Peanut AllergyPhase 2OLFUS-VIPESNCT01955109
Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children
A Phase 2 study testing Viaskin Peanut 250 mcg in people with Peanut Allergy, run by DBV Technologies at 22 sites in 4 countries.
Trial summary
The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are: To assess the efficacy of Viaskin Peanut after up to 36 months of treatment. To evaluate the safety of long-term treatment with Viaskin Peanut. Read more about this study
- Who is it for?
- Ages 7 to 56 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Viaskin Peanut 250 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 22 sitesin 4 countries
- Study dates
- Sep 2013to Sep 2016
- Phase
- Phase 2
- 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 7 to 56 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult and pediatric subjects (≥7 years) who completed the VIPES study, with a mandatory and documented DBPCFC at Month 12 in the VIPES study.
- Signed informed consent from adult subjects or parent(s)/guardian(s) of children <18 years and children's assent for children >7 years or as per country-specific regulations or laws. This consent should be signed no later than Visit 11 in the VIPES study.
- Negative pregnancy test for women of childbearing potential at Visit 10 in the VIPES study.
- Female subject of childbearing potential must use effective methods of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study. Documented sexual abstinence will be accepted as an effective method of contraception for girls below 15 years of age.
- Subjects and/or parents/guardians willing to comply with all study requirements during their participation in the study.
Who cannot join
- Severe reaction during the DBPCFC at Month 12 in the VIPES study, defined as need for intubation, hypotension persisting after epinephrine administration, and/or the need for more than two doses of epinephrine.
- Pregnancy or lactation.
- Females of childbearing potential planning a pregnancy in the coming 2 to 3 years.
- Subjects who became allergic to chocolate or who do not want to consume the chocolate study challenge vehicle anymore.
- Subjects who developed hypersensitivity to excipients of the Viaskin patches or of the food challenge formula used during the VIPES study.
- Inability to discontinue short-acting antihistamines for three days or long-acting antihistamines for five to seven days (depending on half-life) prior to skin prick testing or food challenges.
Show all 21Show fewer
- Subjects with asthma that has evolved and now fulfills any of the criteria defined as follows:
- uncontrolled persistent asthma by National Asthma Education and Prevention Program Asthma guidelines (2007) or by Global Initiative for Asthma (2011) or being treated with combination therapy of medium dose inhaled corticosteroid with a long acting inhaled β2-agonists.
- at least two systemic corticosteroid courses for asthma in the past year or one oral corticosteroid course for asthma in the past three months.
- prior intubation for asthma in the past year.
- Subjects receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.
- Subjects receiving or planning to receive anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy.
- Subjects receiving or planning to receive any type of immunotherapy to any food (e.g. oral immunotherapy, sublingual immunotherapy, specific oral tolerance induction) during their participation in the study.
- Subjects receiving or planning to receive any aeroallergen immunotherapy during their participation in the study.
- Allergy or known history of reaction to Tegaderm® with no possibilities to use an alternative dressing approved by the sponsor.
- Subjects suffering from generalized dermatologic disease (e.g. severe atopic dermatitis, uncontrolled generalized eczema, ichthyosis vulgaris) with no intact zones to apply the patches.
- Any new disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias.
- A history of non compliance in the VIPES study. Non compliance is defined as subjects not applying the patch at all for 60 days or more (this can be either consecutive or intermittent non-application of the patches) during the whole VIPES study duration
- Participation in another clinical intervention study in the past year, other than the VIPES study.
- Subjects on any experimental drugs in the past year, other than those used in the VIPES study.
- Other inclusion/exclusion criteria may apply.
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United States10 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Childrens' Hospital
Boston, Massachusetts, 02115
Children's Memorial Hospital
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Medical Center Dallas
Dallas, Texas, 75235
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of California, Rady Childrens Hospital
San Diego, California, 92123
ASTHMA, Inc.
Seattle, Washington, 98115
Stanford University School of Medicine
Stanford, California, 94305
France6 sites
Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin
Bordeaux, 33076
Hôpital Saint Vincent de Paul
Lille, 59020
GCS des hôpitaux pédiatriques
Nice, 06200
Hôpital Necker
Paris, 75743
Nouvel Hôpital Civil
Strasbourg, 67091
Hôpitaux De Brabois
Vandœuvre-lès-Nancy, 54511
Canada4 sites
Cheema Research Inc.
