Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
Purpose
The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.
Conditions
- Allergy
- Peanut Allergy
Eligibility
- Eligible Ages
- Between 1 Year and 3 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Aged 1 through 3 years at Visit 1 (screening). - Physician-diagnosed peanut allergy and following a strict peanut-free diet - Peanut-specific IgE > 0.7 kUA/L. - A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening). - An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).
Exclusion Criteria
- Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut. - Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region). - Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy). - History of any immunotherapy for peanut allergy, including Epicutaneous immunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT). - Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1. - Uncontrolled persistent asthma.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental DBPC Treatment Period: DBV712 250 mcg |
Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 6 months. |
|
|
Placebo Comparator DBPC Treatment Period: Placebo |
Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 6 months. |
|
|
Experimental Optional Open-Label Extension-Period: DBV712 250 mcg |
The 6-month DBPC period will be followed by an optional open-label extension (OLE) period during which eligible participants will receive DBV712 250 mcg for a duration of 18 months (representing 24 months of active treatment for those participants initially randomized to DBV712 250 mcg and 18 months of active treatment for those participants that were initially randomized to placebo). |
|
Recruiting Locations
AllerVie Clinical Research
Birmingham 4049979, Alabama 4829764 35209
Birmingham 4049979, Alabama 4829764 35209
Modena Allergy & Asthma
La Jolla 5363943, California 5332921 92037
La Jolla 5363943, California 5332921 92037
Allergy & Asthma Associates of Southern California
Mission Viejo 5373763, California 5332921 93691
Mission Viejo 5373763, California 5332921 93691
Allergy & Asthma Medical Group and Research Center
San Diego 5391811, California 5332921 92123
San Diego 5391811, California 5332921 92123
Children's Hospital Colorado
Aurora 5412347, Colorado 5417618 80045
Aurora 5412347, Colorado 5417618 80045
Asthma & Allergy Associates
Colorado Springs 5417598, Colorado 5417618 80907
Colorado Springs 5417598, Colorado 5417618 80907
Allergy, Asthma & Immunology Associates of Tampa Bay
Tampa 4174757, Florida 4155751 33613
Tampa 4174757, Florida 4155751 33613
Emory University - Children's Healthcare of Atlanta, Inc.
Atlanta 4180439, Georgia 4197000 30329
Atlanta 4180439, Georgia 4197000 30329
Sneeze, Wheeze and Itch Associated, LLC
Normal 4903780, Illinois 4896861 61761
Normal 4903780, Illinois 4896861 61761
Allergy and Immunology Associates of Ann Arbor
Ann Arbor 4984247, Michigan 5001836 48197
Ann Arbor 4984247, Michigan 5001836 48197
Allergy and Asthma Research Center of Minnesota
Maplewood 5036588, Minnesota 5037779 55106
Maplewood 5036588, Minnesota 5037779 55106
Children's Mercy Hospital
Kansas City 4393217, Missouri 4398678 64108
Kansas City 4393217, Missouri 4398678 64108
Weiss Medical
Riverdale 5103313, New Jersey 5101760 07457
Riverdale 5103313, New Jersey 5101760 07457
Equity Medical
New York 5128581, New York 5128638 10023
New York 5128581, New York 5128638 10023
Children's Hospital at Montefiore
The Bronx 5110266, New York 5128638 10467
The Bronx 5110266, New York 5128638 10467
Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Gundersen Health System - La Crosse Campus
La Crosse 5258957, Wisconsin 5279468 54601
La Crosse 5258957, Wisconsin 5279468 54601
More Details
- Status
- Recruiting
- Sponsor
- DBV Technologies
Detailed Description
This is a Phase 3 randomized double-blind, placebo-controlled (DBPC) study of 6-months duration to assess the safety of DBV712 250 mcg in subjects 1 through 3 years of age with peanut allergy. Participants who complete the 6-month DBPC period will be eligible to enter an optional 18-month open-label extension (OLE). The overall maximum study duration for each participant will be approximately 112 weeks: Screening Period of 6-weeks, DBPC Treatment Period of 26-weeks, Open-label Period of 78-weeks and Follow-up Period of 2-weeks. For participation eligibility, please refer to eligibility criteria section. Randomization of eligible participants will occur in a 3:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.