Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children (OLFUS-VIPES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01955109
Recruitment Status : Completed
First Posted : October 7, 2013
Results First Posted : June 30, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
DBV Technologies

Study Type Interventional
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
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
Hide Arm/Group 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. 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)
Arm/Group Title VIPES Initial Treatment Group: All Viaskin Peanut Doses VIPES Initial Treatment Group: Placebo Total
Hide Arm/Group 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. 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
Hide Baseline Analysis Population Description
The safety analysis set included all participants who received at least 1 dose of investigational product (IP) during the OLFUS-VIPES study.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
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.
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%
23
  47.9%
83
  48.5%
Adolescents (12-17 years)
34
  27.6%
18
  37.5%
52
  30.4%
Adults (18-55 years)
29
  23.6%
7
  14.6%
36
  21.1%
Adolescents and Adults (12-55 years)
63
  51.2%
25
  52.1%
88
  51.5%
[1]
Measure Description: Participants' ages at OLFUS-VIPES entry.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 48 participants 171 participants
Female
43
  35.0%
18
  37.5%
61
  35.7%
Male
80
  65.0%
30
  62.5%
110
  64.3%
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%
28
  58.3%
108
  63.2%
Black
3
   2.4%
2
   4.2%
5
   2.9%
Hispanic
1
   0.8%
2
   4.2%
3
   1.8%
Asian
16
  13.0%
4
   8.3%
20
  11.7%
Other
5
   4.1%
3
   6.3%
8
   4.7%
Not applicable
18
  14.6%
9
  18.8%
27
  15.8%
[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'
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
1.Primary Outcome
Title Percentage of Treatment Responders at Months 12 and 24
Hide Description 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.
Time Frame Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VIPES Initial Treatment Group: All Viaskin Peanut Doses VIPES Initial Treatment Group: Placebo
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 123 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 12 Number Analyzed 103 participants 46 participants
64.1
(54.0 to 73.3)
50.0
(34.9 to 65.1)
Month 24 Number Analyzed 83 participants 41 participants
67.5
(56.3 to 77.4)
58.5
(42.1 to 73.7)
2.Secondary Outcome
Title Percentage of Participants Unresponsive to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 24
Hide 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.
Time Frame Month 24 (end of treatment) of the OLFUS-VIPES study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VIPES Initial Treatment Group: All Viaskin Peanut Doses VIPES Initial Treatment Group: Placebo
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 83 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.3
(21.6 to 42.4)
7.3
(1.5 to 19.9)
3.Secondary Outcome
Title Percentage of Participants With a Sustained Unresponsiveness to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 26
Hide 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.
Time Frame Month 26 (2 months post-treatment) of the OLFUS-VIPES study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VIPES Initial Treatment Group: All Viaskin Peanut Doses VIPES Initial Treatment Group: Placebo
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 22 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
77.3
(54.6 to 92.2)
100
(29.2 to 100.0)
4.Secondary Outcome
Title Median Cumulative Reactive Dose of Peanut Protein at Months 12 and 24
Hide 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.
Time Frame Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VIPES Initial Treatment Group: All Viaskin Peanut Doses VIPES Initial Treatment Group: Placebo
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 123 48
Median (Inter-Quartile Range)
Unit of Measure: mg
Month 12 Number Analyzed 103 participants 46 participants
480.0
(140.0 to 2240.0)
365.0
(140.0 to 1440.0)
Month 24 Number Analyzed 83 participants 41 participants
440.0
(160.0 to 3040.0)
440.0
(140.0 to 1440.0)
5.Secondary Outcome
Title Mean Cumulative Reactive Dose of Peanut Protein at Months 12 and 24
Hide 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.
Time Frame Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VIPES Initial Treatment Group: All Viaskin Peanut Doses VIPES Initial Treatment Group: Placebo
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 123 48
Mean (Standard Deviation)
Unit of Measure: mg
Month 12 Number Analyzed 103 participants 46 participants
1419.6  (1595.92) 895.9  (1329.14)
Month 24 Number Analyzed 83 participants 41 participants
1751.1  (1962.12) 758.4  (1176.38)
6.Secondary Outcome
Title Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24
Hide 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.
