A Double-blind, Placebo-controlled, Randomized Phase 3 Pivotal Trial to Assess the Efficacy and Safety of Peanut Epicutaneous Immunotherapy With Viaskin Peanut in Peanut-allergic Children
Phase: PHASE3
Conditions: Peanut Allergy
Sponsor: DBV Technologies

A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED PHASE III 
PIVOTAL TRIAL TO ASSESS THE EFFICACY AND SAFETY OF PEANUT 
EPICUTANEOUS IMMUNOTHERAPY WITH VIASKIN® PEANUT IN 
PEANUT-ALLERGIC CHILDREN (PEPITES STUDY)
Sponsor:
DBV TECHNOLOGIES S.A.
Green Square – Bâtiment D
80/84, rue des Meuniers 
92220 Bagneux, France 
Tel: 
Fax:
Clinical Research Organization:
PAREXEL International (IRL) Limited 
(“PAREXEL”)
70 Sir John Rogerson’s Quay 
Dublin 2 
Ireland
Sponsor Protocol No.: 
PEPITES
IND No.:
14366
EudraCT No.: 
2015-002461-37 
Study Drug Name:
Viaskin® Peanut (DBV712) 
Development Phase:
III (Pivotal)
Versions and Dates of Protocol: 
Protocol Version 1.0, 20 Jul 2015 
Protocol Version 2.0, 09 Dec 2015 (including 
Protocol Amendment 1)   
The study will be conducted according to the protocol and in compliance with Good 
Clinical Practice (GCP), with the Declaration of Helsinki and with other applicable 
regulatory requirements. 
This document contains confidential information of DBV Technologies. 
Do not copy or distribute without written permission from the Sponsor.
CONFIDENTIAL
PPD

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
3 of 142
09 Dec 2015
Declaration of the Investigator 
Title: A Double-blind, Placebo-controlled, Randomized Phase III Pivotal Trial to 
Assess the Efficacy and Safety of Peanut Epicutaneous Immunotherapy with 
Viaskin® Peanut in Peanut-allergic Children (PEPITES Study)
I have read and understood and agree to abide by all the conditions and instructions 
contained in this protocol. 
All documentation for this study that is supplied to me and that has not been previously 
published will be kept in the strictest confidence. This documentation includes this study 
protocol, Investigator's Brochure (IB), electronic case report form (CRF), and other 
scientific data.
The study will not be commenced without the prior written approval of a properly 
constituted Institutional Review Board (IRB) or Independent Ethics Committee (IEC). No 
changes will be made to the study protocol without the prior written approval of the 
Sponsor and the IRB or IEC, except where necessary to eliminate an immediate hazard 
to the subjects.
Responsible Investigator of the local study center
_____________________________________ 
_____________________ 
Signature 
Date
_____________________________________
Name (block letters)
_____________________________________
Title (block letters)
_____________________________________
Institution (block letters)
_____________________________________
Phone number 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
4 of 142
09 Dec 2015
PROTOCOL SYNOPSIS
Title
A Double-blind, Placebo-controlled, Randomized Phase III Pivotal Trial to 
Assess the Efficacy and Safety of Peanut Epicutaneous Immunotherapy with 
Viaskin® Peanut in Peanut-allergic Children (PEPITES Study)
Sponsor Study No.
PEPITES
Phase
III (Pivotal)
Sponsor
DBV Technologies
Study Centers
This is a multicenter study to be conducted in Australia, Europe and North
America. It is planned that approximately 28 to 40 sites from 4 to 7 countries 
will participate.
Objective
To assess the efficacy and safety of Viaskin® Peanut to induce desensitization 
to peanut in peanut-allergic subjects 4 through 11 years of age after a 
12-month treatment period by EPicutaneous ImmunoTherapy (EPIT).
Design
This is a 12-month, Phase III, double-blind, placebo-controlled, randomized 
study to assess the efficacy and safety of Viaskin® Peanut, dosed at 250 μg 
peanut protein (per patch) in peanut-allergic children from 4 through 11 years 
of age.
The overall maximum study duration for each subject is approximately 
61 weeks (6-week screening period, 12-month treatment period and 2-week 
follow-up period).  
During the maximum 6-week screening period, subjects will undergo a first 
screening visit and an entry double-blind, placebo-controlled food challenge 
(DBPCFC) to peanut to confirm their allergy and their entry peanut eliciting 
dose (ED). The starting dose of the challenge will be 1 mg peanut protein and 
will escalate up to a highest dose of 300 mg peanut protein. Subjects who 
react at or below the dose of 300 mg peanut protein are considered eligible. 
Randomization of eligible subjects will occur in a 2:1 ratio to Viaskin®
Peanut dosed at 250 μg peanut protein (active treatment) or placebo. Subjects 
will be stratified at randomization by their entry/screening DBPCFC ED in 
1 of the following 2 strata and by study center:  
x
Stratum 1: children with a screening ED of 1 mg, 3 mg or 10 mg; 
x
Stratum 2: children with a screening ED of 30 mg, 100 mg or 
300 mg.
The randomization scheme will ensure that the ratio of active treatment to 
placebo is maintained in each stratum. 
Subjects randomized in the study and consenting for the genetic analysis on a 
voluntary basis will be assessed for mutations in the filaggrin gene. Subjects’ 
participation for this genetic analysis will be optional.
Subjects will apply a Viaskin® patch containing either peanut protein or 
placebo daily for a period of 12 months. At Month 12, a post-treatment 
DBPCFC to peanut will be performed, with a starting dose of 1 mg peanut 
protein with escalation up to a highest dose of 2,000 mg peanut protein. This 
evaluation will help determine the primary efficacy endpoint of this pivotal 
study.
Subjects will undergo other efficacy parameter assessments at Months 3, 
6 and 12, 
including 
immunological 
changes 
in 
peanut-specific 
immunoglobulin E (IgE) and immunoglobulin G4 subtype (IgG4) and skin 
prick tests (SPTs). 
Key assessments of global safety will be performed at each study visit by the 
Investigators, including skin observation of the patch areas of application 
(inter-scapular area of the back), spirometry, peak expiratory flow (PEF) 
measurements, vital signs, physical examinations and clinical laboratory 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
5 of 142
09 Dec 2015
assessments. Atopic dermatitis will also be assessed at baseline and at 
Months 3, 6 and 12 using the SCORAD (Scoring atopic dermatitis), for 
which specific training will be provided for better use and accurate 
assessment.
In between visits, the severity of local skin reactions will be assessed on a 
daily basis by the subjects (parents/guardians) in their diary for 6 months. 
Any other adverse events (AEs), local skin reactions occurring after the first 
6 months of treatment and any concomitant medications will also be reported 
in the diary by the subjects and this will be reviewed by the site medical staff 
at each patient visit.
In addition, the adhesion of the patch to the skin, especially the maintenance 
of the occlusion of the patch, will be assessed by the subjects’ 
parents/guardians for 28 days of treatment (whenever possible, these should 
be consecutive days). This assessment will be conducted during a period 
between Month 3 and Month 9. On the same days, photographs of the patches 
attached to the skin will be made by the subjects’ parents/guardians as 
instructed. The review of these photos will allow the Investigators to control 
and ensure that the parents’ assessments of the patch adhesion were 
satisfactory. The trained site staff will also assess the patch adhesion of all 
subjects at each subject visit.
After completion of the PEPITES study, all subjects, including the placebo 
subjects, will be offered the opportunity to participate in an open-label 
extension study to receive Viaskin® Peanut 250 μg for 24 additional months 
of treatment. Subjects who will decide to roll-over into the extension study 
will have their last PEPITES study visit at Visit 11 and they will start the 
extension study at that visit. Subjects who decide not to roll-over into the 
extension study will continue their visit schedule up to Visit 12.
Treatment
The study drug, Viaskin® Peanut, is an epicutaneous delivery system 
(Viaskin® patch) containing a dry deposit of a formulation of peanut protein 
extract. The drug substance is an unmodified, lyophilized peanut extract 
produced from the extraction and freeze drying of defatted peanut flour of 
biological origin, the peanut seed from the Virginia variety of Arachis 
hypogaea. 
The Viaskin® patch must be applied on the skin for 24 hours (± 4 hours of 
allowance) every day, which means a new patch will be applied every 
24 hours on the inter-scapular area of the back of the subjects. To increase the 
safety of the Viaskin® patch at the initiation of treatment, the duration of 
application of the Viaskin® patch will be progressively increased as follows: 
x
During the first week (from Day 1 through Day 7), the patches will 
be applied for 6 hours every day;
x
During the second week (from Day 8 through Day 14), the patches 
will be applied for 12 hours every day; 
x
From the third week onwards (Day 15), the patches will be applied 
for the entire 24 hours daily. 
Number of Patients
It is planned to screen approximately 470 subjects to achieve 330 subjects 
randomized in a 2:1 ratio (220 subjects in the Viaskin® Peanut group and 
110 subjects in the placebo group) in this study. Assuming that the drop-out 
rate might be up to 15%, this will allow ensuring that approximately 
280 subjects complete the study.
Throughout the screening and randomization process, and to guarantee an 
adequate and sufficient representation of subjects of 4, 5 and 11 years of age 
(the youngest and the oldest of the age range), a minimum of 25 subjects of 
each of these 3 ages must be randomized. Each of these ages will thus 
represent a minimum of 7.5% of the overall number of randomized subjects.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
6 of 142
09 Dec 2015
Two subgroups based on subjects’ age are also defined: the 4-5 year-old and 
the 6-11 year-old subjects. It is planned that a minimum number of 
75 children of either 4 or 5 years of age must be randomized. The 4 to 5 year-
old subgroup will thus represent a minimum of 22.7% of the overall number 
of randomized subjects. 
Population
Subjects will be enrolled in this study only if they meet, among others, the 
following inclusion criteria: Male or female children aged 4 through 11 years 
at Visit 1;
physician-diagnosed
peanut allergy or
children with a 
well-documented medical history of IgE-mediated reactions after ingestion of 
peanut and currently following a strict peanut-free diet. 
Subjects will not be enrolled, if they, among other exclusion criteria, have a 
history of severe anaphylaxis to peanut with any of the following symptoms: 
hypotension, 
hypoxia, 
neurological 
compromise 
(collapse, 
loss 
of 
consciousness or incontinence); if they have a severe reaction during the 
entry/screening DBPCFC (defined as need for intubation, hypotension 
persisting after epinephrine administration, and/or the need for  doses of 
epinephrine), or if they have an objective IgE-mediated reaction to the 
placebo formula during the entry/screening DBPCFC.
All subjects will continue with their usual peanut-free diet and label reading 
of food products to avoid as much as possible any accidental peanut 
consumption for the duration of the study.
Criteria for Evaluation 
of Efficacy
Primary efficacy endpoint:
The primary efficacy endpoint is the percentage of treatment responders at 
Month 12 in the active Viaskin® Peanut 250 μg group compared to the 
placebo group in the overall population. A subject is defined as a treatment 
responder if:
x
The initial ED was >10 mg peanut protein and the ED LV mg 
peanut protein at the post-treatment DBPCFC at Month 12, or;
x
The initial ED ZDV10 mg and the ED LV mg peanut protein at 
the post-treatment DBPCFC at Month 12.
Secondary efficacy endpoints: 
x
Percentage of treatment responders at Month 12 in the active 
Viaskin® Peanut 250 μg group compared to the placebo group in 
each of the 2 screening ED strata.
x
Percentage of treatment responders at Month 12 in the active 
Viaskin® Peanut 250 μg group compared to the placebo group in 
each of the2 age subgroups: 4 to 5 years-old; 6 to 11 years-old. 
x
Mean and median cumulative reactive dose of peanut protein and 
change from baseline at Month 12 in the active Viaskin® Peanut 
250 μg group versus the placebo group, overall as well as in each of 
the 2 screening ED strata; 
x
Mean and median ED of peanut protein and change from baseline at 
Month 12 in the active Viaskin® Peanut 250 μg group versus the 
placebo group, overall as well as in each of the 2 screening ED 
strata; 
x
Percentage
of subjects responsive (those
showing objective 
symptoms leading to DBPCFC
stop) to a cumulative dose 
1,444 mg peanut protein at the post-treatment DBPCFC at 
Month 12 in the active Viaskin® Peanut 250 μg group versus the 
placebo group, overall as well as in each of the 2 screening ED 
strata; 
x
Percentage of subjects unresponsive (those showing no objective 
symptoms leading to DBPCFC
stop) to a cumulative dose 
,444 mg peanut protein at the post-treatment DBPCFC at 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
7 of 142
09 Dec 2015
Month 12 in the active Viaskin® Peanut 250 μg group versus the 
placebo group, overall as well as in each of the 2 screening ED 
strata; 
x
Percentage of subjects unresponsive (those showing no objective 
symptoms leading to DBPCFC stop) to the highest dose of peanut 
protein, which is
the percentage of subjects who pass the 
post-treatment DBPCFC at Month 12 in the active Viaskin® Peanut
250 μg group versus the placebo group, overall as well as in each of 
the 2 screening ED strata.  
Other efficacy endpoints:
x
Change from baseline in peanut-specific IgE and IgG4 at months 3, 
6 and 12 in the active Viaskin® Peanut 250 μg group versus the 
placebo group, overall as well as in each of the 2 screening ED 
strata; 
x
Change from baseline in peanut skin prick testing maximum average 
wheal diameters at months 3, 6 and 12 in the active Viaskin® Peanut 
250 μg group versus the placebo group, in the overall population; 
x
Description of the quality of life questionnaires (Food Allergy 
Quality of Life Questionnaire [FAQLQ]/Food Allergy Independent 
Measure [FAIM]) and change from baseline in FAQLQ score at 
Month 12 in the overall population (for those countries where the 
translated and validated questionnaires are available and used).
Criteria for Evaluation 
of Study Drug Safety
The following safety criteria will be evaluated:
x
AEs and treatment-emergent adverse events (TEAEs) by System 
Organ Class (SOC) and Preferred Terms (PTs); 
x
TEAEs by maximum severity and relatedness to Viaskin® Peanut
250 μg; 
x
Incidence, duration and maximum severity of local cutaneous 
Viaskin® Peanut 250 μg-induced AEs as assessed by the subject;
x
Severity of local cutaneous Viaskin® Peanut 250 μg-induced AEs as 
assessed by the Investigator;
x
Adverse events of special interest (AESI) including grade 4 local 
cutaneous reactions and systemic allergic AEs considered related to 
Viaskin® Peanut 250 μg; 
x
Serious adverse events (SAEs) by SOC and PTs, and relatedness to 
Viaskin® Peanut 250 μg; 
x
Laboratory data, physical examinations and vital signs;
x
Spirometry results or PEF results. 
The above criteria will be studied in the overall Safety population, as well as 
for the age ranges 4 to 5 years, 6 to 8 years and 9 to 11 years, and for each of 
the screening ED strata.  
Criteria for Evaluation 
of Study Procedure 
Safety
x
Objective symptoms elicited during the entry/screening DBPCFC 
and post-treatment DBPCFC at Month 12 by severity;
x
Change in severity of objective symptoms elicited during the 
DBPCFC from baseline to Month 12 in the active Viaskin® Peanut 
250 μg group versus the placebo group;
x
SAEs 
elicited 
during 
the 
entry/screening 
DBPCFC 
and 
post-treatment DBPCFC at Month 12.
A Data and Safety Monitoring Board (DSMB) composed of experts in food 
allergy and in the methodology of clinical studies will review study safety 
data at specific intervals during the study and on an ad hoc basis. A specific 
DSMB meeting will be held when the first 15 subjects 4 to 5 years of age 
have been randomized and treated for at least 4 weeks (that is, have 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
8 of 142
09 Dec 2015
completed the Month 1 visit). This is to assess very early in the study that the 
safety of Viaskin® Peanut is acceptable in the youngest subjects. 
Exploratory endpoints
x
Change from baseline in IgE and IgG4 specific to peanut protein 
components at months 3, 6 and 12 in the active Viaskin®
Peanut 250 μg group versus the placebo group; 
x
Enumeration and characterization of reactions triggered by 
accidental consumption of peanut during the study; 
x
Analysis of “risk-taking behavior” of subjects (voluntary peanut 
consumption) during the study;
x
Epigenetic modifications of the promoters of some specific genes;  
x
Safety sub-analysis in subjects with mutations in the filaggrin gene 
versus wild type subjects;
x
Sensitization status to some other allergies and their evolution over 
the study period;
x
SCORAD evolution over time.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
9 of 142
09 Dec 2015
Statistical Methods
Analysis sets:
Safety population:
The Safety population will be comprised of all subjects who are randomized 
and have received at least 1 dose of the study drug. This population will be 
used to assess comparative safety information. In case the wrong study drug 
is dispensed, the subject will be analyzed according to the study drug
received for the longest period of time.
Intent-to-treat (ITT) population:
The ITT population will be comprised of all subjects who are randomized. 
This population will be used to assess comparative efficacy information.
Full analysis set (FAS):
The FAS will be comprised of all subjects who are randomized and have 
performed at least the peanut challenge of the second DBPCFC at Month 12.
Per-protocol (PP) population:
The PP population will include all subjects from the ITT population who do 
not have major deviations from the protocol that may affect the primary 
efficacy endpoint (for instance, subjects who have not gone through the 
second DBPCFCs at Month 12, subjects with a global treatment compliance 
below 80% etc.). The PP population will be used to perform confirmatory 
analyses of the primary and secondary efficacy evaluations. 
Statistical methods:
Categorical variables will be summarized using the number of observations 
and percentages. The denominator for percentages will be the number of 
subjects in the population with data available unless otherwise stated. 
Continuous variables will be summarized using descriptive statistics (number 
of observations [n], mean, standard deviation, minimum, first quartile [Q1],
median, third quartile [Q3], and maximum).
Primary efficacy analysis:
The primary efficacy endpoint is the percentage of treatment responders at 
Month 12 in the active Viaskin® Peanut 250 μg group compared to the 
placebo group. 
The null hypothesis is that the percentage of treatment responders in the 
active Viaskin® Peanut 250 μg group is the same as that in the placebo group
(which means the parameter estimate associated to the treatment group is 
equal to zero).
The primary efficacy analysis will be performed on the ITT population (that 
is on all randomized subjects), using last observation carried forward (LOCF) 
imputation (which means that subjects with missing DBPCFC value at 
Month 12 will be considered as non-responders). An exact logistic regression 
will be used to compare the percentage of treatment responders at Month 12 
in the active Viaskin® Peanut 250 μg group versus the placebo group,
adjusting for screening ED stratum and including the treatment group as fixed
effect. A 2-sided, 1% significance level will be used to test the null 
hypothesis. The corresponding p-value, as well as the number and percentage 
(95% confidence interval [CI]) of responders, will be presented by treatment 
group. The difference between active treatment and placebo response rates 
and the corresponding 95% CI will be presented. Clinical relevance of 
treatment effect will be evaluated based on the lower bound of the 95% CI 
being higher or equal to 15%. This 15% difference is intended to exhibit a
clear robustness of the treatment effect.
Relative risks of achieving response in the active group compared to the 
placebo group will be assessed using a log-binomial regression with the 
screening ED stratum and treatment group as covariates and will be presented 
together with associated the 95% CI. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
10 of 142
09 Dec 2015
The study will be considered positive, if the p-value from the exact logistic 
regression is significant (p<0.01) and the lower bound of the 95% CI of the 
difference between active treatment and placebo response rates is higher or 
equal to 15%.
Sensitivity analyses of primary efficacy endpoint:
The primary efficacy endpoint analysis will be repeated on the FAS and PP 
population. 
Besides, 
a 
sensitivity 
analysis 
with 
the 
region 
(Australia/Europe/North America) and the interaction between regions and 
treatment group as covariate will be performed. In addition, sensitivity 
analyses of the primary efficacy endpoint will be conducted on the overall 
ITT population using multiple imputation and worst-case imputation instead 
of LOCF imputation to assess the robustness of the primary efficacy analyses 
with regard to handling of missing data.
Secondary efficacy analysis:
Comparison of the percentage of treatment responders in each screening ED 
stratum: 
Within each screening ED stratum, the treatment group comparison is 
conducted on the ITT population at a 2-sided 5% significance level using 
LOCF imputation and the exact logistic model described in the above section. 
The corresponding p-value, as well as the number and percentage of 
responders (95% CI), will be presented by treatment group. The difference 
between active treatment and placebo response rates and the corresponding
95% CI will be presented. The clinical relevance of the treatment effect in 
each stratum will be evaluated based on the lower bound of the 95% CI 
strictly higher than 0%. The relative risk of achieving a response in the active 
treatment group compared to the placebo group within each stratum will be 
assessed using the log-binomial model described above and will be presented 
together with the associated 95% CI.
This analysis will be repeated on the FAS and PP population. Besides, a 
sensitivity analysis with the region (Australia/Europe/North America) and the 
interaction between region and treatment group as covariate will be 
performed. 
Comparison of the percentage of treatment responders in each of the 2 age 
subgroups: 
Within each age subgroup (4 to 5 years-old; 6 to 11 years-old), the treatment 
group comparison is conducted on the ITT population at a 2-sided 5% 
significance level using LOCF imputation and the exact logistic model 
described above. The corresponding p-value, as well as the number and 
percentage of responders (95% CI), will be presented by treatment group. The 
difference between active treatment and placebo response rates and the 
corresponding 95% CI will be presented. The relative risk of achieving a 
response in the active treatment group compared to the placebo group within 
each subgroup will be assessed using the log-binomial model described above 
and will be presented together with the associated 95% CI.
This analysis will be repeated on the FAS and PP population.
Cumulative reactive dose and Eliciting dose at Month 12: 
The peanut protein cumulative reactive dose at Month 12 and the peanut 
protein ED at Month 12 will be summarized descriptively by treatment group 
(for the whole population and for each screening ED stratum), for the ITT 
population using LOCF imputation, as well as for the FAS and PP 
population.
In addition, the peanut protein cumulative reactive dose and the ED in each 
treatment group at Month 12 will be compared using an analysis of 
covariance (ANCOVA) model. The ANCOVA model will include the 
treatment group, baseline value, screening ED stratum and region 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
11 of 142
09 Dec 2015
(Australia/Europe/North America) as covariates. Results will be log-
transformed if needed. The peanut protein cumulative reactive dose and the 
ED will be evaluated for the ITT population using LOCF imputation, as well 
as for the FAS and PP population, overall and for each screening ED stratum, 
at a 2-sided 5% significance level.
Subjects responsive/unUHVSRQVLYH WR D FXPXODWLYH GRVH 1,444 mg peanut 
protein and subjects passing the DBPCFC at Month 12: 
7KHSHUFHQWDJHRIVXEMHFWVUHVSRQVLYHWRDFXPXODWLYHGRVH444 mg peanut 
protein at Month 12, the percentage of subjects unresponsive to a cumulative 
GRVH444 mg peanut protein at Month 12, and the percentage of subjects 
passing the DBPCFC at Month 12 will be summarized descriptively by 
treatment group for the whole population and for each screening ED stratum, 
for the ITT population using LOCF imputation, as well as for the FAS and PP 
population.
In addition, the percentage of subjects responsive to a cumulative dose 
444 mg peanut protein at Month 12, the percentage of subjects 
unresponsLYHWRDFXPXODWLYHGRVH444 mg peanut protein at Month 12 and 
the percentage of subjects passing the DBPCFC in each treatment group at 
Month 12 will be compared using an exact logistic regression (adjusting for 
screening ED stratum and including the treatment group as fixed effect) for 
the overall ITT population using LOCF imputation, as well as for the FAS
and PP population, at a 2-sided 5% significance level.  
Other efficacy analyses:
Immunological markers: 
The change in peanut-specific IgE and IgG4 from baseline to Months 3, 6 and 
12 will be tabulated by treatment group, in the overall ITT population and for 
each screening ED stratum, using observed data. In addition, the peanut-
specific IgE and IgG4 values in each treatment group at Month 12 will be 
compared, in the overall ITT population and for each screening ED stratum, 
using an ANCOVA model. The ANCOVA model will include the treatment 
group, 
baseline 
value, 
screening 
ED 
stratum 
and 
region 
(Australia/Europe/North America) as covariates. 
Skin prick test: 
The change in skin prick test results from baseline to Months 3, 6 and 12 will 
be tabulated by treatment group in the overall ITT using observed data. In 
addition, the skin prick test results in each treatment group at Month 12 will 
be compared, in the overall ITT population, using an ANCOVA model (same 
model as described above). 
Quality of life: 
The change in the Quality of Life score between baseline and Month 12 will 
be summarized in the overall ITT population using observed data. 
Multiplicity issues: 
In order to handle the multiple comparisons versus placebo, the overall type-I
error will be controlled by the use of a hierarchical inferential approach, 
which means a pre-defined hierarchical order will be followed for the primary 
and secondary efficacy endpoints. No further adjustments will be made for 
the other efficacy endpoints for which p-values will be provided for 
descriptive purpose only.
Sample size calculations:
The sample size is calculated based on the following assumptions:
x
A 40% response rate for the active Viaskin® Peanut 250 μg group 
and 10% response rate for the placebo group in the overall 
population, with a 2-sided type-,HUURUUDWHĮVHWWR1%; 
x
A lower bound of the 95% CI of the difference between active 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
12 of 142
09 Dec 2015
treatment and placebo response UDWHV5% in the overall population
and >0% in each stratum; 
x
A 60% response rate for the active Viaskin® Peanut 250 μg group 
and 10% response rate for the placebo group in Stratum 1, with a 
2-sided type-,HUURUUDWHĮVHWWR; 
x
A 30% response rate for the active Viaskin® Peanut 250 μg group 
and 10% response rate for the placebo group in Stratum 2, with a 
2-sided type-,HUURUUDWHĮVHWWRDQGDSRZHU-ȕVHWWR5%;
x
The following expected distribution of the screening ED strata: 
-
1/3 of children having a screening ED from 1 mg to 10 mg;
-
2/3 of children having a screening ED from 30 mg to 300 mg.
x
A ratio 2:1 to maximize the number of subjects treated in the active 
Viaskin® Peanut 250 μg group. 
Therefore, the sample size calculated for Stratum 2 is 185 subjects 
(approximately 123 subjects in the active Viaskin® Peanut 250 μg group and 
62 subjects in the placebo group). Hence, if 185 children with a screening ED 
from 30 mg to 300 mg are required in the study, then, according to the 
expected distribution of the screening ED strata, approximately 95 children 
having a screening ED from 1 mg to 10 mg should be randomized, resulting 
in a total of 280 subjects evaluable for the primary efficacy endpoint in the 
analysis. 
This number of subjects leads to a power of 99% in the overall population
and in the Stratum 1. 
This is summarized in the following Table:
Summary of Sample Size Calculations
Population
alpha
Power
Sample size (N=N1+N2)
Expected Response Rate
Lower 
bound of 
the 95% 
CI of the 
difference
Viaskin®
Peanut 
250 μg
Placebo
Total
Screening 
ED 
Stratum 1
5%
99%
N1=63
60%
N2=32
10%
N=95
>0%
Screening 
ED 
Stratum 2
5%
85% 
N1=123
30%
N2=62
10%
N=185
>0%
Overall 
population
1%
99%
N1=186
40%
N2=94
10%
N=280
5% 
Abbreviations: CI = Confidence interval; ED = Eliciting dose; N = Number of 
subjects.
To allow for a potential premature withdrawal rate of about 15%, the study 
will randomize a total of 330 subjects: 220 subjects will be randomized to 
receive Viaskin® Peanut 250 μg and 110 subjects to placebo. Among the 
330 subjects randomized, a minimum of 25 subjects will be randomized for 
each of the following ages: 4 years, 5 years and 11 years, respectively.
Besides, a minimum number of 75 children of either 4 or 5 years of age must 
be randomized. 
The distribution per ED stratum should lead to approximately 110 subjects 
with a screening ED from 1 mg to 10 mg and approximately 220 subjects 
with a screening ED from 30 mg to 300 mg, provided that the same 
distribution as obtained in the Phase IIb VIPES study is reproduced. If this 
expected distribution is not fully respected during the recruitment in the 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
13 of 142
09 Dec 2015
PEPITES study, a minimum of 50 subjects would need to be included in 
Stratum LQRUGHUWRJXDUDQWHHDSRZHURILn this stratum and at least 
220 subjects would need to be included in Stratum 2 in order to guarantee a 
SRZHURI85% in this stratum.
From experience, the screen failure rate could be as high as 30%; hence, up to 
470 peanut allergic subjects might need to be screened.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
14 of 142
09 Dec 2015
LIST OF STUDY PERSONNEL
Sponsor
Chief Clinical Trial Officer
DBV Technologies S.A.
Green Square – Bâtiment D
80/84, rue des Meuniers 
92220 Bagneux, France 
Director, Regulatory Affairs & Quality
DBV Technologies S.A. (same address as above)
Medical Director
DBV Technologies S.A. (same address as above)
Biostatistician
DBV Technologies S.A. (same address as above)
Contract Research 
Organization 
PAREXEL International (IRL) Limited (“PAREXEL”)
70 Sir John Rogerson’s Quay 
Dublin 2 
Ireland
Central Laboratory 
P
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
CCI

