A Study of Sublingual Immunotherapy in Peanut-allergic Children

Browse trials for

• Hypersensitivity 1,916
• Food Hypersensitivity 340

Keywords

• Peanut Allergy
• Sublingual immunotherapy

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 60 is close to the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Study arms

• Active comparator
  Blinded Peanut SLIT

  Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.

  Drug: Peanut SLIT

• Placebo comparator
  Blinded Placebo SLIT

  Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.

  Drug: Placebo SLIT

• Other
  Ext. maint. open label peanut SLIT

  After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.

  Drug: Peanut SLIT

• Other
  Early unblinded peanut SLIT

  Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.

  Drug: Peanut SLIT

• Other
  Pilot peanut SLIT rollover cohort

  Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.

  Drug: Peanut SLIT

Interventions

• DrugPeanut SLIT

  Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.

  Also known as: Sublingual peanut protein drops

• DrugPlacebo SLIT

  Liquid glycerin without peanut which are dosed under the tongue.

  Also known as: Sublingual glycerin saline drops

Primary outcomes

1. Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing

   Upon completion of 12 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 2500 mg peanut protein DBPCFC without developing symptoms after 12 months of peanut SLIT therapy.

   Time frame: 12 months

Secondary outcomes

1. Percentage of Subjects Tolerating a Peanut Oral Food Challenge 2-4 Weeks After Discontining Peanut SLIT Dosing

   Upon completion of 36-60 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. Peanut SLIT therapy was then discontinued for 2-4 weeks to assess for persistence of the desensitization response called sustained unresponsiveness (SU). The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5000 mg peanut protein DBPCFC without developing symptoms 2-4 weeks after discontinuing peanut SLIT therapy.

   Time frame: 36-60 months

Baseline characteristics

Publications

• Chin SJ, Vickery BP, Kulis MD, Kim EH, Varshney P, Steele P, Kamilaris J, Hiegel AM, Carlisle SK, Smith PB, Scurlock AM, Jones SM, Burks AW. Sublingual versus oral immunotherapy for peanut-allergic children: a retrospective comparison. J Allergy Clin Immunol. 2013 Aug;132(2):476-8.e2. doi: 10.1016/j.jaci.2013.02.017. Epub 2013 Mar 25. No abstract available. PubMed 23534975 ↗
• Kim EH, Bird JA, Kulis M, Laubach S, Pons L, Shreffler W, Steele P, Kamilaris J, Vickery B, Burks AW. Sublingual immunotherapy for peanut allergy: clinical and immunologic evidence of desensitization. J Allergy Clin Immunol. 2011 Mar;127(3):640-6.e1. doi: 10.1016/j.jaci.2010.12.1083. Epub 2011 Feb 1. PubMed 21281959 ↗
• Kulis M, Saba K, Kim EH, Bird JA, Kamilaris N, Vickery BP, Staats H, Burks AW. Increased peanut-specific IgA levels in saliva correlate with food challenge outcomes after peanut sublingual immunotherapy. J Allergy Clin Immunol. 2012 Apr;129(4):1159-62. doi: 10.1016/j.jaci.2011.11.045. Epub 2012 Jan 10. PubMed 22236732 ↗

Individual participant data

Plan to share: No