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

• 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: DBV Technologies
• 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

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
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)

Baseline Characteristics

Arm/Group Title		VIPES Initial Treatment Group: All Viaskin Peanut Doses	VIPES Initial Treatment Group: Placebo	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Percentage of Treatment Responders at Months 12 and 24
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

Adverse Events

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
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• 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):

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.

• 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