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
15 of 142
09 Dec 2015
Drug Manufacturing 
Company
Drug Supply/Packaging 
Company
PPD
PPD
CCI
CCI

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
16 of 142
09 Dec 2015
TABLE OF CONTENTS
PROTOCOL SYNOPSIS .................................................................................................. 4 
LIST OF STUDY PERSONNEL .................................................................................... 14 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS .............................. 22 
1
INTRODUCTION................................................................................................ 24 
1.1 
Background ...................................................................................................... 24 
1.1.1
Summary of Findings from Non-clinical and Clinical Studies ............ 25 
1.1.1.1
Non-clinical Studies ....................................................................... 25 
1.1.1.2
Clinical Studies .............................................................................. 26 
1.2 
Rationale .......................................................................................................... 35 
1.3 
Risk-Benefit Assessment ................................................................................. 35 
2
STUDY OBJECTIVES ........................................................................................ 37 
3
OVERALL DESIGN AND PLAN OF THE STUDY ....................................... 38 
3.1 
Overview .......................................................................................................... 38 
3.2 
Criteria for Evaluation of the Study .............................................................. 40 
3.2.1
Efficacy Criteria ................................................................................... 40 
3.2.1.1
Primary Efficacy Endpoint ............................................................ 40 
3.2.1.2
Secondary Efficacy Endpoint ......................................................... 40 
3.2.1.3
Other Efficacy Endpoints ............................................................... 41 
3.2.2
Safety Criteria ...................................................................................... 41
3.2.3
Exploratory Criteria ............................................................................. 42 
3.3 
Justification of the Study Design ................................................................... 43 
4
STUDY POPULATION ...................................................................................... 44 
4.1 
Inclusion Criteria ............................................................................................ 44 
4.2 
Exclusion Criteria ........................................................................................... 45 
4.3 
Patient Withdrawal and Replacement .......................................................... 47 
4.3.1
Criteria for Withdrawal from Study Treatment and Study .................. 47 
4.3.2
Study Stopping Rules ........................................................................... 48 
4.3.3
Replacement of Withdrawn Subjects ................................................... 48 
4.3.4
Data Collection and Follow-up after Withdrawal ................................ 48
4.4 
Planned Sample Size and Number of Study Centers ................................... 48 
4.5 
Patient Identification and Randomization .................................................... 49 
4.5.1
Patient Identification ............................................................................ 49 
4.5.2
Randomization Scheme ....................................................................... 49 
4.5.3
Allocation/Randomization of Patients to Treatment............................ 49
5
STUDY DRUG ..................................................................................................... 50 
5.1 
Identity ............................................................................................................. 50 
5.2 
Administration ................................................................................................. 50 
5.2.1
Adjustment of Viaskin® Patch Application in Case of Local or 
Systemic Reactions .............................................................................. 52
5.2.2
Safety Precaution Information ............................................................. 53 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
17 of 142
09 Dec 2015
5.3 
Packaging, Labeling and Storage .................................................................. 53 
5.4 
Blinding and Breaking the Blind ................................................................... 54 
5.5 
Drug Accountability ........................................................................................ 55 
5.6 
Compliance ...................................................................................................... 55 
5.7 
Viaskin® Patch Adhesion ................................................................................ 55 
5.8 
Prior and Concomitant Medication ............................................................... 56 
5.8.1
Permitted Concomitant Medication ..................................................... 56 
5.8.2
Prohibited Prior and Concomitant Medication .................................... 57 
6
VARIABLES AND METHODS OF ASSESSMENT ....................................... 58 
6.1 
Efficacy Variables ........................................................................................... 58 
6.1.1
Response to Treatment – DBPCFC to Peanut ..................................... 58 
6.1.1.1
Preparation of Peanut and Placebo Formulas .............................. 59 
6.1.1.2
Time Interval and Doses ................................................................ 59 
6.1.1.3
Entry/screening DBPCFC to Peanut ............................................. 59 
6.1.1.4
Post-treatment DBPCFC to Peanut at Month 12 .......................... 62
6.2 
Safety Variables ............................................................................................... 63 
6.2.1
Adverse Events .................................................................................... 63 
6.2.1.1
Collection of Adverse Events ......................................................... 63 
6.2.1.2
Definitions ...................................................................................... 63 
6.2.1.3
Assessment of Adverse Events ........................................................ 63
6.2.1.4
Recording Adverse Events ............................................................. 67 
6.2.1.5
Reporting Serious Adverse Events ................................................. 67 
6.2.1.6
Follow-up of Adverse Events ......................................................... 68 
6.2.1.7
Pregnancy ...................................................................................... 68 
6.2.1.8
Treatment of Overdose of Study Medication ................................. 68
6.2.2
Laboratory Variables ........................................................................... 69 
6.2.3
Vital Signs ............................................................................................ 69 
6.2.4
Physical Examinations ......................................................................... 70 
6.2.5
Spirometry Test .................................................................................... 70 
6.2.6
Peak Expiratory Flow .......................................................................... 70
6.2.7
Subject Diaries ..................................................................................... 71 
6.2.8
Skin Reaction and Photography ........................................................... 71 
6.2.9
Viaskin®Patch Adhesion ...................................................................... 72 
6.3 
Demographics and Baseline Characteristics ................................................ 73 
6.3.1
Patient Demography............................................................................. 74
6.3.2
Disease History and Medical History .................................................. 74 
6.3.3
Prior and Concomitant Medications .................................................... 74 
6.4 
Exploratory Variables .................................................................................... 74 
6.4.1
Immunological Markers ....................................................................... 74 
6.4.2
Skin Prick Test ..................................................................................... 74
6.4.3
Food Allergy Quality of Life Questionnaire /Food Allergy 
Independent Measure ........................................................................... 75 
6.4.4
Accidental Consumption of Peanuts .................................................... 75 
6.4.5
Epigenetic analyses .............................................................................. 75 
6.4.6
Genetic Screening ................................................................................ 75
6.4.7
Scoring Atopic Dermatitis ................................................................... 76 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
18 of 142
09 Dec 2015
7
STUDY CONDUCT ............................................................................................. 77 
7.1 
Schedule of Procedures ................................................................................... 77 
7.2 
Procedures by Visit ......................................................................................... 82 
7.2.1
Visit 1, Screening (Day -42) ................................................................ 82 
7.2.2
Visit 2, Screening (through Day -2) ..................................................... 82
7.2.3
Visit 3, Screening (within 1 week of Visit 2 and through Day -1) ...... 83 
7.2.4
Visit 4 (Day 1), First Day of Treatment ............................................... 84 
7.2.5
Phone Contacts (Day 4±2 days and Day 22±2 days), Treatment 
Period ................................................................................................... 85 
7.2.6
Visit 5 (Day 8±3 days), Visit 6 (Month 1±3 days) and Visit 9 
(Month 9±7 days), Treatment Period ................................................... 85 
7.2.7
Phone Contacts (Month 2±3 days, Month 4.5±7 days, Month 
7.5±7 days), Treatment Period ............................................................. 86 
7.2.8
Visit 7 (Month 3±7 days) and Visit 8 (Month 6±7 days), 
Treatment Period .................................................................................. 86
7.2.9
Visit 10 (Month 12±7 days), Treatment Period ................................... 87 
7.2.10
Visit ZHHNDIWHU9LVLW(QGRI7UHDWPHQW3HULRG ................ 89 
7.2.11
Visit 12 (2 weeks after Visit 11), End of Study Period ....................... 90 
7.2.12
Early Termination Visit ....................................................................... 90 
7.2.13
Unscheduled Visit ................................................................................ 90
8
STATISTICAL METHODS ............................................................................... 92 
8.1 
Study Patients .................................................................................................. 92 
8.1.1
Disposition of Patients ......................................................................... 92 
8.1.2
Protocol Deviations .............................................................................. 92 
8.1.3
Analysis Sets ........................................................................................ 92
8.1.3.1
Safety Population ........................................................................... 92 
8.1.3.2
Intent-to-treat Population .............................................................. 92 
8.1.3.3
Full analysis set ............................................................................. 93 
8.1.3.4
Per-protocol Population ................................................................ 93 
8.2 
General Considerations .................................................................................. 93 
8.2.1
Statistical Methods ............................................................................... 93 
8.2.2
Analysis and Data Conventions ........................................................... 93 
8.2.2.1
Definition of Baseline .................................................................... 93 
8.2.2.2
Visit Windows................................................................................. 93 
8.2.2.3
Unscheduled Assessments .............................................................. 93
8.2.2.4
Missing Data Conventions ............................................................. 94 
8.2.2.5
Pooling of Centers ......................................................................... 94 
8.3 
Demographics, Disease and Medical Histories, Baseline 
Characteristics, and Concomitant Medications ........................................... 95 
8.4 
Treatment Compliance and Exposure .......................................................... 95 
8.5 
Efficacy Analyses ............................................................................................. 95 
8.5.1
Primary Efficacy Analysis ................................................................... 95 
8.5.1.1
Hypothesis to be tested................................................................... 95 
8.5.1.2
Statistical Methods ......................................................................... 96 
8.5.1.3
Sensitivity Analyses ........................................................................ 96

