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

February 1, 2021 updated by: DBV Technologies
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

393

Phase

  • Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V 4W2
        • Centre De Recherche Applique
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • Children's and Women's Health Centre of Brisith Columbia
    • Ontario
      • Mississauga, Ontario, Canada, L5A 3V4
        • Alpha Medical Research Inc.
      • Ottawa, Ontario, Canada, K1G 6C6
        • Ottawa Allergy Asthma Research Institute
      • Toronto, Ontario, Canada, M4V 1R2
        • Gordon Sussman Clinical Research Inc.
    • Quebec
      • Montréal, Quebec, Canada, H3T 1C5
        • Centre Hospitalier Universitaire Sainte Justine
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital
    • California
      • Mission Viejo, California, United States, 92691
        • Allergy & Asthma Associates of Southern California
      • Rolling Hills Estates, California, United States, 90274
        • Palos Verdes Medical Group
      • Stanford, California, United States, 94304
        • Stanford University School of Medicine
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Clinical Research
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Atlanta Allergy & Asthma Clinic
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Normal, Illinois, United States, 62704
        • Sneeze, Wheeze and Itch Associates,Clinical Research
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Boston Childrens' Hospital
    • Minnesota
      • Plymouth, Minnesota, United States, 55441
        • Clinical Research Institute
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • The Asthma and Allergy Center
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The University of North Carolina - Chapell Hill
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15213
        • Children's Hospital of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • National Allergy and Asthma Research
    • Texas
      • Dallas, Texas, United States, 75390-9105
        • Children's Medical Center of Dallas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine - Texas Children's Hospital
      • San Antonio, Texas, United States, 78229
        • Sylvana Research
      • San Antonio, Texas, United States, 78251
        • STAAMP Research
    • Washington
      • Seattle, Washington, United States, 98115-2060
        • ASTHMA, Inc. Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Viaskin Peanut 250 mcg
Viaskin Peanut 250 mcg, daily administration
Biological: Viaskin Peanut 250 mcg
Placebo Comparator: Placebo
Placebo patch, daily administration
Biological: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Through study completion, an average of 3 years
Through study completion, an average of 3 years

Other Outcome Measures

Outcome Measure
Time Frame
Change in peanut-specific Immunoglobulins E (IgE)
Time Frame: Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42
Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42
Change in peanut-specific Immunoglobulins G4 (IgG4)
Time Frame: Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42
Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DBV Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

September 22, 2017

Study Completion (Actual)

October 7, 2020

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REALISE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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