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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 : Active, not recruiting
First Posted : July 7, 2017
Last Update Posted : February 8, 2018
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

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


Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
United States, New York
Mount Sinai Medical Center
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, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
DBV Technologies

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 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases