Safety Study of Viaskin Peanut to Treat Peanut Allergy

Peanut Allergy Clinical Trial

— REALISE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916446
• Other study ID #: REALISE
• Status: Completed
• Phase: Phase 3
• Start date: October 2016
• Est. completion date: October 7, 2020

Study information

• Verified date: February 2021
• Source: DBV Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 393
• Est. completion date: October 7, 2020
• Est. primary completion date: September 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

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 ß-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).

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Biological:
• Viaskin Peanut 250 mcg

• Placebo

Locations

Country	Name	City	State
Canada	Alpha Medical Research Inc.	Mississauga	Ontario
Canada	Centre Hospitalier Universitaire Sainte Justine	Montréal	Quebec
Canada	Ottawa Allergy Asthma Research Institute	Ottawa	Ontario
Canada	Centre De Recherche Applique	Québec
Canada	Gordon Sussman Clinical Research Inc.	Toronto	Ontario
Canada	Children's and Women's Health Centre of Brisith Columbia	Vancouver	British Columbia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	The Asthma and Allergy Center	Bellevue	Nebraska
United States	Boston Childrens' Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The University of North Carolina - Chapell Hill	Chapel Hill	North Carolina
United States	National Allergy and Asthma Research	Charleston	South Carolina
United States	Ann & Robert H. Lurie Children's Hospital of CHicago	Chicago	Illinois
United States	Children's Medical Center of Dallas	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
United States	Baylor College of Medicine - Texas Children's Hospital	Houston	Texas
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Atlanta Allergy & Asthma Clinic	Marietta	Georgia
United States	Allergy & Asthma Associates of Southern California	Mission Viejo	California
United States	Mount Sinai Medical Center	New York	New York
United States	Sneeze, Wheeze and Itch Associates,Clinical Research	Normal	Illinois
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Clinical Research Institute	Plymouth	Minnesota
United States	Palos Verdes Medical Group	Rolling Hills Estates	California
United States	STAAMP Research	San Antonio	Texas
United States	Sylvana Research	San Antonio	Texas
United States	Sarasota Clinical Research	Sarasota	Florida
United States	ASTHMA, Inc. Clinical Research	Seattle	Washington
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
DBV Technologies

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in peanut-specific Immunoglobulins E (IgE)		Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42
Other	Change in peanut-specific Immunoglobulins G4 (IgG4)		Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42
Primary	Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		Through study completion, an average of 3 years