Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
393 participants
INTERVENTIONAL
2016-10-31
2020-10-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
NCT03211247
Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy
NCT01675882
Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children
NCT03013517
Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects
NCT05476497
Reduction of Peanut Reactivity and Immune Modulation With Anti-IgE Therapy
NCT02194530
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Viaskin Peanut 250 mcg
Viaskin Peanut 250 mcg, daily administration
Viaskin Peanut 250 mcg
Placebo
Placebo patch, daily administration
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Viaskin Peanut 250 mcg
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
4 Years
11 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
DBV Technologies
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Allergy & Asthma Associates of Southern California
Mission Viejo, California, United States
Palos Verdes Medical Group
Rolling Hills Estates, California, United States
Stanford University School of Medicine
Stanford, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, 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
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Childrens' Hospital
Boston, Massachusetts, 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
National Allergy and Asthma Research
Charleston, South Carolina, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, United States
Sylvana Research
San Antonio, Texas, United States
STAAMP Research
San Antonio, Texas, United States
ASTHMA, Inc. Clinical Research
Seattle, Washington, United States
Children's and Women's Health Centre of Brisith Columbia
Vancouver, British Columbia, Canada
Alpha Medical Research Inc.
Mississauga, Ontario, Canada
Ottawa Allergy Asthma Research Institute
Ottawa, Ontario, Canada
Gordon Sussman Clinical Research Inc.
Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte Justine
Montreal, Quebec, Canada
Centre De Recherche Applique
Québec, , Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REALISE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.