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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Tracking Information | |||
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First Submitted Date ICMJE | September 24, 2013 | ||
First Posted Date ICMJE | October 7, 2013 | ||
Results First Submitted Date ICMJE | April 7, 2022 | ||
Results First Posted Date ICMJE | June 30, 2022 | ||
Last Update Posted Date | June 30, 2022 | ||
Study Start Date ICMJE | September 2013 | ||
Actual Primary Completion Date | September 2016 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
Increase in the threshold dose of peanut protein during long-term treatment assessed by double-blind, placebo-controlled food challenges (DBPCFC) [ Time Frame: From baseline in the VIPES study to Month 12 and to Month 24 (end of treatment) in the OLFUS-VIPES study ] At Month 12 and at Month 24 in the OLFUS-VIPES study and by treatment group, the proportion of subjects with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut protein or with a ≥10-fold increase of the eliciting dose compared to their baseline eliciting dose observed in the VIPES study. Subjects having received placebo in the VIPES study (Treatment Group 1) and subjects having received Viaskin Peanut in the VIPES study (Treatment Group 2) will be analyzed separately.
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Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||
Brief Title ICMJE | Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children | ||
Official Title ICMJE | Open-label Follow-up Study of the VIPES Study to Evaluate Long-term Efficacy and Safety of the Viaskin Peanut | ||
Brief 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:
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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. |
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Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Peanut Allergy | ||
Intervention ICMJE | Biological: Viaskin Peanut 250 mcg
Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract
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Study Arms ICMJE | Experimental: Viaskin Peanut 250 mcg
Intervention: Biological: Viaskin Peanut 250 mcg
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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. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
171 | ||
Original Estimated Enrollment ICMJE |
220 | ||
Actual Study Completion Date ICMJE | September 2016 | ||
Actual Primary Completion Date | September 2016 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other inclusion/exclusion criteria may apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 7 Years to 56 Years (Child, Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Canada, France, Netherlands, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01955109 | ||
Other Study ID Numbers ICMJE | OLFUS-VIPES 2013-001754-10 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | DBV Technologies | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | DBV Technologies | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | DBV Technologies | ||
Verification Date | June 2022 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |