AllergyPhase 3NCT07003919
Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
A Phase 3 study testing DBV712 250 mcg in people with Allergy and Peanut Allergy, run by DBV Technologies at 91 sites in 8 countries.
Trial summary
The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Allergy, Peanut Allergy
- What is being tested?
- DBV712 250 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 91 sitesin 8 countries
- Study dates
- 24 Jun 2025to May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 1 through 3 years at Visit 1 (screening).
- Physician-diagnosed peanut allergy and following a strict peanut-free diet
- Peanut-specific IgE > 0.7 kUA/L.
- A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening).
- An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).
Who cannot join
- Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut.
- Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region).
- Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy).
- History of any immunotherapy for peanut allergy, including Epicutaneous immunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT).
- Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
- Uncontrolled persistent asthma.
Trial locations and contacts
91 sites in 8 countries.
91 sites in 8 countries
United States56 sites
Regents of the University of Michigan
Ann Arbor, Michigan, 48106
Allergy and Immunology Associates of Ann Arbor
Ann Arbor, Michigan, 48197
Emory University - Children's Healthcare of Atlanta, Inc.
Atlanta, Georgia, 30329
Children's Hospital Colorado
Aurora, Colorado, 80045
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Johns Hopkins Hospital
Baltimore, Maryland, 21287
AllerVie Clinical Research
Birmingham, Alabama, 35209
University of Alabama at Birmingham Pediatric Primary Care Clinic
Birmingham, Alabama, 35233
MassGeneral Hospital for Children
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
UNC Hospitals Children's Specialty Clinics in Chapel Hill at Carolina Pointe II
Chapel Hill, North Carolina, 27517
Medical University of South Carolina
Charleston, South Carolina, 29425
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
University of Chicago Medicine Comer Children's Hospital
Chicago, Illinois, 60637
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Asthma & Allergy Associates
Colorado Springs, Colorado, 80907
Children's Medical Center Dallas
Dallas, Texas, 75207
Western Sky Medical Research
El Paso, Texas, 79903
Deaconess Clinic - Downtown Evansville
Evansville, Indiana, 47713
Northwell Health Allergy and Immunology at the Irving Goldman Family Care Center
Great Neck, New York, 11021
Penn State Children's Hospital
Hershey, Pennsylvania, 17036
Texas Children's Hospital
Houston, Texas, 77030
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
The University of Kansas Health System - Main Campus, Medical Pavilion
Kansas City, Kansas, 66160
Children's Mercy Hospital
Kansas City, Missouri, 64108
Gundersen Health System - La Crosse Campus
La Crosse, Wisconsin, 54601
Modena Allergy & Asthma
La Jolla, California, 92037
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Modena Allergy and Asthma
Long Beach, California, 90808
UCLA Health Westwood Pediatrics
Los Angeles, California, 90024
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Allergy and Asthma Research Center of Minnesota
Maplewood, Minnesota, 55106
Le Bonheur Children's Hospital
Memphis, Tennessee, 38120
Children's Wisconsin, The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Allergy & Asthma Associates of Southern California
Mission Viejo, California, 93691
NYU Langone Health
New York, New York, 10016
Equity Medical
New York, New York, 10023
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Sneeze, Wheeze and Itch Associated, LLC
Normal, Illinois, 61761
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Weiss Medical
Riverdale, New Jersey, 07457
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester Medical Center
Rochester, New York, 14642
Allergy & Asthma Medical Group and Research Center
San Diego, California, 92123
Rady Children's Hospital - San Diego
San Diego, California, 92123
Modena Allergy & Asthma
Scottsdale, Arizona, 85254
St. Louis Children's Hospital
St Louis, Missouri, 63110
University of South Florida Children's Research Institute
St. Petersburg, Florida, 33701
Allergy, Asthma & Immunology Associates of Tampa Bay
Tampa, Florida, 33613
Children's Hospital at Montefiore
The Bronx, New York, 10467
Orso Health Torrance
Torrance, California, 90505
University of Arizona Asthma and Airway Disease Research Center
Tucson, Arizona, 85750
Children's National - Main Hospital
Washington D.C., District of Columbia, 20016
Allergy Asthma Specialists of Maryland - White Marsh
White Marsh, Maryland, 21162
Canada9 sites
Halton Pediatric Allergy
Burlington, Ontario, L7L 6W6
Hamilton Allergy
Hamilton, Ontario, L8S 1G5
McMaster University Medical Center
Hamilton, Ontario, L8S 4L8
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
Ottawa Allergy Research Corporation
Ottawa, Ontario, K1H 1E4
Canadian Allergy Research and Education (CARE) Corporation
Ottawa, Ontario, K1H1E4
Clinique Specialisee en Allergie de la Capitale
Québec, Quebec, G1V 4W2
Sick Kids, The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Manitoba Allergy Research, Inc.
