Trial Outcomes & Findings for Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy (NCT NCT02636699)

Last Updated: 2025-06-18

Results Overview

The Double-Blind Placebo-Controlled Food Challenges (DBPCFCs) to determine Eliciting Dose (ED) were performed at screening and Month 12, with each challenge occurring over 2 days. The participant was gradually fed increasing amounts of standardized blinded oral formulas containing either peanut protein (during 1 of the 2 days of the challenge), or without any peanut protein (during the other day of the challenge). A participant was defined as a treatment responder if: * ED was ≥300 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 1), or * ED was ≥1,000 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 2). Participants with missing treatment response at Month 12 were imputed as non-responders. The percentage of treatment responders at Month 12 is presented. Analysis of the difference in response rates between treatment groups is presented in the subsequent statistical analysis table. Analysis was performed in the overall population.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

500 participants

Primary outcome timeframe

At Month 12

Results posted on

2025-06-18

Participant Flow

This Phase III study was conducted in participants aged 4 to 11 years old with peanut allergy at 31 active centers in Australia, Canada, Germany, Ireland and USA. Participants were randomized in a 2:1 ratio to receive DBV712 250 micrograms (μg) (Viaskin® Peanut 250 μg) or placebo.

A total of 500 participants signed an informed consent form and were enrolled in the study: 144 were screened failed and 356 were eligible and randomized in a 2:1 ratio to receive DBV712 250µg (n=238) or placebo (n=118). Maximum study duration for each participant was approximately 61 weeks (6-week screening period, 53-week treatment period and 2-week follow-up period).

Participant milestones

Participant milestones
Measure	DBV712 250 μg Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).	Placebo Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).	Screened Total number of participant who signed an Informed Consent and were screened in the study to determine eligibility.
Screening Period STARTED	0	0	500
Screening Period COMPLETED	0	0	356
Screening Period NOT COMPLETED	0	0	144
Treatment and Follow-up Periods STARTED	238	118	0
Treatment and Follow-up Periods COMPLETED	213	107	0
Treatment and Follow-up Periods NOT COMPLETED	25	11	0

Reasons for withdrawal

Reasons for withdrawal
Measure	DBV712 250 μg Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).	Placebo Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).	Screened Total number of participant who signed an Informed Consent and were screened in the study to determine eligibility.
Screening Period Inclusion/Exclusion Failure	0	0	117
Screening Period Withdrawal by Subject	0	0	23
Screening Period Adverse Event	0	0	1
Screening Period Other not specified	0	0	3
Treatment and Follow-up Periods Adverse Event	4	0	0
Treatment and Follow-up Periods Lost to Follow-up	3	3	0
Treatment and Follow-up Periods Non-compliance with the investigational product (IP)	2	0	0
Treatment and Follow-up Periods Physician Decision	0	1	0
Treatment and Follow-up Periods Withdrawal by Subject	13	6	0
Treatment and Follow-up Periods Other	3	1	0

Baseline Characteristics

Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DBV712 250 μg n=238 Participants Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).	Placebo n=118 Participants Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).	Total n=356 Participants Total of all reporting groups
Age, Continuous	7.4 years STANDARD_DEVIATION 2.11 • n=5 Participants	7.3 years STANDARD_DEVIATION 2.30 • n=7 Participants	7.3 years STANDARD_DEVIATION 2.17 • n=5 Participants
Age, Customized 4 to 5 years	55 Participants n=5 Participants	32 Participants n=7 Participants	87 Participants n=5 Participants
Age, Customized 6 to 11 years	183 Participants n=5 Participants	86 Participants n=7 Participants	269 Participants n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	49 Participants n=7 Participants	138 Participants n=5 Participants
Sex: Female, Male Male	149 Participants n=5 Participants	69 Participants n=7 Participants	218 Participants n=5 Participants
Race/Ethnicity, Customized White	194 Participants n=5 Participants	96 Participants n=7 Participants	290 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	19 Participants n=5 Participants	8 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Other	24 Participants n=5 Participants	12 Participants n=7 Participants	36 Participants n=5 Participants
Screening Eliciting Dose (ED) Subgroup Screening ED Subgroup 1	41 Participants n=5 Participants	20 Participants n=7 Participants	61 Participants n=5 Participants
Screening Eliciting Dose (ED) Subgroup Screening ED Subgroup 2	197 Participants n=5 Participants	98 Participants n=7 Participants	295 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 12

Population: The Intent-to-Treat (ITT) population was comprised of all participants who were randomized.

