Peanut AllergyPhase 3EPOPEXNCT03859700
Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children
A Phase 3 study testing DBV712 250 mcg in people with Peanut Allergy, run by DBV Technologies at 26 sites in United States.
Trial summary
Open-label, follow-up study for subjects who completed the EPITOPE study. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- DBV712 250 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 26 sitesUnited States
- Study dates
- 6 Dec 2018to 13 May 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- completion of the EPITOPE study
Who cannot join
- Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches.
- Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
University of Michigan - Allergy Specialty Clinic and Food Allergy Clinic
Ann Arbor, Michigan, 48106
Children's Healthcare of Atlanta
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, 21205
Boston Childrens' Hospital
Boston, Massachusetts, 02115
The University of North Carolina - Chapell Hill
Chapel Hill, North Carolina, 27599
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Comer Children's Hospital
Chicago, Illinois, 60637
Children's Medical Center Dallas
Dallas, Texas, 75235
Baylor College of Medicine
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
David Geffen School of Medicine at University of California Los Angeles
Los Angeles, California, 90095
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105
Vanderbilt University Medical Center
Nashville, Tennessee, 37204
Mount Sinai Medical Center
New York, New York, 10029
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
University of Rochester
Rochester, New York, 14642
Rady Children's Hospital San Diego
San Diego, California, 92123
University of California San Francisco
San Francisco, California, 94158
Seattle Allergy & Asthma Research Institute
Seattle, Washington, 98115
Stanford University School of Medicine
Stanford, California, 94305
Banner University Medical Center Tucson
Tucson, Arizona, 85724-5030
Children's National Health Center
Washington D.C., District of Columbia, 20010
About this study
Official title: EPITOPE Open-label Extension Study to Evaluate the Long-term Clinical Benefit and Safety of DBV712 in Peanut-Allergic Children
Open-label, follow-up study for subjects who completed the EPITOPE study.
- Conditions
- Peanut Allergy
- Being tested
- DBV712 250 mcg
- Keywords
- EPIT, Epicutaneous, Immunotherapy, Viaskin
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBV712 250 mcgBiological
DBV712 250 mcg, once daily
| Study group | Role | What they receive |
|---|---|---|
| DBV712 250mcg | Experimental | DBV712 250 mcg, once daily Receives: Biological: DBV712 250 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Were Treatment Responders at Months 12, 24, 36 and 48
A participant was defined as treatment responder if:
- The V712-304 (EPITOPE) baseline ED was >10 mg peanut protein and the ED was ≥1000 mg peanut protein at the post-baseline DBPCFCs or;
- The V712-304 (EPITOPE) baseline ED was ≤10 mg and the ED is ≥300 mg peanut protein at the post-baseline DBPCFCs.
DBPCFC occurred at baseline and every 12 months, with the first post-baseline one being performed at the end of the EPITOPE trial (corresponding to Month 12).
Measured: Months 12, 24, 36 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start6 Dec 2018
- Primary completion13 May 2025
- Study completion13 May 2025
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 (2)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 304 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
- NCT03859700
- Sponsor's protocol ID
- EPOPEX (V712-305)
- Acronym
- EPOPEX
- Status last verified
- Oct 2026
- First submitted
- 19 Feb 2019
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greenhawt M, Albright D, Anvari S, Arends N, Arkwright PD, Begin P, Blumchen K, Brown-Whitehorn T, Cassell H, Chan ES, Ciaccio CE, Deschildre A, Divaret-Chauveau A, Dorris S, Dorsey M, Du Toit G, Eiwegger T, Erlewyn-Lajeunesse M, Fleischer DM, Ford LS, Garcia-Lloret M, O'B Hourihane J, Jay N, Jones SM, Kim EH, Kloepfer K, Leonard S, Lezmi G, Lieberman J, Lomas J, Makhija M, O'Sullivan M, Parrish C, Peake J, Perrett KP, Petroni D, Pongracic JA, Quinn P, Robison RG, Sanders G, Schneider L, Sharma H, Sindher SB, Trujillo J, Turner PJ, Tuttle K, Upton J, Varshney P, Vickery BP, Vogelberg C, Wainstein B, Wang J, Wood R, Bee KJ, Campbell DE, Green TD, Rouissi R, Bahnson HT, Bois T, Sampson HA, Burks AW. Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers: Open-Label Extension to EPITOPE. J Allergy Clin Immunol Pract. 2025 May;13(5):1176-1187.e7. doi: 10.1016/j.jaip.2025.02.004. Epub 2025 Feb 14.
