Safety Study of Viaskin Peanut to Treat Peanut Allergy

Phase 3

Completed

• Conditions: Peanut Allergy
• Interventions: Biological: Viaskin Peanut 250 mcg; Biological: Placebo

• Registration Number: NCT02916446
• Lead Sponsor: DBV Technologies

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-27
• Study Start: 2016-10
• Primary Completion: 2017-09-22
• Disposition First Submitted: 2019-02-19
• Disposition First Submitted QC: 2019-02-19
• Disposition First Posted: 2019-02-21
• Study Completion: 2020-10-07
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 393

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Viaskin Peanut 250 mcg	Viaskin Peanut 250 mcg	Viaskin Peanut 250 mcg, daily administration
Placebo	Placebo	Placebo patch, daily administration

Primary Outcome Measures

Name	Time	Method
Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Through study completion, an average of 3 years

Trial Locations

Locations (32)

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

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

Palos Verdes Medical Group; 🇺🇸 Rolling Hills Estates, California, United States

Allergy & Asthma Associates of Southern California; 🇺🇸 Mission Viejo, California, United States

Sarasota Clinical Research; 🇺🇸 Sarasota, Florida, United States

Atlanta Allergy & Asthma Clinic; 🇺🇸 Marietta, Georgia, United States

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

Sneeze, Wheeze and Itch Associates,Clinical Research; 🇺🇸 Normal, Illinois, United States

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

Clinical Research Institute; 🇺🇸 Plymouth, Minnesota, United States

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

The Asthma and Allergy Center; 🇺🇸 Bellevue, Nebraska, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

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

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

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

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

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

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

Alpha Medical Research Inc.; 🇨🇦 Mississauga, Ontario, Canada

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

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

Centre De Recherche Applique; 🇨🇦 Québec, Canada

STAAMP Research; 🇺🇸 San Antonio, Texas, United States

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

Sylvana Research; 🇺🇸 San Antonio, Texas, United States

Centre Hospitalier Universitaire Sainte Justine; 🇨🇦 Montréal, Quebec, Canada

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

National Allergy and Asthma Research; 🇺🇸 Charleston, South Carolina, United States

Children's and Women's Health Centre of Brisith Columbia; 🇨🇦 Vancouver, British Columbia, Canada

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

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