Peanut AllergyPhase 3EPITOPENCT03211247
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
A Phase 3 study testing Part A Viaskin Peanut 250 mcg, Part A Viaskin Peanut 100 mcg and Part B Viaskin Peanut 250 mcg in people with Peanut Allergy, run by DBV Technologies at 51 sites in 8 countries.
Trial summary
The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT). Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Part A Viaskin Peanut 250 mcg, Part A Viaskin Peanut 100 mcg and Part B Viaskin Peanut 250 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 414 participants
- Where
- 51 sitesin 8 countries
- Study dates
- 31 Jul 2017to 27 Apr 2022
- 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 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female from 1-3 years of age;
- Physician-diagnosed peanut allergy;
- Peanut-specific IgE level > 0.7 kU/L;
- Positive peanut SPT with a largest wheal diameter ≥ 6 mm;
- Positive DBPCFC at ≤ 300 mg peanut protein;
Who cannot join
- Uncontrolled asthma;
- History of severe anaphylaxis to peanut;
- Prior immunotherapy to any food or other immunotherapy;
- Generalized severe dermatologic disease;
Trial locations and contacts
51 sites in 8 countries.
51 sites in 8 countries
United States27 sites
University of Michigan Health System
Ann Arbor, Michigan, 48106
Emory University
Atlanta, Georgia, 30329
Children's Hospital Colorado
Aurora, Colorado, 80045
Dell Children's Medical Center
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
The Universal of Chicago Medical Center
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Children's Medical Center of Dallas
Dallas, Texas, 75235
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, 77030
Riley Hospital for Children at Indiana University
Indianapolis, Indiana, 46202
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
University of California School of Medicine
Los Angeles, California, 10833
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mount Sinai Medical Center
New York, New York, 10029
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Rochester
Rochester, New York, 14642
University of California, Rady Children's Hospital
San Diego, California, 92123
University of California San Francisco
San Francisco, California, 94158
ASTHMA, Inc.
Seattle, Washington, 98115
Stanford University School of Medicine
Stanford, California, 94305
University of Arizona Health Science
Tucson, Arizona, 85719
Children's national Health System
Washington D.C., District of Columbia, 20010
Australia6 sites
Perth Children's Hospital
Nedlands, Western Australia, 6009
The Women's and children's hospital
North Adelaide, South Australia, 5006
The Royal Children's Hospital
Parkville, Victoria, 3052
Sydney Children's Hospital
Randwick, NWS, 2031
Queensland Children's Hospital
South Brisbane, Queensland, 4101
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
France5 sites
CHRU Lille
Lille, 59037
CHRU Metz-Thionville
Metz, 57085
Hopitaux Pediatriques de Nice
Nice, 06200
Hopital Necker
Paris, 75015
CHRU Nancy
Vandœuvre-lès-Nancy, 54511
United Kingdom5 sites
Guy's and Saint Thomas' NHS Foundation Trust
London, SE17EH
St.Mary's Hospital
London, W21NY
ROyal Manchester Children's Hospital
Manchester, M139WL
Sheffield Children's Hospital
Sheffield, S102TH
University Hospital Southampton NHS Foundation Trust
Southampton, SO166YD
Canada3 sites
CHUM & CHU Sainte-Justine
Montreal, Quebec, H3T 1C4
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
British Columbia Children's Hospital
Vancouver, British Columbia, V5H 3V4
Germany3 sites
Universitatsklinikum Carl Gustav Carus
Dresden, 01307
Universitatsklinikum Frankfurt
Frankfurt, 60590
Universitatklinikum Giessen und Marburg
Marburg, 35033
About this study
Official title: A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.
The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).
Read the detailed description
The study comprised of two parts:
- In part A, subjects were randomized to receive either Viaskin Peanut 250 mcg, or Viaskin Peanut 100 mcg or the placebo in a 2:1 ratio, for 12 months. After 3 months of treatment, a data safety monitoring board had to determine the active dose to be applyed during the part B
- In Part B, subjects were randomized to receive either Viaskin Peanut 250 mcg or the placebo in a 2:1 ratio, for 12 months
- Conditions
- Peanut Allergy
- Being tested
- Part A Viaskin Peanut 250 mcg, Part A Viaskin Peanut 100 mcg, Part A Placebo, Part B Viaskin Peanut 250 mcg, Part B Placebo
- 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.