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
19 of 142
09 Dec 2015
8.5.2
Secondary Efficacy Analyses .............................................................. 96 
8.5.2.1
Percentage of treatment responders in each screening ED 
stratum ........................................................................................... 96 
8.5.2.2
Percentage of treatment responders in each age subgroup ........... 97 
8.5.2.3
Mean and Median Cumulative Reactive/Eliciting Doses .............. 97
8.5.2.4
Responsive/Unresponsive Subjects, Subjects Passing 
DBPCFC ........................................................................................ 97 
8.5.3
Pre-defined Hierarchical Order for the Analysis of Efficacy 
Endpoints ............................................................................................. 98 
8.5.4
Other Efficacy Analyses ...................................................................... 99
8.6 
Safety Analyses ................................................................................................ 99 
8.6.1
Adverse Events .................................................................................... 99 
8.6.2
Laboratory Assessments .................................................................... 100 
8.6.3
Vital Signs .......................................................................................... 100 
8.6.4
Physical Examination......................................................................... 101
8.6.5
Spirometry and Peak Expiratory Flow Results .................................. 101 
8.6.6
Subject Diaries ................................................................................... 101 
8.6.7
Skin Reactions ................................................................................... 102 
8.6.8
Symptomatic Reactions During the DBPCFC ................................... 102 
8.7 
Exploratory Analyses .................................................................................... 102 
8.8 
Patch adhesion ............................................................................................... 103 
8.9 
Interim Analyses ............................................................................................ 103 
8.10 
Determination of Sample Size ...................................................................... 103 
9
ETHICAL, LEGAL, AND ADMINISTRATIVE ASPECTS ........................ 106 
9.1 
Data Quality Assurance ................................................................................ 106 
9.1.1
Database Management and Quality Control ...................................... 106 
9.2 
Case Report Forms and Source Documentation ........................................ 106 
9.2.1
Data Collection .................................................................................. 107 
9.3 
Access to Source Data ................................................................................... 107 
9.3.1
Routine Monitoring ............................................................................ 107
9.3.2
Inspections and Auditing Procedures ................................................. 107 
9.4 
Data Processing ............................................................................................. 108 
9.5 
Archiving Study Records .............................................................................. 108 
9.6 
Good Clinical Practice .................................................................................. 109 
9.7 
Informed Consent .......................................................................................... 109 
9.8 
Protocol Approval and Amendment ............................................................ 110 
9.9 
Data and Safety Monitoring Board ............................................................. 110 
9.10 
Duration of the Study .................................................................................... 111 
9.11 
Premature Termination of the Study .......................................................... 111 
9.12 
Confidentiality ............................................................................................... 111 
9.13 
Contractual and Financial Details ............................................................... 112 
9.14 
Liability and Insurance ................................................................................. 112 
9.15 
Publication Policy .......................................................................................... 112 
9.16 
Study Center File Management ................................................................... 112 
9.17 
Clinical Study Report ................................................................................... 113 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
20 of 142
09 Dec 2015
10
REFERENCE LIST ........................................................................................... 114 
APPENDICES ................................................................................................................ 117 
APPENDIX 1 .................................................................................................................. 118 
APPENDIX 2 .................................................................................................................. 125 
APPENDIX 3 .................................................................................................................. 127 
APPENDIX 4 .................................................................................................................. 128 
APPENDIX 5 .................................................................................................................. 129 
APPENDIX 6 .................................................................................................................. 130 
APPENDIX 7 .................................................................................................................. 132 
APPENDIX 8 .................................................................................................................. 142 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
21 of 142
09 Dec 2015
Tables in Text
Table 1: Incidence of Dosing Reactions Per Age Group in the CoFAR6 Study ............... 30 
Table 2: Summary of Occurrence of Dosing Symptoms Per Applied Dose and Per 
Age Group in the CoFAR6 Study ............................................................................... 30 
Table 3: Summary of Viaskin® Peanut-related Adverse Events in the VIPES Study in 
Children (6- to 11-Years-Old) ..................................................................................... 32 
Table 4: Time of Occurrence of Viaskin® Peanut-related Treatment-Emergent 
Adverse Events in the VIPES Study in Children (6- to 11-Years Old) ...................... 33 
Table 5: Safety Data of Viaskin® Peanut 250 μg According to Age Group in the 
VIPES Study in Children (6- to 11-Years-Old) .......................................................... 33
Table 6: Skin Reaction Grading System ............................................................................ 72 
Table 7: Schedule of Procedures ........................................................................................ 78 
Table 8: Pre-defined Hierarchical Order for Analysis of Efficacy Endpoints ................... 98 
Table 9: Criteria to assess Clinically Relevant Abnormalities in Vital Signs ................. 101 
Table 10: Summary of Sample Size Calculation ............................................................. 104
Figures in Text
Figure 1: Study Design ...................................................................................................... 40 
Figure 2: Schematic Representation of Viaskin® Patch Application on the Back of 
the Subjects ................................................................................................................. 51
List of Appendices
Appendix 1
Declaration of Helsinki
Appendix 2 
Dosages of Inhaled Corticosteroids 
Appendix 3 
Activity of Corticosteroids 
Appendix 4 
Short-acting and Long-acting Antihistamines based on Terminal
Elimination Half-Lives
Appendix 5 
Anaphylaxis Staging System
Appendix 6 
Oral Food Challenge Symptom Score Sheet 
Appendix 7 
FAQLQ/FAIM Questionnaires 
Appendix 8 
SCORAD

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
22 of 142
09 Dec 2015
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS
AE
Adverse Event
AESI
Adverse Event of Special Interest
ANCOVA
ANalysis of COVAriance
APC
Antigen-Presenting Cells
AP-HP
Assistance Publique-Hôpitaux de Paris.
ATC
Anatomical Therapeutic Chemical (Classification System) 
ATS
American Thoracic Society
CI
Confidence Interval 
CoFAR
Consortium of Food Allergy Research 
CSR
Clinical Study Report 
CTCAE
Common Terminology Criteria for Adverse Events 
DBPCFC
Double-Blind, Placebo-Controlled Food Challenge
DSMB
Data and Safety Monitoring Board 
EAACI
European Academy of Allergy and Clinical Immunology
e-CRF
Electronic Case Report Form
ED
Eliciting Dose 
EDC
Electronic Data Capture 
EPIT
EPicutaneous ImmunoTherapy
FAQLQ/FAIM
Food Allergy Quality of Life Questionnaire/Food Allergy 
Independent Measure 
FAS
Full Analysis Set
FEV1
Forced Expiratory Volume in 1 second
FDA
Food and Drug Administration
GA2LEN
Global Allergy and Asthma European Network 
GCP
Good Clinical Practice
IB
Investigator’s Brochure
ICF
Informed Consent Form
ICH
International Conference on Harmonization 
IEC
Independent Ethics Committee 
IgE, IgG, IgG4
Immunoglobulin E, Immunoglobulin G, Immunoglobulin G4 subtype 
IRB
Institutional Review Board

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
23 of 142
09 Dec 2015
ITT
Intent-To-Treat
IV
Intravenous 
IWRS
Interactive Web Response System
LEAP
Learning Early About Peanut Allergy 
LOCF
Last Observation Carried Forward
MedDRA
Medical Dictionary for Regulatory Activities
NIH
National Institute of Health
OFC
Oral Food Challenge
OIT
Oral ImmunoTherapy
PEF
Peak Expiratory Flow 
PP
Per-Protocol 
PT
Preferred Term
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SCORAD
SCORing Atopic Dermatitis
SLIT
SubLingual ImmunoTherapy
SOC
System Organ Class
SPT
Skin Prick Test
TEAE
Treatment-Emergent Adverse Event 
US(A) 
United States (of America) 
WHO
World Health Organization

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
24 of 142
09 Dec 2015
1
INTRODUCTION
1.1
Background 
Peanut allergy is the most common cause of fatal food allergy reactions (1,2). An 
estimated 1% of the population of the United States of America (USA), over 3 million 
people, is allergic to peanuts or tree nuts (3). The prevalence of peanut allergy in children 
has been increasing over the last 2 decades, as indicated by surveys conducted in the 
USA and United Kingdom: the rate of peanut allergy in children doubled within a range 
of 5 to 6 years (4,5) and more than tripled between 1997 and 2008 with a prevalence of 
0.4% in 1997, 0.8% in 2002 and 1.4% in 2008 (3). Studies indicate that peanut allergy 
might resolve in about 20% of cases (6,7,8,9), but may recur in some desensitized 
individuals, making this allergy a life-long affliction in the vast majority of cases. 
A recent randomized study of peanut consumption in infants at high risk of developing 
peanut allergy, the Learning Early About Peanut Allergy (LEAP) study, has evaluated 
the strategies of peanut consumption or avoidance at very early ages, between 4 and 
11 months of age (10). In the subset of infants at high risk to develop peanut allergy, 
which were infants with eczema, positive egg skin prick test (SPT), negative or slightly 
positive peanut SPT, the results of this prospective study demonstrated that early (during 
infancy) peanut consumption might be preferable to avoidance of peanut consumption 
for preventing the occurrence of peanut allergy in infants at high risk. 
Peanut allergy falls within the Immunoglobulin E (IgE)-mediated category of food 
allergies, with immediate reactions triggered by circulating allergen-specific IgE upon 
exposure to the allergen (11). IgE-mediated allergic reactions to foods have a rapid onset, 
usually within a few minutes following exposure to the allergen. IgE-mediated allergic 
reactions to peanut provoke characteristic responses in the skin, gastrointestinal tract,
upper and lower respiratory tract, and cardiovascular system (12). IgE-mediated reactions 
to food may also trigger generalized reactions, that is anaphylaxis, a severe, potentially 
fatal, systemic allergic reaction that occurs suddenly after contact with an allergy-causing 
substance (13). 
The complete mechanism of IgE-mediated food allergy remains unknown. However, it is 
thought that the development of an IgE-mediated response to an allergen is the result of a 
series of molecular and cellular interactions involving Antigen-Presenting Cells (APCs),
T cells and B cells (14,15). Upon re-exposure to the sensitizing food, the allergen 
crosslinks the specific IgEs bound on mast cells and basophils, triggering release of 
vasoactive and inflammatory mediators such as histamine, leukotrienes, prostaglandins, 
and platelet-activating factor. The massive release of these mediators induces immediate 
allergic systemic symptoms, including anaphylaxis.
There are no approved treatments available for peanut allergy (16). Currently, the only 
therapeutic option available for peanut-allergic subjects is strict avoidance. However, 
since peanut is a ubiquitous ingredient in many foods, strict avoidance is difficult to 
achieve, and accidental ingestion of peanut by peanut-allergic subjects may result in 
severe reactions and fatal outcomes (17).
The only available countermeasure in case of severe systemic and/or life-threatening 
reactions/anaphylaxis to peanuts is injectable epinephrine as recommended by the World 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
25 of 142
09 Dec 2015
Allergy Organization (18). Epinephrine remains a rescue therapeutic agent and is not 
designed for a routine use.  
Various non-specific and food allergen-specific treatment approaches have been under 
evaluation. Non-specific approaches to food allergy include the use of monoclonal 
anti-IgE antibodies, which might increase the Eliciting Dose (ED) threshold for the food 
allergen (19,20). Food allergen-specific approaches in clinical development include Oral 
ImmunoTherapy (OIT), SubLingual ImmunoTherapy (SLIT), and EPicutaneous 
ImmunoTherapy (EPIT) (21). Food-specific approaches may be advantageous as they 
target the specific foods that cause the severe IgE-mediated anaphylactic reactions (22). 
Studies on SLIT and OIT have demonstrated some encouraging efficacy results (clinical 
desensitization), including beneficial immunologic changes (23,24,25,26). Oral 
immunotherapy has shown evidence for inducing desensitization in most subjects, with 
immunologic changes over time (25,26,27). These advances are, however, hampered by 
the significant risk of side effects and occurrence of eosinophilic esophagitis in the 
context of OIT (28,29,30,31,32). Sublingual immunotherapy for peanut allergy has 
demonstrated evidence of clinical success, with some subjects showing signs of 
desensitization with a more satisfactory side effect profile compared to OIT and with 
significant immunologic changes noted during the first year of therapy (24). Despite the 
evident interest of clinicians to further evaluate these treatment procedures, OIT and 
SLIT will not likely be applicable across all ages and risk categories of peanut-allergic 
children and adults. Alternative immunotherapeutic approaches for peanut allergy are 
therefore needed, with a clinically meaningful benefit. 
The study drug, Viaskin® Peanut (or DBV712), consists of an epicutaneous delivery 
system (Viaskin® patch) containing a dry deposit of a formulation of peanut protein 
extract. The peanut protein allergens are deposited on the backing of an occlusive 
chamber by electrospraying a liquid formulation of the peanut protein extract. The drug
substance is an unmodified, lyophilized peanut extract produced from the extraction and 
freeze drying of defatted peanut flour, derived from the peanut seed, Arachis hypogaea.
Further details can be found in the IB (33), which contains comprehensive information 
on the study drug. 
The PEPITES study is a 12-month, Phase III, double-blind, placebo-controlled, 
randomized study to assess the efficacy and safety of Viaskin® Peanut, dosed at 250 μg 
peanut protein (per patch) in peanut-allergic children from 4 through 11 years of age. The 
objective of this study is to assess the efficacy and safety of Viaskin® Peanut 250 μg 
peanut protein to induce desensitization to peanut in peanut-allergic children 
4 through 11 years of age after a 12-month treatment by EPIT.  
1.1.1
Summary of Findings from Non-clinical and Clinical Studies
Further details on the studies summarized below can be found in the IB (33).
1.1.1.1
Non-clinical Studies 
DBV Technologies has conducted a number of non-clinical studies supporting the 
clinical development of Viaskin® Peanut. These include ISO 10993-compliant 
biocompatibility studies performed for the device component independent of the drug 
component, which is the Viaskin® patch, and non-clinical studies performed with the 
combined product, which includes in vitro pharmacokinetic/absorption studies, in vivo

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
26 of 142
09 Dec 2015
pharmacology (efficacy) studies in a mouse model of peanut allergy, and Good 
Laboratory Practice-compliant toxicology studies in the rabbit and in a guinea pig model 
of peanut allergy.  
1.1.1.2
Clinical Studies 
1.1.1.2.1
1.1.1.2.2 ARACHILD Study: Phase II Pilot Efficacy and Safety Study (Completed) 
This pilot double-blind, placebo-controlled Phase II study was sponsored by the largest 
French public hospital organization, Assistance Publique-Hôpitaux de Paris (AP-HP). 
The primary objective of this study was to demonstrate the efficacy of EPIT with 
Viaskin® Peanut to desensitize children 5 to 17 years of age with a documented peanut 
allergy. A double-blind, placebo-controlled food challenge (DBPCFC) was conducted at 
study entry and subjects reacting below a cumulative dose of 300 mg peanut protein were 
eligible. A total of 54 subjects were randomized at a 1:1 ratio to receive either Viaskin®
Peanut 100 ȝJor placebo for a period of 6 months of blinded treatment. This was first 
followed by a 12-month open-label treatment period with Viaskin® Peanut 100 μg; the 
children who were in the placebo group during the first 6 months then crossed-over to 
also receive Viaskin® Peanut 100 ȝJ for the remaining 12 months, up to Month 18. An 
amendment to the protocol further extended the open-label treatment period to an 
additional 18 months for subjects randomized to receive active Viaskin® Peanut 
treatment from the beginning, and to an additional 24 months for subjects randomized to 
the placebo group. A total of 30 subjects accepted to extend their study participation 
under this amendment.  
The response rate in the ARACHILD study was defined as the percentage of subjects 
who reached a cumulative reactive dose of 1,000 mg peanut protein after EPIT treatment 
CCI
CCI

