Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children (OLFUS-VIPES)
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ClinicalTrials.gov Identifier: NCT01955109 |
Recruitment Status :
Completed
First Posted : October 7, 2013
Results First Posted : June 30, 2022
Last Update Posted : June 30, 2022
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Sponsor:
DBV Technologies
Information provided by (Responsible Party):
DBV Technologies
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Peanut Allergy |
Intervention |
Biological: Viaskin Peanut 250 mcg |
Enrollment | 171 |
Participant Flow
Recruitment Details | 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. |
Pre-assignment Details | 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. |
Arm/Group Title | VIPES Initial Treatment Group: All Viaskin Peanut Doses | VIPES Initial Treatment Group: Placebo |
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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. | 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. |
Period Title: Overall Study | ||
Started | 123 | 48 |
Completed Study Until Month 12 | 103 | 46 |
Completed [1] | 78 | 39 |
Not Completed | 45 | 9 |
Reason Not Completed | ||
Adverse Event | 2 | 0 |
Participant unwilling to continue | 35 | 7 |
Physician Decision | 2 | 0 |
Lost to Follow-up | 3 | 1 |
Non-compliance | 3 | 1 |
[1]
Completed Month 24 (or Month 26 if applicable)
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Baseline Characteristics
Arm/Group Title | VIPES Initial Treatment Group: All Viaskin Peanut Doses | VIPES Initial Treatment Group: Placebo | Total | |
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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. | 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. | Total of all reporting groups | |
Overall Number of Baseline Participants | 123 | 48 | 171 | |
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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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Age, Continuous
[1] Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 123 participants | 48 participants | 171 participants | |
13.7 (6.64) | 13.0 (6.59) | 13.5 (6.61) | ||
[1]
Measure Description: Mean age at OLFUS-VIPES entry.
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Age, Customized
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 123 participants | 48 participants | 171 participants |
Children (6-11 years) |
60 48.8%
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23 47.9%
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83 48.5%
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Adolescents (12-17 years) |
34 27.6%
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18 37.5%
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52 30.4%
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Adults (18-55 years) |
29 23.6%
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7 14.6%
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36 21.1%
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Adolescents and Adults (12-55 years) |
63 51.2%
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25 52.1%
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88 51.5%
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[1]
Measure Description: Participants' ages at OLFUS-VIPES entry.
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 123 participants | 48 participants | 171 participants | |
Female |
43 35.0%
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18 37.5%
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61 35.7%
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Male |
80 65.0%
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30 62.5%
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110 64.3%
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Race/Ethnicity, Customized
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 123 participants | 48 participants | 171 participants |
Caucasian |
80 65.0%
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28 58.3%
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108 63.2%
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Black |
3 2.4%
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2 4.2%
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5 2.9%
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Hispanic |
1 0.8%
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2 4.2%
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3 1.8%
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Asian |
16 13.0%
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4 8.3%
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20 11.7%
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Other |
5 4.1%
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3 6.3%
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8 4.7%
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Not applicable |
18 14.6%
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9 18.8%
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27 15.8%
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[1]
Measure Description: 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'
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 123 participants | 48 participants | 171 participants |
Canada | 40 | 14 | 54 | |
Netherlands | 5 | 1 | 6 | |
United States | 60 | 24 | 84 | |
France | 18 | 9 | 27 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Chief Medical Officer |
Organization: | DBV Technologies |
Phone: | 33-1-55-42-78-78 |
EMail: | clinicaltrials@dbv-technologies.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | DBV Technologies |
ClinicalTrials.gov Identifier: | NCT01955109 |
Other Study ID Numbers: |
OLFUS-VIPES 2013-001754-10 ( EudraCT Number ) |
First Submitted: | September 24, 2013 |
First Posted: | October 7, 2013 |
Results First Submitted: | April 7, 2022 |
Results First Posted: | June 30, 2022 |
Last Update Posted: | June 30, 2022 |