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A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy

Primary Purpose

Peanut Hypersensitivity, Food Hypersensitivity, Immediate Hypersensitivity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Peanut powder
Peanut extract
Placebo extract
Placebo powder
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Hypersensitivity focused on measuring Peanut Allergy

Eligibility Criteria

6 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Are ages 6 to 21 years of either sex, any race, and any ethnicity at the time of the initial visit.
  • Have a physician diagnosed peanut allergy or a convincing clinical history of peanut allergy (urticaria, upper or lower respiratory symptoms, GI disturbances, rash or oral symptoms).
  • Have a skin prick test positive to peanut (diameter of wheal 3 mm ≥ negative control) and detectable serum peanut-specific IgE level (UniCAP ≥ 0.35 kU/L).
  • Have a positive reaction to a cumulative dose of ≤1,000 mg of peanut powder in the initial qualifying DBPCFC.
  • Use an effective method of contraception by females of childbearing potential to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
  • Ability to perform spirometry maneuvers in accordance with the American Thoracic Society (ATS) guidelines (1994).
  • Have self-injectable epinephrine (i.e. EpiPen® or EpiPen Jr.®) available at all times.
  • Provide signed informed consent (by parent or legal guardian if the subject is a minor) and informed assent if applicable.

Exclusion Criteria:

  • Have a history of severe anaphylaxis to peanut with hypoxia (cyanosis or peripheral capillary oxygen saturation (SpO2) ≤92% at any stage), hypotension or neurological compromise (confusion, collapse, loss of consciousness or incontinence).
  • Tolerates more than 1,000 mg of peanut powder at the initial qualifying DBPCFC.
  • Have a viral upper respiratory infection (URI) or gastroenteritis within 7 days of OFC (OFC will need to be rescheduled).
  • Currently participating in a study using an investigational new drug.
  • Participation in any interventional study for the treatment of food allergy in the past 12 months.
  • Pregnancy or lactation
  • Allergy to placebo ingredients (Glycerin or oat flour) OR reacts to any dose of placebo during the qualifying OFC.
  • Currently in a buildup phase of any allergy immunotherapy.
  • Poor control of atopic dermatitis.
  • Have pulmonary function tests with forced expiratory volume 1 (FEV1) value <80% predicted or any clinical features of greater than moderate persistent asthma and greater than high daily doses of inhaled corticosteroids (>500µg/day fluticasone or equivalent).
  • Use of steroid medications (oral steroids, such as prednisone or Medrol, steroid injections, such as Kenalog, or IV or oral corticosteroid burst) in the following manners:

    o History of daily oral steroid dosing within 4 weeks prior to baseline visit or for > 1 month during the past year or burst oral steroid course in the past 6 months or > 1 burst oral steroid course in the past year.

  • Asthma requiring

    • ≥1 hospitalization in the past year for asthma or
    • >1 ER visit in the past 6 months for asthma
  • Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immuno-modulatory therapy (not including corticosteroids) or biologic therapy within the past year.
  • Use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB), calcium channel blockers or tricyclic antidepressant therapy.
  • Inability to discontinue antihistamines for 5 days for long acting and 3 days for short acting prior to skin testing or OFC's.
  • History of alcohol or drug abuse.
  • Active eosinophilic gastrointestinal disease in the past two years.
  • Have other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders) which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions.
  • Any previous intubation due to allergies or asthma.
  • Severe reaction at initial DBPCFC, defined as:

    • Life-threatening anaphylaxis
    • Requiring overnight hospitalization

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active SLIT/Placebo OIT

Active OIT/Placebo SLIT

Arm Description

These subjects will receive peanut powder given orally and placebo extract given sublingually.

These subjects will receive peanut extract given sublingually and placebo powder given orally.

Outcomes

Primary Outcome Measures

Number of Participants With Induced Peanut Desensitization at 12 Months
Peanut desensitization was defined as a greater than 10-fold increase in oral food challenge (OFC) threshold after 12 months of therapy.