Mississauga, Ontario, L5A 3V4
Ottawa Allergy Asthma Research Institute
Ottawa, Ontario, K1Y 4G2
Centre de Recherche Appliquée en Asthme et Allergie de Québec
Sainte-Foy, Quebec, G1V 4M6
Gordon Sussman Clinical Research
Toronto, Ontario, M4V 1R2
Netherlands2 sites
Erasmus MC
Rotterdam, 3015 GD
UMC Utrecht
Utrecht, 3584 CX
About this study
Official title: Open-label Follow-up Study of the VIPES Study to Evaluate Long-term Efficacy and Safety of the Viaskin Peanut
The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are:
- To assess the efficacy of Viaskin Peanut after up to 36 months of treatment.
- To evaluate the safety of long-term treatment with Viaskin Peanut.
- To evaluate sustained unresponsiveness to peanut after a period of 2 months without treatment in subjects showing desensitization to peanut after treatment with Viaskin Peanut.
Read the detailed description
Peanut allergy is a common allergy in the United States, with a prevalence in the general population as high as 1%. Peanut allergy management is based on strict peanut avoidance and injectable epinephrine after the allergic systemic reactions have started. Specific Immunotherapy methods currently available have shown some limitations in their use because of safety issues. Hence, there is an important unmet medical need for efficient and safe treatment of peanut allergy.
DBV Technologies has developed an epicutaneous delivery system, called Viaskin, a method based on delivering precise quantity of the allergen on the upper layers of the skin. Avoiding contact between the allergen and the bloodstream should confer to epicutaneous immunotherapy (EPIT) a higher level of safety as systemic reactions should be circumvented
The OLFUS-VIPES study is an open-label follow-up study for subjects who previously were randomized and have completed the VIPES efficacy and safety study. Subjects will be offered enrollment in this follow-up study to receive an additional 24 months of Viaskin Peanut treatment followed by a period of 2 months without treatment while maintaining a peanut-free diet.
The trial will be conducted at the same sites as the VIPES study with investigators and staff trained and experienced in the diagnosis and the management of peanut allergy and anaphylaxis, and who are capable of performing a double-blind placebo-controlled food challenge (DBPCFC) in adult and/or pediatric subjects.
According to the current amended study protocol, all subjects enrolling into the OLFUS-VIPES study after having completed the VIPES study will receive the highest dose of Viaskin Peanut, i.e. 250 mcg peanut protein, regardless of prior treatment (placebo, 50 mcg, 100 mcg or 250 mcg Viaskin Peanut) they were receiving in the VIPES study. Subjects who already enrolled into the OLFUS-VIPES study under the initial protocol design will all switch to receive the 250 mcg dose at Month 6 or at Month 12 of treatment in the OLFUS-VIPES study upon approval of the amended protocol at their sites. The study will remain blinded for all subjects until the VIPES study is unblinded. All subjects completing the OLFUS-VIPES study should receive overall 24 months of active treatment followed by a period of 2 months without treatment for those subjects being assessed for sustained unresponsiveness.
- Conditions
- Peanut Allergy
- Being tested
- Viaskin Peanut 250 mcg
- Keywords
- Food allergy, Immediate hypersensitivity, Whole peanut extract, Allergenic product, Specific Immunotherapy, Epicutaneous Immunotherapy (EPIT)
- Medical subject headings
- Peanut Hypersensitivity, Food Hypersensitivity, Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viaskin Peanut 250 mcgBiological
Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract
| Study group | Role | What they receive |
|---|---|---|
| Viaskin Peanut 250 mcg | Experimental | Not described Receives: Biological: Viaskin Peanut 250 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Treatment Responders at Months 12 and 24
A treatment responder was defined as a participant with a peanut protein eliciting dose (ED) equal to or greater than 1000 milligram (mg) peanut protein or with at least a 10-fold increase of the ED compared to their initial ED observed at the VIPES baseline, as determined by double-blind placebo-controlled food challenge (DBPCFC) at Months 12 and 24. At Month 12, participants had received 24 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 12 months of active treatment for those who received placebo in the VIPES study. At Month 24, participants had received 36 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 24 months of active treatment for those who received placebo in the VIPES study. The percentage of responders at Month 12 and Month 24 are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Measured: Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study
Secondary outcomes (7)
Percentage of Participants Unresponsive to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 24
Participants were considered unresponsive if they showed no objective symptoms leading to stopping the challenge during the Month 24 DBPCFC with a cumulative dose of at least 1440 mg of peanut protein, up to a cumulative dose of 5044 mg peanut protein. The percentage of unresponsive participants is presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Measured: Month 24 (end of treatment) of the OLFUS-VIPES study
Percentage of Participants With a Sustained Unresponsiveness to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 26
