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Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy (PEPITES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02636699
Recruitment Status : Completed
First Posted : December 22, 2015
Last Update Posted : March 5, 2019
Information provided by (Responsible Party):
DBV Technologies

Brief Summary:
The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age after a 12-month treatment by epicutaneous immunotherapy (EPIT).

Condition or disease Intervention/treatment Phase
Peanut Allergy Biological: Viaskin Peanut 250mcg Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomized Phase 3 Pivotal Trial to Assess the Efficacy and Safety of Peanut Epicutaneous Immunotherapy With Viaskin Peanut in Peanut-allergic Children
Study Start Date : December 2015
Actual Primary Completion Date : August 18, 2017
Actual Study Completion Date : August 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Viaskin Peanut 250mcg Biological: Viaskin Peanut 250mcg
Peanut extract cutaneous patch
Other Name: DBV712

Placebo Comparator: Placebo Biological: Placebo
Cutaneous patch containing an inactive deposit manufactured to mimic peanut extract

Primary Outcome Measures :
  1. Percentage of treatment responders in the overall population [ Time Frame: Month 12 ]

    A subject is defined as a treatment responder if:

    • The initial eliciting dose (ED) was >10 mg peanut protein and the ED is ≥1,000 mg peanut protein at the post treatment double-blind placebo controlled food challenge (DBPCFC), or
    • The initial eliciting dose (ED) was ≤10 mg and the ED is ≥300 mg peanut protein at the post-treatment DBPCFC.

Secondary Outcome Measures :
  1. Percentage of treatment responders in each of the 2 screening ED strata [ Time Frame: Month 12 ]
  2. Change from baseline of mean and median cumulative reactive dose of peanut protein [ Time Frame: Baseline and Month 12 ]
  3. Change from baseline of mean and median eliciting dose of peanut protein [ Time Frame: Baseline and Month 12 ]

Other Outcome Measures:
  1. Safety as assessed by Number of participants with treatment-related adverse events [ Time Frame: Through study completion, an average of 1 year ]
  2. Composite measure of physical examinations [ Time Frame: At screening and at Day1, Day 8, Month 1, Month 3, Month 6, Month 9 and Month 12 ]
  3. Composite measure of vital signs [ Time Frame: At screening and at Day1, Day 8, Month 1, Month 3, Month 6, Month 9 and Month 12 ]
  4. Peak exploratory flow (PEF) [ Time Frame: At screening and at Day1, Day 8, Month 1, Month 3, Month 6, Month 9 and Month 12 ]
  5. Composite measure of laboratory data (hematology and biochemistry analyses) [ Time Frame: At screening and at Month 3, Month 6 and Month 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main Inclusion Criteria:

  1. Male or female children aged 4 through 11 years;
  2. Physician-diagnosis of peanut allergy or children with a well documented medical history of IgE-mediated symptoms after ingestion of peanut and currently following a strict peanut-free diet, but without a physician diagnosis;
  3. Peanut-specific IgE level (ImmunoCAP system) >0.7 kU/L;
  4. Positive peanut skin prick test (SPT) with a largest wheal diameter:

    • ≥6 mm for children 4 through 5 years of age at Visit 1,
    • ≥8 mm for children 6 years and above at Visit 1;
  5. Positive DBPCFC at ≤300 mg peanut protein.

Main Exclusion Criteria:

  1. History of severe anaphylaxis to peanut with any of the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence);
  2. Generalized dermatologic disease
  3. Diagnosis of mast cell disorders, including mastocytosis or uricaria pigmentosa as well as hereditary or idiopathic angioedema;
  4. Diagnosis of asthma that fulfills any of the following criteria:

    • Uncontrolled persistent asthma as defined by National Asthma Education and Prevention Program Asthma guidelines 2007 or by Global Initiative for Asthma guidelines 2015,
    • Asthma treated with either a high daily high dose of inhaled corticosteroid or with a combination therapy of a medium or high daily dose of inhaled corticosteroid with a long acting inhaled β2 agonist or with a combination therapy of a high daily dose of inhaled corticosteroid with a long acting inhaled β2 agonist. Asthmatic subjects treated with a medium daily dose of inhaled corticosteroids are eligible. Intermittent asthmatic subjects who require intermittent use of inhaled corticosteroids for rescue are also eligible,
    • Two or more systemic corticosteroid courses for asthma in the past year or 1 oral corticosteroid course for asthma within 3 months prior to Visit 1, or during screening period,
    • Prior intubation/mechanical ventilation for asthma within 1 year prior to Visit 1, or during screening;
  5. Receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy;
  6. Received anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy within 1 year prior to Visit 1, during screening period or during study participation;
  7. Use of systemic long-acting corticosteroids within 12 weeks prior to Visit 1 and/or use of systemic short-acting corticosteroids within 4 weeks prior to Visit 1 or during screening;
  8. Prior or concomitant history of any immunotherapy to any food;
  9. Receiving or planning to receive any aeroallergen immunotherapy during their participation in the study. Aeroallergen immunotherapy must be discontinued at the time of Visit 1;
  10. Any disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02636699

Hide Hide 31 study locations
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United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
University of California, Rady Children's Hospital
San Diego, California, United States, 92123
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
National Jewish Health
Denver, Colorado, United States, 80206
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Childrens' Hospital
Boston, Massachusetts, United States, 02115
United States, New York
Jaffe Food Allergy Institute
New York, New York, United States, 10029
United States, North Carolina
The University of North Carolina - Chapell Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Children's Medical Center of Dallas
Dallas, Texas, United States, 75235
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Washington
Seattle, Washington, United States, 98115
Allergy Medical
Brisbane, Australia
Princess Margaret Hospital for Children
Perth, Australia
Children's Hospital Westmead
Sydney, Australia
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V5H 3V4
Canada, Ontario
Cheema Research Inc.
Mississauga, Ontario, Canada, L5A 3V4
Ottawa Allergy Asthma Research Institute
Ottawa, Ontario, Canada, K1Y 4G2
Gordon Sussman Clinical Research Inc.
Toronto, Ontario, Canada, M4V 1R2
Canada, Quebec
CHUM & CHU Sainte-Justine
Montréal, Quebec, Canada, H3T 1C4
Centre de Recherche Appliquée en Allergie de Québec (CRAAQ)
Quebec, Canada, QC G1V4M6
Charité Universitätsmedizin Berlin
Berlin, Germany, D-13353
Bonn, Germany, D-53115
Universitätsklinikum Erlangen
Erlangen, Germany
Clinical Investigations Unit
Cork, Ireland
Our Lady's Children's Hospital
Dublin, Ireland
Sponsors and Collaborators
DBV Technologies
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: DBV Technologies Identifier: NCT02636699    
Other Study ID Numbers: PEPITES
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate