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Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age (VITESSE)

Primary Purpose

Allergy, Peanut

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DBV712
Placebo
Sponsored by
DBV Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergy, Peanut focused on measuring Peanut Hypersensitivity, Epicutaneous Immunotherapy (EPIT), Epicutaneous, Immunotherapy, Viaskin, Nut and Peanut Hypersensitivity, Food Hypersensitivity, Peanut Allergy, Food Allergy, Nut and Peanut Allergy

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Aged 4 through 7 years at Visit 1 (screening). Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet. Peanut-specific IgE of >0.7 kilo allergy unit per liter (kUA/L) and a positive peanut SPT with the largest wheal diameter of ≥6 millimeter (mm) at Visit 1. An ED of ≤100 mg peanut protein at screening DBPCFC. Key Exclusion Criteria: Severe generalized dermatologic disease involving the application area (interscapular region) Uncontrolled persistent asthma. Past or current immunotherapy for peanut allergy, including oral immunotherapy (OIT). Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy), or treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.

Sites / Locations

  • DBV Investigative SiteRecruiting
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  • DBV Investigative Site
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  • DBV Investigative SiteRecruiting
  • DBV Investigative Site
  • DBV Investigative SiteRecruiting
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  • DBV Investigative SiteRecruiting
  • DBV Investigative Site
  • DBV Investigative Site
  • DBV Investigative Site
  • DBV Investigative SiteRecruiting
  • DBV Investigative SiteRecruiting
  • DBV Investigative Site
  • DBV Investigative Site
  • DBV Investigative SiteRecruiting
  • DBV Investigative SiteRecruiting
  • DBV Investigative SiteRecruiting
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DBV712 250 mcg

Placebo

Arm Description

Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).

Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).

Outcomes

Primary Outcome Measures

Percentage of Treatment Responders in the DBV712 Group Compared to Placebo Group
A participant is defined as a treatment responder if: The initial ED was ≤30 mg peanut protein and the ED is ≥ 300 mg peanut protein at the post-treatment DBPCFC at Month 12; OR the initial ED was > 30 mg peanut protein and the ED is ≥600 mg peanut protein at the post-treatment DBPCFC at Month 12. Percentage of treatment responders in the DBV712 group compared to the placebo group after 12 months of treatment in the target population will be reported.

Secondary Outcome Measures

Cumulative Reactive Dose (CRD) of Peanut Protein
The Peanut Protein CRD is defined as the sum of all peanut protein doses taken by the subject during the DBPCFC (including the ED and any partial dose given before the reaction).
Eliciting Dose (ED) of Peanut Protein
Percentage of Participants with an Eliciting Dose (ED) ≥600 mg and ≥1,000 mg Peanut Protein at Month 12
Number of Participants by Maximum Severity of Allergic Reaction During the Peanut Oral Food Challenge
The maximum severity of allergic reaction will be assessed according to Consortium of Food Allergy Research (CoFAR) Grading Scale Version 3.0. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction.