Part A Viaskin Peanut 250 mcgBiological
Viaskin Peanut 250 mcg, once daily
Part A Viaskin Peanut 100 mcgBiological
Viaskin Peanut 100 mcg, once daily
Part A PlaceboBiological
Placebo patch, once daily
Part B Viaskin Peanut 250 mcgBiological
Viaskin Peanut 250 mcg, once daily
Part B PlaceboBiological
Placebo patch, once daily
| Study group | Role | What they receive |
|---|---|---|
| Part A Viaskin Peanut 250 mcg | Experimental | Not described Receives: Biological: Part A Viaskin Peanut 250 mcg |
| Part A Viaskin Peanut 100 mcg | Experimental | Not described Receives: Biological: Part A Viaskin Peanut 100 mcg |
| Part A Placebo | Placebo comparator | Not described Receives: Biological: Part A Placebo |
| Part B Viaskin Peanut 250 mcg | Experimental | Not described Receives: Biological: Part B Viaskin Peanut 250 mcg |
| Part B Placebo | Placebo comparator | Not described Receives: Biological: Part B Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Treatment Responders at Month 12
A participant was defined as a treatment responder if the initial eliciting dose (ED) was > 10 milligram (mg) peanut protein and the ED was ≥1000 mg peanut protein at the post-treatment double-blind placebo-controlled food challenge (DBPCFC) at Month 12 OR the initial ED at baseline was ≤10 mg peanut protein and the ED was ≥300 mg peanut protein at the post-treatment DBPCFC at Month 12.
Measured: Month 12
Secondary outcomes (5)
Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model
The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows:
If the ED reported by the investigator in the electronic case report form (eCRF) is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses. The CRD in each treatment group at Month 12 was compared using ANCOVA model.
Measured: Month 12
Change From Baseline in CRD of Peanut Protein to Month 12
The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows:
If the ED reported by the investigator in the eCRF is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses.
Measured: Baseline (Day 1) and Month 12
ED of Peanut Protein at Month 12 Using ANCOVA Model
The peanut protein ED was the individual dose of peanut protein administered to participants during the food challenge procedure, which triggered objective allergic reactions, leading to stopping the challenge. The ED in each treatment group at Month 12 was compared using ANCOVA model.
Measured: Month 12
Change From Baseline in ED of Peanut Protein to Month 12
The peanut protein ED was the individual dose of peanut protein administered to participants during the food challenge procedure, which triggered objective allergic reactions, leading to stopping the challenge.
Measured: Baseline (Day 1) and Month 12
Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge
The objective symptoms collected during the DBPCFC included skin (erythematous rash, pruritus, urticaria/angioedema, rash), upper respiratory (sneezing/itching, nasal congestion, rhinorrhea, laryngeal), lower respiratory (wheezing), gastrointestinal (diarrhea, vomiting, cardiovascular), and eyes (conjunctivitis, any other objective symptoms), with the exception of erythematous rash (recorded as Yes/No), each symptom was graded as: 0=" absent",1=" mild", 2=" moderate" or 3=" severe". For erythematous rash, the percent area involved was collected. Percentages were calculated based on the number of participants in each time point. Subjective abdominal pain (when graded 2 or 3) was also considered for this analysis.
Measured: Baseline (Day 1) and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start31 Jul 2017
- Primary completion20 Aug 2019
- Study completion27 Apr 2022
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 414 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
- NCT03211247
- Sponsor's protocol ID
- EPITOPE
- Acronym
- EPITOPE
- Status last verified
- Dec 2024
- First submitted
- 5 Jul 2017
- Last updated
- 16 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scurlock AM, Fleischer DM, Toit GD, Arends NJT, Pongracic JA, Trujillo J, Turner P, Vogelberg C, Bee KJ, Green TD, Meney J, Bois T, Campbell DE, Sampson HA, Burks AW. Efficacy and safety of epicutaneous immunotherapy in children with peanut allergy with atopic comorbidities. Ann Allergy Asthma Immunol. 2025 Aug;135(2):203-210. doi: 10.1016/j.anai.2025.04.002. Epub 2025 Apr 7.
PubMed 40204253Greenhawt 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 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.