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
27 of 142
09 Dec 2015
or subjects able to multiply by 10 their cumulative reactive dose after treatment as 
compared to baseline.
This study is the first proof of concept pilot study to demonstrate safety and efficacy of 
EPIT using Viaskin® Peanut at a unique dose of 100 μg peanut protein. After 6 months 
of treatment during the blinded period, there was no statistical difference between the
2 treatment groups in the overall population (7.4% response in the active group versus 
7.7% in the placebo group). However, after 12 months and 18 months of treatment, the 
overall response rate of the active group increased to 20% and 40%, respectively. 
Surprisingly, there were no responders among the 12- to 17-year-old adolescents. All 
responders were children (15) from 5 to 11 years of age. The response rate in these 
children was 5/15 (33.3%) and 10/15 (66.7%), respectively, at Month 12 and Month 18. 
Also, in the children (5- to 11-years-old) who received Viaskin® Peanut, the starting 
mean cumulative reactive dose at baseline was 23.14±29.31 mg which had progressed to 
reach 357.66±542.95 mg after 18 months. 
In this study, there were 20 SAEs (18 cases). Five were considered related to study 
procedure, occurring during the DBPCFC: 3 anaphylactic reactions, 1 cutaneous and 
digestive anaphylaxis, and 1 bronchospasm. All of these events resolved within 24 hours. 
Four SAEs were considered possibly related to study drug by the Investigators: 
1 herpetic gingivostomatitis, 1 pilonidal abscess on a probable pilonidal cyst, 
1 recurrence of this pilonidal cyst, and 1 anaphylactic reaction after eating a “kebab” 
sandwich. In the Viaskin® Peanut group, there was 1 doubtful event of eye pruritus by 
contact after patch removal in 1 adolescent and 1 edema of the upper lip after patch 
application in 1 child. 
Viaskin® Peanut 100 μg demonstrated an overall satisfactory safety profile. During the 
double-blind period of the study, 11.5% severe AEs occurred in the placebo group versus 
7.1% in the Viaskin® Peanut group with mostly skin disorders (none severe), 
gastrointestinal disorders (2 severe AEs of abdominal pain in the Viaskin® Peanut 
group), and respiratory disorders (none severe) as compared to placebo. The safety 
profile of Viaskin® Peanut was compatible with a daily, long term application.
1.1.1.2.3 VIPES Study: Phase IIb Efficacy and Safety Study (Completed) 
This Phase IIb, double-blind, placebo-controlled study assessed the safety and efficacy of 
EPIT with Viaskin® Peanut in 221 peanut-allergic subjects (113 children, 73 adolescents 
and 35 adults) who were randomized to receive Viaskin® Peanut 50 ȝJ ȝJ ȝJ
or placebo for 12 months.  
With regard to efficacy, the primary efficacy endpoint was met. The treatment response 
rate in the whole population at Month 12 showed a statistically significant higher 
responder rate in the Viaskin® Peanut 250 μg group with 28 (50.0%) responders 
compared to 14 (25.0%) responders in the placebo group (p-value = 0.0108). The study 
population was composed of 2 age strata: children (6 to 11 years of age) and adolescents 
and adults (12 years and above). Fifteen (53.6%) children (6- to 11-years-old) were 
responders in the Viaskin® Peanut 250 μg group at Month 12 compared to 6 (19.4%) 
children in the placebo group (p-value = 0.0076). For the main secondary efficacy 
endpoints analyzed, there was a better response with the highest dose of Viaskin® Peanut 
(250 μg) than with the lower doses (50 μg and 100 μg) compared to placebo. The results 
for the children (6- to 11-years-old) were very favorable in all analyses, as differences 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
28 of 142
09 Dec 2015
compared to placebo were generally even more pronounced with better statistical 
significance than the results seen in the whole population. In the adolescent and adult age 
strata, even though Viaskin® Peanut 250 μg showed higher effects for all endpoints 
analyzed, these were not statistically significant. 
Generally, in terms of safety, Viaskin® Peanut patches at 50 ȝJ ȝJRU ȝJSHDQXW
protein were well tolerated. The most common and most frequent AEs reported by the 
subjects were local cutaneous reactions at the sites of the patch application in more than 
90% of the subjects treated with any dose of Viaskin® Peanut, versus 50% of the subjects 
in placebo. These local reactions were generally of mild or moderate severity, and 
resulted in withdrawal from treatment in only 2/221 (0.9%) of subjects. 
There were no clinical differences for Viaskin® Peanut-related AEs between the 3 active 
Viaskin® Peanut groups. There were clear differences between the 3 active Viaskin®
Peanut groups and the placebo group for these local cutaneous AEs (pruritus/itching, 
erythema/redness, edema/swelling) at sites of patch application as auto-evaluated on a 
daily basis by the subjects over the first 3 months of EPIT and as assessed by the 
Investigators over the 12 months of EPIT. One case of grade 4 local skin reaction (on a 
scale of 0 = negative to 4 = erythema, vesicles) of erythema with 2-3 vesicles was 
reported by 1 subject without resulting in subject withdrawal. At all time-points, a higher 
percentage of subjects in any of the 3 active Viaskin® Peanut groups was assessed as 
having skin reactions of higher severity than the subjects in the placebo group. Over the 
course of the study, skin reactions of grades 1 to 3 appeared during the first month of 
treatment as the duration of the patch application gradually increased to 24 hours daily. 
For 50% of the subjects, the local skin reactions lasted less than 2 months and in the 
other half of subjects the local skin reactions mostly declined over time up to Month 9 or 
Month 12. Generalized itching after patch removal occurred in 1 child in the Viaskin®
Peanut 250 μg group.
There were no SAEs related to Viaskin® Peanut in the VIPES study. Of the 20 SAEs that 
occurred, 14 SAEs were related to the study procedure of DBPCFC, with subjects 
reporting anaphylactic reactions that required prolonged hospitalization overnight.  
1.1.1.2.4 OLFUS-VIPES Study: Open-label Follow-up Study of the VIPES Study 
(Ongoing) 
This study evaluates the long-term efficacy and safety of Viaskin® Peanut in children, 
adolescents and adults. Subjects previously randomized in the VIPES study and who 
completed the study were offered to receive the Viaskin® Peanut 250 μg treatment for 
24 additional months. From the 207 subjects who completed the VIPES study up to 
Month 12, 171 (83%) have rolled over into the OLFUS-VIPES study. As of 
31 May 2015, 20 subjects (11.7%) have withdrawn from the study and 151 subjects were
still under treatment. Eight SAEs were reported, none of which were related to Viaskin®
Peanut and none of which were related to the conduct of the food challenges. 
1.1.1.2.5 CoFAR6 Study: Phase II Efficacy and Safety Study (Ongoing) 
This is a randomized, double-blind, placebo-controlled, Phase II study in children, 
adolescents and adults sponsored by the National Institute of Health (NIH) and 
conducted in the USA by the Consortium of Food Allergy Research (CoFAR). The 
primary objective of this study is to assess the safety and efficacy of EPIT with Viaskin®

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
29 of 142
09 Dec 2015
Peanut in peanut-allergic subjects. In parallel, immunological effects using a set of 
immune-focused mechanistic studies as well as cellular modifications induced by EPIT 
are studied. A total of 75 subjects aged 4 to 25 years (including 10 children aged 4 to 
5 years) have been randomized in this study to be treated with either Viaskin® Peanut
100 μg or 250 μg or placebo (ratio 1:1:1). After their first year of blinded treatment in the 
CoFAR6 study, subjects enter the open-label phase of the study and receive treatment 
with the 250 ȝJGRVe for either 18 additional months for those under active treatment 
during the blinded phase of the study or for 30 months for those who were under placebo. 
As of 13 May 2015, an estimated minimum of 60 subjects completed the double-blind 
period and all subjects rolled over to receive the active treatment with Viaskin® Peanut 
250 μg for a total of 30 months. 
Six randomized subjects (2 children, 3 adolescents and 1 adult) have withdrawn 
prematurely from the study or discontinued dosing; 1 adolescent due to local skin 
reactions (experience of several days of grade 3 skin reactions with erythema extending 
beyond the patch application site and one grade 4 reaction, i.e. erythema with vesicles), 
1 adolescent due to an unrelated SAE (syncopal episodes) and 4 subjects due to other 
circumstances. The 6-year-old child withdrew after 1 week of patch treatment because of 
expressed anxiety surrounding future food challenges associated to the protocol 
combined to a strong aversion to the peanut taste, and the 8-year-old child withdrew even 
before any patch treatment because of unforeseen family circumstances. No drop-out 
occurred in the children 4 to 5 years of age. 
Three SAEs were reported (1 child and 2 adolescents), none had a causal relationship
with the study product. No SAEs were reported in the population of 4- to 5-year-old 
children. No subject has died while on study. 
In this study, skin reactions at the site of patch application were graded on a scale from 
grade 0 (negative according to clinical assessment; normal skin, no reaction, according to 
subject assessment) to grade 4 (erythema, vesicles, according to clinical assessment; 
redness with blisters, according to subject assessment). The symptoms outside the patch 
site (in a separate area from the patch site, not those that extended beyond the patch site) 
included assessment of skin reactions, gastrointestinal reactions and respiratory reactions 
which were scored in severity as mild, moderate or severe.
In January 2014, grading of skin reactions at site of patch application showed that out of 
the first 366 doses administered, there were 56% with no reactions, 23.3% grade 1, 
18.6% grade 2 and 1.9% grade 3 reactions. One dose resulted in the appearance of 
vesicles at site of patch application which resulted in the subject’s permanent 
GLVFRQWLQXDWLRQIURPWUHDWPHQWDQGIURPWKHVWXG\$OVRWKHUHZHUHGRVHV5%) 
resulting in reactions beyond the size of the patch or distant from the patch site, including 
hives, redness, and pruritus. Of note, 1 of these doses resulting in reactions beyond the 
patch was an urticaria lesion which extended largely and covered the upper right quartile 
of the subject’s back. 
Safety data gathered for 4- to 5-year old subjects in the CoFAR6 study: 
A specific safety assessment for the 4- to 5-year-old subjects was made available for the 
study period up to 25 May 2014. The incidence of dosing reactions for all subjects by age 
category is presented in Table 1 and the occurrence of dosing symptoms per applied 
doses is summarized in Table 2. Six subjects, all in the -years-old age group, who did 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
30 of 142
09 Dec 2015
not have any dosing data as of the database closure on 25 May 2014, were not included 
in the analysis.
Table 1: Incidence of Dosing Reactions Per Age Group in the CoFAR6 Study
Type of Dosing Reaction 
4 to <6 years
 years
Subjects with no dosing reaction (%)
10.0
12.2
Subjects with patch site reaction only (%)
40.0
67.3
Subjects with patch site and non-patch site reaction (%)
50.0
20.4
Subjects with grade 3 patch site reaction (%)
20.0
8.2
Subjects with grade 4 patch site reaction (%)
0.0
2.0
Table 2: Summary of Occurrence of Dosing Symptoms Per Applied Dose and Per Age Group in the 
CoFAR6 Study
There were no non-patch site reactions with severe symptoms and there were no doses 
that resulted in treatment with epinephrine. A total of 87 doses were not taken (13 doses 
in the 4- to <6-years-old group, and 74 GRVHVLQWKH-years-old group). 
In conclusion, as of 13 May 2015, no drop-outs and no SAEs occurred in the 10 children 
4 to 5 years of age, all randomized for more than 12 months in the CoFAR6 study. The 
comparative safety assessment available for the study period up to 25 May 2014 showed 
no specific safety concerns in this study population compared to -year-old subjects. A 
similar percentage of subjects in the age group 4 to 5 years and the age group  years
reported dosing reactions (90% versus 87.8%, respectively). Even though more 4- to 
5 year- old children experienced non-patch site reactions (50% versus 20.4%), none of 
these reactions were severe. Occurrence of patch site reactions per applied doses was 
slightly higher in the age group 4 to 5 years (70.2% versus 59.5%) but these were limited 
to local reactions up to grade 3 (only 1 adolescent subject had a severe grade 4 local 
Dosing Symptoms  
4 to <6 years
 years
Total doses reported (n)
1,028
2,751
Any symptoms (%)
70.4
59.7
Patch site reactions (%)
70.2
59.5
Grade 2 patch site reactions (%)
26.0
15.4
Grade 3 patch site reactions (%)
0.3
0.2
Grade 4 patch site reactions (%)
0.0
0.04
Reactions extending beyond the patch site (%)
6.9
6.1
Grade 2 reactions extending beyond the patch site (%)
0.2
1.8
Grade 3 reactions extending beyond the patch site (%) 
0.1
0.0
Non-patch site reactions (%)
1.2
0.8
Non-patch site reactions with mild symptoms (%)
1.0
0.7
Non-patch site reaction with moderate symptoms (%)
0.1
0.0
Symptoms lasting >8 hours (%)
64.3
38.5
Treatment was administered (%)
23.4
23.4
Treated with topical steroids (%)  
16.6
12.2
Treated with oral antihistamines (%)
5.4
5.5

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
31 of 142
09 Dec 2015
reaction leading to study discontinuation). Furthermore, similar medications were 
administered across age groups to treat these AEs.
1.1.1.2.6
Clinically Relevant Adverse Events Related to Viaskin® Peanut
Safety data are summarized in tabular format in the IB for all Phase I to II trials 
conducted so far with Viaskin® Peanut (33). To date, Viaskin® Peanut, regardless of the 
dose or the age of the subjects, was investigated in 4 randomized controlled trials and in 
1 open-label follow-up study (see Section 1.1.1.2.1 to Section 1.1.1.2.5) in more than 
400 subjects with peanut allergy.
Safety data of the VIPES study with 113 Viaskin® Peanut-treated children are available. 
The AEs considered related to Viaskin® Peanut by the Investigators are summarized in 
Table 3. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
32 of 142
09 Dec 2015
Table 3: Summary of Viaskin® Peanut-related Adverse Events in the VIPES Study in Children 
(6- to 11-Years-Old)
MedDRA SOC
AEs – PTs
Eyes disorders
Eye swelling (common)
Eyelid oedema (common)
Conjunctivitis (uncommon)
Eye pruritus (uncommon)
Gastrointestinal disorders
Abdominal pain upper (common)
Constipation (uncommon)
Diarrhea (uncommon)
General disorders and
administration site conditions
Application site erythema (common)
Application site pruritus (common)
Application site swelling (common)
Application site dermatitis (common)
Application site papules (common)
Application site rash (common)
Application site eczema (uncommon)
Application site discoloration (uncommon)
Application site erosion (uncommon)
Application site irritation (uncommon)
Application site oedema (uncommon)
Application site reaction (uncommon)
Application site bleeding (uncommon)
Application site dryness (uncommon)
Application site exfoliations (uncommon)
Application site haematoma (uncommon)
Application site vesicles (uncommon)
Immune system disorders
Food allergy (uncommon)
Infections and infestations
Ear infections (uncommon)
Respiratory, thoracic and mediastinal disorders
Asthma (uncommon)
Rhinitis allergic (uncommon)
Skin and subcutaneous tissue disorders
Urticaria (uncommon)
Eczema (uncommon)
Pruritus (uncommon)
Rash papular (uncommon)
Rash (uncommon)
Erythema (uncommon)
Dermatitis (uncommon)
Pruritus generalised (uncommon)
Rash pruritic (uncommon)
Skin irritation (uncommon)
Skin lesion (uncommon)
Urticaria contact (uncommon)
Abbreviations: AE = Adverse event, MedDRA = Medical Dictionary for Regulatory Activities, 
SOC = System organ class, PT = Preferred term.
Note: The expected frequencies in brackets are defined as: common (1/100, <1/10), uncommon 
(1/1,000, <1/100). 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
33 of 142
09 Dec 2015
The experience from the VIPES study with Viaskin® Peanut 250 μg used to treat children 
showed that the most frequently observed local skin AEs to be expected are application 
site erythema, application site pruritus, application site swelling, application site 
dermatitis, and application site papules. In approximately 35% of the subjects these local 
skin reactions may be severe during 1 day or more. The majority of the local skin 
reactions developed within the first 2 months of therapy. They generally decreased in 
severity over time and resolved without sequelae and without treatment discontinuation. 
In the children (6- to 11-years-old), time of occurrence of treatment-emergent AEs 
(TEAEs) considered related to Viaskin® Peanut was distributed as indicated in Table 4
with 70% of events appearing during the first 6 months. 
Table 4: Time of Occurrence of Viaskin® Peanut-related Treatment-Emergent Adverse Events in the 
VIPES Study in Children (6- to 11-Years Old)
Time TEAE occurred
Time frame
Frequency
Percent
Cumulative 
Frequency
Cumulative 
Percent
<Day 90
127
37.03
127
37.03
'D\WR'D\
114
33.24
241
70.26
'D\180 to <Day 270
62
18.08
303
88.34
'D\270
40
11.66
343
100.00
Abbreviations: TEAE = Treatment-emergent adverse event.
The safety profile of the Viaskin® Peanut 250 μg group in the VIPES study according to 
the age range of children (6- to 7-years-old, 8- to 9-years-old and 10- to 11-years-old) 
and total is shown in Table 5.
Table 5: Safety Data of Viaskin® Peanut 250 μg According to Age Group in the VIPES Study in
Children (6- to 11-Years-Old)
6 to 7 years
N=7
8 to 9 years
N=13
10-11 years
N=8
Total
(N=28)
Data from Subject Diary
Proportion of Days*, Mean (SD)
Itching
Grade 2-3 
28.4 (32.7)
16.2 (22.3)
26.3 (26.5)
22.1 (25.9)
Grade 3
6.5 (14.4)
1.6 (2.7)
12.2 (23.4)
5.9 (14.5)
Redness
Grade 2-3 
35.1 (37.3)
16.9 (18.7)
31.5 (29.1)
25.6 (27.5)
Grade 3
10.5 (18.8)
0.4 (0.6)
4.4 (7.3)
4.1 (10.5)
Swelling
Grade 2-3 
27.6 (37.3)
12.1 (14.8)
29.0 (33.1)
20.8 (27.5)
Grade 3
12.7 (22.1)
0.4 (0.7)
8.8 (14.9)
5.9 (14.0)
Investigator Skin Observation, n (%)
Month 1, prior to patch application
Grade 0
3 (42.9)
5 (38.5)
5 (62.5)
13 (46.4)
Grade 1
1 (14.3)
2 (15.4)
1 (12.5)
4 (14.3)

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
34 of 142
09 Dec 2015
6 to 7 years
N=7
8 to 9 years
N=13
10-11 years
N=8
Total
(N=28)
Grade 2
1 (14.3)
3 (23.1)
2 (25.0)
6 (21.4)
Grade 3
2 (28.6)
3 (23.1)
0 (0.0)
5 (17.9)
Month 3, prior to patch application
Grade 0
2 (33.3)
4 (30.8)
2 (28.6)
8 (30.8)
Grade 1
2 (33.3)
2 (15.4)
1 (14.3)
5 (19.2)
Grade 2
0 (0.0)
5 (38.5)
3 (42.9)
8 (30.8)
Grade 3
2 (33.3)
2 (15.4)
1 (14.3)
5 (19.2)
Missing
1 
0 
1 
2 
TEAEs Considered Related, n (%)
Any TEAE
7 (100)
12 (92.3)
8 (100)
27 (96.4)
Eyes disorders
1 (14.3)
0 (0.0)
0 (0.0)
1 (3.6)
Gastrointestinal disorders
3 (42.9)
0 (0.0)
0 (0.0)
3 (10.7)
General disorders and 
administration site conditions
6 (85.7)
12 (92.3)
8 (100)
26 (92.9)
Skin and subcutaneous tissue 
disorders
3 (42.9)
6 (46.2)
1 (12.5)
10 (35.7)
TEAEs considered related by maximum severity, n (%)
Any TEAE
Mild
4 (57.1)
6 (46.2)
4 (50.0)
14 (50.0)
Moderate
2 (28.6)
6 (46.2)
4 (50.0)
12 (42.9)
Severe
1 (14.3)
0 (0.0)
0 (0.0)
1 (3.6)
General disorders and 
administration site conditions
Mild
4 (57.1)
7 (53.8)
4 (50.0)
15 (53.6)
Moderate
1 (14.3)
5 (38.5)
4 (50.0)
10 (35.7)
Severe
1 (14.3)
0 (0.0)
0 ( 0.0)
1 (3.6)
Skin and subcutaneous tissue 
disorders
Mild
1 (14.3)
3 (23.1)
0 (0.0)
4 (14.3)
Moderate
1 (14.3)
3 (23.1)
1 (12.5)
5 (17.9)
Severe
1 (14.3)
0 (0.0)
0 (0.0)
1 (3.6)
Abbreviations: n = Number of subjects; SD = Standard deviation; TEAE = Treatment-emergent adverse 
event.
*During the 90 first days of study treatment.
With regards to the incidence of subjects with itching, redness or swelling by grade, 
assessed by the subjects over the first 3 months of treatment, there was no clinically 
significant difference in the Viaskin® Peanut 250 μg group between the children 
6- to 7-year-old and the 10- to 11-year-old, suggesting that the younger children and the 
older children would react alike locally. Even though it seemed that subjects 
8- to 9-year-old reported less frequent local cutaneous reactions 
Regarding the Investigator skin observation assessments, the pooled incidences of 
severity of Grade 2 and 3 were similar in the 3 age ranges at the Month 3, with a slight 
trend towards less reactions for the 6-7 year old subjects.  