Full Information

First Posted
February 14, 2023
Last Updated
September 15, 2023
Sponsor
DBV Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT05741476
Brief Title
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
Acronym
VITESSE
Official Title
A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy With DBV712 250 μg in 4-7-year-old Children With Peanut Allergy (VITESSE)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DBV Technologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month treatment period.
Detailed Description
The overall maximum study duration for each participant will be approximately 58 weeks: Screening Period of 4-weeks, Treatment Period of 12-months and Follow-up Period of 2-weeks. During the 4-week Screening Period, participants are required to meet 2 sequential screening parameters to determine eligibility prior to randomization: Assessment of peanut skin prick test (SPT) and serum peanut immunoglobulin-E (IgE) Peanut double-blind placebo-controlled food challenge (DBPCFC) to confirm peanut allergy and establish an entry peanut eliciting dose (ED). Participants with a peanut protein ED less than or equal to (≤) 100 milligram (mg) will be eligible for randomization. The starting dose of the eligibility peanut DBPCFC will be 1 mg peanut protein and will escalate up to a highest single dose of 100 mg peanut protein (cumulative 144 mg) via the following schedule: 1, 3, 10, 30, 100 mg. Participants who react, with an eliciting dose (ED) (with dose-limiting symptoms) at or below the dose of 100 mg peanut protein will be considered eligible. Randomization of eligible participants will occur in a 2:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy, Peanut
Keywords
Peanut Hypersensitivity, Epicutaneous Immunotherapy (EPIT), Epicutaneous, Immunotherapy, Viaskin, Nut and Peanut Hypersensitivity, Food Hypersensitivity, Peanut Allergy, Food Allergy, Nut and Peanut Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DBV712 250 mcg
Arm Type
Experimental
Arm Description
Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).
Intervention Type
Drug
Intervention Name(s)
DBV712
Other Intervention Name(s)
ViaskinTM Peanut
Intervention Description
DBV712 250 mcg epicutaneous system.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
DBV712 matching placebo epicutaneous system.
Primary Outcome Measure Information:
Title
Percentage of Treatment Responders in the DBV712 Group Compared to Placebo Group
Description
A participant is defined as a treatment responder if: The initial ED was ≤30 mg peanut protein and the ED is ≥ 300 mg peanut protein at the post-treatment DBPCFC at Month 12; OR the initial ED was > 30 mg peanut protein and the ED is ≥600 mg peanut protein at the post-treatment DBPCFC at Month 12. Percentage of treatment responders in the DBV712 group compared to the placebo group after 12 months of treatment in the target population will be reported.
Time Frame
At Month 12
Secondary Outcome Measure Information:
Title
Cumulative Reactive Dose (CRD) of Peanut Protein
Description
The Peanut Protein CRD is defined as the sum of all peanut protein doses taken by the subject during the DBPCFC (including the ED and any partial dose given before the reaction).
Time Frame
At Month 12
Title
Eliciting Dose (ED) of Peanut Protein
Time Frame
At Month 12
Title
Percentage of Participants with an Eliciting Dose (ED) ≥600 mg and ≥1,000 mg Peanut Protein at Month 12
Time Frame
At Month 12
Title
Number of Participants by Maximum Severity of Allergic Reaction During the Peanut Oral Food Challenge
Description
The maximum severity of allergic reaction will be assessed according to Consortium of Food Allergy Research (CoFAR) Grading Scale Version 3.0. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction.
Time Frame
Baseline up to Month 12
Other Pre-specified Outcome Measures:
Title
Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESI)
Description
An AE: any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. TEAEs were defined as AEs that developed or worsened or became serious during on- treatment period. A serious TEAE: any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. AESI defined as: Local AESIs- severe local site reactions; systemic AESIs systemic allergic reactions, including those leading to epinephrine use, whatever the causal relationship to IP; AEs leading to epinephrine or inhaled or systemic corticosteroid use irrespective of the causal relationship to IP. TEAE's will include physical examination, vital signs, AEs leading to topical corticosteroid use, assessment of pain.
Time Frame
Screening up to Month 14
Title
Number of Participants With Systemic Allergic Reactions
Description
Number of participants with systemic allergic reactions will be reported.
Time Frame
Baseline up to Month 13
Title
Total Score for Scoring Atopic Dermatitis (SCORAD)
Description
SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. Extent and intensity of eczema as well as subjective signs insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Time Frame
Baseline up to Month 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Aged 4 through 7 years at Visit 1 (screening). Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet. Peanut-specific IgE of >0.7 kilo allergy unit per liter (kUA/L) and a positive peanut SPT with the largest wheal diameter of ≥6 millimeter (mm) at Visit 1. An ED of ≤100 mg peanut protein at screening DBPCFC. Key Exclusion Criteria: Severe generalized dermatologic disease involving the application area (interscapular region) Uncontrolled persistent asthma. Past or current immunotherapy for peanut allergy, including oral immunotherapy (OIT). Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy), or treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DBV Technologies
Phone
908-679-5200
Email
clinicaltrials@dbv-technologies.com
First Name & Middle Initial & Last Name or Official Title & Degree
DBV Technologies
Phone
908-679-5200
Facility Information:
Facility Name
DBV Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36067
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative site
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
San Jose
State/Province
California
ZIP/Postal Code
92691
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30002
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Rome
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Taunton
State/Province
Massachusetts
ZIP/Postal Code
02780
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Loudon
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DBV I Site
Facility Name
DBV Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3J 059
Country
Canada
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7L6W6
Country
Canada
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M3B3S6
Country
Canada
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Name
DBV Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B3S6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1C4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1v4W2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
DBV Investigative Site
City
Hamilton
ZIP/Postal Code
L8SIG5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DBV I Site

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age

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