Clinical Trial Results:
Open-label follow-up study of the VIPES study to evaluate long-term efficacy and safety of the Viaskin Peanut
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Summary
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EudraCT number |
2013-001754-10 |
Trial protocol |
NL |
Global end of trial date |
29 Sep 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Apr 2022
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First version publication date |
25 Apr 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
V712-203 (OLFUS-VIPES)
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01955109 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
DBV Technologies
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Sponsor organisation address |
177-181 avenue Pierre Brossolette, Montrouge, France, 92120
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Public contact |
Chief Medical Officer, DBV Technologies, 33 1-55-42-78-78, clinicaltrials@dbv-technologies.com
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Scientific contact |
Chief Medical Officer, DBV Technologies, 33 1-55-42-78-78, clinicaltrials@dbv-technologies.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-001481-PIP01-13 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Sep 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Sep 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the efficacy of Viaskin® Peanut (DBV712) after up to 36 months of epicutaneous immunotherapy (EPIT) in peanut-allergic participants.
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Protection of trial subjects |
The investigator was responsible for obtaining informed consent from each participant in the study, in accordance with the International Conference on Harmonisation-Good Clinical Practice (GCP) Guidelines, the Declaration of Helsinki, and applicable regulatory requirements. Before initiating a study, the investigator/institution had to have written and dated approval/favorable opinion from the Independent Ethics Committee (IEC)/Institutional Review Board (IRB) for the study protocol/amendment(s), written informed consent form, any consent form updates, participant recruitment procedures, and any written information to be provided to participants and a statement from the IEC/IRB that they comply with GCP requirements.
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Background therapy |
Participants received either Viaskin Peanut 50 micrograms (μg), 100 μg, 250 μg or placebo patch on intact skin for 24 hours daily for 12 months in the VIPES study (V712-202). | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Aug 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Canada: 54
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Country: Number of subjects enrolled |
France: 27
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Country: Number of subjects enrolled |
Netherlands: 6
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Country: Number of subjects enrolled |
United States: 84
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Worldwide total number of subjects |
171
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EEA total number of subjects |
33
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
83
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Adolescents (12-17 years) |
52
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Adults (18-64 years) |
36
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants who were previously randomized in and completed the VIPES study were eligible to enroll in this Phase II open-label follow-up study to receive an additional 24 months of Viaskin Peanut EPIT. Participants were enrolled in 21 study centers in 4 countries from 30 August 2013 and the last participant completed 29 September 2016. | ||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Participants who received 50, 100 or 250 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. | ||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||
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Arms
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Arm title
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Viaskin Peanut 250 μg | ||||||||||||||||||||||||||||
Arm description |
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for up to 24 months. Each patch contained 250 μg peanut protein extract for epicutaneous administration. For participants who were unresponsive to a cumulative dose of 1440 milligrams (mg) peanut protein or more at Month 24 double-blind placebo-controlled food challenge (DBPCFC), 24 months of treatment was followed by a period of 2 months without treatment while maintaining a peanut-free diet. | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Viaskin Peanut
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Investigational medicinal product code |
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Other name |
DBV712
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Pharmaceutical forms |
Cutaneous patch
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Routes of administration |
Epicutaneous use
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Dosage and administration details |
Viaskin Peanut cutaneous patch containing a dry deposit of a formulation of peanut protein extract applied on intact skin for 24 hours daily for 24 months. The drug substance is an unmodified, lyophilized peanut extract produced from the extraction and freeze drying of defatted peanut flour.