Winnipeg, Manitoba, R3J 0S9
United Kingdom7 sites
Royal Hospital for Children
Glasgow, G51 4TF
University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW
Guy's and Saint Thomas' NHS Foundation Trust St Thomas' Hospital
London, SE1 7EH
Allergy Centre of Excellence
London, W1B 9AG
Royal Manchester Children's Hospital, Manchester University NHS Foundation Trust
Manchester, M13 PWL
Sheffield Children's NHS Foundation Trust Sheffield Children's Hospital
Sheffield, S10 2TH
University Hospital Southampton NHS Foundation Trust Southampton Children's Hospital
Southampton, S016 6YD
Australia5 sites
Perth Children's Hospital
Nedlands, Western Australia, 6009
Royal Children's Hospital Melbourne
Parkville, Victoria, 3052
Epworth Healthcare Richmond
Richmond, Victoria, 3121
Queensland Children's Hospital and Health Service
South Brisbane, Queensland, 4101
Westmead Childrens Hospital
Westmead, New South Wales, 2145
France5 sites
Centre Hospitalier Universitaire d'Angers
Angers, 49933
Hospices Civils of Lyon, Hôpital Femme Mère Enfant
Bron, 69500
Centre Hospitalier Régional Universitaire de Lille Hôpital Jeanne de Flandre
Lille, 59037
Centre Hospitalier Universitaire Montpellier
Montpellier, 34090
Centre Hospitalier Régional Universitaire de Nancy
Vandœuvre-lès-Nancy, 54511
Spain5 sites
Institut de Recerca Sant Joan de Déu.
Barcelona, 08950
Hospital Infantil Universitario Niño Jesús
Madrid, 28009
Hospital Universitario Ramón y Caja
Madrid, 28034
Hospital Regional Universitario de Málaga, Hospital Materno Infantil
Málaga, 29011
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, 15706
Ireland2 sites
Cork University Hospital
Cork, T12DC4A
Royal College of Surgeons in Ireland. Children's Health Ireland (CHI) at Crumlin
Dublin, D01F772
Netherlands2 sites
Erasmus MC Sophia Children's Hospital
Rotterdam, 3015CN
University Medical Center Utrecht (UMCU)
Utrecht, 3584CX
About this study
Official title: A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy With DBV712 250 mcg in 1-through 3-year-old Children With Peanut Allergy
The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.
Read the detailed description
This is a Phase 3 randomized double-blind, placebo-controlled (DBPC) study of 6-months duration to assess the safety of DBV712 250 mcg in subjects 1 through 3 years of age with peanut allergy. Participants who complete the 6-month DBPC period will be eligible to enter an optional 18-month open-label extension (OLE).
The overall maximum study duration for each participant will be approximately 112 weeks: Screening Period of 6-weeks, DBPC Treatment Period of 26-weeks, Open-label Period of 78-weeks and Follow-up Period of 2-weeks.
For participation eligibility, please refer to eligibility criteria section.
Randomization of eligible participants will occur in a 3:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.
- Conditions
- Allergy, Peanut Allergy
- Being tested
- DBV712 250 mcg, Placebo
- Keywords
- Peanut hypersensitivity, Epicutaneous Immunotherapy (EPIT), Epicutaneous, Immunotherapy, Viaskin, Nut and Peanut Hypersensitivity, Food Hypersensitivity, Peanut Allergy, Food Allergy, Nut and Peanut Allergy, Safety Study
- Medical subject headings
- Hypersensitivity, Peanut Hypersensitivity, Nut and Peanut Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBV712 250 mcgCombination product
Also called Viaskin® Peanut Patch
DBV712 250 mcg epicutaneous system.
