Clinical Trial: Oral Immunotherapy (OIT) for Peanut Allergy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Oral Immunotherapy for Peanut Allergy- Peanut Oral Immunotherapy (PnOIT3)

Brief Summary: Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).

Detailed Summary: Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies it tends to be more persistent and also its prevalence seems to be rising. Currently there is no proven treatment other than strict avoidance. We are attempting to decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut using peanut oral immunotherapy (OIT). We are also studying the effect of peanut OIT on the peanut specific immune response to determine if tolerance to peanut protein will develop. Children ages one to six years of age with peanut allergy will be randomized to peanut OIT or placebo (active subjects). Thirty subjects will also be recruited as controls. These subjects will not receive any peanut or placebo but only have skin prick testing and lab work in addition to a history and physical exam. Active subjects will undergo a modified rush immunotherapy on the first day and then increase the doses at least every two weeks up to a maintenance dose of 4 grams (equivalent to about 13 peanuts). Doses will be taken daily at home except for dose increases which will be done on the research unit. Outcome variables of interest include response to double-blind placebo controlled food challenge, skin prick testing, peanut specific IgE, and adverse events. These results will be compared between the start and end of peanut OIT using appropriate statistical analysis.
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: Percentage of Subjects Achieving Tolerance as Defined by a Negative DBPCFC 4 Weeks After Discontinuation of Peanut OIT Therapy. [ Time Frame: 61 months for those randomized to active treatment and 73 months for those randomized to placebo for the initial 12 months of therapy ]

Upon completion of 60 months of peanut OIT treatment, subjects discontinued peanut OIT for 4 weeks. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms 4 weeks after discontinuing peanut OIT.


Original Primary Outcome: To treat peanut-allergic subjects with peanut OIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes long-term tolerance. [ Time Frame: 4 years ]

Current Secondary Outcome:

  • The Percentage of Subjects Achieving Full Desensitization as Defined by a Negative DBPCFC After 60 Months of Peanut OIT Therapy. [ Time Frame: 60 months for those randomized to active treatment and 72 months for those randomized to placebo for the initial 12 months of therapy ]
    Upon completion of 60 months of peanut OIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCPFC) to assess desensitization. The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms after completing peanut OIT therapy.
  • The Percentage of Subjects Who Tolerated the Initial-day Escalation to 6 mg of Peanut [ Time Frame: first day of peanut OIT dosing ]
    The first day of peanut OIT dosing involved multiple increasing doses of peanut flour in what was called an initial escalation day up to a maximum dose of 6 mg of peanut protein. The secondary outcome measure assessed the percentage of subjects were successfully able to reach this 6 mg dose.
  • The Percentage of Subjects Who Are Successfully Able to Escalate up to the 4000 mg Maximum Maintenance Dose of Peanut Protein OIT During the 60 Month Desensitization Phase of the Study [ Time Frame: approximately 40 weeks (10 months) ]
    During the desensitization phase of the study, subjects under go an initial day escalation up to a maximum of 6 mg of peanut protein. They then undergo biweekly dose escalation over approximately 10 months up to a maximum dose of 4000 mg of peanut protein. This outcome reports the percentage of subjects that achieve this.
  • Incidence of All Serious Adverse Events During the Study [ Time Frame: 61 months for those randomized to active peanut OIT and 73 months for those randomized to placebo for the initial 12 months of the study. ]
    All serious adverse events during the blinded and open-label phases of the study were recorded and reported as a safety outcome.


Original Secondary Outcome: To determine the molecular-level effect that peanut OIT has on the peanut-specific cellular and humoral activity/response in peanut-allergic subjects. [ Time Frame: 4 years ]

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: December 26, 2008
Date Started: April 2009
Date Completion: June 30, 2017
Last Updated: May 11, 2017
Last Verified: May 2017