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Safety Study of Viaskin Peanut to Treat Peanut Allergy (REALISE)

Primary Purpose

Peanut Allergy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Viaskin Peanut 250 mcg
Placebo
Sponsored by
DBV Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy

Eligibility Criteria

4 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Physician-diagnosed peanut allergy;
  • A peanut Skin Prick Test (SPT) with a wheal largest diameter ≥8 mm;
  • A specific-peanut Immunoglobulin E (IgE) ≥14 kU/L;
  • Subjects following a strict peanut-free diet.

Exclusion Criteria:

  • Generalized dermatologic disease
  • Spirometry forced expiratory volume in 1 second (FEV1) <80% of the predicted value, or peak expiratory flow (PEF) <80% of predicted value;
  • Receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy; anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy;
  • Prior or concomitant history of any immunotherapy to any food allergy (for example EPIT, OIT, SLIT, or specific oral tolerance induction).

Sites / Locations

  • Arkansas Children's Hospital
  • Allergy & Asthma Associates of Southern California
  • Palos Verdes Medical Group
  • Stanford University School of Medicine
  • Children's Hospital Colorado
  • National Jewish Health
  • Sarasota Clinical Research
  • Atlanta Allergy & Asthma Clinic
  • Ann & Robert H. Lurie Children's Hospital of CHicago
  • Sneeze, Wheeze and Itch Associates,Clinical Research
  • Johns Hopkins Hospital
  • Massachusetts General Hospital
  • Boston Childrens' Hospital
  • Clinical Research Institute
  • Children's Mercy Hospital
  • The Asthma and Allergy Center
  • Mount Sinai Medical Center
  • The University of North Carolina - Chapell Hill
  • Children's Hospital of Philadelphia
  • Children's Hospital of Pittsburgh
  • National Allergy and Asthma Research
  • Children's Medical Center of Dallas
  • Baylor College of Medicine - Texas Children's Hospital
  • Sylvana Research
  • STAAMP Research
  • ASTHMA, Inc. Clinical Research
  • Children's and Women's Health Centre of Brisith Columbia
  • Alpha Medical Research Inc.
  • Ottawa Allergy Asthma Research Institute
  • Gordon Sussman Clinical Research Inc.
  • Centre Hospitalier Universitaire Sainte Justine
  • Centre De Recherche Applique

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Viaskin Peanut 250 mcg

Placebo

Arm Description

Viaskin Peanut 250 mcg, daily administration

Placebo patch, daily administration

Outcomes

Primary Outcome Measures

Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Secondary Outcome Measures

Full Information

First Posted
September 26, 2016
Last Updated
February 1, 2021
Sponsor
DBV Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT02916446
Brief Title
Safety Study of Viaskin Peanut to Treat Peanut Allergy
Acronym
REALISE
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 22, 2017 (Actual)
Study Completion Date
October 7, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the safety of Viaskin Peanut 250 mcg in the treatment of peanut allergy in children from 4 to 11 years of age. Subjects will receive either Viaskin Peanut 250 mcg or a placebo for a period of 6 months, after which all subjects will be receiving the active treatment up to a period of 3 years under active treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Viaskin Peanut 250 mcg
Arm Type
Experimental
Arm Description
Viaskin Peanut 250 mcg, daily administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo patch, daily administration
Intervention Type
Biological
Intervention Name(s)
Viaskin Peanut 250 mcg
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame
Through study completion, an average of 3 years
Other Pre-specified Outcome Measures:
Title
Change in peanut-specific Immunoglobulins E (IgE)
Time Frame
Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42
Title
Change in peanut-specific Immunoglobulins G4 (IgG4)
Time Frame
Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Physician-diagnosed peanut allergy; A peanut Skin Prick Test (SPT) with a wheal largest diameter ≥8 mm; A specific-peanut Immunoglobulin E (IgE) ≥14 kU/L; Subjects following a strict peanut-free diet. Exclusion Criteria: Generalized dermatologic disease Spirometry forced expiratory volume in 1 second (FEV1) <80% of the predicted value, or peak expiratory flow (PEF) <80% of predicted value; Receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy; anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy; Prior or concomitant history of any immunotherapy to any food allergy (for example EPIT, OIT, SLIT, or specific oral tolerance induction).
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Allergy & Asthma Associates of Southern California
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Palos Verdes Medical Group
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
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
Sarasota Clinical Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Atlanta Allergy & Asthma Clinic
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of CHicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Sneeze, Wheeze and Itch Associates,Clinical Research
City
Normal
State/Province
Illinois
ZIP/Postal Code
62704
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
Clinical Research Institute
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
The Asthma and Allergy Center
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Mount Sinai Medical Center
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
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
National Allergy and Asthma Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
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
Sylvana Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
STAAMP Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States
Facility Name
ASTHMA, Inc. Clinical Research
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115-2060
Country
United States
Facility Name
Children's and Women's Health Centre of Brisith Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Facility Name
Alpha Medical 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
Centre Hospitalier Universitaire Sainte Justine
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Centre De Recherche Applique
City
Québec
ZIP/Postal Code
G1V 4W2
Country
Canada

12. IPD Sharing Statement

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Safety Study of Viaskin Peanut to Treat Peanut Allergy

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