Secondary Outcome Measures

Between Arm Change in IgG4 From Baseline to End of Dose Build-up (up to 16 Weeks)
Serum immunoglobulin G4 (IgG4) levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at the end of dose build-up (up to 16 weeks)
Between Arm Change in IgG4 From Baseline to 6 Months
IgG4 levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at 6 months
Between Arm Change in IgG4 From Baseline to 12 Months
IgG4 levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at 12 months
Between Arm Change in IgE From Baseline to End of Dose Build-up (up to 16 Weeks)
Between Arm Change in IgE From Baseline to 6 Months
Serum immunoglobulin E (IgE) levels are measured in kilo units of Antibody per liter (kUa/L) and were collected at baseline and at 6 months
Between Arm Change in IgE From Baseline to 12 Months
IgE levels are measured in kilo units of Antibody per liter (kUa/L) and were collected at baseline and at 12 months

Full Information

First Posted
March 8, 2010
Last Updated
February 23, 2017
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01084174
Brief Title
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy
Official Title
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to explore the safety and efficacy of a sublingual (under the tongue) immunotherapy (SLIT) dosing regimen and an oral immunotherapy (OIT) regimen in inducing desensitization and long term tolerance in children with persistent peanut allergy.
Detailed Description
To effectively address the Primary Objectives of this pilot study, 30 subjects aged 6-21 years with: (1) a convincing clinical history of peanut allergy (PA), (2) a serum immunoglobulin E (IgE) specific to peanut of >0.35 kilo units per liter (kU/L) and a skin prick test (SPT) wheal >3 mm, will be enrolled. Subjects will be recruited from the Johns Hopkins Pediatric Allergy Clinic. Participants will undergo an initial screening visit that will include a medical history, physical exam, skin testing, and phlebotomy. Informed consent and assent will be obtained. At the next two visits, 20 participants will complete a double-blind placebo-controlled food challenge (DBPCFC). Eligible subjects will be randomized in a 1:1 ratio into two groups. One group will receive active SLIT with placebo OIT and the other group will begin active OIT with placebo SLIT dose escalation. Over the next 16 weeks of the study, subjects will undergo SLIT and OIT dose increases. A maintenance dose will then be taken at home daily for 12 months. A DBPCFC will be completed after 6 months and 12 months of home dosing. Those patients who pass the DBPCFC will be taken off SLIT and OIT for 4 weeks. A final challenge will be administered at the end of this period. Ten additional peanut-allergic subjects age 6-21 years will be enrolled and followed as longitudinal controls for the mechanistic studies. These subjects will follow a modified schedule compared to those subjects receiving study treatment and will be evaluated by phlebotomy, end point titration prick skin testing, and saliva collection. These patients will continue strict avoidance of peanut unless otherwise advised by their personal physician.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Hypersensitivity, Food Hypersensitivity, Immediate Hypersensitivity
Keywords
Peanut Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active SLIT/Placebo OIT
Arm Type
Experimental
Arm Description
These subjects will receive peanut powder given orally and placebo extract given sublingually.
Arm Title
Active OIT/Placebo SLIT
Arm Type
Experimental
Arm Description
These subjects will receive peanut extract given sublingually and placebo powder given orally.
Intervention Type
Drug
Intervention Name(s)
Peanut powder
Intervention Description
Delivered orally
Intervention Type
Drug
Intervention Name(s)
Peanut extract
Intervention Description
Delivered sublingually
Intervention Type
Drug
Intervention Name(s)
Placebo extract
Intervention Description
Delivered sublingually
Intervention Type
Drug
Intervention Name(s)
Placebo powder
Intervention Description
Delivered orally
Primary Outcome Measure Information:
Title
Number of Participants With Induced Peanut Desensitization at 12 Months
Description
Peanut desensitization was defined as a greater than 10-fold increase in oral food challenge (OFC) threshold after 12 months of therapy.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Between Arm Change in IgG4 From Baseline to End of Dose Build-up (up to 16 Weeks)
Description
Serum immunoglobulin G4 (IgG4) levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at the end of dose build-up (up to 16 weeks)
Time Frame
Baseline and end of dose build-up (up to 16 weeks)
Title
Between Arm Change in IgG4 From Baseline to 6 Months
Description
IgG4 levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at 6 months
Time Frame
Baseline and 6 months
Title
Between Arm Change in IgG4 From Baseline to 12 Months