Participants who were unresponsive to a cumulative dose of 1440 mg of peanut protein or above at the Month 24 DBPCFC, had an additional 2-month period without treatment and continued on a peanut-free diet to assess for sustained unresponsiveness by a DBPCFC at Month 26. The percentage of participants with this sustained unresponsiveness, i.e, who showed no objective symptoms leading to stopping the challenge during the DBPCFC to a cumulative dose of 1440 mg of peanut protein or above at Month 26, are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Measured: Month 26 (2 months post-treatment) of the OLFUS-VIPES study
Median Cumulative Reactive Dose of Peanut Protein at Months 12 and 24
The cumulative reactive dose was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC. To distinguish participants who reached the highest dose of the DBPCFC without objective symptoms 1000 mg was added to the cumulative reactive dose to obtain an adjusted value. The median cumulative reactive doses at Months 12 and 24 are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Measured: Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study
Mean Cumulative Reactive Dose of Peanut Protein at Months 12 and 24
The cumulative reactive dose was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC. To distinguish participants who reached the highest dose of the DBPCFC without objective symptoms 1000 mg was added to the cumulative reactive dose to obtain an adjusted value. The mean cumulative reactive doses at Months 12 and 24 are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Measured: Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study
Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24
The change from the VIPES Baseline in peanut-specific IgE values at Months 6, 12, 18 and 24 of the OLFUS-VIPES study are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Measured: VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES study
Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24
The change from the VIPES Baseline in peanut-specific IgG4 values at Months 6, 12, 18 and 24 of the OLFUS-VIPES study are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Measured: VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES study
Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24
The change from the VIPES Baseline in the wheal diameter from the undiluted skin prick tests at Months 6, 12, 18 and 24 of the OLFUS-VIPES study are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Measured: VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) in the OLFUS-VIPES study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2016
- Study completionSep 2016
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 171 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
- NCT01955109
- Sponsor's protocol ID
- OLFUS-VIPES
- Other IDs
- 2013-001754-10
- Acronym
- OLFUS-VIPES
- Status last verified
- Jun 2022
- First submitted
- 24 Sep 2013
- Last updated
- 30 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lewis MO, Brown-Whitehorn TF, Cianferoni A, Rooney C, Spergel JM. Peanut-allergic patient experiences after epicutaneous immunotherapy: peanut consumption and impact on QoL. Ann Allergy Asthma Immunol. 2019 Jul;123(1):101-103. doi: 10.1016/j.anai.2019.04.006. Epub 2019 Apr 10. No abstract available.
PubMed 30978404
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Follow-up Study of the VIPES Study to Evaluate Long-term Efficacy and Safety of the Viaskin Peanut
- ClinicalTrials.gov ID
- NCT01955109
- Acronym / sponsor ID
- OLFUS-VIPES / OLFUS-VIPES
- Conditions
- Peanut Allergy
- Keywords
- Food allergy, Immediate hypersensitivity, Whole peanut extract, Allergenic product, Specific Immunotherapy, Epicutaneous Immunotherapy (EPIT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- DBV TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Posted 30 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are:
- To assess the efficacy of Viaskin Peanut after up to 36 months of treatment.
- To evaluate the safety of long-term treatment with Viaskin Peanut.
- To evaluate sustained unresponsiveness to peanut after a period of 2 months without treatment in subjects showing desensitization to peanut after treatment with Viaskin Peanut.
Detailed description
Peanut allergy is a common allergy in the United States, with a prevalence in the general population as high as 1%. Peanut allergy management is based on strict peanut avoidance and injectable epinephrine after the allergic systemic reactions have started. Specific Immunotherapy methods currently available have shown some limitations in their use because of safety issues. Hence, there is an important unmet medical need for efficient and safe treatment of peanut allergy.
DBV Technologies has developed an epicutaneous delivery system, called Viaskin, a method based on delivering precise quantity of the allergen on the upper layers of the skin. Avoiding contact between the allergen and the bloodstream should confer to epicutaneous immunotherapy (EPIT) a higher level of safety as systemic reactions should be circumvented
The OLFUS-VIPES study is an open-label follow-up study for subjects who previously were randomized and have completed the VIPES efficacy and safety study. Subjects will be offered enrollment in this follow-up study to receive an additional 24 months of Viaskin Peanut treatment followed by a period of 2 months without treatment while maintaining a peanut-free diet.
