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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001754-10 | EudraCT Number |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viaskin Peanut 250 mcg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viaskin Peanut 250 mcg | Biological | Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
Subjects with asthma that has evolved and now fulfills any of the criteria defined as follows:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Rady Childrens Hospital | San Diego | California | 92123 | United States | ||
| Stanford University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30978404 | Derived | 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. |
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Participants who received 50, 100 or 250 micrograms (μg) Viaskin Peanut in VIPES continued on same dose in OLFUS-VIPES; those receiving placebo were re-randomized 1:1:1 to 50, 100 or 250 μg Viaskin Peanut. After protocol amendment 1, all participants received 250 μg dose from start of OLFUS-VIPES; those already enrolled were switched to 250 μg at Month 6 visit.
Children, adolescent and adult participants who were previously randomized in and completed the VIPES study (V712-202; NCT01675882) were eligible to enroll in this Phase II open-label follow-up study to receive an additional 24 months of Viaskin® Peanut (DBV712) Epicutaneous Immunotherapy (EPIT). Participants were enrolled in 21 study centers in 4 countries in France, the Netherlands, Canada and the USA from 30 August 2013 and the last participant completed 29 September 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | VIPES Initial Treatment Group: All Viaskin Peanut Doses | Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. | 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. | 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. | 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. | 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. | 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. | VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) in the OLFUS-VIPES study |
| Stanford |
| California |
| 94305 |
| United States |
| Children's Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston Childrens' Hospital | Boston | Massachusetts | 02115 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | United States |
| ASTHMA, Inc. | Seattle | Washington | 98115 | United States |
| Cheema Research Inc. | Mississauga | Ontario | L5A 3V4 | Canada |
| Ottawa Allergy Asthma Research Institute | Ottawa | Ontario | K1Y 4G2 | Canada |
| Gordon Sussman Clinical Research | Toronto | Ontario | M4V 1R2 | Canada |
| Centre de Recherche Appliquée en Asthme et Allergie de Québec | Sainte-Foy | Quebec | G1V 4M6 | Canada |
| Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin | Bordeaux | 33076 | France |
| Hôpital Saint Vincent de Paul | Lille | 59020 | France |
| GCS des hôpitaux pédiatriques | Nice | 06200 | France |
| Hôpital Necker | Paris | 75743 | France |
| Nouvel Hôpital Civil | Strasbourg | 67091 | France |
| Hôpitaux De Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Erasmus MC | Rotterdam | 3015 GD | Netherlands |
| UMC Utrecht | Utrecht | 3584 CX | Netherlands |
| FG001 |
| VIPES Initial Treatment Group: Placebo |
Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months. |
| Completed Study Until Month 12 |
|
| COMPLETED | Completed Month 24 (or Month 26 if applicable) |
|
| NOT COMPLETED |
|
|
The safety analysis set included all participants who received at least 1 dose of investigational product (IP) during the OLFUS-VIPES study.
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| ID | Title | Description |
|---|---|---|
| BG000 | VIPES Initial Treatment Group: All Viaskin Peanut Doses | Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months. |
| BG001 | VIPES Initial Treatment Group: Placebo | Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean age at OLFUS-VIPES entry. | Mean | Standard Deviation | years |
| ||||||||||||||
| Age, Customized | Participants' ages at OLFUS-VIPES entry. | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | The ethnicity of the participants at French local sites was not collected as it was not applicable as per local law. As such, these participants are included in the category of 'Not applicable' | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 12 and 24 DBPCFC performed. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study |
|
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| ||||||||||||||||||||||||||||
| Secondary | 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. | The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Month 24 DBPCFC performed. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 24 (end of treatment) of the OLFUS-VIPES study |
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| Secondary | 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. | The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for participants who had the Month 26 DBPCFC performed. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 26 (2 months post-treatment) of the OLFUS-VIPES study |
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| Secondary | 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. | The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 12 and 24 DBPCFC performed. | Posted | Median | Inter-Quartile Range | mg | Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study |
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| Secondary | 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. | The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 12 and 24 DBPCFC performed. | Posted | Mean | Standard Deviation | mg | Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study |
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| Secondary | 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. | The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 6, 12, 18 and 24 DBPCFC performed. | Posted | Median | Full Range | kilo units per liter | VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES study |
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| Secondary | 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. | The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 6, 12, 18 and 24 DBPCFC performed. | Posted | Median | Full Range | mg/L | VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES study |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 6, 12, 18 and 24 DBPCFC performed. | Posted | Median | Full Range | millimeters | VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) in the OLFUS-VIPES study |
|
Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VIPES Initial Treatment Group: All Viaskin Peanut Doses | Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months. | 0 | 123 | 7 | 123 | 113 | 123 |
| EG001 | VIPES Initial Treatment Group: Placebo | Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months. | 0 | 48 | 3 | 48 | 47 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders | MedDRA v15.0 | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v15.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v15.0 | Systematic Assessment |
| |
| Viral pericarditis | Infections and infestations | MedDRA v15.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA v15.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA v15.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA v15.0 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA v15.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Application site dermatitis | General disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Application site eczema | General disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Application site irritation | General disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Application site oedema | General disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Application site papules | General disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Application site rash | General disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Application site swelling | General disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Application site urticaria | General disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Allergy to animal | Immune system disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA v15.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v15.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA v15.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v15.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v15.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v15.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v15.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v15.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v15.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | DBV Technologies | 33-1-55-42-78-78 | clinicaltrials@dbv-technologies.com |
| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Adolescents (12-17 years) |
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| Adults (18-55 years) |
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| Adolescents and Adults (12-55 years) |
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| Male |
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| Black |
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| Hispanic |
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| Asian |
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| Other |
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| Not applicable |
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| Netherlands |
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| United States |
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| France |
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| Month 24 |
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Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
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