PubMed 39956162Greenhawt M, Sindher SB, Wang J, O'Sullivan M, du Toit G, Kim EH, Albright D, Anvari S, Arends N, Arkwright PD, Begin P, Blumchen K, Bourrier T, Brown-Whitehorn T, Cassell H, Chan ES, Ciaccio CE, Deschildre A, Divaret-Chauveau A, Dorris SL, Dorsey MJ, Eiwegger T, Erlewyn-Lajeunesse M, Fleischer DM, Ford LS, Garcia-Lloret M, Giovannini-Chami L, Hourihane JO, Jay N, Jones SM, Kerns LA, Kloepfer KM, Leonard S, Lezmi G, Lieberman JA, Lomas J, Makhija M, Parrish C, Peake J, Perrett KP, Petroni D, Pfutzner W, Pongracic JA, Quinn P, Robison RG, Sanders G, Schneider L, Sharma HP, Trujillo J, Turner PJ, Tuttle K, Upton JE, Varshney P, Vickery BP, Vogelberg C, Wainstein B, Wood RA, Bee KJ, Campbell DE, Green TD, Rouissi R, Peillon A, Bahnson HT, Bois T, Sampson HA, Burks AW. Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy. N Engl J Med. 2023 May 11;388(19):1755-1766. doi: 10.1056/NEJMoa2212895.
PubMed 37163622
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPITOPE Open-label Extension Study to Evaluate the Long-term Clinical Benefit and Safety of DBV712 in Peanut-Allergic Children
- ClinicalTrials.gov ID
- NCT03859700
- Acronym / sponsor ID
- EPOPEX / EPOPEX (V712-305)
- Conditions
- Peanut Allergy
- Keywords
- EPIT, Epicutaneous, Immunotherapy, Viaskin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- DBV TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Posted 28 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, follow-up study for subjects who completed the EPITOPE study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBV712 250mcg | Experimental | Biological: DBV712 250 mcgDBV712 250 mcg, once daily |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- completion of the EPITOPE study
Key exclusion criteria (2 listed)
- Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches.
- Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma
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 mcgDBV712 250 mcg, once daily | Biological | DBV712 250mcg |
Primary outcome
Percentage of Participants Who Were Treatment Responders at Months 12, 24, 36 and 48
Time frame: Months 12, 24, 36 and 48
A participant was defined as treatment responder if: * The V712-304 (EPITOPE) baseline ED was >10 mg peanut protein and the ED was ≥1000 mg peanut protein at the post-baseline DBPCFCs or; * The V712-304 (EPITOPE) baseline ED was ≤10 mg and the ED is ≥300 mg peanut protein at the post-baseline DBPCFCs. DBPCFC occurred at baseline and every 12 months, with the first post-baseline one being performed at the end of the EPITOPE trial (corresponding to Month 12).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39956162Greenhawt M, Albright D, Anvari S, Arends N, Arkwright PD, Begin P, Blumchen K, Brown-Whitehorn T, Cassell H, Chan ES, Ciaccio CE, Deschildre A, Divaret-Chauveau A, Dorris S, Dorsey M, Du Toit G, Eiwegger T, Erlewyn-Lajeunesse M, Fleischer DM, Ford LS, Garcia-Lloret M, O'B Hourihane J, Jay N, Jones SM, Kim EH, Kloepfer K, Leonard S, Lezmi G, Lieberman J, Lomas J, Makhija M, O'Sullivan M, Parrish C, Peake J, Perrett KP, Petroni D, Pongracic JA, Quinn P, Robison RG, Sanders G, Schneider L, Sharma H, Sindher SB, Trujillo J, Turner PJ, Tuttle K, Upton J, Varshney P, Vickery BP, Vogelberg C, Wainstein B, Wang J, Wood R, Bee KJ, Campbell DE, Green TD, Rouissi R, Bahnson HT, Bois T, Sampson HA, Burks AW. Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers: Open-Label Extension to EPITOPE. J Allergy Clin Immunol Pract. 2025 May;13(5):1176-1187.e7. doi: 10.1016/j.jaip.2025.02.004. Epub 2025 Feb 14.
- Derived from this study: PubMed 37163622Greenhawt M, Sindher SB, Wang J, O'Sullivan M, du Toit G, Kim EH, Albright D, Anvari S, Arends N, Arkwright PD, Begin P, Blumchen K, Bourrier T, Brown-Whitehorn T, Cassell H, Chan ES, Ciaccio CE, Deschildre A, Divaret-Chauveau A, Dorris SL, Dorsey MJ, Eiwegger T, Erlewyn-Lajeunesse M, Fleischer DM, Ford LS, Garcia-Lloret M, Giovannini-Chami L, Hourihane JO, Jay N, Jones SM, Kerns LA, Kloepfer KM, Leonard S, Lezmi G, Lieberman JA, Lomas J, Makhija M, Parrish C, Peake J, Perrett KP, Petroni D, Pfutzner W, Pongracic JA, Quinn P, Robison RG, Sanders G, Schneider L, Sharma HP, Trujillo J, Turner PJ, Tuttle K, Upton JE, Varshney P, Vickery BP, Vogelberg C, Wainstein B, Wood RA, Bee KJ, Campbell DE, Green TD, Rouissi R, Peillon A, Bahnson HT, Bois T, Sampson HA, Burks AW. Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy. N Engl J Med. 2023 May 11;388(19):1755-1766. doi: 10.1056/NEJMoa2212895.
- Individual participant dataSharing planned: No
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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.
26 sites in 1 country: 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 Peanut Allergy, run by DBV Technologies at 26 sites in United States.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. 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. 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?
Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Were Treatment Responders at Months 12, 24, 36 and 48 (time frame: Months 12, 24, 36 and 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03859700, which also lists 2 linked publications.
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 28 Oct 2026.