Time Frame VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VIPES Initial Treatment Group: All Viaskin Peanut Doses VIPES Initial Treatment Group: Placebo
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 123 48
Median (Full Range)
Unit of Measure: kilo units per liter
VIPES Baseline to Month 6 Number Analyzed 117 participants 48 participants
2.150
(-306.00 to 500.12)
18.900
(-72.37 to 344.79)
VIPES Baseline to Month 12 Number Analyzed 104 participants 46 participants
-0.370
(-189.17 to 1168.12)
4.785
(-447.41 to 233.11)
VIPES Baseline to Month 18 Number Analyzed 95 participants 43 participants
-1.870
(-1091.88 to 433.97)
-0.710
(-389.03 to 716.20)
VIPES Baseline to Month 24 Number Analyzed 85 participants 41 participants
-3.160
(-381.93 to 861.24)
-10.060
(-384.03 to 332.83)
7.Secondary Outcome
Title Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24
Hide 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.
Time Frame VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VIPES Initial Treatment Group: All Viaskin Peanut Doses VIPES Initial Treatment Group: Placebo
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 123 48
Median (Full Range)
Unit of Measure: mg/L
VIPES Baseline to Month 6 Number Analyzed 118 participants 46 participants
1.935
(-6.82 to 28.95)
0.775
(-0.80 to 8.86)
VIPES Baseline to Month 12 Number Analyzed 105 participants 44 participants
2.890
(-7.06 to 34.80)
1.510
(-0.61 to 11.93)
VIPES Baseline to Month 18 Number Analyzed 95 participants 43 participants
2.780
(-5.04 to 21.90)
2.370
(-0.26 to 16.98)
VIPES Baseline to Month 24 Number Analyzed 85 participants 41 participants
2.170
(-5.64 to 27.51)
1.950
(-0.89 to 15.40)
8.Secondary Outcome
Title Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24
Hide 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.
Time Frame VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) in the OLFUS-VIPES study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VIPES Initial Treatment Group: All Viaskin Peanut Doses VIPES Initial Treatment Group: Placebo
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 123 48
Median (Full Range)
Unit of Measure: millimeters
VIPES Baseline to Month 6 Number Analyzed 121 participants 48 participants
-2.30
(-17.0 to 8.5)
-1.50
(-14.0 to 3.5)
VIPES Baseline to Month 12 Number Analyzed 106 participants 47 participants
-3.00
(-15.0 to 7.3)
-1.00
(-14.5 to 22.5)
VIPES Baseline to Month 18 Number Analyzed 97 participants 45 participants
-3.00
(-27.6 to 8.0)
-1.40
(-14.5 to 10.5)
VIPES Baseline to Month 24 Number Analyzed 85 participants 43 participants
-2.00
(-15.0 to 13.0)
-1.50
(-15.0 to 6.5)
Time Frame Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
Adverse Event Reporting Description The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
 
Arm/Group Title VIPES Initial Treatment Group: All Viaskin Peanut Doses VIPES Initial Treatment Group: Placebo
Hide Arm/Group 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. 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.
All-Cause Mortality
VIPES Initial Treatment Group: All Viaskin Peanut Doses VIPES Initial Treatment Group: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/123 (0.00%)      0/48 (0.00%)    
Hide Serious Adverse Events
VIPES Initial Treatment Group: All Viaskin Peanut Doses VIPES Initial Treatment Group: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/123 (5.69%)      3/48 (6.25%)    
Gastrointestinal disorders     
Crohn's disease  1  1/123 (0.81%)  1 0/48 (0.00%)  0
Immune system disorders     
Anaphylactic reaction  1  2/123 (1.63%)  2 0/48 (0.00%)  0
Food allergy  1  0/123 (0.00%)  0 1/48 (2.08%)  1
Infections and infestations     
Appendicitis  1  0/123 (0.00%)  0 1/48 (2.08%)  1
Pneumonia  1  1/123 (0.81%)  1 0/48 (0.00%)  0
Viral pericarditis  1  1/123 (0.81%)  1 0/48 (0.00%)  0
