Peanut AllergyPhase 3REALISENCT02916446
Safety Study of Viaskin Peanut to Treat Peanut Allergy
A Phase 3 study testing Viaskin Peanut 250 µg in people with Peanut Allergy, run by DBV Technologies at 32 sites in 2 countries.
Trial summary
This study evaluates the safety of Viaskin Peanut 250 µg in the treatment of peanut allergy in children from 4 to 11 years of age. Subjects will receive either Viaskin Peanut 250 µg 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… Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Viaskin Peanut 250 µg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 393 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 25 Oct 2016to 7 Oct 2020
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States26 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins Hospital
Baltimore, Maryland, 21205
The Asthma and Allergy Center
Bellevue, Nebraska, 68123
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
The University of North Carolina - Chapell Hill
Chapel Hill, North Carolina, 27599
National Allergy and Asthma Research
Charleston, South Carolina, 29407
Ann & Robert H. Lurie Children's Hospital of CHicago
Chicago, Illinois, 60611
Children's Medical Center of Dallas
Dallas, Texas, 75390-9105
National Jewish Health
Denver, Colorado, 80206
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, 77030
Children's Mercy Hospital
Kansas City, Missouri, 64108
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Atlanta Allergy & Asthma Clinic
Marietta, Georgia, 30060
Allergy & Asthma Associates of Southern California
Mission Viejo, California, 92691
Mount Sinai Medical Center
New York, New York, 10029
Sneeze, Wheeze and Itch Associates,Clinical Research
Normal, Illinois, 62704
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Clinical Research Institute
Plymouth, Minnesota, 55441
Palos Verdes Medical Group
Rolling Hills Estates, California, 90274
Sylvana Research
San Antonio, Texas, 78229
STAAMP Research
San Antonio, Texas, 78251
Sarasota Clinical Research
Sarasota, Florida, 34239
ASTHMA, Inc. Clinical Research
Seattle, Washington, 98115-2060
Stanford University School of Medicine
Stanford, California, 94304
Canada6 sites
Alpha Medical Research Inc.
Mississauga, Ontario, L5A 3V4
Centre Hospitalier Universitaire Sainte Justine
Montreal, Quebec, H3T 1C5
Ottawa Allergy Asthma Research Institute
Ottawa, Ontario, K1G 6C6
Centre De Recherche Applique
Québec, G1V 4W2
Gordon Sussman Clinical Research Inc.
Toronto, Ontario, M4V 1R2
Children's and Women's Health Centre of Brisith Columbia
Vancouver, British Columbia, V6H 3N1
About this study
Official title: Long-Term Assessment of Safety and Therapeutic Benefit of Viaskin® Peanut Epicutaneous Treatment in Peanut-Allergic Children: A 6-Month Randomized, Double-Blind, Placebo-Controlled Phase III Study Followed by an Open-Label Active Treatment (REALISE Study)
This study evaluates the safety of Viaskin Peanut 250 µg in the treatment of peanut allergy in children from 4 to 11 years of age. Subjects will receive either Viaskin Peanut 250 µg 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.
Read the detailed description
This is a randomized 36-month, Phase III, safety study to assess the long-term safety of Viaskin® Peanut, dosed at 250 µg peanut protein (per patch) in peanut-allergic children from 4 through 11 years of age.
The study design is in 2 main parts:
- A randomized, double-blind, placebo-controlled design for the first 6 months of treatment,
- Followed by an open-label, single arm active treatment design with Viaskin® Peanut 250 µg for remaining 30 months.
- Conditions
- Peanut Allergy
- Being tested
- Viaskin Peanut 250 µg, Placebo
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viaskin Peanut 250 µgBiological
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Viaskin Peanut 250 µg | Experimental | Viaskin Peanut 250 µg, daily administration Receives: Biological: Viaskin Peanut 250 µg |
| Placebo | Placebo comparator | Placebo patch, daily administration Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence that occurred in a participant administered IP, whether or not considered related to IP. A TEAE was defined as an AE that began or worsened in severity after at least 1 dose of IP had been administered.
Measured: From Day 1 up to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start25 Oct 2016
- Primary completion22 Sep 2017
- Study completion7 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- DBV Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916446
- Sponsor's protocol ID
- REALISE
- Acronym
- REALISE
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2016
- Last updated
- 8 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Expanded access
- Available
Publications
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.
PubMed 40023371