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

NCT00580606 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: DAIT CoFAR4
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Food Hypersensitivity; Hypersensitivity; Immediate Hypersensitivity; Peanut Hypersensitivity

Keywords

Food Allergy; Peanut Allergy; Sublingual Immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Week 44 (Double Blind Period)

Secondary Outcomes (6)

• Percent of Participants Who Achieved a Maintenance Dose of 1,386 mcg

  Week 44 (Double Blind Period)

• 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

  Week 44 after initiating crossover open label peanut protein consumption

• Percent of Crossover Participants Who Achieved an Open Label Peanut Protein Consumption Maintenance Dose of 3,696 mcg

  Week 44 after initiating crossover open label peanut protein consumption

• Number of Participants With Serious Adverse Events (SAEs)

  Baseline through Week 44 (Double Blind Period)

• Number of Crossover Participants With Serious Adverse Events (SAEs) During 44 Weeks of Open Label Peanut Protein Consumption

  Initiation of open label peanut protein study therapy through Week 44 of open label peanut protein consumption

Study Arms (2)

Low Dose Peanut SLIT (Double Blind to Open Label)

EXPERIMENTAL

Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume \>= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy.

Drug: Glycerinated peanut allergenic extract

Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)

PLACEBO COMPARATOR

Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.

Drug: Placebo for peanut extract (glycerin)

Interventions

Glycerinated peanut allergenic extract DRUG

Glycerinated peanut extract delivered sublingually.

Also known as: Peanut SLIT

Low Dose Peanut SLIT (Double Blind to Open Label)

Placebo for peanut extract (glycerin) DRUG

Placebo (glycerin) delivered sublingually.

Also known as: Placebo

Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Physician-diagnosed peanut allergy OR convincing clinical history of peanut allergy
• Reacts to a cumulative dose of 2,000 mg or less of peanut powder
• Positive peanut allergy skin prick test OR detectable serum peanut-specific IgE level
• Willing to use an acceptable method of contraception for the duration of the study
• Ability to perform spirometry maneuver in accordance with the American Thoracic Society guidelines

You may not qualify if:

• History of severe anaphylaxis to peanut
• Currently participating in a study using a new investigational new drug
• Participation in any interventional study for the treatment of food allergy in the 12 months prior to study entry
• Allergic to placebo ingredients (glycerin or oat flour) OR reacts to any dose of placebo during study entry oral food challenge (OFC)
• Currently in a buildup phase of any allergy immunotherapy
• Poor control of atopic dermatitis
• Moderate or severe asthma despite therapy
• Current treatment with greater than medium daily doses of inhaled corticosteroids
• Use of steroid medications
• Use of omalizumab or other nontraditional forms of allergen immunomodulatory therapy (not including corticosteroids) or biologic therapy in the 12 months prior to study entry
• Use of beta blockers, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium channel blockers
• Inability to discontinue antihistamines for skin testing and OFCs
• History of ischemic cardiovascular disease
• History of alcohol or drug abuse
• Other significant medical conditions that, in the opinion of the investigator, prevent participation in the study

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Consortium of Food Allergy Research: collaborator

Study Sites (5)

University of Arkansas

Little Rock, Arkansas, 72202, United States

Location

National Jewish Medical and Research Center

Denver, Colorado, 80208, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21218, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University of North Carolina

Durham, North Carolina, 27706, United States

Location

Related Publications (5)

• de Leon MP, Rolland JM, O'Hehir RE. The peanut allergy epidemic: allergen molecular characterisation and prospects for specific therapy. Expert Rev Mol Med. 2007 Jan 9;9(1):1-18. doi: 10.1017/S1462399407000208.

  PMID: 17210088 BACKGROUND

• Enrique E, Cistero-Bahima A. Specific immunotherapy for food allergy: basic principles and clinical aspects. Curr Opin Allergy Clin Immunol. 2006 Dec;6(6):466-9. doi: 10.1097/01.all.0000246618.41871.a4.

  PMID: 17088653 BACKGROUND

• Sicherer SH, Sampson HA. Peanut allergy: emerging concepts and approaches for an apparent epidemic. J Allergy Clin Immunol. 2007 Sep;120(3):491-503; quiz 504-5. doi: 10.1016/j.jaci.2007.07.015. Epub 2007 Aug 8.

  PMID: 17689596 BACKGROUND

• Fleischer DM, Burks AW, Vickery BP, Scurlock AM, Wood RA, Jones SM, Sicherer SH, Liu AH, Stablein D, Henning AK, Mayer L, Lindblad R, Plaut M, Sampson HA; Consortium of Food Allergy Research (CoFAR). Sublingual immunotherapy for peanut allergy: a randomized, double-blind, placebo-controlled multicenter trial. J Allergy Clin Immunol. 2013 Jan;131(1):119-27.e1-7. doi: 10.1016/j.jaci.2012.11.011.

  PMID: 23265698 RESULT

• Burks AW, Wood RA, Jones SM, Sicherer SH, Fleischer DM, Scurlock AM, Vickery BP, Liu AH, Henning AK, Lindblad R, Dawson P, Plaut M, Sampson HA; Consortium of Food Allergy Research. Sublingual immunotherapy for peanut allergy: Long-term follow-up of a randomized multicenter trial. J Allergy Clin Immunol. 2015 May;135(5):1240-8.e1-3. doi: 10.1016/j.jaci.2014.12.1917. Epub 2015 Feb 3.

  PMID: 25656999 RESULT

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Main Areas of Focus: Consortium of Food Allergy Research (CoFAR)

MeSH Terms

Conditions

Food Hypersensitivity; Hypersensitivity; Hypersensitivity, Immediate; Peanut Hypersensitivity

Interventions

Glycerol

Condition Hierarchy (Ancestors)

Immune System Diseases; Nut and Peanut Hypersensitivity

Intervention Hierarchy (Ancestors)

Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Limitations and Caveats

Refer to the original results published in the Journal of Allergy and Clinical Immunology, Vol 135, Number 5, page 1247 for a full description of the limitations of the current study.

Results Point of Contact

• Title: Director, Clinical Research Operations Program
• Organization: DAIT/NIAID

DAITClinicalTrialsgov@niaid.nih.gov

301-594-7669

Study Officials

• Wesley Burks, MD

  Duke University

  STUDY CHAIR

• David Fleischer, MD

  National Jewish Health

  STUDY CHAIR

• Hugh A. Sampson, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Stacie Jones, MD

  Arkansas Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Robert Wood, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 25, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2014
• Last Updated: August 21, 2019
• Results First Posted: October 30, 2012

Record last verified: 2019-08

Locations

US (5)