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

Phase 3

• Conditions: Peanut Allergy
• Interventions: Drug: Viaskin Peanut 250µg

• Registration Number: NCT03013517
• Lead Sponsor: DBV Technologies

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Study Start: 2017-01-23
• Primary Completion: 2019-11-23
• Status Verified: 2020-12
• Disposition First Submitted: 2020-12-01
• Disposition First Submitted QC: 2020-12-01
• Last Update Submitted: 2020-12-01
• Disposition First Posted: 2020-12-02
• Last Update Posted: 2020-12-02
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Subjects who completed the PEPITES study.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Viaskin Peanut 250µg	Viaskin Peanut 250µg	-

Primary Outcome Measures

Name	Time	Method
% 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

Trial Locations

Locations (31)

Clinical Investigations Unit; 🇮🇪 Cork, Ireland

Princess Margaret Hospital for Children; 🇦🇺 Perth, Australia

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

University of California, Rady Children's Hospital; 🇺🇸 San Diego, California, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Ann & Robert Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

National Jewish Health; 🇺🇸 Denver, Colorado, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Boston Childrens' Hospital; 🇺🇸 Boston, Massachusetts, United States

The University of North Carolina - Chapell Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Jaffe Food Allergy Institute; 🇺🇸 New York, New York, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Children's Medical Center of Dallas; 🇺🇸 Dallas, Texas, United States

ASTHMA, Inc.; 🇺🇸 Seattle, Washington, United States

Baylor College of Medicine - Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Allergy Medical; 🇦🇺 Brisbane, Australia

Ottawa Allergy Asthma Research Institute; 🇨🇦 Ottawa, Ontario, Canada

Children's Hospital Westmead; 🇦🇺 Sydney, Australia

Cheema Research Inc.; 🇨🇦 Mississauga, Ontario, Canada

British Columbia Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Gordon Sussman Clinical Research Inc.; 🇨🇦 Toronto, Ontario, Canada

CHUM & CHU Sainte-Justine; 🇨🇦 Montreal, Quebec, Canada

Our Lady's Children's Hospital; 🇮🇪 Dublin, Ireland

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Centre de Recherche Appliquée en Allergie de Quebec; 🇨🇦 Quebec, Canada

St.-Marien-Hospital; 🇩🇪 Bonn, Germany

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany