A Randomized, Double-Blind Placebo-Controlled Peanut Sublingual Immunotherapy Trial

• Percent of Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge [ Time Frame: Week 44 (Double Blind Period) ] [ Designated as safety issue: No ]
  Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.
  
  

• Percent of Participants Who Achieved a Maintenance Dose of 1,386 mcg [ Time Frame: Week 44 (Double Blind Period) ] [ Designated as safety issue: Yes ]
  During the build-up phase, escalation was to occur every 2 weeks until the 1,386 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.
  
  
• Percent of Crossover Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge After 44 Weeks of Open Label Peanut Protein Consumption [ Time Frame: Week 44 after initiating crossover open label peanut protein consumption ] [ Designated as safety issue: No ]
  Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.
  
  
• Percent of Crossover Participants Who Achieved an Open Label Peanut Protein Consumption Maintenance Dose of 3,696 mcg [ Time Frame: Week 44 after initiating crossover open label peanut protein consumption ] [ Designated as safety issue: Yes ]
  During the build-up phase, escalation was to occur every 2 weeks until the 3,696 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.
  
  
• Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Baseline through Week 44 (Double Blind Period) ] [ Designated as safety issue: Yes ]
  This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
  
  
• Number of Crossover Participants With Serious Adverse Events (SAEs) During 44 Weeks of Open Label Peanut Protein Consumption [ Time Frame: Initiation of open label peanut protein study therapy through Week 44 of open label peanut protein consumption ] [ Designated as safety issue: Yes ]
  All subjects who were in the Placebo group during the double-blind phase of the study who initiated crossover peanut sublingual immunotherapy during the open label phase of the study will be included.
  
  
• Percent of Participants Who Successfully Consumed 10,000 mg of Peanut Powder [ Time Frame: Approximately 8 weeks after discontinuing study therapy after 3 years on maintenance study therapy ] [ Designated as safety issue: No ]
  Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of peanut powder during a double-blind placebo-controlled oral food challenge were then given an open feeding of peanut butter and those who successfully consumed the open feeding were counted as successes.
  
  

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.