Injury, poisoning and procedural complications     
Clavicle fracture  1  0/123 (0.00%)  0 1/48 (2.08%)  1
Joint dislocation  1  0/123 (0.00%)  0 1/48 (2.08%)  1
Radius fracture  1  1/123 (0.81%)  1 0/48 (0.00%)  0
Ulna fracture  1  1/123 (0.81%)  1 0/48 (0.00%)  0
Psychiatric disorders     
Anxiety  1  1/123 (0.81%)  1 0/48 (0.00%)  0
1
Term from vocabulary, MedDRA v15.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
VIPES Initial Treatment Group: All Viaskin Peanut Doses VIPES Initial Treatment Group: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   113/123 (91.87%)      47/48 (97.92%)    
Eye disorders     
Conjunctivitis  1  5/123 (4.07%)  5 4/48 (8.33%)  5
Gastrointestinal disorders     
Abdominal pain  1  9/123 (7.32%)  10 7/48 (14.58%)  14
Abdominal pain upper  1  10/123 (8.13%)  13 4/48 (8.33%)  11
Diarrhoea  1  8/123 (6.50%)  11 2/48 (4.17%)  2
Nausea  1  7/123 (5.69%)  8 6/48 (12.50%)  9
Vomiting  1  12/123 (9.76%)  14 8/48 (16.67%)  8
General disorders     
Application site dermatitis  1  9/123 (7.32%)  12 4/48 (8.33%)  5
Application site eczema  1  14/123 (11.38%)  18 7/48 (14.58%)  9
Application site erythema  1  69/123 (56.10%)  238 28/48 (58.33%)  96
Application site irritation  1  5/123 (4.07%)  6 3/48 (6.25%)  8
Application site oedema  1  7/123 (5.69%)  13 3/48 (6.25%)  5
Application site papules  1  9/123 (7.32%)  10 7/48 (14.58%)  7
Application site pruritus  1  57/123 (46.34%)  194 33/48 (68.75%)  117
Application site rash  1  10/123 (8.13%)  16 8/48 (16.67%)  16
Application site swelling  1  28/123 (22.76%)  111 20/48 (41.67%)  67
Application site urticaria  1  9/123 (7.32%)  27 1/48 (2.08%)  5
Pyrexia  1  18/123 (14.63%)  32 6/48 (12.50%)  7
Immune system disorders     
Allergy to animal  1  7/123 (5.69%)  12 1/48 (2.08%)  1
Food allergy  1  14/123 (11.38%)  37 4/48 (8.33%)  4
Hypersensitivity  1  6/123 (4.88%)  7 4/48 (8.33%)  7
Seasonal allergy  1  6/123 (4.88%)  9 7/48 (14.58%)  15
Infections and infestations     
Ear infection  1  3/123 (2.44%)  5 5/48 (10.42%)  7
Influenza  1  8/123 (6.50%)  8 4/48 (8.33%)  4
Nasopharyngitis  1  25/123 (20.33%)  41 14/48 (29.17%)  30
Pharyngitis streptococcal  1  6/123 (4.88%)  6 3/48 (6.25%)  4
Rhinitis  1  8/123 (6.50%)  17 2/48 (4.17%)  2
Sinusitis  1  6/123 (4.88%)  6 3/48 (6.25%)  4
Upper respiratory tract infection  1  17/123 (13.82%)  37 11/48 (22.92%)  26
Viral infection  1  5/123 (4.07%)  9 3/48 (6.25%)  4
Viral upper respiratory tract infection  1  3/123 (2.44%)  6 4/48 (8.33%)  5
Injury, poisoning and procedural complications     
Ligament sprain  1  2/123 (1.63%)  2 3/48 (6.25%)  5
Procedural pain  1  2/123 (1.63%)  2 3/48 (6.25%)  3
Musculoskeletal and connective tissue disorders     
Back pain  1  8/123 (6.50%)  10 2/48 (4.17%)  2
Nervous system disorders     
Headache  1  25/123 (20.33%)  80 12/48 (25.00%)  44
Respiratory, thoracic and mediastinal disorders     
Asthma  1  9/123 (7.32%)  17 6/48 (12.50%)  10
Cough  1  21/123 (17.07%)  28 14/48 (29.17%)  29
Dyspnoea  1  7/123 (5.69%)  7 1/48 (2.08%)  2
Nasal congestion  1  13/123 (10.57%)  26 8/48 (16.67%)  15
Oropharyngeal pain  1  13/123 (10.57%)  19 10/48 (20.83%)  11
Rhinitis allergic  1  17/123 (13.82%)  22 9/48 (18.75%)  12
Rhinorrhoea  1  9/123 (7.32%)  17 1/48 (2.08%)  1
Throat irritation  1  8/123 (6.50%)  11 4/48 (8.33%)  5
Wheezing  1  6/123 (4.88%)  9 6/48 (12.50%)  25
Skin and subcutaneous tissue disorders     
Acne  1  6/123 (4.88%)  7 4/48 (8.33%)  7
Dermatitis atopic  1  1/123 (0.81%)  1 3/48 (6.25%)  6
Rash  1  5/123 (4.07%)  6 4/48 (8.33%)  5
Urticaria  1  17/123 (13.82%)  20 6/48 (12.50%)  9
1
Term from vocabulary, MedDRA v15.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: DBV Technologies
Phone: 33-1-55-42-78-78
EMail: clinicaltrials@dbv-technologies.com
Layout table for additonal information
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