Peanut AllergyPhase 3PEOPLENCT03013517
Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children
A Phase 3 study testing Viaskin Peanut 250µg in people with Peanut Allergy, run by DBV Technologies at 31 sites in 5 countries.
Trial summary
This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active treatment in the PEPITES study, or for 3 years if previously on placebo in the PEPITES study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Viaskin Peanut 250µg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 31 sitesin 5 countries
- Study dates
- 23 Jan 2017to Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who completed the PEPITES 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
31 sites in 5 countries.
31 sites in 5 countries
United States17 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Childrens' Hospital
Boston, Massachusetts, 02115
The University of North Carolina - Chapell Hill
Chapel Hill, North Carolina, 27599
Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
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
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Jaffe Food Allergy Institute
New York, New York, 10029
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of California, Rady Children's Hospital
San Diego, California, 92123
ASTHMA, Inc.
Seattle, Washington, 98115
Stanford University School of Medicine
Stanford, California, 94304
Canada6 sites
Cheema Research Inc.
Mississauga, Ontario, L5A 3V4
CHUM & CHU Sainte-Justine
Montreal, Quebec, H3T 1C4
Ottawa Allergy Asthma Research Institute
Ottawa, Ontario, K1G 6C6
Centre de Recherche Appliquée en Allergie de Quebec
Québec, QC G1V4M6
Gordon Sussman Clinical Research Inc.
Toronto, Ontario, M4V 1R2
British Columbia Children's Hospital
Vancouver, British Columbia, V5H 3V4
Australia3 sites
Allergy Medical
Brisbane
Princess Margaret Hospital for Children
Perth
Children's Hospital Westmead
Sydney
Germany3 sites
Charité Universitätsmedizin Berlin
Berlin, D13353
St.-Marien-Hospital
Bonn, D-53115
Universitätsklinikum Erlangen
Erlangen, 91054
Ireland2 sites
Clinical Investigations Unit
Cork
Our Lady's Children's Hospital
Dublin
About this study
Official title: Open-label Follow-up Study of the PEPITES Study to Evaluate the Long-term Efficacy and Safety of Viaskin Peanut
This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active treatment in the PEPITES study, or for 3 years if previously on placebo in the PEPITES study.
- Conditions
- Peanut Allergy
- Being tested
- Viaskin Peanut 250µg
- Keywords
- Allergy, food allergy, viaskin, peanut, epicutaneous
- Medical subject headings
- Peanut Hypersensitivity, Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viaskin Peanut 250µgDrug
DBV712 250 µg, once daily
| Study group | Role | What they receive |
|---|---|---|
| Viaskin Peanut 250µg | Experimental | Not described Receives: Drug: Viaskin Peanut 250µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of subjects originating from the active arm of PEPITES reaching an Eliciting Dose (ED) ≥ 1,000 mg after 24 months of additional treatment in PEOPLE
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start23 Jan 2017
- Primary completion23 Nov 2019
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 300 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
- NCT03013517
- Sponsor's protocol ID
- PEOPLE
- Acronym
- PEOPLE
- Status last verified
- Dec 2020
- First submitted
- 2 Jan 2017
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Follow-up Study of the PEPITES Study to Evaluate the Long-term Efficacy and Safety of Viaskin Peanut
- ClinicalTrials.gov ID
- NCT03013517
- Acronym / sponsor ID
- PEOPLE / PEOPLE
- Conditions
- Peanut Allergy
- Keywords
- Allergy, food allergy, viaskin, peanut, epicutaneous
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- DBV TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 23 Nov 2019 (actual)
- Study completion
- Mar 2023 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- 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.
This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active treatment in the PEPITES study, or for 3 years if previously on placebo in the PEPITES study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Viaskin Peanut 250µg | Experimental | Drug: Viaskin Peanut 250µg |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who completed the PEPITES 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 |
|---|---|---|
| Viaskin Peanut 250µgDBV712 250 µg, once daily | Drug | Viaskin Peanut 250µg |
Primary outcome
% of subjects originating from the active arm of PEPITES reaching an Eliciting Dose (ED) ≥ 1,000 mg after 24 months of additional treatment in PEOPLE
Time frame: Month 24
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 2 Dec 2020.
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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.
31 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Viaskin Peanut 250µg in people with Peanut Allergy, run by DBV Technologies at 31 sites in 5 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 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: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada, Australia, Germany, Ireland. 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?
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?
% of subjects originating from the active arm of PEPITES reaching an Eliciting Dose (ED) ≥ 1,000 mg after 24 months of additional treatment in PEOPLE (time frame: Month 24). 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 2 Dec 2020.