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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Peanut Allergy
• Intervention / Treatment: Drug: Viaskin Peanut 250µg

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Expanded Access

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

Contacts and Locations

Study Locations

• Australia
  • Brisbane, Australia
    • Allergy Medical
  • Perth, Australia
    • Princess Margaret Hospital for Children
  • Sydney, Australia
    • Children's Hospital Westmead
• Canada
  • Quebec, Canada, QC G1V4M6
    • Centre De Recherche Appliquée en Allergie De Québec
  • British Columbia
    • Vancouver, British Columbia, Canada, V5H 3V4
      • British Columbia Children's Hospital
  • Ontario
    • Mississauga, Ontario, Canada, L5A 3V4
      • Cheema Research Inc.
    • Ottawa, Ontario, Canada, K1G 6C6
      • Ottawa Allergy Asthma Research Institute
    • Toronto, Ontario, Canada, M4V 1R2
      • Gordon Sussman Clinical Research Inc.
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C4
      • CHUM & CHU Sainte-Justine
• Germany
  • Berlin, Germany, D13353
    • Charité Universitätsmedizin Berlin
  • Bonn, Germany, D-53115
    • St.-Marien-Hospital
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen
• Ireland
  • Cork, Ireland
    • Clinical Investigations Unit
  • Dublin, Ireland
    • Our Lady's Children's Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • California
    • San Diego, California, United States, 92123
      • University of California, Rady Children's Hospital
    • 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
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert Lurie Children's Hospital of Chicago
  • 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
  • New York
    • New York, New York, United States, 10029
      • Jaffe Food Allergy Institute
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • The University of North Carolina - Chapell Hill
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15213
      • Children's Hospital of Pittsburgh
  • 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
  • Washington
    • Seattle, Washington, United States, 98115
      • ASTHMA, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Viaskin Peanut 250µg	Drug: Viaskin Peanut 250µg; DBV712 250 µg, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
% 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	Month 24

Collaborators and Investigators

• Sponsor: DBV Technologies

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2017
• Primary Completion (Actual): November 23, 2019
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: January 2, 2017
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (Estimate): January 6, 2017

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Allergy; food allergy; peanut; viaskin; epicutaneous
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: PEOPLE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No