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

This study is not yet open for participant recruitment.

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Contacts and Locations

Verified July 2017 by DBV Technologies

Sponsor:

Information provided by (Responsible Party):

DBV Technologies

ClinicalTrials.gov Identifier:

NCT03211247

First received: July 5, 2017

Last updated: NA

Last verified: July 2017

History: No changes posted

Purpose

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	Intervention	Phase
Peanut Allergy	Biological: Viaskin Peanut 250 mcg Biological: Viaskin Peanut 100 mcg Biological: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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.

Resource links provided by NLM:

Drug Information available for: Arachis hypogaea

U.S. FDA Resources

Further study details as provided by DBV Technologies:

Primary Outcome Measures:

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:

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


Estimated Enrollment:	331
Anticipated Study Start Date:	July 31, 2017
Estimated Study Completion Date:	May 30, 2020
Estimated Primary Completion Date:	May 30, 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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;

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211247

Locations


United States, North Carolina
University of North Carolina, School of Medicine	Not yet recruiting
Chapel Hill, North Carolina, United States, 27710

Sponsors and Collaborators

DBV Technologies

More Information


Responsible Party:	DBV Technologies
ClinicalTrials.gov Identifier:	NCT03211247 History of Changes
Other Study ID Numbers:	EPITOPE
Study First Received:	July 5, 2017
Last Updated:	July 5, 2017
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

ClinicalTrials.gov processed this record on July 11, 2017

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