The trial will be conducted at the same sites as the VIPES study with investigators and staff trained and experienced in the diagnosis and the management of peanut allergy and anaphylaxis, and who are capable of performing a double-blind placebo-controlled food challenge (DBPCFC) in adult and/or pediatric subjects.
According to the current amended study protocol, all subjects enrolling into the OLFUS-VIPES study after having completed the VIPES study will receive the highest dose of Viaskin Peanut, i.e. 250 mcg peanut protein, regardless of prior treatment (placebo, 50 mcg, 100 mcg or 250 mcg Viaskin Peanut) they were receiving in the VIPES study. Subjects who already enrolled into the OLFUS-VIPES study under the initial protocol design will all switch to receive the 250 mcg dose at Month 6 or at Month 12 of treatment in the OLFUS-VIPES study upon approval of the amended protocol at their sites. The study will remain blinded for all subjects until the VIPES study is unblinded. All subjects completing the OLFUS-VIPES study should receive overall 24 months of active treatment followed by a period of 2 months without treatment for those subjects being assessed for sustained unresponsiveness.
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 250 mcg | Experimental | Biological: Viaskin Peanut 250 mcg |
Who may qualify
- Ages
- 7 to 56 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Adult and pediatric subjects (≥7 years) who completed the VIPES study, with a mandatory and documented DBPCFC at Month 12 in the VIPES study.
- Signed informed consent from adult subjects or parent(s)/guardian(s) of children <18 years and children's assent for children >7 years or as per country-specific regulations or laws. This consent should be signed no later than Visit 11 in the VIPES study.
- Negative pregnancy test for women of childbearing potential at Visit 10 in the VIPES study.
- Female subject of childbearing potential must use effective methods of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study. Documented sexual abstinence will be accepted as an effective method of contraception for girls below 15 years of age.
- Subjects and/or parents/guardians willing to comply with all study requirements during their participation in the study.
Key exclusion criteria (21 listed)
- Severe reaction during the DBPCFC at Month 12 in the VIPES study, defined as need for intubation, hypotension persisting after epinephrine administration, and/or the need for more than two doses of epinephrine.
- Pregnancy or lactation.
- Females of childbearing potential planning a pregnancy in the coming 2 to 3 years.
- Subjects who became allergic to chocolate or who do not want to consume the chocolate study challenge vehicle anymore.
- Subjects who developed hypersensitivity to excipients of the Viaskin patches or of the food challenge formula used during the VIPES study.
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 250 mcgSubjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract | Biological | Viaskin Peanut 250 mcg |
Primary outcome
Percentage of Treatment Responders at Months 12 and 24
Time frame: Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study
A treatment responder was defined as a participant with a peanut protein eliciting dose (ED) equal to or greater than 1000 milligram (mg) peanut protein or with at least a 10-fold increase of the ED compared to their initial ED observed at the VIPES baseline, as determined by double-blind placebo-controlled food challenge (DBPCFC) at Months 12 and 24. At Month 12, participants had received 24 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 12 months of active treatment for those who received placebo in the VIPES study. At Month 24, participants had received 36 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 24 months of active treatment for those who received placebo in the VIPES study. The percentage of responders at Month 12 and Month 24 are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
7 secondary outcomes
Percentage of Participants Unresponsive to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 24
Time frame: Month 24 (end of treatment) of the OLFUS-VIPES study
Percentage of Participants With a Sustained Unresponsiveness to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 26
Time frame: Month 26 (2 months post-treatment) of the OLFUS-VIPES study
Median Cumulative Reactive Dose of Peanut Protein at Months 12 and 24
Time frame: Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study
Mean Cumulative Reactive Dose of Peanut Protein at Months 12 and 24
Time frame: Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study
Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24
Time frame: VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES study
Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24
Time frame: VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES study
Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24
Time frame: VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) in the OLFUS-VIPES study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30978404Lewis MO, Brown-Whitehorn TF, Cianferoni A, Rooney C, Spergel JM. Peanut-allergic patient experiences after epicutaneous immunotherapy: peanut consumption and impact on QoL. Ann Allergy Asthma Immunol. 2019 Jul;123(1):101-103. doi: 10.1016/j.anai.2019.04.006. Epub 2019 Apr 10. No abstract available.
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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.
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Viaskin Peanut 250 mcg in people with Peanut Allergy, run by DBV Technologies at 22 sites in 4 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 21 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 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, France, Canada, Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 30 Jun 2022). 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 Months 12 and 24 (time frame: Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study). 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 NCT01955109, which also lists 1 linked publication.
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 30 Jun 2022.