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
35 of 142
09 Dec 2015
The incidence of TEAEs by System Organ Class (SOC) considered treatment related 
were not clinically significantly different between the 3 age ranges, except for the SOC 
gastrointestinal disorders, with few more cases in the group of 6 to 7-year-old children. 
The data presented above support an overall conclusion that no safety concerns have 
been raised in association with the use of Viaskin® Peanut 250 μg in children, regardless
of age. This is also confirmed by the fact that no children withdrew due to AEs. 
1.2
Rationale 
Viaskin® Peanut is a ready-to-use and easy-to-administer form of allergen 
immunotherapy, particularly adapted to the pediatric population. It is intended to induce 
clinical desensitization/tolerization to peanut in subjects allergic to peanut through
interaction with the local APCs such as the epidermic Langerhans and dendritic cells. By
utilizing the epicutaneous route of administration, Viaskin® Peanut is able to initiate 
these immunomodulatory processes while minimizing the potential safety concerns 
associated with systemic exposure to peanut allergenic proteins. 
In the 12-month, Phase IIb VIPES study, among the 3 doses tested (50 μg, 100 μg and 
250 μg), the highest dose of 250 μg Viaskin® Peanut displayed a strong efficacy with the 
highest magnitude of effect in children with a good safety profile as described in Section
1.1.1.2.3. Based on these findings, Viaskin® Peanut at 250 μg used for EPIT for a 
duration of 12 months is considered to be the optimal and suitable dose for treating
children with peanut allergy. The dose of 250 ȝJZDVWKXVFKRVHQWRLQYHVWLJDWH the
efficacy of Viaskin® Peanut in children aged 4 through 11 years for this pivotal Phase III
study.
1.3
Risk-Benefit Assessment
The primary safety concern for any allergen specific immunotherapy is related to the risk 
of inducing systemic, severe or life-threatening allergic reactions. Viaskin® Peanut 
applied epicutaneously was developed in this sense, which is to dramatically reduce the 
risk of these severe systemic reactions by applying the peanut allergens on the skin and 
reaching the immune system through the cutaneous Langerhans and dendritic cells. 
Safety information from the completed Phase Ib PEP01.09 study, the Phase II 
ARACHILD study and the Phase IIb VIPES study, as well as available safety 
information from the ongoing studies OLFUS-VIPES and CoFAR6, have demonstrated a 
good safety profile for Viaskin® Peanut 250 μg in children as of 4 years of age and 
above. The expected local skin reactions triggered by Viaskin® Peanut at the site of patch 
application, which are pruritus, erythema, edema, and urticaria, are in the majority of 
cases mild or moderate and managed and controlled satisfactorily by the subjects with
topical medications containing corticosteroids. As a consequence, a very good 
compliance was shown in the studies conducted so far. 
Furthermore, especially in the Phase IIb VIPES study, Viaskin® Peanut 250 μg has 
shown a statistically significant magnitude of effect with up to 53.6% of children 
responding positively to the treatment versus 19.4% for placebo, as per the dose-finding 
study primary endpoint. In a post-hoc analysis with a higher stringent criterion for the 
treatment benefit (the same stringency is used for the primary efficacy endpoint in this 
Phase III pivotal PEPITES study), the magnitude of effect of Viaskin® Peanut 250 μg 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
36 of 142
09 Dec 2015
was even higher (46.5% response rate in the active treatment group versus 6.5% response 
rate for placebo).
Overall, the available information gathered from several clinical studies conducted in 
children with Viaskin® Peanut for several years suggest that Viaskin® Peanut 250 μg 
dose presents a favorable benefit-risk ratio.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
37 of 142
09 Dec 2015
2
STUDY OBJECTIVES
The objective of this study is to assess the efficacy and safety of Viaskin® Peanut to 
induce desensitization to peanut in peanut-allergic subjects 4 through 11 years of age 
after a 12-month treatment period by EPIT.  

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
38 of 142
09 Dec 2015
3
OVERALL DESIGN AND PLAN OF THE STUDY
3.1
Overview
This is a 12-month, Phase III, double-blind, placebo-controlled, randomized study to 
assess the efficacy and safety of Viaskin® Peanut, dosed at 250 μg peanut protein (per 
patch) in peanut-allergic male and female children from 4 through 11 years of age. 
During the maximum 6-week screening period, subjects will undergo an entry/screening 
DBPCFC to peanut to confirm their allergy to peanut and to determine their entry or 
screening peanut ED. The starting dose of the challenge will be 1 mg peanut protein and 
will escalate up to a highest dose of 300 mg peanut protein. Subjects who react at or 
below the dose of 300 mg peanut protein are considered eligible. Randomization of 
eligible subjects will occur in a 2:1 ratio to Viaskin® Peanut dosed at 250 μg peanut 
protein or placebo. An Interactive Web Response System (IWRS) will be used to ensure 
that the randomization and the allocation of treatments to subjects during the 12-month 
treatment period are performed in a blinded manner. Detailed information on study 
assessments and procedures is provided in Section 6.
Subjects randomized in the study and consenting for the genetic analysis will be 
evaluated for mutations in the filaggrin gene. 
Subjects will apply a Viaskin® patch containing either peanut or placebo daily for a
period of 12 months. At Month 12, a post-treatment DBPCFC to peanut will be 
performed, with a starting dose of 1 mg peanut protein with escalation up to a highest 
dose of 2,000 mg peanut protein. This evaluation will help determine the primary 
efficacy endpoint of this pivotal study. 
The follow-up period will comprise a maximum of 3 weeks.
The overall maximum study duration for each subject is approximately 61 weeks
(6-week screening period, 12-month treatment period and 2-week follow-up period). 
During this period, subjects will attend a total of 12 study visits, including 3 visits during 
the screening period, 8 visits during the treatment period, and 1 visit at the end of the 
follow-up period. In addition, 5 telephone contacts will be made during the treatment 
period. 
After completion of the 12-month blinded study, all subjects, including the placebo 
subjects, will be offered the opportunity to participate in an open-label extension study to 
receive an additional 24 months of treatment with active Viaskin® Peanut.
It is planned to screen approximately 470 subjects in this study to achieve 330 subjects 
randomized (220 subjects in the Viaskin® Peanut group and 110 subjects in the placebo 
group) and 280 subjects evaluable for the primary efficacy endpoint (185 subjects in the 
Viaskin® Peanut group and 95 subjects in the placebo group).  
Throughout the screening and randomization process, and to guarantee an adequate and 
sufficient representation of subjects of 4, 5 and 11 years of age (the youngest and the 
oldest of the age range), a minimum of 20 subjects of each of these 3 ages must be 
randomized. Each of these ages will thus represent a minimum of 7.5% of the overall 
number of randomized subjects. Besides, a minimum number of 75 children of either 4 
or 5 years of age must be randomized. The 4 to 5 years old subgroup will thus represent 
22.7% of the overall number of randomized subjects. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
39 of 142
09 Dec 2015
Subjects will be stratified at randomization by their entry/screening DBPCFC ED in 1 of 
the 2 strata defined below and by study center. The entry/screening DBPCFC ED strata 
are defined as follows: 
x
Stratum 1: Children with a screening ED of 1 mg, 3 mg or 10 mg;
x
Stratum 2: Children with a screening ED of 30 mg, 100 mg or 300 mg. 
The randomization scheme will ensure that the ratio of active treatment to placebo is 
maintained in each stratum. No randomization ratio will be fixed for the 2 screening ED 
strata; however, according to the Phase IIb VIPES study data, the following distribution 
could be expected:
x
1/3 of children with a screening ED from 1 mg to 10 mg;
x
2/3 of children with a screening ED from 30 mg to 300 mg.
The study will be conducted at approximately 28 to 40 centers in 4 to 7 countries in 
Australia, Europe and North America with Investigators and staff who are trained and 
experienced in the diagnosis and management of peanut allergy and anaphylaxis, and 
equipped and capable of performing a DBPCFC in children.  
Criteria for subject withdrawal and study stopping rules are described in Section 4.3.
A Data and Safety Monitoring Board (DSMB) composed of experts in food allergy and 
in the methodology of clinical studies will review study safety data at specific intervals 
during the study and on an ad hoc basis. A specific DSMB meeting will be held when the 
first 15 subjects 4 to 5 years of age have been randomized and treated for at least 4 weeks 
(that is, have completed the Month 1 visit) (see Section 9.9).
No interim analyses are planned for this study. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
40 of 142
09 Dec 2015
The Schedule of Procedures is shown in Table 7 and the study design is presented in 
Figure 1. 
Abbreviations: DBPCFC = Double-blind, placebo-controlled food challenge; EPIT = Epicutaneous 
immunotherapy; IgE = Immunoglobulin E; pp = peanut protein; SPT = Skin prick test.
Figure 1: Study Design
3.2
Criteria for Evaluation of the Study 
3.2.1
Efficacy Criteria
3.2.1.1
Primary Efficacy Endpoint 
The primary efficacy endpoint is the percentage of treatment responders at Month 12 in 
the active Viaskin® Peanut 250 μg group compared to the placebo group in the overall 
population. A subject is defined as a treatment responder if:
x
The initial ED was >10 mg peanut protein and the ED LV  mg peanut 
protein at the post-treatment DBPCFC at Month 12; or 
x
The initial ED ZDV10 mg peanut protein and the ED LV mg peanut protein 
at the post-treatment DBPCFC at Month 12. 
3.2.1.2
Secondary Efficacy Endpoint 
The following secondary efficacy endpoints will be analyzed: 
x
The percentage of treatment responders at Month 12 in the active Viaskin®
Peanut 250 μg group compared to the placebo group in each of the 2 screening 
ED strata;  
x
The percentage of treatment responders at Month 12 in the active Viaskin®
Peanut 250 μg group compared to the placebo group in each of the 2 age 
subgroups (4 to 5 years-old; 6 to 11 years-old); 
x
The mean and median cumulative reactive dose of peanut protein and change 
from baseline at Month 12 in the active Viaskin® Peanut 250 μg group versus the 
placebo group, overall and for each screening ED stratum;  

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
41 of 142
09 Dec 2015
x
The mean and median ED of peanut protein and change from baseline at 
Month 12 in the active Viaskin® Peanut 250 μg group versus the placebo group,
overall as well as in each of the 2 screening ED strata; 
x
The percentage of subjects responsive (those showing objective symptoms 
leading to DBPCFC VWRSWRDFXPXODWLYHGRVH,444 mg peanut protein at the 
post-treatment DBPCFC at Month 12 in the active Viaskin® Peanut 250 μg group 
versus the placebo group, overall as well as in each of the 2 screening ED strata;  
x
The percentage of subjects unresponsive (those showing no objective symptoms 
leading to DBPCFC stopWRDFXPXODWLYHGRVH,444 mg peanut protein at the 
post-treatment DBPCFC at Month 12 in the active Viaskin® Peanut 250 μg group 
versus the placebo group, overall as well as in each of the 2 screening ED strata; 
x
The percentage of subjects unresponsive (those showing no objective symptoms 
leading to DBPCFC stop) to the highest dose of peanut protein, which is the 
percentage of subjects who pass the post-treatment DBPCFC at Month 12 in the 
active Viaskin® Peanut 250 μg group versus the placebo group, overall as well as 
in each of the 2 screening ED strata. 
3.2.1.3
Other Efficacy Endpoints 
x
The change from baseline in peanut-specific IgE and immunoglobulin G4 
subtype (IgG4) at months 3, 6 and 12 in the active Viaskin® Peanut 250 μg group 
versus the placebo group, overall as well as in each of the 2 screening ED strata; 
x
The change from baseline in peanut skin prick testing maximum average wheal 
diameters at months 3, 6 and 12 in the active Viaskin® Peanut 250 μg group 
versus the placebo group, in the overall population; 
x
Description of the quality of life questionnaires (Food Allergy Quality of Life 
Questionnaire [FAQLQ]/Food Allergy Independent Measure [FAIM]) and 
change from baseline in FAQLQ score at Month 12 in the overall population (for 
those countries where the translated and validated questionnaires are available 
and used). 
Details of the assessment of each of the efficacy endpoints are provided in Section 6.1
and details of the corresponding statistical analysis are provided in Section 8.5.
3.2.2
Safety Criteria
The following study drug safety criteria will be evaluated:
x
AEs and treatment-emergent adverse events (TEAEs) by System Organ Class
(SOC) and Preferred Terms (PTs);
x
TEAEs by maximum severity and relatedness to Viaskin® Peanut 250 μg; 
x
Incidence, duration and maximum severity of local cutaneous Viaskin® Peanut 
250 μg-induced AEs as assessed by the subject;
x
Severity of local cutaneous Viaskin® Peanut 250 μg-induced AEs as assessed by 
the Investigator;

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
42 of 142
09 Dec 2015
x
Adverse events of special interest (AESI) including grade 4 local cutaneous 
reactions and systemic allergic AEs considered related to Viaskin® Peanut 
250 μg;
x
Serious adverse events (SAEs) by SOC and PTs, and relatedness to Viaskin®
Peanut 250 μg;  
x
Laboratory data, physical examinations and vital signs;
x
Spirometry results or Peak Expiratory Flow (PEF) results.
The above criteria will be studied in the overall Safety population, as well as for each of 
the age ranges 4 to 5 years, 6 to 8 years and 9 to 11 years, and for each of the screening 
ED strata.
Besides, the following study procedure safety criteria will be evaluated:
x
Objective symptoms elicited during the entry/screening DBPCFC and 
post-treatment DBPCFC at Month 12 by severity;
x
Change in severity of objective symptoms elicited during the DBPCFC from 
baseline to Month 12 in the active Viaskin® Peanut 250 μg group versus the 
placebo group;
x
SAEs elicited during the entry/screening DBPCFC and post-treatment DBPCFC 
at Month 12. 
Details of the assessment of each of the safety criteria are provided in Section 6.2 and 
details of the corresponding statistical analysis are provided in Section 8.6.
3.2.3
Exploratory Criteria
The following exploratory criteria will be evaluated:
x
The change from baseline in IgE and IgG4 specific to peanut protein components 
at months 3, 6 and 12 in the active Viaskin® Peanut 250 μg group versus the 
placebo group; 
x
Enumeration and characterization of reactions triggered by accidental 
consumption of peanut during the study; 
x
Analysis of “risk-taking behavior” of subjects (voluntary peanut consumption) 
during the study; 
x
Epigenetic modifications of the promoters of some specific genes; 
x
Safety sub-analysis in subjects with mutations in the filaggrin gene versus wild 
type subjects; 
x
Sensitization status to some other allergies and their evolution over the study 
period; 
x
Scoring atopic dermatitis (SCORAD) evolution over time. 
Details of the assessment of each of the exploratory criteria are provided in Section 6.4
and details of the corresponding statistical analysis are provided in Section 8.7.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
43 of 142
09 Dec 2015
3.3
Justification of the Study Design 
This study is designed to assess the efficacy and safety of Viaskin® Peanut 250 μg in 
children aged 4 through 11 years compared to placebo.  
The study design follows the International Conference on Harmonization (ICH) guideline 
on general considerations for clinical studies (34).
Subject randomization and double-blinding with regard to treatment with Viaskin®
Peanut and placebo were chosen in order to prevent bias in treatment allocation and in 
the assessment of both safety and efficacy. The use of a placebo group in this study is 
justified to obtain reliable scientific evidence for the evaluation of this new medicinal 
product.  
Peanut allergy is of increasing prevalence in children (3,4,5). It is thus anticipated that 
the selected pediatric population of peanut allergic subjects will draw a direct benefit 
from this study.  
The DBPCFC is the “gold standard” to diagnose food allergy (35). Since it carries a risk 
of inducing potentially severe allergic reactions, subjects will be appropriately selected 
for the challenge, based on their clinical history and peanut-specific IgE test results.
Subjects participating in this study must have a positive DBPCFC at 300 mg of peanut 
protein. The ED of peanut protein, that is the dose of peanut protein administered to
subjects during the DBPCFC procedure which causes an objective allergic reaction
leading to stopping the challenge, is capped to 300 mg, with the starting dose of 1 mg.
Although the average amount of peanut consumed in an accidental exposure has not been 
accurately quantified, it is generally believed to be no more than 1 to 2 peanut kernels, or 
the equivalent of approximately 300 to 600 mg of peanut protein (36,37,38). Thus, this 
study will enroll subjects who would react at or below 300 mg peanut protein with the 
objective of inducing desensitization in order to increase significantly the subjects’ 
threshold levels of peanut. 
The selected protein dose of 250 μg for treating peanut-allergic children in this Phase III 
PEPITES study is based on the safety and efficacy results for children 6 to11 years of age 
in the 12-month Phase IIb VIPES study, but also on the safety information from the 
CoFAR6 study for subjects 4 to 5 years of age (see Sections 1.1.1.2.3 and 1.1.1.2.5).
All subjects will continue with their usual peanut-free diet and label reading to avoid as 
much as possible any accidental peanut consumption during the duration of the study. 
The primary endpoint in this study will be assessed at Month 12 based on positive results 
of previous clinical studies showing evidence of desensitization with peanut EPIT after 
12 months of treatment.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
44 of 142
09 Dec 2015
4
STUDY POPULATION
The study population will consist of children with peanut allergy. Study participation will 
require consent from a legally authorized representative. Subjects must meet all the 
inclusion criteria and none of the exclusion criteria. 
All subjects will continue with their usual peanut-free diet and label reading of food 
products to avoid as much as possible any accidental peanut consumption for the 
duration of the study. 
4.1
Inclusion Criteria
Subjects will be enrolled in this study only if they meet all of the following criteria:
1. Male or female children aged 4 through 11 years at Visit 1; 
2. Physician-diagnosis of peanut allergy or children with a well-documented medical 
history of IgE-mediated symptoms after ingestion of peanut and currently following a 
strict peanut-free diet, but without a physician diagnosis; 
3. Signed informed consent of parents/guardians of the child and child’s assent (for 
children 7 years of age or as per the country-specific regulations); 
4. Negative urine pregnancy test for female subjects of childbearing potential. Female 
subjects of childbearing potential must agree and commit to use effective medical 
methods of contraception for the entire duration of their participation in the study. 
Sexual abstinence will be accepted as an effective method of contraception; 
5. Peanut-specific IgE level (ImmunoCAP system) >0.7 kU/L; 
6. Positive peanut SPT with a largest wheal diameter: 
a.
6 mm for children 4 through 5 years of age at Visit 1, 
b.
8 mm for children 6 years and above at Visit 1; 
7. 3RVLWLYH'%3&)&DW300 mg peanut protein: the ED of peanut protein during the 
entry/screening DBPCFC is capped to 300 mg, as in subjects must have objective 
IgE-mediated symptoms to peanut leading to stopping the challenge DW mg 
peanut protein; 
8. Ability to perform spirometry in accordance with the American Thoracic Society 
(ATS) guidelines 2007 (39) IRUVXEMHFWV years of age. Ability to perform peak 
H[SLUDWRU\IORZ3()PHDVXUHPHQWVIRUVXEMHFWV years of age. Subjects from 6 to 
8 years of age who have documented inability to adequately perform spirometry can 
perform the PEF measurement instead. Subjects 4 years of age can be enrolled if they 
had no clinical features of moderate or severe persistent asthma1 within 1 year prior 
to visit 1. 
1 National Heart, Lung, and Blood Institute. Expert panel report 3: guidelines for the diagnosis and 
management of asthma - summary report, 2007. Available online at: 
http://www.nhlbi nih.gov/guidelines/asthma/asthsumm.pdf. Accessed July 06, 2015.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
45 of 142
09 Dec 2015
9. Subject and/or parents/guardians willing to comply with all study requirements 
during the subject’s participation in the study. 
4.2
Exclusion Criteria
Subjects will be enrolled in this study only if they meet none of the following criteria:
1. History of severe anaphylaxis to peanut with any of the following symptoms: 
hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or 
incontinence); 
2. Pregnancy or lactation; 
3. Severe reaction during the entry/screening DBPCFC, defined as need for intubation, 
hypotension persisting after epinephrine administration, and/or the need for 3 doses 
of epinephrine; 
4. Objective IgE-mediated symptoms to the placebo formula during the entry/screening 
DBPCFC and leading to stopping the challenge; 
5. Viral upper respiratory infection or gastroenteritis within 7 days of a food challenge 
(challenge must be rescheduled to occur at least 7 days after recovery);  
6. Any clinically significant abnormality identified at the time of screening such as 
major infectious diseases (for example chicken pox, measles) which in the judgment 
of the Investigator may preclude safe participation or strict compliance with the 
protocol procedures (subjects can be considered for the study after recovery from 
these diseases);  
7. Generalized dermatologic disease (for example active atopic dermatitis, uncontrolled 
generalized active eczema, ichthyosis vulgaris) extending widely on the skin and
especially on the back with no intact zones to apply the Viaskin® patches; 
8. Symptomatic seasonal allergies that may interfere with the conduct of a DBPCFC. 
Subjects should be screened at a time when such allergies are asymptomatic (for 
example outside of the culprit season);
9. Known hypersensitivity to any of the Viaskin® patch components (except peanut),
including the adhesive film; 
10. Known hypersensitivity to any component of the food challenge formula (except 
peanut); 
11. Inability to discontinue short-acting antihistamines or long-acting antihistamines for 
the minimum wash-out periods as specified in the table in APPENDIX 4) prior to the 
skin prick testings or the food challenges; 
12. Spirometry forced expiratory volume in 1 second (FEV1) <80% of the predicted 
YDOXHDWVFUHHQLQJYLVLWIRUVXEMHFWV years of age and able to perform the 
spirometry, or PEF <80% of predicted value at screening (visit 1) for subjects 
performing only the PEF measurements.   
13. Diagnosis of asthma that fulfills any of the following criteria:

