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Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age (EPITOPE)

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ClinicalTrials.gov Identifier: NCT03211247
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
DBV Technologies

Brief Summary:
The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).

Condition or disease Intervention/treatment Phase
Peanut Allergy Biological: Viaskin Peanut 250 mcg Biological: Viaskin Peanut 100 mcg Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 331 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 III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Viaskin Peanut 250 mcg Biological: Viaskin Peanut 250 mcg
Viaskin Peanut 250 mcg, once daily

Experimental: Viaskin Peanut 100 mcg Biological: Viaskin Peanut 100 mcg
Viaskin Peanut 100 mcg, once daily

Placebo Comparator: Placebo Biological: Placebo
Placebo patch, once daily




Primary Outcome Measures :
  1. Differences between the percentage of treatment responders in the selected active Viaskin Peanut group compared to the placebo group. [ Time Frame: Month 12 ]

Other Outcome Measures:
  1. Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) [ Time Frame: Throughout the study during 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male or female from 1-3 years of age;
  • Physician-diagnosed peanut allergy;
  • Peanut-specific IgE level > 0.7 kU/L;
  • Positive peanut SPT with a largest wheal diameter ≥ 6 mm;
  • Positive DBPCFC at ≤ 300 mg peanut protein;

Key Exclusion Criteria:

  • Uncontrolled asthma;
  • History of severe anaphylaxis to peanut;
  • Prior immunotherapy to any food or other immunotherapy;
  • Generalized severe dermatologic disease;

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 ClinicalTrials.gov identifier (NCT number): NCT03211247


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Locations
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United States, Arizona
University of Arizona Health Science Recruiting
Tucson, Arizona, United States, 85719
Contact: Heather Cassell, MD    520-626-7780    heathercassell@peds.arizona.edu   
Principal Investigator: Heather Cassell, MD         
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Stacie M. Jones, MD    501-364-1060    jonesstaciem@uams.edu   
Principal Investigator: Stacie M. Jones, MD         
United States, California
University of California School of Medicine Recruiting
Los Angeles, California, United States, 10833
Contact: Maria Garcia-Lloret, MD    310-825-6481    Migarcia@mednet.ucla.edu   
Principal Investigator: Maria Garcia-Lloret, MD         
University of California, Rady Children's Hospital Not yet recruiting
San Diego, California, United States, 92123
Contact: Stephanie Leonard, MD    858-966-5961    saleonard@ucsd.edu   
Principal Investigator: Stephanie Leonard, MD         
University of California San Francisco Not yet recruiting
San Francisco, California, United States, 94158
Contact: Morna DORSEY, MD    415-476-3086    Morna.Dorsey@ucsf.edu   
Principal Investigator: Morna DORSEY, MD         
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Sayantani Sindher    650-724-0293    SNPCenterAllergy.Inquiry@stanford.edu   
Principal Investigator: Sayantani Sindher, MD         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: David M. Fleischer, MD    720-777-2575    david.fleischer@childrenscolorado.org   
Principal Investigator: David M. Fleischer, MD         
United States, District of Columbia
Children's national Health System Not yet recruiting
Washington, District of Columbia, United States, 20010
Contact: Hemant Sharma, MD    202-476-6080    HSharma@childrensnational.org   
Principal Investigator: Hemant Sharma, MD         
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30329
Contact: Brian VICKERY, MD    404-727-8536    brian.p.vickery@emory.edu   
Principal Investigator: Brian VICKERY, MD         
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of CHicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Michelle Catalano    312-227-6474    allergystudy@luriechildrens.org   
Principal Investigator: Jacqueline Pongracic, MD         
The Universal of Chicago Medical Center Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Christina Ciaccio, MD    773-834-4010    cciaccio@peds.bsd.uchicago.edu   
Principal Investigator: Christina Ciaccio, MD         
United States, Indiana
Riley Hospital for Children at Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kirsten KLOEPFER, MD    317-278-7860    kloepfer@iu.edu   
Principal Investigator: Kirsten KLOEPFER, MD         
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Robert Wood, MD    410-955-5883    rwood@jhmi.edu   
Principal Investigator: Robert Wood, MD         
United States, Massachusetts
Boston Childrens' Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lynda Schneider, MD    617-355-6180    lynda.schneider@childrens.harvard.edu   
Principal Investigator: Lynda Schneider, MD         
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Georgiana M Sanders, MD    734-936-5634    gsanders@med.umich.edu   
Principal Investigator: Georgiana M Sanders, MD         
United States, New York
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Julie Wang, MD    212-241-5548    julie.wang@mssm.edu   
Principal Investigator: Julie Wang, MD         
University of Rochester Not yet recruiting
Rochester, New York, United States, 14642
Contact: Jeanne Lomas, MD    716-604-6928    Jeanne_Lomas@urmc.rochester.edu   
Principal Investigator: Jeanne Lomas, MD         
United States, North Carolina
The University of North Carolina - Chapell Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Edwin Kim, MD    919-843-9087    edwinkim@med.unc.edu   
Principal Investigator: Edwin Kim, MD         
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Leigh Ann KERNS, MD    216-444-6340    KernsL2@ccf.org   
Principal Investigator: Leigh Ann KERNS, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Terri Brown-Whitehorn, MD    215-590-2549    brownte@email.chop.edu   
Principal Investigator: Terri Brown-Whitehorn, MD         
Children's Hospital of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Deborah Albright, MD    412-692-8296    albrightd@chp.edu   
Principal Investigator: Deborah Albright, MD         
United States, Tennessee
Le Bonheur Children's Hospital Not yet recruiting
Memphis, Tennessee, United States, 38105
Contact: Jay LIEBERMAN, MD    901-287-7337    jlieber1@uthsc.edu   
Principal Investigator: Jay LIEBERMAN, MD         
United States, Texas
Dell Children's Medical Center Recruiting
Austin, Texas, United States, 78723
Contact: Pooja VARSHNEY, MD    512-628-1870    pVarshney@ascension.org   
Principal Investigator: Pooja VARSHNEY, MD         
Children's Medical Center of Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Christopher Parrish, MD    214-456-5730    dChristopher.Parrish@UTSouthwestern.edu   
Principal Investigator: Christopher Parrish, MD         
Baylor College of Medicine - Texas Children's Hospital Not yet recruiting
Houston, Texas, United States, 77030
Contact: Sara Anvari, MD    832-825-4668    sanvari@bcm.edu   
Principal Investigator: Sara Anvari, MD         
United States, Washington
ASTHMA, Inc. Recruiting
Seattle, Washington, United States, 98115
Contact: Daniel Petroni, MD    206-525-5520    dpetroni@nwasthma.com   
Principal Investigator: Daniel Petroni, MD         
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V5H 3V4
Contact: Chan Edmond, MD    1 604 875 2628    EChan5@cw.bc.ca   
Principal Investigator: Chan Edmond, MD         
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Thomas Eiwegger    416-813-7654    thomas.eiwegger@sickkids.ca   
Canada, Quebec
CHUM & CHU Sainte-Justine Recruiting
Montréal, Quebec, Canada, H3T 1C4
Contact: Philippe Begin    514-567-9599    philippe.begin@umontreal.ca   
Principal Investigator: Philippe Begin         
Sponsors and Collaborators
DBV Technologies

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Responsible Party: DBV Technologies
ClinicalTrials.gov Identifier: NCT03211247     History of Changes
Other Study ID Numbers: EPITOPE
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by DBV Technologies:
EPIT
Epicutaneous
Immunotherapy
Viaskin

Additional relevant MeSH terms:
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Peanut Hypersensitivity
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases