Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy

NCT01170286 | Completed Phase 1 DMC

• 1 other identifier: PEP01.09
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this phase 1b study is to evaluate the safety and tolerability of repeated epicutaneous applications of peanut proteins using a patch delivery system (Viaskin device) in peanut allergic subjects.

Conditions

Peanut Allergy

Keywords

Food allergy; Immediate hypersensitivity; Whole peanut extract; Allergenic product; Specific Immunotherapy; Epicutaneous Immunotherapy (EPIT); Safety

Outcome Measures

Primary Outcomes (1)

• Safety evaluation

  The primary outcome measure is safety and the subjects will undergo the following procedures: physical examination including patch application site examination for evaluation of any skin reaction, vital signs, blood and urine collection for blood and urine analysis, ECG, Peak Expiratory Flow and spirometry (FEV1). Adverse events, treatment-emergent adverse events, and serious adverse events will be classified according to severity, treatment relatedness, the system/organ class affected, and the countermeasures taken.

  Safety evaluation to be performed at each visit during the 2-week treatment and at the follow-up visit one week after the end of treatment.

Secondary Outcomes (1)

• Systemic reactions evaluation and treatment; treatment adherence

  Safety evaluation to be performed at each visit during the 2-week treatment and at the follow-up visit one week after the end of treatment.

Study Arms (2)

DBV712 Viaskin

EXPERIMENTAL

The experimental arm is composed of subjects treated with whole peanut extract on an epicutaneous delivery system (Viaskin patch)

Biological: Whole peanut extract

Placebo Viaskin

PLACEBO COMPARATOR

The placebo arm is composed of subjects treated with a placebo formulation on an epicutaneous delivery system (Viaskin patch)

Biological: Placebo formulation

Interventions

Whole peanut extract BIOLOGICAL

Four different doses of whole peanut extract expressed as micrograms (mcg) of peanut proteins (20, 100, 250, 500 mcg) and two different dosing regimen (epicutaneous application for 24 hours every 24 hours and epicutaneous application for 48 hours every 48 hours) will be tested for determination of the maximum tolerated dose during a 2-week treatment period.

Also known as: DBV712 Viaskin

DBV712 Viaskin

Placebo formulation BIOLOGICAL

Matching placebo at two different dosing regimen (epicutaneous application for 24 hours every 24 hours and epicutaneous application for 48 hours every 48 hours) will be tested in parallel to the peanut proteins doses for determination of the maximum tolerated dose during a 2-week treatment period.

Also known as: Placebo Viaskin

Placebo Viaskin

Eligibility Criteria

• Age: 6 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or Female age 6 to 50 years at enrollment, any race, and any ethnicity.
• Physician-diagnosed peanut allergy or convincing history of peanut allergy regardless of the degree of the reaction. Subjects with history of severe anaphylaxis to peanuts (Grades 4 or 5 with dyspnea, cyanosis, hypoxia, hypotension, or neurological compromise) can be enrolled only after assessment of the safety of DBV712 Viaskin in subjects with historic non-severe anaphylaxis (Grade≤3).
• A peanut-specific IgE measured by ImmunoCAP \>0.7 kU/L for all subjects and a positive skin prick test to peanut with a wheal diameter \>8 mm for all non-severe subjects. A skin prick test to peanut for severe subjects will be performed only if deemed necessary by the investigator.
• Use of an effective method of contraception by females of childbearing potential and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study. Women who have had a hysterectomy or tubal ligation at least 6 months prior to the screening visit or who have been post-menopausal for at least 1 year prior to the screening visit are not considered to be of childbearing potential.
• Ability to perform spirometry maneuvers in accordance with the American Thoracic Society guidelines (1994).
• Able to understand the protocol and willing to comply with all study requirements during participation in the study.
• Provide signed informed consent and assent as appropriate.

You may not qualify if:

• Participation in a study using an investigational new drug in the last 30 days prior to the screening visit.
• Participation in any interventional study for the treatment of food allergy in the past 6 months prior to the screening visit.
• Pregnancy or lactation.
• Allergy or known hypersensitivity to the Viaskin patch or adhesives.
• Severe or poorly controlled atopic dermatitis or generalized eczema.
• FEV1 value \<80% predicted or any clinical features of moderate or severe persistent asthma at baseline and treated by doses greater than high daily doses of inhaled corticosteroids (as defined in dosing tables from the 2007 NHLBI guidelines).
• Use of steroid medications in the following manners: history of daily oral steroid dosing 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, prior to the screening visit. Use of oral steroids as described above after the screening visit and before randomization will render the subject non eligible for randomization.
• Asthma requiring 1 or more hospitalization(s) in the past year or \>1 emergency department visit in the past 6 months, prior to the screening visit. Occurrence of asthma in these conditions after the screening visit and before randomization will render the subject non eligible for randomization.
• Use of omalizumab or immunomodulatory or biologic therapy in the past year prior to the screening visit.
• Use of nontraditional forms of allergen immunotherapy (such as oral immunotherapy or sublingual immunotherapy) in the past year prior to the screening visit.
• Use of subcutaneous immunotherapy other than a stable maintenance dose for less than a year prior to the screening visit.
• Use of beta-blockers, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers.
• Inability to discontinue antihistamines for at least 1 week to allow skin testing at the screening visit.
• History of alcohol or drug abuse.
• Uncontrolled hypertension.

Sponsors & Collaborators

• DBV Technologies: lead

Study Sites (5)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

CRI Worldwide

Willingboro, New Jersey, 08046, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

Related Publications (1)

• Jones SM, Agbotounou WK, Fleischer DM, Burks AW, Pesek RD, Harris MW, Martin L, Thebault C, Ruban C, Benhamou PH. Safety of epicutaneous immunotherapy for the treatment of peanut allergy: A phase 1 study using the Viaskin patch. J Allergy Clin Immunol. 2016 Apr;137(4):1258-1261.e10. doi: 10.1016/j.jaci.2016.01.008. Epub 2016 Feb 24. No abstract available.

  PMID: 26920463 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity; Immune System Diseases

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2010
• First Posted: July 27, 2010
• Study Start: July 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 23, 2012

Record last verified: 2012-03

Locations

US (5)