Description
IgG4 levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at 12 months
Time Frame
Baseline and 12 months
Title
Between Arm Change in IgE From Baseline to End of Dose Build-up (up to 16 Weeks)
Time Frame
Baseline to end of dose build-up (up to 16 weeks)
Title
Between Arm Change in IgE From Baseline to 6 Months
Description
Serum immunoglobulin E (IgE) levels are measured in kilo units of Antibody per liter (kUa/L) and were collected at baseline and at 6 months
Time Frame
Baseline and 6 months
Title
Between Arm Change in IgE From Baseline to 12 Months
Description
IgE levels are measured in kilo units of Antibody per liter (kUa/L) and were collected at baseline and at 12 months
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are ages 6 to 21 years of either sex, any race, and any ethnicity at the time of the initial visit. Have a physician diagnosed peanut allergy or a convincing clinical history of peanut allergy (urticaria, upper or lower respiratory symptoms, GI disturbances, rash or oral symptoms). Have a skin prick test positive to peanut (diameter of wheal 3 mm ≥ negative control) and detectable serum peanut-specific IgE level (UniCAP ≥ 0.35 kU/L). Have a positive reaction to a cumulative dose of ≤1,000 mg of peanut powder in the initial qualifying DBPCFC. Use an effective method of contraception by females of childbearing potential to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study. Ability to perform spirometry maneuvers in accordance with the American Thoracic Society (ATS) guidelines (1994). Have self-injectable epinephrine (i.e. EpiPen® or EpiPen Jr.®) available at all times. Provide signed informed consent (by parent or legal guardian if the subject is a minor) and informed assent if applicable. Exclusion Criteria: Have a history of severe anaphylaxis to peanut with hypoxia (cyanosis or peripheral capillary oxygen saturation (SpO2) ≤92% at any stage), hypotension or neurological compromise (confusion, collapse, loss of consciousness or incontinence). Tolerates more than 1,000 mg of peanut powder at the initial qualifying DBPCFC. Have a viral upper respiratory infection (URI) or gastroenteritis within 7 days of OFC (OFC will need to be rescheduled). Currently participating in a study using an investigational new drug. Participation in any interventional study for the treatment of food allergy in the past 12 months. Pregnancy or lactation Allergy to placebo ingredients (Glycerin or oat flour) OR reacts to any dose of placebo during the qualifying OFC. Currently in a buildup phase of any allergy immunotherapy. Poor control of atopic dermatitis. Have pulmonary function tests with forced expiratory volume 1 (FEV1) value <80% predicted or any clinical features of greater than moderate persistent asthma and greater than high daily doses of inhaled corticosteroids (>500µg/day fluticasone or equivalent). Use of steroid medications (oral steroids, such as prednisone or Medrol, steroid injections, such as Kenalog, or IV or oral corticosteroid burst) in the following manners: o History of daily oral steroid dosing within 4 weeks prior to baseline visit or for > 1 month during the past year or burst oral steroid course in the past 6 months or > 1 burst oral steroid course in the past year. Asthma requiring ≥1 hospitalization in the past year for asthma or >1 ER visit in the past 6 months for asthma Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immuno-modulatory therapy (not including corticosteroids) or biologic therapy within the past year. Use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB), calcium channel blockers or tricyclic antidepressant therapy. Inability to discontinue antihistamines for 5 days for long acting and 3 days for short acting prior to skin testing or OFC's. History of alcohol or drug abuse. Active eosinophilic gastrointestinal disease in the past two years. Have other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders) which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions. Any previous intubation due to allergies or asthma. Severe reaction at initial DBPCFC, defined as: Life-threatening anaphylaxis Requiring overnight hospitalization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Wood, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-3923
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25528358
Citation
Narisety SD, Frischmeyer-Guerrerio PA, Keet CA, Gorelik M, Schroeder J, Hamilton RG, Wood RA. A randomized, double-blind, placebo-controlled pilot study of sublingual versus oral immunotherapy for the treatment of peanut allergy. J Allergy Clin Immunol. 2015 May;135(5):1275-82.e1-6. doi: 10.1016/j.jaci.2014.11.005. Epub 2014 Dec 18.
Results Reference
result

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A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy

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