- ClinicalTrials.gov ID
- NCT03211247
- Acronym / sponsor ID
- EPITOPE / EPITOPE
- Conditions
- Peanut Allergy
- Keywords
- EPIT, Epicutaneous, Immunotherapy, Viaskin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- DBV TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Posted 16 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).
Detailed description
The study comprised of two parts:
- In part A, subjects were randomized to receive either Viaskin Peanut 250 mcg, or Viaskin Peanut 100 mcg or the placebo in a 2:1 ratio, for 12 months. After 3 months of treatment, a data safety monitoring board had to determine the active dose to be applyed during the part B
- In Part B, subjects were randomized to receive either Viaskin Peanut 250 mcg or the placebo in a 2:1 ratio, for 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A Viaskin Peanut 250 mcg | Experimental | Biological: Part A Viaskin Peanut 250 mcg |
| Part A Viaskin Peanut 100 mcg | Experimental | Biological: Part A Viaskin Peanut 100 mcg |
| Part A Placebo | Placebo comparator | Biological: Part A Placebo |
| Part B Viaskin Peanut 250 mcg | Experimental | Biological: Part B Viaskin Peanut 250 mcg |
| Part B Placebo | Placebo comparator | Biological: Part B Placebo |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female from 1-3 years of age;
- Physician-diagnosed peanut allergy;
- Peanut-specific IgE level > 0.7 kU/L;
- Positive peanut SPT with a largest wheal diameter ≥ 6 mm;
- Positive DBPCFC at ≤ 300 mg peanut protein;
Key exclusion criteria (4 listed)
- Uncontrolled asthma;
- History of severe anaphylaxis to peanut;
- Prior immunotherapy to any food or other immunotherapy;
- Generalized severe dermatologic disease;
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 |
|---|---|---|
| Part A Viaskin Peanut 250 mcgViaskin Peanut 250 mcg, once daily | Biological | Part A Viaskin Peanut 250 mcg |
| Part A Viaskin Peanut 100 mcgViaskin Peanut 100 mcg, once daily | Biological | Part A Viaskin Peanut 100 mcg |
| Part A PlaceboPlacebo patch, once daily | Biological | Part A Placebo |
| Part B Viaskin Peanut 250 mcgViaskin Peanut 250 mcg, once daily | Biological | Part B Viaskin Peanut 250 mcg |
| Part B PlaceboPlacebo patch, once daily | Biological | Part B Placebo |
Primary outcome
Percentage of Treatment Responders at Month 12
Time frame: Month 12
A participant was defined as a treatment responder if the initial eliciting dose (ED) was > 10 milligram (mg) peanut protein and the ED was ≥1000 mg peanut protein at the post-treatment double-blind placebo-controlled food challenge (DBPCFC) at Month 12 OR the initial ED at baseline was ≤10 mg peanut protein and the ED was ≥300 mg peanut protein at the post-treatment DBPCFC at Month 12.
5 secondary outcomes
Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model
Time frame: Month 12
Change From Baseline in CRD of Peanut Protein to Month 12
Time frame: Baseline (Day 1) and Month 12
ED of Peanut Protein at Month 12 Using ANCOVA Model
Time frame: Month 12
Change From Baseline in ED of Peanut Protein to Month 12
Time frame: Baseline (Day 1) and Month 12
Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge
Time frame: Baseline (Day 1) and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40204253Scurlock AM, Fleischer DM, Toit GD, Arends NJT, Pongracic JA, Trujillo J, Turner P, Vogelberg C, Bee KJ, Green TD, Meney J, Bois T, Campbell DE, Sampson HA, Burks AW. Efficacy and safety of epicutaneous immunotherapy in children with peanut allergy with atopic comorbidities. Ann Allergy Asthma Immunol. 2025 Aug;135(2):203-210. doi: 10.1016/j.anai.2025.04.002. Epub 2025 Apr 7.
- 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.
51 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 Part A Viaskin Peanut 250 mcg, Part A Viaskin Peanut 100 mcg and Part B Viaskin Peanut 250 mcg in people with Peanut Allergy, run by DBV Technologies at 51 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 4 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Australia, France, United Kingdom, Canada 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?
Yes. Results are posted in the registry (first posted 16 Dec 2024). 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 Treatment Responders at Month 12 (time frame: Month 12). 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 NCT03211247, 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 16 Dec 2024.