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
46 of 142
09 Dec 2015
a. Uncontrolled persistent asthma as defined by National Asthma Education and 
Prevention Program Asthma guidelines 2007 (40) or by Global Initiative for 
Asthma guidelines 2015 (41),  
b. Asthma treated with either a high daily dose of inhaled corticosteroid or with a
combination therapy of a medium daily dose of inhaled corticosteroid with a 
long-DFWLQJLQKDOHGȕ-agonist or with a combination therapy of a high daily 
dose of inhaled corticosteroid with a long-DFWLQJLQKDOHGȕ-agonist (a list of
daily dosages of inhaled corticosteroid is provided in APPENDIX 2). Asthmatic 
subjects treated with a medium daily dose of inhaled corticosteroids are eligible. 
Intermittent asthmatic subjects who require intermittent use of inhaled 
corticosteroids for rescue are also eligible, 
c. Two or more systemic corticosteroid courses for asthma in the past year or 
1 oral corticosteroid course for asthma within 3 months prior to Visit 1, or 
during screening period (unless used to treat symptoms triggered by the 
DBPCFC),
d. Prior intubation/mechanical ventilation for asthma within 1 year prior to Visit 1, 
or during screening; 
14. RHFHLYLQJȕ-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-
receptor blockers, calcium channel blockers or tricyclic antidepressant therapy; 
15. Received anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or 
any biologic immunomodulatory therapy within 1 year prior to Visit 1, during 
screening period or during study participation; 
16. Use of systemic long-acting corticosteroids within 12 weeks prior to Visit 1 and/or 
use of systemic short-acting corticosteroids within 4 weeks prior to Visit 1 or during 
screening (unless used for DBPCFC symptoms) (see APPENDIX 3); 
17. Prior or concomitant history of any immunotherapy to any food allergy (for example
EPIT, OIT, SLIT, or specific oral tolerance induction); 
18. Receiving or planning to receive any aeroallergen immunotherapy during their 
participation in the study. Aeroallergen immunotherapy must be discontinued at the 
time of Visit 1; 
19. Subject or parents/guardians of subjects with obvious excessive anxiety and unlikely 
to cope with the conditions of a food challenge; 
20. Past or currently active disease(s) which, in the opinion of the Investigator or the 
Sponsor, may affect the subject’s participation in this study or place the subject at 
increased risk during participation in the study, including but not limited to 
eosinophilic gastrointestinal disorders, autoimmune disorders, immunodeficiency, 
malignancy, uncontrolled diseases (for example hypertension, psychiatric illness,
cardiac disease), or other disorders (for example liver, gastrointestinal, kidney, 
cardiovascular, pulmonary disease, or blood disorders); 
21. Any disorder in which epinephrine is contraindicated such as coronary artery disease, 
uncontrolled hypertension, or serious ventricular arrhythmias; 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
47 of 142
09 Dec 2015
22. Subjects unable to follow the protocol requirements; 
23. Current participation in another clinical trial or participation in another clinical trial
in the last 3 months prior to visit 1; 
24. Diagnosis of mast cell disorders including mastocytosis or urticaria pigmentosa as 
well as hereditary or idiopathic angioedema;
25. Subjects receiving cyclosporine or other immunosuppressive agents within 1 year 
prior to Visit 1, or during the screening period or during study participation. Topical 
calcineurin inhibitors are permitted; 
26. Subjects with severe psychiatric, psychological or neurological disorders; 
27. Subjects being in any relationship or dependency with the sponsor and/or the 
investigator or the study staff. 
4.3
Patient Withdrawal and Replacement 
4.3.1
Criteria for Withdrawal from Study Treatment and Study 
Subjects may withdraw from the study including follow-up at any time without penalty 
and for any reason without prejudice to their future medical care.
Subjects must be withdrawn from the study treatment under the following 
circumstances:
x
Pregnancy (see Section 6.2.1.7);
x
Severe “maculo-papular rash” or severe “dermatitis” failed to be controlled by 
adequate corrective treatments (including topical corticosteroids) and in spite of 
several study treatment interruptions; 
x
Severe anaphylaxis (or stage 3 anaphylaxis) (see APPENDIX 5) related to 
Viaskin® Peanut 250 μg patch application; 
x
More than 1 epinephrine injection for an AE related to Viaskin® Peanut 250 μg
patch application (and not occurring during the DBPCFC).
If subjects are to withdraw due to pregnancy, the procedures that should be followed are 
described in Section 6.2.1.7.
Subjects may be required to withdraw from the study treatment or study after 
discussion with the Sponsor and/or Investigator for the following reasons: 
x
AE(s); 
x
At the discretion of the Investigator, if she/he decides that it is in the subject’s 
best interest to be withdrawn from the study; 
x
The subject is unwilling to continue in the study (consent withdrawal); 
x
Lack of compliance with protocol requirements and procedures; 
x
The Sponsor, Regulatory Authorities, or Independent Ethics Committees 
(IECs)/Institutional Review Boards (IRBs) for any reason, stop the study; 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
48 of 142
09 Dec 2015
x
The subject fails to return to the clinic for scheduled visits and does not respond 
to telephone or written attempts at contact (lost to follow-up); 
x
Premature termination of the entire study as described in Section 9.11.
In all cases, the primary reason for withdrawal, must be recorded in the e-CRF.
4.3.2
Study Stopping Rules
Study enrollment will be suspended pending an expedited safety review by the 
independent DSMB if any of the following occur: 
1. Any death related to Viaskin® patch dosing; 
2. More than one case of severe anaphylaxis (or stage 3 anaphylaxis) (see
APPENDIX 5) related to Viaskin® Peanut 250 μg patch application (not 
occurring during the DBPCFC);
3. More than 3 subjects requiring more than 1 injection of epinephrine for an AE
related to the Viaskin® Peanut 250 μg patch application (and not occurring during 
the DBPCFC).
Upon safety review, 1 of the following outcomes will be determined: 
x
Accrual to the study may continue without modification; 
x
Accrual to the study may continue with modifications as prescribed by the 
DSMB;
x
Accrual to the study should be discontinued. 
4.3.3
Replacement of Withdrawn Subjects
Subjects who withdraw prematurely after having been randomized and having received 
at least 1 dose of the study drug will not be replaced. 
4.3.4
Data Collection and Follow-up after Withdrawal 
If a subject is prematurely withdrawn from the study drug for any reason before 
completing all study visits, the Investigator must make every effort to perform the 
evaluations described for the Early Termination Visit (see Section 7.2.12). The 
Investigator must furthermore complete all appropriate subject diary and e-CRF pages, 
providing the date and explanation for the subject’s withdrawal/discontinuation. When 
indicated, the Investigator must arrange for appropriate follow-up and/or alternative 
medical care of the discontinued subject. 
If the subject fails to attend a scheduled End of Study Visit, there will be at least 
2 attempts to contact the subject’s parents/guardians via telephone and written 
communication. If these receive no reply, the subject will be considered as lost to 
follow-up. 
4.4
Planned Sample Size and Number of Study Centers
It is planned to randomize 330 subjects at 28 to 40 centers in 4 to 7 countries for this 
study. See Section 8.10 for a discussion of sample size. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
49 of 142
09 Dec 2015
4.5
Patient Identification and Randomization
4.5.1
Patient Identification
At screening, each subject will receive a unique, 4-digit, screening number. Screened
subjects who drop out of the study before randomization will retain their screening 
number. The screening number for each subject will be a combination of the 2-digit site 
number plus the 2-digit number assigned to the subject according to her/his 
chronological order of screening at that site. The screening number will be used as the 
subject identifier throughout the study.  
4.5.2
Randomization Scheme 
An IWRS will randomize subjects and assign the appropriate treatment number or kit 
number. Subjects will be randomized on a 2:1 basis to Viaskin® Peanut 250 μg or 
placebo.  
Randomization will be stratified by center and by screening ED and managed centrally.
The randomization scheme will ensure that the ratio of active treatment to placebo is 
maintained in Stratum 1 (children with a screening ED from 1 mg to 10 mg) and Stratum 
2 (children with a screening ED from 30 mg to 300 mg).
No randomization ratio will be fixed for the 2 screening ED strata; however, according to 
the Phase IIb VIPES study, the following distribution could be expected: 
x
1/3 of children with a screening ED from 1 mg to 10 mg;
x
2/3 of children with a screening ED from 30 mg to 300 mg.
The randomization codes will be maintained by IWRS. 
Blinding and breaking the blind procedures are described in Section 5.4. 
4.5.3
Allocation/Randomization of Patients to Treatment 
Randomization of subjects to treatment will occur at Visit 4 after all screening 
procedures have been performed and eligibility for the study confirmed. Each 
randomized subject will be assigned by the IWRS a kit number based on a pre-defined 
algorithm/pre-defined randomization list.  

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
51 of 142
09 Dec 2015
Figure 2: Schematic Representation of Viaskin® Patch Application on the Back of the Subjects
To better ensure the safety of the Viaskin® patch at the initiation of treatment, the
duration of application of the Viaskin® patch will be progressively increased as follows:  
x
During the first week (from Day 1 through Day 7), the patches will be applied for 
6 hours every day; 
x
During the second week (from Day 8 through Day 14), the patches will be 
applied for 12 hours every day; 
x
From the third week onwards (Day 15), the patches will be applied for the entire 
24 hours. 
If possible, the subjects should take advantage of their shower/bath time to change the 
patch. The previous Viaskin® patch should be removed just before the shower/bath, and 
the new Viaskin® patch should be applied a few minutes after the shower/bath and after 
drying the skin. Application of the Viaskin® patch at a similar time for each daily 
application (morning or evening) is recommended. If the subject does not bathe or 
shower daily or at the same time daily, it is recommended that the zone to which the 
patch will be applied be cleaned with a moist disposable napkin or tissue and dried prior 
to application. 
A Viaskin® patch must not be re-applied. In case the Viaskin® patch comes off, it should 
be immediately discarded.  
A new patch can be applied the same day to replace the previous patch that came off only 
if that patch came off within 2 hours after being applied. However, no new patch should 
be applied the same day if the previous patch came off more than 2 hours after being 
applied. In that case, a new patch will be applied once 24 hours have passed since the 
previous patch (the one that came off) was applied. After the Viaskin® patch comes off, 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
52 of 142
09 Dec 2015
or after removing a Viaskin® patch to apply a new one, it is recommended that the 
subject’s parents/guardians wipes the zone with a moist disposable napkin or a moist 
disposable tissue and then washes her/his hands to prevent accidental manual 
transmission of peanut protein.  
After the first application of the Viaskin® patch at the study site, all subjects will be 
observed for 3 hours before being discharged in order to check and grade any reactions
under or around the patch. 
Because the study includes children aged 4 through 5 years, additional safety measures 
have been adopted and generalized to all ages. On Day 4 and on Day 22, specific phone 
contacts will be made to the parents/guardians to assess the safety of patch applications 
on the back. If required, the subjects may come to the site sooner than planned to be seen 
and evaluated by the Investigator.
Of note, the recommended duration of daily Viaskin® patch application is 24 hours of 
application per day. However, any daily duration of Viaskin® patch application of 
24 hours ± 4 hours will be allowed. 
5.2.1
Adjustment of Viaskin® Patch Application in Case of Local or Systemic 
Reactions
When subjects are unable to apply the Viaskin® patch for the recommended durations as 
described above because of local intense or severe reactions, under or adjacent to the 
patch site, the patch should be removed immediately, the site of application wiped with a 
moist disposable tissue and a topical corticosteroid medication might be topically applied 
to treat the reaction. The parents/guardians should take a photo of the back of the subject
to document how intense and extended the local reactions are. In the specific case of 
local intense or severe reactions, it is mandatory that the next Viaskin® patch is applied 
only the next day on the next zone; no other Viaskin® patch must be applied the same 
day. In case of re-appearance of the local intense or severe reactions after application of 
the next patch the following day, the patch must again be removed. The next Viaskin®
patch should be applied only the next day on the next zone. And the same process is 
repeated every day after patch application in case of local intense or severe reactions. 
As a consequence, the daily duration of Viaskin® patch application should be 
adjusted/reduced as necessary, and subjects may need more than the 14 days previously 
described before they can apply and tolerate the Viaskin® patch for the full 24 hours 
daily. 
In case of any suspected systemic reactions related to patch application (including 
cutaneous reactions distant from the sites of patch application), the same safety 
precautions should be followed: the Viaskin® patch is removed immediately, the site of 
application wiped with a moist disposable tissue and a treatment can be given to treat the 
reaction: antihistamines or topical corticosteroids with additional oral corticosteroids or 
similar anti-allergic drugs, as deemed necessary by the Investigator. The next Viaskin®
patch should be applied the next day on the next zone. As a consequence, the daily 
duration of patch application should be adjusted/reduced as necessary, and subjects may 
need more time than initially defined before they can apply the Viaskin® patch for the 
full 24 hours daily. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
53 of 142
09 Dec 2015
The subject’s parents/guardians will be instructed to contact the Investigator in case of 
intense or severe local reactions lasting for more than 1 day or any unexpected reactions 
during the treatment period, in particular in case of appearance of vesicles under the 
Viaskin® patch or close to the Viaskin® patch site application. It is then recommended 
that the parents/guardian take a photo of the back of the subject to document these 
intense or severe reactions.
5.2.2
Safety Precaution Information 
A leaflet with safety precautions for using the Viaskin® patch and instructions to follow 
in case of any safety issue will be given to each subject. This safety leaflet will specify at 
least the following information:
1. Instructions and procedures to apply the patch safely and correctly in the back of 
the subject;
2. Necessity to call the investigative site staff in case of intense or severe local 
reactions lasting for more than 1 day or any unexpected reactions during the 
treatment period, in particular any appearance of vesicles/blisters under the patch 
or close to the area of patch application and a recommendation to take photos of 
the site of application to document such a situation; 
3. Necessity to call the investigative site staff in case of occurrence of chicken pox 
or measles. At the same time, interruption of patch application until recovery;
4. In case of active eczema extending on the back of the child: stop applying the 
patch until recovery from the active eczema on the back; 
5. Anaphylaxis Emergency Action Plan in case of a suspected anaphylactic reaction
and how to administer the epinephrine auto-injector to rapidly treat the reaction;
6. Subject stopping rules (subject are consequently withdrawn): 
a.
Severe “maculo-papular rash” or severe “dermatitis” at sites of patch 
application not controlled by topical corticosteroids, 
b. Severe anaphylaxis related to Viaskin® Peanut 250 μg patch application 
confirmed by an expedited safety review. 
c.
More than 1 epinephrine injection in relation to Viaskin® Peanut 250 μg
patch application (and not occurring during DBPCFC). 
5.3
Packaging, Labeling and Storage 
The study drug (active and placebo) will be packaged and labeled by CREAPHARM 
(Bordeaux, France) in accordance with applicable local regulatory requirements. One 
Viaskin® patch will be placed per pouch and each pouch will be labeled. The labeled 
pouches will be placed in labeled treatment boxes to be dispensed to subjects at each 
visit, with enough quantity of Viaskin® patches to cover the period between 
2 consecutive visits. 
The labeled and packaged study drug must be stored in accordance with the Sponsor’s 
instructions (in the monitored refrigerator between 2°C and 8°C [35.6°F to 46.4°F]. 
Shipments from depots to clinical sites will be performed at refrigerated temperature 
between 2°C to 8°C [35.6°F to 46.4°F] with a temperature monitoring device. Storage at 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
54 of 142
09 Dec 2015
ambient temperature for short and/or intermittent periods of time, including 
transportation from the clinical site to the subject’s home, is permitted.
Upon receipt of a shipment request via IWRS, the study drug will be shipped to the 
clinical site. The site pharmacist or any other staff member designated for this task will 
receive and store the study drug until the time of dispensing it to the Investigators. Until 
dispensed by the Investigator to the subjects, the study drug will be stored in a securely 
locked area, accessible to authorized personnel only. At the end of the study, or at times 
designated by the Sponsor, and after complete accountability, the site pharmacist or the 
designated person will be responsible for preparing the return of the unused study drug to 
the study drug distributor. Destruction of study drug on-site should be avoided. However, 
in some cases, and upon authorization from the Sponsor, destroying the unused study 
drug on-site, with provision of a corresponding certificate of destruction, may be 
allowed. 
5.4
Blinding and Breaking the Blind
The study will be performed in a double-blind manner. Active and placebo Viaskin®
patches will be supplied in identical pouches and will be similar in physical appearance, 
thereby enabling double-blind conditions. 
The treatment codes will be held according to the IWRS. Further instructions for 
emergency code break will be provided in a separate IWRS Manual. 
The study blind should not be broken except in a medical emergency (where knowledge 
of the study drug received would affect the treatment of the emergency) or due to a 
regulatory requirement (for example for suspected unexpected serious adverse reactions). 
The blind will only be broken at the discretion of the Investigator, and if possible, 
following discussion on a case-by-case basis with the Sponsor/Medical Monitor. All calls 
resulting in an unblinding event will be recorded and reported by the IWRS to the 
Medical Monitor and the Sponsor. 
In case of IWRS failure, a backup system is operated 24 hours every day of the year by 
the Sponsor enabling unblinding of treatment by calling the following universal toll free 
DBV Technologies numbers: 
Germany and Ireland:    
Canada and USA:                  
Australia: 
If the blind is broken, the date, time, and reason must be recorded in the subject’s source 
documents, in the e-CRF and any associated AE must be reported.  
If an Investigator, site personnel performing assessments, or subject (parents/guardians), 
is unblinded, the subject must be listed as major protocol deviation and will be 
withdrawn from the study.
Serious unexpected suspected adverse reactions, which are subject to expedited 
reporting, will be unblinded by the Sponsor before submission to the Regulatory 
Authorities.
PPD

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
55 of 142
09 Dec 2015
The overall randomization code will be broken only for reporting purposes. This will 
occur once all final clinical data have been entered into the database and all data queries 
have been resolved, the e-CRF has been signed and locked, and the assignment of 
subjects to the analysis sets has been completed.
5.5
Drug Accountability
The Investigator is responsible for maintaining accurate study drug accountability 
records throughout the study. Each site will have to complete a site study drug 
accountability log and an individual study drug accountability log for each subject. These 
records should include the amounts and dates that study drug supplies were received
on-site, dispensed to the subject, returned by the subject, and returned to study drug 
distributor (or destroyed on-site, if applicable). 
Each dispensing of study drug will be documented in the e-CRF via IWRS.
5.6
Compliance
It is the Investigators’ responsibility to ensure that subjects (parents/guardians) are 
correctly instructed on how to store and administer the study drug. Records of study drug
used and intervals between visits will be kept during the study. Drug accountability will 
be monitored by PAREXEL’s site monitor during site monitoring visits and at the 
completion of the study. Subjects (parents/guardians) will be asked to return their unused 
study drug (boxes) when they come back for their study visits. All unused study drug 
(boxes) should be returned at the end of the study to the study drug distributor. The study 
drug should be dispensed by the Investigator, or by a qualified individual under the 
Investigator’s supervision. An up-to-date treatment inventory/dispensing record must be 
maintained (see Section 5.5).
At each visit, prior to dispensing the study drug, previously dispensed study drug will be 
retrieved by the Investigator and compliance assessed. A global compliance of 80% 
over the whole treatment period is sought. Global compliance is defined as the total 
number of patches applied in the treatment period versus the number of days in that 
period of time. Compliance at each visit is to be calculated taking into account the total 
number of patches applied since the last visit versus the number of days in that period of 
time. Subjects exhibiting poor compliance (below 80%) at any specific time point during 
the treatment period should be counseled on the importance of good compliance to the 
study dosing regimen. 
Subjects who are persistently non-compliant will be withdrawn from the study.
5.7
Viaskin® Patch Adhesion
An evaluation of the Viaskin® patch adhesion will be conducted. The assessment of the 
patch adhesion to the skin will consist of a 28-day specific analysis to occur between 
Month 3 and Month 6 (whenever possible, these should be consecutive days). This 
assessment period can be extended up to Month 9 in case it has not been completed 
between Month 3 and Month 6 (see Section 6.2.9).

