A Study of Sublingual Immunotherapy in Peanut-allergic Children
Condition: Food Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The specific aim of this study is to determine if peanut allergen-specific SLIT will cause
      clinical desensitization and tolerance to develop in peanut-allergic young children.
    

Detailed description: 
      In spite of increased recognition and understanding of food allergies, food-induced
      anaphylaxis remains the single most common cause of anaphylaxis seen in hospital emergency
      departments, accounting for about one third of anaphylaxis cases seen. It is estimated that
      about 30,000 food-induced anaphylactic events are seen in U.S. emergency departments each
      year and that about 200 fatal cases occur in the U.S. each year. Either peanuts or tree nuts
      cause more than 80% of these reactions. No treatments are available and avoidance is the only
      approved intervention.

      The goal of this study is to investigate peanut sublingual immunotherapy (SLIT) as a
      treatment for children with peanut allergy. This study is primarily designed to evaluate the
      efficacy and safety of peanut SLIT compared to placebo after 12 months. Secondarily, the
      study is designed to evaluate the efficacy of extended maintenance dosing of peanut SLIT in
      inducing lasting tolerance after discontinuation of the peanut SLIT. Mechanistic studies will
      be completed concurrently as exploratory endpoints to understand changes in the allergic
      immune response related to peanut SLIT.
    

Intervention name(s): Peanut SLIT; Placebo SLIT
Intervention type(s): Drug; Drug
Intervention description(s): Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.; Liquid glycerin without peanut which are dosed under the tongue.
Other intervention name(s): Sublingual peanut protein drops; Sublingual glycerin saline drops
Intervention MeSH terms: Glycerol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: For the initial 12 months of the study, subjects were blinded to receive either peanut SLIT or placebo. After unblinding, subjects on placebo are crossed over to receive open-label peanut SLIT. They underwent an identical dosing protocol as those that were initially randomized to active treatment.
After 12 months of peanut SLIT dosing, whether initially randomized to active or crossed over from placebo, all subjects remained part of an open-label extended maintenance phase for the duration of the study (total peanut SLIT dosing 36-60 months)
2 additional cohorts were included in the protocol. One cohort, called the Early Unblinded Peanut SLIT cohort, was unblinded prior to the scheduled 12 month time point for pharmacy safety concerns. The second cohort, called the Pilot Peanut SLIT Rollover cohort involved subjects from the prior pilot study (NCT00429429) who were added to the study through an amendment and received open-label peanut SLIT.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Peanut Allergy; Sublingual immunotherapy