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| Notes [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Participants who had previously received either Viaskin Peanut 50 μg, 100 μg, 250 μg or placebo in the VIPES study and randomized in the OLFUS-VIPES study to receive Viaskin Peanut are presented in the separate milestones. [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Participants who had previously received either Viaskin Peanut 50 μg, 100 μg, 250 μg or placebo in the VIPES study and randomized in the OLFUS-VIPES study to receive Viaskin Peanut are presented in the separate milestones. [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Participants who had previously received either Viaskin Peanut 50 μg, 100 μg, 250 μg or placebo in the VIPES study and randomized in the OLFUS-VIPES study to receive Viaskin Peanut are presented in the separate milestones. [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: After protocol amendment 1, participants who were already enrolled were switched to 250 μg at Month 6 visit. |
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Baseline characteristics reporting groups
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Reporting group title |
Viaskin Peanut 250 μg
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Reporting group description |
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for up to 24 months. Each patch contained 250 μg peanut protein extract for epicutaneous administration. For participants who were unresponsive to a cumulative dose of 1440 milligrams (mg) peanut protein or more at Month 24 double-blind placebo-controlled food challenge (DBPCFC), 24 months of treatment was followed by a period of 2 months without treatment while maintaining a peanut-free diet. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Viaskin Peanut 250 μg
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Reporting group description |
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for up to 24 months. Each patch contained 250 μg peanut protein extract for epicutaneous administration. For participants who were unresponsive to a cumulative dose of 1440 milligrams (mg) peanut protein or more at Month 24 double-blind placebo-controlled food challenge (DBPCFC), 24 months of treatment was followed by a period of 2 months without treatment while maintaining a peanut-free diet. | ||
Subject analysis set title |
VIPES Treatment Group: All Viaskin Peanut Doses
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
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.
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Subject analysis set title |
VIPES Treatment Group: Placebo
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
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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End point title |
Percentage of Treatment Responders at Months 12 and 24 [1] | ||||||||||||||||||
End point description |
A treatment responder was defined as a participant with a peanut protein eliciting dose (ED) equal to or greater than 1000 mg peanut protein or with at least a 10-fold increase of ED compared to their initial ED observed at VIPES baseline, as determined by DBPCFCs at Months 12 and 24. At Month 12, participants had received 24 months of active treatment for those who received Viaskin Peanut in VIPES study and 12 months of active treatment for those who received placebo in VIPES study. At Month 24, participants had received 36 months of active treatment for those who received Viaskin Peanut in VIPES study and 24 months of active treatment for those who received placebo in VIPES study. Percentage of responders at Months 12 and 24 are presented according to whether participants received Viaskin Peanut or placebo during VIPES study. The full analysis set was the intent-to-treat population which consisted of all participants. Here, n= number of participants analyzed at specific timepoint.
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End point type |
Primary
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End point timeframe |
Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive statistical analysis was performed for the primary endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Percentage of Participants Unresponsive to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 24 | ||||||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Month 24 (end of treatment) of the OLFUS-VIPES study
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants With a Sustained Unresponsiveness to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 26 | ||||||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Month 26 (2 months post-treatment) of the OLFUS-VIPES study
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Median Cumulative Reactive Dose of Peanut Protein at Months 12 and 24 | ||||||||||||||||||
End point description |
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. Here, n= number of participants analyzed at specific timepoint.
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End point type |
Secondary
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End point timeframe |
Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Mean Cumulative Reactive Dose of Peanut Protein at Months 12 and 24 | ||||||||||||||||||
End point description |
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. Here, n= number of participants analyzed at specific timepoint.
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End point type |
Secondary
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End point timeframe |
Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24 | ||||||||||||||||||||||||
End point description |
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. Here, n= number of participants analyzed at specific timepoint.
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End point type |
Secondary
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End point timeframe |
VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES study
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24 | ||||||||||||||||||||||||
End point description |
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. Here, n= number of participants analyzed at specific timepoint.
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End point type |
Secondary
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End point timeframe |
VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES study
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24 | ||||||||||||||||||||||||
End point description |
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. Here, n= number of participants analyzed at specific timepoint.
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End point type |
Secondary
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End point timeframe |
VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) in the OLFUS-VIPES study
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
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Adverse event reporting additional description |
The safety analysis set included all participants who received at least 1 dose of investigational product during the OLFUS-VIPES study. All participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut or placebo and then received at least 1 dose of 250 μg Viaskin Peanut in the OLFUS-VIPES study.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.0
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Reporting groups
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Reporting group title |
Viaskin Peanut 250 μg
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Reporting group description |
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for up to 24 months. Each patch contained 250 μg peanut protein extract for epicutaneous administration. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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04 Dec 2013 |
Protocol was amended to treat all participants in the OLFUS-VIPES study at the highest safe dose administered during the VIPES study (i.e., 250 μg Viaskin Peanut), which may maximize their chances of clinical response. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
