A Randomized, Double-Blind Placebo-Controlled Peanut Sublingual Immunotherapy Trial
Condition: Food Hypersensitivity; Hypersensitivity; Immediate Hypersensitivity; Peanut Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and immune response to daily sublingual
      (under the tongue) immunotherapy (SLIT) with peanut extract in adults and children with
      peanut allergies.
    

Detailed description: 
      Peanut allergy is a common ailment in the United States. Research suggests that the
      prevalence of peanut allergy in the United States has doubled over the last 5 years.
      Currently, the only effective treatment for peanut allergy is a peanut-free diet and quick
      access to self-injectable epinephrine in the event of peanut exposure. The sublingual route
      is a potential method to administer immunotherapy for the treatment of food allergies. The
      intent of this study is to induce desensitization and eventually tolerance to peanut protein
      and evaluate the safety and immunologic effects of daily sublingual immunotherapy (SLIT) for
      individuals with peanut allergy. The trial will enroll 40 participants. After the first 10
      participants between the ages of 18 and 40 are enrolled, safety information will be reviewed.
      If there are no safety concerns, the study will continue to enroll the remaining participants
      between the ages of 12 and 40.

      This clinical trial will last 172 to 216 weeks. Participants will be randomly assigned to
      receive peanut SLIT or placebo SLIT. All participants will have an entry oral food challenge
      (OFC). The treatment group will receive gradual dosing escalations of peanut SLIT and
      maintenance therapy over a 44-week period, followed by another OFC. Following the OFC,
      participants will be unblinded, and the placebo group will receive peanut SLIT escalated to a
      higher maximum dose than the first treatment group. Maintenance therapy will continue for
      both groups for more than 2 years.

      Study visits will occur every 2 weeks during dosing escalations of peanut SLIT, followed by
      visits gradually spacing out during maintenance to every 12 weeks. At selected visits, a
      physical examination, skin prick tests, blood and urine collection, and atopic dermatitis and
      asthma evaluations will occur. Approximately 6 OFCs will be administered to each participant
      throughout the course of the study. Additionally, 10 participants will be enrolled as control
      participants who will not receive any study therapy and will only have blood drawn at 3
      visits throughout the course of the trial.
    

Intervention name(s): Glycerinated peanut allergenic extract; Placebo for peanut extract (glycerin)
Intervention type(s): Drug; Drug
Intervention description(s): Glycerinated peanut extract delivered sublingually.; Placebo (glycerin) delivered sublingually.
Other intervention name(s): Peanut SLIT; Placebo
Intervention MeSH terms: Glycerol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Food Allergy; Peanut Allergy; Sublingual Immunotherapy