Safety Study of Viaskin Peanut to Treat Peanut Allergy
REALISE
1 other identifier
interventional
393
2 countries
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2016
Typical duration for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2016
CompletedFirst Posted
Study publicly available on registry
September 27, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2020
CompletedFebruary 3, 2021
February 1, 2021
12 months
September 26, 2016
February 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Through study completion, an average of 3 years
Other Outcomes (2)
Change in peanut-specific Immunoglobulins E (IgE)
Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42
Change in peanut-specific Immunoglobulins G4 (IgG4)
Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42
Study Arms (2)
Viaskin Peanut 250 mcg
EXPERIMENTALViaskin Peanut 250 mcg, daily administration
Placebo
PLACEBO COMPARATORPlacebo patch, daily administration
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DBV Technologieslead
Study Sites (32)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Allergy & Asthma Associates of Southern California
Mission Viejo, California, 92691, United States
Palos Verdes Medical Group
Rolling Hills Estates, California, 90274, United States
Stanford University School of Medicine
Stanford, California, 94304, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
National Jewish Health
Denver, Colorado, 80206, United States
Sarasota Clinical Research
Sarasota, Florida, 34239, United States
Atlanta Allergy & Asthma Clinic
Marietta, Georgia, 30060, United States
Ann & Robert H. Lurie Children's Hospital of CHicago
Chicago, Illinois, 60611, United States
Sneeze, Wheeze and Itch Associates,Clinical Research
Normal, Illinois, 62704, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21205, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Childrens' Hospital
Boston, Massachusetts, 02115, United States
Clinical Research Institute
Plymouth, Minnesota, 55441, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
The Asthma and Allergy Center
Bellevue, Nebraska, 68123, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
The University of North Carolina - Chapell Hill
Chapel Hill, North Carolina, 27599, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
National Allergy and Asthma Research
Charleston, South Carolina, 29407, United States
Children's Medical Center of Dallas
Dallas, Texas, 75390-9105, United States
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, 77030, United States
Sylvana Research
San Antonio, Texas, 78229, United States
STAAMP Research
San Antonio, Texas, 78251, United States
ASTHMA, Inc. Clinical Research
Seattle, Washington, 98115-2060, United States
Children's and Women's Health Centre of Brisith Columbia
Vancouver, British Columbia, V6H 3N1, Canada
Alpha Medical Research Inc.
Mississauga, Ontario, L5A 3V4, Canada
Ottawa Allergy Asthma Research Institute
Ottawa, Ontario, K1G 6C6, Canada
Gordon Sussman Clinical Research Inc.
Toronto, Ontario, M4V 1R2, Canada
Centre Hospitalier Universitaire Sainte Justine
Montreal, Quebec, H3T 1C5, Canada
Centre De Recherche Applique
Québec, G1V 4W2, Canada
Related Publications (1)
Pongracic JA, Gagnon R, Sussman G, Siri D, Oriel RC, Brown-Whitehorn TF, Anvari S, Berger WE, Bird JA, Chan ES, Chinthrajah RS, Chong HJ, Fineman SM, Fleischer DM, Gonzalez-Reyes E, Kim EH, Lanser BJ, MacGinnitie A, Mehta H, Petroni D, Rupp N, Schneider LC, Scurlock AM, Sher LD, Shreffler WG, Sindher SB, Wood R, Yang WH, Sampson HA, Bois T, Green TD, Campbell DE, Bee KJ, Begin P. Long-Term Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: An Open-Label Active Treatment (REALISE Study). J Allergy Clin Immunol Pract. 2025 May;13(5):1190-1200.e3. doi: 10.1016/j.jaip.2025.02.024. Epub 2025 Feb 27.
PMID: 40023371DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
September 26, 2016
First Posted
September 27, 2016
Study Start
October 1, 2016
Primary Completion
September 22, 2017
Study Completion
October 7, 2020
Last Updated
February 3, 2021
Record last verified: 2021-02