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
56 of 142
09 Dec 2015
5.8
Prior and Concomitant Medication 
Any medication the subject takes other than the study drug, including herbal and other 
non-traditional remedies, is considered as concomitant medication. Any medication used 
in the last 6 months or being administered at the time of screening is considered as prior 
medication.  
At screening, subjects will be asked what medications they have been taking during the 
last 6 months. At each subsequent study visit, subjects will be asked what concomitant 
medications they are currently taking. All concomitant and prior medications must be 
recorded in the e-CRF. 
The following information must be recorded in the e-CRF for each prior and concomitant 
medication: generic name, route of administration, start date, stop date, dosage, total 
daily dose, and indication. Any changes in the dosage or regimen of a concomitant 
medication must be recorded in the e-CRF. 
Of note, prior or concomitant medication prescribed to a subject but not actually taken or 
administered should not be reported in the e-CRF, such as the epinephrine auto-injector 
prescribed for use in case of anaphylaxis but never injected intramuscularly. 
5.8.1
Permitted Concomitant Medication 
Application of a topical corticosteroid to treat any local condition (eczematous lesions, 
pruritus, edema, etc.) is allowed and should be recorded as concomitant medication. For 
local reactions to the Viaskin® patch, a topical medication (ointment, gel, cream) with 
1% hydrocortisone or equivalent will be distributed to each randomized subject at 
discharge on Day 1. In case the 1% hydrocortisone topical medication is not sufficient to 
treat the local reaction, a topical medication containing a more potent corticosteroid can 
be prescribed and locally applied. 
Oral antihistamines or oral corticosteroids are allowed to treat conditions determined as 
being allergic reactions and should be recorded as concomitant medications. These 
treatments should be limited in duration and stopped as soon as the condition has 
resolved. The Investigator will determine the best choice of treatment, the dose and the 
regimen according to the subject’s age, and the type and the degree of severity of the 
reactions. Cetirizine is recommended as the oral antihistamine of choice.
Intramuscularly injectable epinephrine (EpiPen® or Twinject® or AnaPen®, or any other 
trade name available at the right dosage in the different countries) (auto-injector) will be 
distributed to each subject at discharge on Day 1 to be used in case of symptoms of 
anaphylaxis. The Investigator will explain to the subject/parents/guardians when and how 
to (self) inject the epinephrine according to the Anaphylaxis Emergency Action Plan 
which will also be given to the subject. The intramuscularly injectable epinephrine will 
be replaced if used or if it expires. Any use of injectable epinephrine should be recorded 
as a concomitant medication.
All other treatments prescribed by the Investigator or any other physician to treat any 
conditions are also permitted. Medications that are not noted in the Section 5.8.2 are also 
permitted. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
57 of 142
09 Dec 2015
5.8.2
Prohibited Prior and Concomitant Medication
Prohibited prior and concomitant medications as outlined in the exclusion criteria 
(Section 4.2) are the following: 
x
Short-acting antihistamines or long-acting antihistamines taken must be washed 
out for the minimum period of time specified in the table in APPENDIX 4 prior 
to the skin prick testing or to the food challenges; 
x
Treatment with a high daily dose of inhaled corticosteroid or treatment with a
combination therapy of a medium daily dose of inhaled corticosteroid with a 
long-DFWLQJLQKDOHGȕ-agonist or treatment with a combination therapy of a high 
daily dose of inhaled corticosteroid with a long-DFWLQJLQKDOHGȕ-agonist (a list 
of dosages of inhaled corticosteroids is provided in APPENDIX 2. 
x
Two or more systemic corticosteroid courses for asthma taken in the year prior to 
Visit 1 or 1 oral corticosteroid course for asthma taken within 3 months prior to 
Visit 1, or during screening period (unless used to treat symptoms triggered by 
the DBPCFC); 
x
ȕ-blocking agents, angiotensin-converting enzyme inhibitors, 
angiotensin-receptor blockers, calcium channel blockers or tricyclic 
antidepressant therapy, during the screening period or during study participation; 
x
Anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any 
biologic immunomodulatory therapy taken within 1 year prior to Visit 1, during 
screening period or during study participation; 
x
Cyclosporine or other immunosuppressive agents used within 1 year prior to 
Visit 1, during the screening period or during the study participation. Topical 
calcineurin inhibitors are permitted,
x
Systemic long-acting corticosteroids used within 12 weeks prior to Visit 1 and/or 
systemic short-acting corticosteroids used within 4 weeks prior to Visit 1 or 
during screening (unless used for DBPCFC symptoms); 
x
Any prior or concomitant immunotherapy administered to any food (for example
EPIT or OIT or SLIT or specific oral tolerance induction); 
x
Any aeroallergen immunotherapy administered during study participation.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
58 of 142
09 Dec 2015
6
VARIABLES AND METHODS OF ASSESSMENT
The efficacy, safety and exploratory endpoints are listed in Section 3.2. The Schedule of 
Procedures is provided in Table 7. 
6.1
Efficacy Variables 
6.1.1
Response to Treatment – DBPCFC to Peanut 
The DBPCFC to peanut will be performed at study entry and post-treatment at Month 12 
in order to assess the primary efficacy endpoint (percentage of treatment responders in 
the active Viaskin® Peanut 250 μg group compared to the placebo group), the main 
secondary efficacy endpoint (percentage of treatment responders in the active Viaskin®
Peanut 250 μg group compared to the placebo group in each screening ED stratum), as 
well as the other secondary efficacy endpoints (mean and median cumulative reactive/ED
of peanut protein and change from baseline at Month 12; percentage of subjects 
UHVSRQVLYHXQUHVSRQVLYHWRDFXPXODWLYHGRVH,444 mg peanut protein at Month 12; 
percentage of subjects unresponsive to the highest cumulative dose of peanut protein at 
Month 12). 
The DBPCFC is the gold standard to diagnose and assess food allergy. The challenges 
will occur over 2 days; the subject will be gradually fed increasing amounts of 
standardized blinded oral formulas containing either peanut protein during one of the two 
days of the challenge, or without any peanut protein during the other day of the 
challenge, or vice et versa. Challenges must take place under direct medical supervision 
in a hospital/clinic setting with resuscitation equipment and emergency medications and 
staff immediately available. An IV line can be established prior to the challenge when 
judged necessary by the Investigator. In that case, a local anesthetic cream can be used 
for establishing the IV line. If a site prefers to have the subjects come to the hospital the 
day before the conduct of the DBPCFC, to get them ready for the following day, this is 
allowed and will not be considered an SAE. 
Subjects should wash out any antihistamines for the minimum period of time specified in 
the table in APPENDIX 4) prior to performing the DBPCFC. 
Subjects will not be allowed to use long-acting E2-agonists within 36 hours prior to the 
DBPCFC. Subjects who received more than a 3-day course of systemic corticosteroids 
within 4 weeks of the DBPCFC should have the DBPCFC delayed to allow for 4 weeks 
of corticosteroid wash-out. If a subject has a reaction during the first day of the DBPCFC 
that requires treatment with systemic corticosteroids on the first day, the subject has to 
wait at least 3 days before performing the second day of the DBPCFC. 
The subject should have a light breakfast and may drink water at home at least 2 hours 
before starting the DBPCFC at the site. During the conduct of the challenge, no food 
other than the challenge formulas should be consumed by the subject. Drinking a sip of 
water to help swallow the formulas during the challenge, if necessary, is allowed. 
After the last dose of the challenge formula is administered, the medical staff should wait 
at least 1 hour before feeding the subject with any other food and/or water. This first
feeding should be light. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
60 of 142
09 Dec 2015
Subjects will receive 1 formula (placebo or peanut) on the first day and the other formula 
(peanut or placebo) on the second day. All subjects will undergo both days of the 
DBPCFC. The second day of a challenge might not be performed if the subject reacted 
severely or seriously during the first day of the challenge, leaving no doubt about the 
nature of the formula administered, which is peanut (i.e. need for intubation, hypotension 
persisting after epinephrine administration, and/or the need for  doses of epinephrine). 
In this rare case and in this case only, the formula will be unblinded to confirm that the 
subject received the peanut formula. 
At the end of the second day of challenge, the sequence of the 2 formulas given on the 
2 days will be unblinded and revealed to the medical staff by the unblinded study-trained 
person responsible for reconstituting the formulas and the results of the challenge will be 
established following the decision making algorithm below: 
1. The subject had objective IgE-mediated symptoms to the placebo formula at any 
dose of the challenge. She/he cannot be randomized in the study; 
2. The subject had no objective IgE-mediated symptoms during the 2 days of the 
DBPCFC, neither to the placebo nor to the peanut formulas, even at the 300 mg 
dose of peanut protein. She/he cannot be randomized in the study; 
3. The subject had no objective symptom when receiving placebo but had an 
objective symptom at 1 of the doses of the peanut formula consumed between 
1 mg and 300 mg inclusive. She/he will be randomized in the study in the 
screening ED stratum that corresponds to the subject’s ED. 
Only clear-cut OBJECTIVE immediate-type symptom(s) requiring treatment will 
be considered as a reason to stop the challenge and to determine the eliciting dose 
(highest dose given during the challenge) as well as the Cumulative Reactive Dose 
(CRD) of peanut protein. Subjective symptoms will be graded but shall not count to 
stop the challenge.
The OFC Symptom Score Sheet in the protocol APPENDIX 6 will be used to score the 
severity of each symptom (classified under the 5 categories: Skin, Upper respiratory, 
Lower Respiratory, Gastrointestinal and Cardiovascular/Neurologic).  

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
61 of 142
09 Dec 2015
More specifically, the food challenge must be stopped if:
x
7KHUHLV-point rise in an objective symptom from 1 category in the OFC Symptom 
Score Sheet with the following exceptions:  
The followings require a >1-point rise to stop the challenge if present alone
o
Urticaria 
o
Rash
o
Laryngeal (if explained and not persistent)  
The followings require a >2-point rise to stop the challenge if present alone:
o
Pruritus
o
Sneezing/Itching 
o
Nasal Congestion  
o
Rhinorrhea 
o
Conjunctivitis
x
7KHUHLV-SRLQWULVHLQDQREMHFWLYHV\PSWRPIURP categories in the OFC 
Symptom Score Sheet with the following exceptions: 
7KHIROORZLQJH[FHSWLRQVUHTXLUHD point rise in one of these symptoms plus a 
-point from another category: 
o
Pruritus
o
Sneezing/Itching
o
Nasal Congestion 
o
Rhinorrhea 
o
Conjunctivitis
Conjunctivitis (erythema of the conjunctiva) is not mentioned in the OFC Symptom 
Score Sheet but is an objective symptom that could appear during the challenges and is 
pre-specified in the e-CRF. Please also report in the e-CRF with a grade when this 
occurs, together with any other symptoms that could occur during the challenge.  
In case of symptoms that develop but do not meet stopping rules, consider allowing 30 
additional minutes to see if the reactions subside or progress to meet stopping criteria. 
You can also repeat the dose or step up at your discretion.  
Further details are provided in the study-specific Manual of Procedures for the DBPCFC 
that will be provided to the sites. 
In case of subjective symptoms, for example mouth pruritus, throat pruritus, nausea, 
abdominal pains or any other subjective symptoms, the severity of which might signify 
that objective symptoms are developing according to the Investigator’s judgment, the 
time between the previous dose and the next dose might be extended to see how the 
subject’s symptoms evolve. The same dose of peanut protein can be repeated to check 
whether the subjective symptoms reappear or not and with what severity, or whether 
objective symptoms now appear. If objective symptoms meeting stopping rules appear, 
they should be treated and the food challenge will be stopped. The dose given that 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
62 of 142
09 Dec 2015
triggers the objective symptoms is considered the ED. If only subjective symptoms 
persist even after the repeated dose, the next planned peanut protein dose is then given to 
the subject, and the challenge should continue until the appearance of clear objective 
symptoms meeting stopping rules, at which time the challenge will be stopped and the 
symptoms treated. 
As a safety precaution, the objective symptoms signaling the end of the DBPCFC will be 
treated. The medication used will be left to the Investigator’s judgment. 
The Investigator and medical staff will use their own clinical judgment for the most 
effective treatment to give to the subject considering her/his age, the type of the allergic 
reactions and their severity. Also refer to recommendations made by Sampson et al. for 
treating anaphylaxis (42).
Suggested treatments for the different objective symptoms are detailed in the 
study-specific Manual of Procedures for the DBPCFC provided to the sites. 
Should epinephrine need to be administered, it should be injected intramuscularly in the 
anterolateral thigh using auto-injectors commercially available in each specific 
site/country. Intravenous epinephrine should NOT be considered at the investigative sites 
to treat the reactions.  
Subjects will be kept under observation for an additional 3 hours after the ingestion of 
the last dose of the challenge formula. Based on the Investigator’s judgment, the 
observation period could be extended beyond the first 3 hours to ensure that all 
symptoms have subsided before the subject is discharged. For instance, an overnight stay 
may be considered necessary by the Investigator if the symptoms have not completely 
resolved within the 3 hours or if the symptoms have been severe or serious and require 
longer observation periods. 
Complete information for all reactions will be reported first in source documents then in 
the e-CRF, along with doses given, symptoms observed and their highest grades, time of 
appearance of the symptoms and an Investigator’s assessment of the ED. 
6.1.1.4
Post-treatment DBPCFC to Peanut at Month 12 
The DBPCFC at Month 12 is conducted following exactly the same procedures as for the 
entry/screening DBPCFC. However, it is not stopped at the 300 mg dose. The challenge 
must instead be continued up to the last dose of 2,000 mg peanut protein or until 
objective reactions leading to stopping the DBPCFC occur. 
Only clear-cut OBJECTIVE immediate-type symptom(s) requiring treatment will 
be considered as a permissible reason to stop the challenge and to determine the eliciting 
dose (highest dose given during the challenge) as well as the Cumulative Reactive Dose 
(CRD) of peanut protein. Subjective symptoms will be graded but shall not count to 
stop the challenge. The same instructions provided above to stop the challenge at the 
entry challenge will be followed to stop the challenge post-treatment.
During the duration of the study, DBPCFCs to other foods cannot be conducted for any 
randomized subject.  

