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

NCT01084174 | Completed Phase 1 Results DMC

• 1 other identifier: NA_00032256
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Peanut Hypersensitivity; Food Hypersensitivity; Immediate Hypersensitivity

Keywords

Peanut Allergy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (6)

• Between Arm Change in IgG4 From Baseline to End of Dose Build-up (up to 16 Weeks)

  Baseline and end of dose build-up (up to 16 weeks)

• Between Arm Change in IgG4 From Baseline to 6 Months

  Baseline and 6 months

• Between Arm Change in IgG4 From Baseline to 12 Months

  Baseline and 12 months

• Between Arm Change in IgE From Baseline to End of Dose Build-up (up to 16 Weeks)

  Baseline to end of dose build-up (up to 16 weeks)

• Between Arm Change in IgE From Baseline to 6 Months

  Baseline and 6 months

Study Arms (2)

Active SLIT/Placebo OIT

EXPERIMENTAL

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

Drug: Peanut powder; Drug: Placebo extract

Active OIT/Placebo SLIT

EXPERIMENTAL

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

Drug: Peanut extract; Drug: Placebo powder

Interventions

Peanut powder DRUG

Delivered orally

Active SLIT/Placebo OIT

Peanut extract DRUG

Delivered sublingually

Active OIT/Placebo SLIT

Placebo extract DRUG

Delivered sublingually

Active SLIT/Placebo OIT

Placebo powder DRUG

Delivered orally

Active OIT/Placebo SLIT

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287-3923, United States

Location

Related Publications (1)

• 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.

  PMID: 25528358 RESULT

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Robert A. Wood, MD
• Organization: Johns Hopkins University

rwood@jhmi.edu

410-955-5883

Study Officials

• 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 10, 2010
• Study Start: March 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2013
• Last Updated: April 7, 2017
• Results First Posted: April 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)