Outcome measures

Outcome measures
Measure	DBV712 250 μg n=238 Participants Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).	Placebo n=118 Participants Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).
Difference in Percentages of Treatment Responders at Month 12; Analyzed in the Overall Population	35.3 percentage of participants Interval 29.5 to 41.6	13.6 percentage of participants Interval 8.5 to 20.9

SECONDARY outcome

Timeframe: At Month 12

Population: The Intent-to-Treat (ITT) population was comprised of all participants who were randomized.

The Double-Blind Placebo-Controlled Food Challenges (DBPCFCs) to determine Eliciting Dose (ED) were performed at screening and Month 12, with each challenge occurring over 2 days. The participant was gradually fed increasing amounts of blinded oral formulas containing either peanut protein (during 1 of the 2 days of the challenge), or without any peanut protein (during the other day of the challenge). A participant was defined as a treatment responder if: * ED was ≥300 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 1), or * ED was ≥1,000 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 2). Participants with missing treatment response at Month 12 were imputed as non-responders. The percentage of treatment responders at Month 12 is presented below. Analysis of the difference in response rates between treatment groups is presented in the subsequent statistical analysis table. Analysis was performed for each separate screening ED subgroup.

Outcome measures

Outcome measures
Measure	DBV712 250 μg n=238 Participants Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).	Placebo n=118 Participants Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).
Difference in Percentages of Treatment Responders at Month 12; Analyzed in Each Screening Eliciting Dose (ED) Subgroup Screening ED subgroup 1	39.0 percentage of participants Interval 25.7 to 54.3	20.0 percentage of participants Interval 8.1 to 41.6
Difference in Percentages of Treatment Responders at Month 12; Analyzed in Each Screening Eliciting Dose (ED) Subgroup Screening ED subgroup 2	34.5 percentage of participants Interval 28.2 to 41.4	12.2 percentage of participants Interval 7.1 to 20.2

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: The Intent-to-Treat (ITT) population was comprised of all participants who were randomized.

The CRD was calculated as the sum of all doses given (including any repeated and partial doses). The median CRD of peanut protein at baseline and Month 12 is presented. Analysis was performed using the modified baseline observation carried forward method to impute missing data at Month 12.

Outcome measures

Outcome measures
Measure	DBV712 250 μg n=238 Participants Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).	Placebo n=118 Participants Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).
Cumulative Reactive Dose (CRD) of Peanut Protein at Baseline and Month 12 Baseline	144.0 mg Interval 44.0 to 444.0	144.0 mg Interval 44.0 to 444.0
Cumulative Reactive Dose (CRD) of Peanut Protein at Baseline and Month 12 Month 12	444.0 mg Interval 144.0 to 1444.0	144.0 mg Interval 44.0 to 444.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Months 3, 6 and 12

Population: The Intent-to-Treat (ITT) population was comprised of all participants who were randomized. Only those with non-missing data were included in the analysis.

Venous blood samples were drawn to assess peanut-specific IgE levels at baseline and Months 3, 6 and 12. The median relative changes from baseline in IgE levels for each timepoint are presented. Relative change from baseline=100×(value at the visit-value at baseline)/value at baseline.

