A Study of Sublingual Immunotherapy in Peanut-allergic Children

NCT00597727 | Completed Phase 2 Results DMC

• 2 other identifiers: 11-22965R01AT004435-09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Food Hypersensitivity

Keywords

Peanut Allergy; Sublingual immunotherapy

Outcome Measures

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.

  12 months

Secondary Outcomes (1)

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

  36-60 months

Study Arms (5)

Blinded Peanut SLIT

ACTIVE COMPARATOR

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

Drug: Peanut SLIT

Blinded Placebo SLIT

PLACEBO COMPARATOR

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

Drug: Placebo SLIT

Ext. maint. open label peanut SLIT

OTHER

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

Early unblinded peanut SLIT

OTHER

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

Drug: Peanut SLIT

Pilot peanut SLIT rollover cohort

OTHER

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

Peanut SLIT DRUG

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

Also known as: Sublingual peanut protein drops

Blinded Peanut SLIT; Early unblinded peanut SLIT; Ext. maint. open label peanut SLIT; Pilot peanut SLIT rollover cohort

Placebo SLIT DRUG

Liquid glycerin without peanut which are dosed under the tongue.

Also known as: Sublingual glycerin saline drops

Blinded Placebo SLIT

Eligibility Criteria

• Age: 1 Year - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Peanut IgE \> 7kU/L (\> 2kU/L for children aged 2 years and under) AND
• History of significant clinical symptoms within 60 minutes after the ingestion of peanuts.

You may not qualify if:

• History of severe life-threatening anaphylaxis to peanut, OR
• Medical history that would prevent a DBPCFC to peanut, OR
• Subjects with wheat or oat allergy (which are used in the placebo), OR
• Unable to cooperate with challenge procedures, OR
• Unable to be reached by telephone for follow-up

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (3)

• 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.

  PMID: 23534975 BACKGROUND

• 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.

  PMID: 21281959 RESULT

• 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.

  PMID: 22236732 RESULT

MeSH Terms

Conditions

Food Hypersensitivity; Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity

Limitations and Caveats

The initial 27 subjects in the study were unblinded in 12/2009 due to concerns for study drug integrity. These subjects were offered reentry into the study on open label drug. 18 accepted and are presented as the Early Unblinded Peanut SLIT cohort.

Results Point of Contact

• Title: Edwin Kim, Director UNC Food Allergy Initiative
• Organization: University of North Carolina at Chapel Hill

edwinkim@email.unc.edu

919-843-9087

Study Officials

• Wesley Burks, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 18, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 27, 2018
• Results First Posted: May 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)