanut protein to administer at home.

      Subject will return every 2 weeks for dose adjustments. Once subjects have tolerated a dose
      under observation, subjects will then continue dosing at home with OIT and return to the
      research unit every 2 weeks for a 1-step dose escalation to a maximum daily dose of 1000 mg.
      Participants who do not reach the 1000mg dose by 40-weeks of build-up phase may enter the
      maintenance phase at their highest tolerated dose.

      When subjects reach their maximum tolerated dose of either 1000 mg per day, or the maximum
      tolerated dose during the 40 weeks of the build-up phase, subjects will enter the maintenance
      phase. Subjects will continue daily dosing of peanut protein at the maximum tolerated dose
      during the 12-week maintenance phase.

      At the end of the maintenance phase, subjects will undergo an open peanut oral food challenge
      to a maximum of 4000 mg of peanut protein to determine individualized guidelines for the
      introduction of peanut into the subject's diet based on the outcome of the open peanut
      challenge The primary objective of this protocol is to provide open label peanut oral
      immunotherapy (OIT) for those subjects who received placebo treatment in the IMPACT Study .

      Secondary objectives will include:

      1. Efficacy of the treatment, as defined by an end of treatment oral peanut challenge.

      Safety, as measured by the incidence of adverse events and the proportion of subjects who
      discontinue treatment due to adverse events
    

Intervention name(s): Peanut Flour
Intervention type(s): Drug
Intervention description(s): open label oral immunotherapy
Other intervention name(s): Peanut Oral Immunotherapy
Intervention MeSH terms: Immunomodulating Agents
Intervention model: Single Group Assignment
Intervention model description: Open Label crossover
Masking: None (Open Label)
Primary purpose: Treatment