Outcome measures

Outcome measures
Measure	DBV712 250 μg n=232 Participants Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).	Placebo n=115 Participants Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).
Relative Change From Baseline in Peanut-specific Immunoglobulin E (IgE) Over Time Month 3	78.716 Percent of change Interval 26.557 to 174.588	16.964 Percent of change Interval -12.591 to 48.802
Relative Change From Baseline in Peanut-specific Immunoglobulin E (IgE) Over Time Month 6	39.716 Percent of change Interval -3.676 to 109.69	4.605 Percent of change Interval -26.38 to 30.352
Relative Change From Baseline in Peanut-specific Immunoglobulin E (IgE) Over Time Month 12	2.858 Percent of change Interval -24.739 to 61.058	-6.919 Percent of change Interval -31.468 to 25.291

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Months 3, 6 and 12

Population: The Intent-to-Treat (ITT) population was comprised of all participants who were randomized. Only those with non-missing data were included in the analysis.

Venous blood samples were drawn to assess peanut-specific IgG4 levels at baseline and Months 3, 6 and 12. The median relative changes from baseline in IgG4 levels for each timepoint are presented. Relative change from baseline=100×(value at the visit-value at baseline)/value at baseline.

Outcome measures

Outcome measures
Measure	DBV712 250 μg n=231 Participants Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).	Placebo n=115 Participants Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).
Relative Changes From Baseline in Peanut-specific Immunoglobulin G4 Subtype (IgG4) Over Time Month 3	127.778 Percent of change Interval 55.66 to 259.615	14.286 Percent of change Interval 0.0 to 45.833
Relative Changes From Baseline in Peanut-specific Immunoglobulin G4 Subtype (IgG4) Over Time Month 6	258.491 Percent of change Interval 107.843 to 549.351	11.492 Percent of change Interval -9.677 to 42.105
Relative Changes From Baseline in Peanut-specific Immunoglobulin G4 Subtype (IgG4) Over Time Month 12	513.487 Percent of change Interval 196.458 to 1105.235	10.496 Percent of change Interval -10.108 to 33.333

Adverse Events

DBV712 250 μg

Serious events: 10 serious events

Other events: 222 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 96 other events

Deaths: 0 deaths

Screened

Serious events: 9 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DBV712 250 μg n=238 participants at risk Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).	Placebo n=118 participants at risk Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).	Screened n=500 participants at risk Participants enrolled in the study during the screening period prior randomization
Immune system disorders Anaphylactic reaction	2.5% 6/238 • Number of events 7 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	2.5% 3/118 • Number of events 3 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	1.6% 8/500 • Number of events 8 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.
Immune system disorders Food allergy	0.42% 1/238 • Number of events 1 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	0.00% 0/118 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	0.00% 0/500 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.
Infections and infestations Appendicitis	0.42% 1/238 • Number of events 1 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	0.85% 1/118 • Number of events 1 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	0.00% 0/500 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.
Infections and infestations Tonsillitis	0.42% 1/238 • Number of events 1 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	0.00% 0/118 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	0.00% 0/500 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.42% 1/238 • Number of events 1 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	0.00% 0/118 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	0.00% 0/500 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.
Respiratory, thoracic and mediastinal disorders Wheezing	0.42% 1/238 • Number of events 1 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	0.00% 0/118 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	0.00% 0/500 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.
Eye disorders Visual impairment	0.00% 0/238 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	0.85% 1/118 • Number of events 1 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	0.00% 0/500 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.
Gastrointestinal disorders Coeliac disease	0.00% 0/238 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	0.85% 1/118 • Number of events 1 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	0.00% 0/500 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.
Infections and infestations Encephalitis influenzal	0.00% 0/238 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	0.00% 0/118 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.	0.20% 1/500 • Number of events 1 • Screened arm: Adverse Events (AEs) collected from signing the informed consent up to the end of the screening period. DBV712 250µg and placebo arms: Treatment-Emergent Adverse Events (TEAEs) collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks. Adverse Events were collected for the time the informed consent was signed up to the end of the study.

Other adverse events

Additional Information

Chief Medical Officer

DBV Technologies

Phone: 33-1-55-42-78-78

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place