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Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children (PEOPLE)

Primary Purpose

Peanut Allergy

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Viaskin Peanut 250µg
Sponsored by
DBV Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring Allergy, food allergy, viaskin, peanut, epicutaneous

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who completed the PEPITES study.

Exclusion Criteria:

  • Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches.
  • Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma.

Sites / Locations

  • Arkansas Children's Hospital
  • University of California, Rady Children's Hospital
  • Stanford University School of Medicine
  • Children's Hospital Colorado
  • National Jewish Health
  • Ann & Robert Lurie Children's Hospital of Chicago
  • Johns Hopkins Hospital
  • Massachusetts General Hospital
  • Boston Childrens' Hospital
  • Jaffe Food Allergy Institute
  • The University of North Carolina - Chapell Hill
  • Cincinnati Children's Hospital Medical Center
  • Children's Hospital of Philadelphia
  • Children's Hospital of Pittsburgh
  • Children's Medical Center of Dallas
  • Baylor College of Medicine - Texas Children's Hospital
  • ASTHMA, Inc.
  • Allergy Medical
  • Princess Margaret Hospital for Children
  • Children's Hospital Westmead
  • British Columbia Children's Hospital
  • Cheema Research Inc.
  • Ottawa Allergy Asthma Research Institute
  • Gordon Sussman Clinical Research Inc.
  • CHUM & CHU Sainte-Justine
  • Centre de Recherche Appliquée en Allergie de Quebec
  • Charité Universitätsmedizin Berlin
  • St.-Marien-Hospital
  • Universitätsklinikum Erlangen
  • Clinical Investigations Unit
  • Our Lady's Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Viaskin Peanut 250µg

Arm Description

Outcomes

Primary Outcome Measures

% of subjects originating from the active arm of PEPITES reaching an Eliciting Dose (ED) ≥ 1,000 mg after 24 months of additional treatment in PEOPLE

Secondary Outcome Measures

Full Information

First Posted
January 2, 2017
Last Updated
December 1, 2020
Sponsor
DBV Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT03013517
Brief Title
Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children
Acronym
PEOPLE
Official Title
Open-label Follow-up Study of the PEPITES Study to Evaluate the Long-term Efficacy and Safety of Viaskin Peanut
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 23, 2017 (Actual)
Primary Completion Date
November 23, 2019 (Actual)
Study Completion Date
March 2023 (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
This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active treatment in the PEPITES study, or for 3 years if previously on placebo in the PEPITES study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
Allergy, food allergy, viaskin, peanut, epicutaneous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Viaskin Peanut 250µg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Viaskin Peanut 250µg
Intervention Description
DBV712 250 µg, once daily
Primary Outcome Measure Information:
Title
% of subjects originating from the active arm of PEPITES reaching an Eliciting Dose (ED) ≥ 1,000 mg after 24 months of additional treatment in PEOPLE
Time Frame
Month 24

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who completed the PEPITES study. Exclusion Criteria: Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches. Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma.
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
University of California, Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Ann & Robert Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Childrens' Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Jaffe Food Allergy Institute
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
The University of North Carolina - Chapell Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Children's Medical Center of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9105
Country
United States
Facility Name
Baylor College of Medicine - Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
ASTHMA, Inc.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Facility Name
Allergy Medical
City
Brisbane
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
Country
Australia
Facility Name
Children's Hospital Westmead
City
Sydney
Country
Australia
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5H 3V4
Country
Canada
Facility Name
Cheema Research Inc.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5A 3V4
Country
Canada
Facility Name
Ottawa Allergy Asthma Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 6C6
Country
Canada
Facility Name
Gordon Sussman Clinical Research Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4V 1R2
Country
Canada
Facility Name
CHUM & CHU Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C4
Country
Canada
Facility Name
Centre de Recherche Appliquée en Allergie de Quebec
City
Quebec
ZIP/Postal Code
QC G1V4M6
Country
Canada
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
D13353
Country
Germany
Facility Name
St.-Marien-Hospital
City
Bonn
ZIP/Postal Code
D-53115
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Clinical Investigations Unit
City
Cork
Country
Ireland
Facility Name
Our Lady's Children's Hospital
City
Dublin
Country
Ireland

12. IPD Sharing Statement

Learn more about this trial

Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children

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