PlaceboCombination product
DBV712 matching placebo epicutaneous system.
| Study group | Role | What they receive |
|---|---|---|
| DBPC Treatment Period: DBV712 250 mcg | Experimental | Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 6 months. Receives: Combination Product: DBV712 250 mcg |
| DBPC Treatment Period: Placebo | Placebo comparator | Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 6 months. Receives: Combination Product: Placebo |
| Optional Open-Label Extension-Period: DBV712 250 mcg | Experimental | The 6-month DBPC period will be followed by an optional open-label extension (OLE) period during which eligible participants will receive DBV712 250 mcg for a duration of 18 months (representing 24 months of active treatment for those participants initially randomized to DBV712 250 mcg and 18 months of active treatment for those participants that were initially randomized to placebo). Receives: Combination Product: DBV712 250 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
DBPC Treatment Period: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
Measured: Through DBPC Treatment Period, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start24 Jun 2025
- Primary completionNov 2026 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DBV Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003919
- Sponsor's protocol ID
- V712-308
- Status last verified
- Jul 2026
- First submitted
- 27 May 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy With DBV712 250 mcg in 1-through 3-year-old Children With Peanut Allergy
- ClinicalTrials.gov ID
- NCT07003919
- Acronym / sponsor ID
- V712-308
- Conditions
- Allergy, Peanut Allergy
- Keywords
- Peanut hypersensitivity, Epicutaneous Immunotherapy (EPIT), Epicutaneous, Immunotherapy, Viaskin, Nut and Peanut Hypersensitivity, Food Hypersensitivity, Peanut Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- DBV TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.
Detailed description
This is a Phase 3 randomized double-blind, placebo-controlled (DBPC) study of 6-months duration to assess the safety of DBV712 250 mcg in subjects 1 through 3 years of age with peanut allergy. Participants who complete the 6-month DBPC period will be eligible to enter an optional 18-month open-label extension (OLE).
The overall maximum study duration for each participant will be approximately 112 weeks: Screening Period of 6-weeks, DBPC Treatment Period of 26-weeks, Open-label Period of 78-weeks and Follow-up Period of 2-weeks.
For participation eligibility, please refer to eligibility criteria section.
Randomization of eligible participants will occur in a 3:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DBPC Treatment Period: DBV712 250 mcg | Experimental | Combination Product: DBV712 250 mcgParticipants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 6 months. |
| DBPC Treatment Period: Placebo | Placebo comparator | Combination Product: PlaceboParticipants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 6 months. |
| Optional Open-Label Extension-Period: DBV712 250 mcg | Experimental | Combination Product: DBV712 250 mcgThe 6-month DBPC period will be followed by an optional open-label extension (OLE) period during which eligible participants will receive DBV712 250 mcg for a duration of 18 months (representing 24 months of active treatment for those participants initially randomized to DBV712 250 mcg and 18 months of active treatment for those participants that were initially randomized to placebo). |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 1 through 3 years at Visit 1 (screening).
- Physician-diagnosed peanut allergy and following a strict peanut-free diet
- Peanut-specific IgE > 0.7 kUA/L.
- A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening).
- An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).
Key exclusion criteria (6 listed)
- Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut.
- Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region).
- Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy).
- History of any immunotherapy for peanut allergy, including Epicutaneous immunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT).
- Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBV712 250 mcgAlso: Viaskin® Peanut PatchDBV712 250 mcg epicutaneous system. | Combination product | DBPC Treatment Period: DBV712 250 mcg, Optional Open-Label Extension-Period: DBV712 250 mcg |
| PlaceboDBV712 matching placebo epicutaneous system. | Combination product | DBPC Treatment Period: Placebo |
Primary outcome
DBPC Treatment Period: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
Time frame: Through DBPC Treatment Period, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
91 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DBV712 250 mcg in people with Allergy and Peanut Allergy, run by DBV Technologies at 91 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 91 sites in United States, Canada, United Kingdom, Australia, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DBPC Treatment Period: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs) (time frame: Through DBPC Treatment Period, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.