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
63 of 142
09 Dec 2015
6.2
Safety Variables 
6.2.1
Adverse Events
Coding of AEs will be performed as described in Section 9.4.
6.2.1.1
Collection of Adverse Events
It is the responsibility of the Investigator to collect all AEs (both serious and non-serious) 
derived by spontaneous, unsolicited reports of subjects, by observation and by routine 
open questionings, for example "How have you felt since I last saw you?". 
6.2.1.2
Definitions
An AE is any untoward medical occurrence that occurs in a patient or clinical 
investigation subject administered a pharmaceutical product, and which does not 
necessarily have to have a causal relationship with this treatment. An AE can therefore 
be any unfavorable and unintended sign (including abnormal laboratory finding), 
symptom, or disease temporally associated with the use of an investigational product, 
whether or not considered related to the product. 
All AEs, including intercurrent illnesses, occurring during the study will be documented 
in the e-CRF. Concomitant illnesses, which existed before entry into the study, will not 
be considered AEs unless they worsen during the treatment period. All AEs, regardless 
of the source of identification (for example physical examination, laboratory assessment, 
electrocardiogram [ECG], reported by subject), must be documented. 
Pre-existing conditions will be recorded in the e-CRF on the Medical History or
appropriate page.  
A TEAE will be defined as an AE that begins or that worsens in severity after at least 
1 dose of study drug has been administered.
A pretreatment-emergent AE will be defined as an AE that begins or that worsens in 
severity after the first screening visit, but before the first dose of study drug has been 
administered.
AEs and TEAEs due to DBPCFC will also be recorded in the e-CRF but will be analyzed 
separately.
6.2.1.3
Assessment of Adverse Events 
Each AE will be assessed by the Investigator with regard to the following categories.
6.2.1.3.1 Seriousness 
An SAE is defined as any untoward medical occurrence that at any dose:
x
Results in death; 
x
Is life-threatening; This means that the subject is at risk of death at the time of the 
event; it does not mean that the event hypothetically might have caused death if it 
were more severe;
x
Requires hospitalization (overnight or longer) or prolongation of existing 
hospitalization;
x
Results in persistent or significant disability or incapacity;

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
64 of 142
09 Dec 2015
x
Is a congenital anomaly or birth defect;
x
Is an important medical event that may not be immediately life-threatening or 
result in death or hospitalization but that may jeopardize the subject or require 
intervention to prevent one of the above outcomes. Examples of such events are 
intensive treatment in an emergency room or at home for allergic bronchospasm; 
blood dyscrasias or convulsions that do not result in hospitalization; or 
development of drug dependency or drug abuse. 
Medical and scientific judgment should be exercised in deciding whether a case is 
serious and whether expedited reporting is appropriate.
Events associated with hospitalization for the following will not be considered as an 
SAE:
1. Evaluation or treatment of a pre-existing and non-exacerbating condition as long as 
the condition is associated with the hospitalization:
a. Existed prior to the subject’s entry into the study and has been recorded in the 
subject’s disease/medical history as documented in the e-CRF, 
b. Has not worsened in severity or frequency during the subject’s exposure to 
study drug, 
c. Has not required a change in treatment management during the subject’s 
exposure to the study drug; 
2. Elective or pre-planned treatment of a pre-existing and non-exacerbating condition; 
3. Early hospitalization of a subject the day prior to the day of DBPCFC in order to 
have the subject prepared in advance.
6.2.1.3.2 Severity
The severity of each AE must be assessed by the Investigator using 1 of the following 
categories, and recorded in the e-CRF: 
x
Mild: The AE was transient and easily tolerated by the subject;
x
Moderate: The AE caused discomfort and interference with the subject's general 
condition; 
x
Severe: The AE caused considerable interference with the subject's general 
condition and may have been incapacitating.
6.2.1.3.3 Causality
The Investigator will assess the causality/relationship between the study drug and the AE 
and record that assessment in the source documents and in the e-CRF.  
The most likely cause of an AE/SAE (for example disease under treatment, concomitant 
disease, concomitant medication, other) will be indicated in the e-CRF with details of the 
concomitant disease or medication or other cause.
The causal relationship of the AE to study drug will be described in terms of:
x
Related: the AE:
o
Follows a clear temporal sequence from administration of the study drug. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
65 of 142
09 Dec 2015
o
Has no other possible explanations, such as the subject’s clinical state, 
environmental or toxic factors or other therapies administrated to the 
subject.
o
Disappears or decreases on cessation or reduction in dose of the study 
drug. 
o
Follows a clear pattern of response to the study drug. 
o
Reappears or worsens upon rechallenge. 
x
Probable: the AE: 
o
Follows a reasonable temporal sequence from administration of the study 
drug. 
o
Could not be reasonably explained by the subject’s clinical state, 
environmental or toxic factors or other therapies administrated to the 
subject.
o
Disappears or decreases on cessation or reduction in dose of the study 
drug. 
o
Follows a known pattern of response to the study drug. 
o
Reappears or worsens upon rechallenge. 
x
Possible: the AE:
o
Follows a reasonable temporal sequence from administration of the study 
drug. 
o
Could be reasonably explained by the subject’s clinical state, 
environmental or toxic factors or other therapies administrated to the 
subject.
o
Follows a known pattern of response to the study drug. 
x
Unlikely: the AE
o
Does not follow a reasonable temporal sequence from administration of 
the study drug. 
o
Could be reasonably explained by the subject’s clinical state, 
environmental or toxic factors or other therapies administrated to the 
subject.
o
Does not follow a known pattern of response to the study drug. 
o
Does not reappear or worsen upon rechallenge.
x
Not related:
o
The AE does not meet the above criteria.
o
There is sufficient information that the etiology of the AE is not related to 
the study drug. 
The study conduct relatedness for SAEs will also be assessed and documented.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
66 of 142
09 Dec 2015
6.2.1.3.4 Local Skin Reactions 
The incidence, duration and maximum severity of skin reactions induced by the study 
drug will be reported by the subject (parents/guardians) in the diary. Photos of these local 
reactions should be taken at home by the parents/guardians. Additionally, the 
Investigator will assess the severity of local skin reactions induced by the study drug at 
each site visit during the physical examination and photos should be taken during the site 
visits by the medical staff to document these local skin reactions (see Sections 6.2.4 and 
6.2.8). 
6.2.1.3.5 Adverse Events of Special Interest
Adverse events of special interest to Sponsor in this study include grade 4 local skin 
reactions seen under the patch while the patch is still applied on the skin or upon removal 
of the patch from the skin. Skin reactions will be examined at the time points specified in 
the Schedule of Procedures (Table 7) according to grading in Table 6 (Section 6.2.8). 
Specifically, the appearance of any vesicles or ulcerative skin lesions or any other 
significant skin lesion which could potentially lead to skin barrier disruption at sites of 
Viaskin® patch applications will be considered AESI. Subjects (parents/guardians) will 
be instructed to take a photograph in case of appearance of any vesicles or ulcerative skin 
lesions. In these rare specific cases, subjects should transiently discontinue patch 
application and return to the site for evaluation and treatment of the wounded area, as 
well as for the next patch application and adequate evaluation and treatment of the 
wounded zone.
Upon re-application of the new patch, the subject should remain at the site for 1 hour 
before being discharged. The site must contact the subject (parents/guardians) by phone 
the day after this visit to ensure that no additional local blisters or vesicles developed and 
to confirm that the treatment can continue normally. 
Any occurrence of IgE-mediated systemic-type of symptoms distant from the patch 
application site and considered at least possibly related to the study drug will also be 
considered as AESI and analyzed specifically as such at the end of the study at the time 
of the final analysis of study results. 
6.2.1.3.6  Symptoms during to the Double-blind, Placebo-controlled Food Challenge 
The severity of the objective and subjective symptoms elicited during the entry and 
post-treatment DBPCFC will be assessed by the Investigator. These objective and 
subjective symptoms assessed by the Investigator will not be reported in the AE pages of 
the e-CRF. Complete information for all these symptoms will be reported in the 
DBPCFC pages of the e-CRF, along with all peanut protein doses given, the symptoms 
observed and their highest grades, time of appearance of the symptoms, the doses of 
epinephrine with an auto-injector given, the doses of corticosteroids and antihistamines 
given and the Investigator’s assessment of the peanut ED as well as the peanut 
cumulative dose. If, as per the Investigator’s judgment, the combination of all these 
symptoms resulted in an anaphylaxis requiring a prolonged (minimally overnight) 
hospitalization, then this will be considered an SAE. Any such SAE with its specific 
verbatim must be reported in the AE pages of the e-CRF. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
67 of 142
09 Dec 2015
6.2.1.4
Recording Adverse Events
Adverse event reporting will start at the signature of the informed consent form (ICF) 
and end after the 2-week follow-up period (End of Study V12 Visit). During the 
screening period (that is, from the time of ICF signature through Day-1), only SAEs will 
be recorded in the e-CRF; during the screening period, AEs that do not meet any 
seriousness criteria will be documented in the subject’s source documents. Adverse 
events occurring after the end of the study should be reported to the Sponsor by the 
Investigator if the Investigator considers that there is a causal relationship with the study 
drug.  
Adverse events still ongoing at the time of the End of Study Visit will be followed up for 
an additional 30 days, or until they resolve or stabilize, whichever comes first. 
All AEs occurring on or after the day of the first dose of study drug, regardless of the 
relationship to the study drug, will be recorded in the e-CRF.
All AE reports in the e-CRF should contain the following information of the event: date 
and time of onset, date and time of resolution, severity, treatment required, relationship 
to study drug, action taken with the study drug, outcome, and whether the event is 
classified as serious or not. 
6.2.1.5
Reporting Serious Adverse Events 
All SAEs must be reported within 24 hours of the site becoming aware of the event by 
filling in the SAE pages in the e-CRF. In case of technical issues with the e-CRF, the 
reporting can be done by faxing a completed SAE Report Form to the PAREXEL safety 
center at the following FAX numbers:
x
Centers in Europe and Australia dial the following FAX numbers:
x
Centers in North America dial the following FAX number: 
The minimum information required for an initial report is:
x
Name of person sending the report (that is name and address of Investigator);
x
Subject identification (screening number, NOT the subject’s name);
x
Protocol number; 
x
Description of the SAE including a comprehensive verbatim term; 
x
Causality assessment, if possible.
However, as far as possible all points in the SAE pages in the e-CRF (or on the SAE 
Report Form, in case of technical issues with the e-CRF) should be covered in the initial 
report. If an SAE occurs during the DBPCFC, the verbatim of the SAE must specify 
“during the DBPCFC” or “due to the DBPCFC” both on the SAE Report Form and in the 
SAE pages of the e-CRF. 
PPD
PPD

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
68 of 142
09 Dec 2015
6.2.1.6
Follow-up of Adverse Events
All AEs experienced by a subject, irrespective of the suspected causality, will be 
monitored until the AE has resolved, any abnormal laboratory values have returned to 
baseline or stabilized at a level acceptable to the Investigator and Medical Monitor, until 
there is a satisfactory explanation for the changes observed, until the subject is lost to 
follow-up, or until the subject has died. 
6.2.1.7
Pregnancy 
Pregnancy will be determined by evaluation of urine pregnancy tests. Subjects who are 
pregnant at screening are excluded from the study. Subjects who become pregnant during 
treatment must be discontinued from the study.
The Sponsor has a responsibility to monitor the outcome of pregnancies where there has 
been maternal exposure to the study drug.  
Pregnancy alone is not regarded as an AE unless there is a suspicion that the study drug 
may have interfered with the effectiveness of a contraceptive medication.
Elective abortions without complications should not be handled as AEs, unless they were 
therapeutic abortions (see below). Hospitalization for normal delivery of a healthy 
newborn will not be considered a SAE. 
All pregnancies must be reported by the Investigator to PAREXEL/Sponsor in the 
specific pregnancy pages in the e-CRF within 30 days after becoming aware of the 
pregnancy. The Investigator must follow up and document the course and the outcome of 
all pregnancies even if the subject was discontinued from the study or if the study has 
finished. 
All outcomes of pregnancy must be reported by the Investigator to PAREXEL/Sponsor 
in the specific pregnancy pages in the e-CRF within 30 days after she/he has gained 
knowledge of the normal delivery or elective abortion. 
Any SAE that occurs during pregnancy (including SAEs occurring after last 
administration of study drug) must be recorded in the SAE pages in the e-CRF (for 
example maternal serious complications, spontaneous or therapeutic abortion, ectopic 
pregnancy, stillbirth, neonatal death, congenital anomaly, or birth defect) and reported 
within 24 hours in accordance with the procedure for reporting SAEs. 
6.2.1.8
Treatment of Overdose of Study Medication 
Overdose is defined as the concomitant application of 2 Viaskin® patches or more on the 
skin of the subject, whatever the duration of the concomitance of the multiple patch 
application.
One patch applied the same day after the previous patch was removed or has fallen off is 
NOT an overdose. 
There has been no experience of overdosing with Viaskin® patches so far. No specific 
treatment for overdosing is known. The first action will be to remove any additional 
patch from the skin, leaving only 1 patch on the skin Treatment given to a subject in case 
of overdosing should be symptomatic and supportive. 
Any case of overdose, with or without associated AEs, must be reported to PAREXEL. 
Overdose will be reported in the SAE pages of the e-CRF (with Overdose as event term) 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
69 of 142
09 Dec 2015
within 24 hours of learning of the overdose. In case of technical issues with the e-CRF,
this can be done by faxing a completed SAE Report Form to the PAREXEL safety 
center. Any AEs associated with the overdose should be reported in the relevant AE/SAE 
sections in the e-CRF. 
6.2.2
Laboratory Variables 
Laboratory assessments will be performed by a central laboratory, as identified in the 
List of Study Personnel. 
Venous blood samples will be taken for hematology and biochemistry testing. 
The following laboratory variables will be determined in accordance with the Schedule
of Procedures (Table 7): 
x
Hematology: hemoglobin, hematocrit, platelets, red blood cells, white blood cells 
with differential cell count; 
x
Biochemistry: alanine aminotransferase, aspartate aminotransferase, total 
bilirubin, total protein, blood urea nitrogen, creatinine; 
x
A urine pregnancy test will be performed at the site.
Details of the procedures to be followed for sample collection, storage, and shipment will 
be documented in the Laboratory Manual. 
Clinically significant changes (abnormalities) in laboratory parameters, in the judgment 
of the Investigator, will be recorded as AEs and appropriate countermeasures taken.
In the event of unexplained abnormal laboratory test values of clinical significance, the 
tests should be repeated at a reasonable time point and followed up until they have 
returned to the normal range and/or an adequate explanation of the abnormality is found. 
Additional and repeat laboratory safety testing outside the study may be performed at the 
discretion of the Investigator. 
6.2.3
Vital Signs
The following vital signs will be assessed in accordance with the Schedule of Procedures 
(Table 7):
x
Blood pressure (systolic and diastolic; mmHg),
x
Heart rate (beats per minute),
x
Respiration rate (breaths per minute). 
Systolic blood pressure and diastolic blood pressure will be measured in sitting position 
on the same arm after the subject has been resting.
Heart rate will be recorded simultaneously with blood pressure measurements, followed 
by respiratory rate.
During the study, the measurement of vital signs may be repeated at the discretion of the 
Investigator for safety reasons. Clinically relevant abnormal findings will be reported as 
AEs.
Vital signs must be assessed before the DBPCFC. Additional assessments can be 
repeated during the DBPCFC procedure on both days at any time if judged necessary by 
the Investigator.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
70 of 142
09 Dec 2015
6.2.4
Physical Examinations 
Physical examinations will be performed in accordance with the Schedule of Procedures
(Table 7). 
Physical examinations will be performed by a physician or a master level clinician
qualified for performing physical examinations (Nurse Practitioners or physician
assistants) and will include examination of the following: 
x
General appearance, 
x
Head, ears, eyes, nose and throat, 
x
Neck,
x
Complete skin examination, 
x
Cardiovascular system, 
x
Respiratory system,
x
Abdominal system,
x
Nervous system, 
x
Body weight (kg), 
x
Height (cm).
Body weight will be measured without shoes, jacket, or diaper and per Schedule of 
Procedures and as frequently as necessary. 
Height will be measured without shoes and per Schedule of Procedures and as frequently 
as necessary for this population of subjects in active growth, especially for the pulmonary 
function tests (spirometry, PEF measurements).
For each body system, an assessment of normal or abnormal will be recorded in the e-
CRF at screening and the abnormality will be documented. Besides, the skin aspect will 
be graded for the sites of patch application (see Section 6.2.8).
Physical examinations must be performed before the DBPCFC. Additional assessments 
can be repeated during the DBPCFC procedure on both days at any time judged 
necessary by the Investigator. 
Clinically significant changes (abnormalities) in physical examination findings, in the 
judgment of the Investigator, will be recorded as AEs and appropriate countermeasures 
taken.
6.2.5
Spirometry Test
For subjects 6 years of age (unless they have documented inability to adequately 
perform spirometry), FEV1 will be measured on a standardized calibrated spirometer 
following the ATS guidelines. At least 3 acceptable FEV1 maneuvers will be obtained 
and the highest of the 3 attempts will be recorded in the e-CRF. 
6.2.6
Peak Expiratory Flow 
For all the subjects 5 years of age, PEF will be measured on a peak flow meter. At least 
3 acceptable measures will be obtained and the highest of the 3 attempts will be reported
in the e-CRF. The PEF assessment must be performed at all visits. On the days where a 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
71 of 142
09 Dec 2015
challenge is performed the PEF assessment must be performed just before the DBPCFC. 
This can be repeated during the DBPCFC if needed.  
For subjects 4 years of age at Visit 1, PEF will not be requested.
6.2.7
Subject Diaries
Subject diaries will be provided to each subject to report specific information between
visits, as follows. Subjects and/or their parents/guardians will be asked to record on a 
daily basis in their diaries the time of application and removal of each Viaskin® patch,
along with the reason for any early removal (should that occur). They will also record the 
grade of any observed local skin reactions to the Viaskin® patch. Evaluation of local skin 
reactions (pruritus, erythema and edema) will be reported daily by the subjects 
(parents/guardians) in their diaries for6 months. Subjects (parents/guardians) will also be 
instructed to record in their diaries any other AEs, local skin reactions occurring after the 
6 months of treatment and any concomitant medication or treatment taken for any type of 
AEs. The subject diary will be reviewed by the site medical staff at each patient visit.
In addition, the adhesion of the Viaskin® patch to the skin will be assessed by the 
parents/guardians for 28 days of treatment between Month 3 and Month 6 (whenever 
possible, these should be consecutive days) and the assessment noted in a specific diary.
Assessment may be continued during Month 6 and Month 9 to complete the evaluations 
started but not completed between Month 3 and Month 6. Assessment may also be done 
between Month 6 and Month 9 in some circumstances, especially when not adequately 
performed between Month 3 and Month 6. A specific scoring system to assess the 
maintenance of the occlusion of the Viaskin® patches after 24 hours of application is 
described in Section 6.2.9. This scoring system will be explained to the parents/guardians 
to ensure good assessment of patch adhesion. If the patch has been removed deliberately 
prior to the 24 hours of application for safety reasons or for subject’s personal reasons on 
a specific day, the adhesion score of that specific day should also be reported, even 
though this will not count as an evaluable day of assessment for the adhesion evaluation. 
More days of assessment would then be needed to compensate for such cases and ensure 
that 28 evaluable days have been recorded.
Subjects must bring their diary back to the Investigator at each visit, and the Investigator 
must check the diary for completeness and accuracy. It is the Investigators’ responsibility 
to instruct the subjects and/or parents/guardians about the use of the diary, and to ensure 
that the diary is completed accurately. Any problems with completing the diary will be 
addressed with the subjects and/or parents/guardians. At each site visit, the completed 
pages of the diary will be collected and kept by the Investigators. The remaining blank 
pages of the diary will be given back to the subject at each visit before discharge. All 
diaries must be returned to the site at completion of the study, or if the subject 
discontinues. 
6.2.8
Skin Reaction and Photography 
Local skin reactions under the Viaskin® patch or on any of the previous sites of patch 
application will be graded as a whole at each visit according to the recommendations of 
the European Academy of Allergology and Clinical Immunology (EAACI) and the 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
72 of 142
09 Dec 2015
Global Allergy and Asthma European Network (GA2LEN) (43), and modified as 
follows: 
Table 6: Skin Reaction Grading System
Skin Reaction 
Grade if localized 
under the patch
Grade if extending 
beyond the patch
Negative
Grade 0
Grade 0
Only erythema, or erythema + infiltration
Grade 1A
Grade 1B
Erythema, few papules
Grade 2A
Grade 2B
Erythema, many or spreading papules
Grade 3A
Grade 3B
Erythema, vesicles
Grade 4A
Grade 4B
The Viaskin® patch is transparent and the degree of the local reactions under the 
Viaskin® patch can be easily seen through the patch. Grading of the local skin reactions 
on the back will start being recorded at Visit 4 right after the Viaskin® patch has been 
applied and while the subject is kept at site under observation and subsequently when 
subjects arrive at site for their further visits.  
At Visit 4, observations should be recorded at 30 minutes, 1 hour, 2 hours, and 3 hours 
after the Viaskin® patch is applied (through the patch, without removing it). 
Photographic records of the sites of application of the Viaskin® patch will be taken and 
filed in the subject’s medical records or source documents. The subject’s face will not, at 
any time, be captured in the photograph. Photography acquisition guidelines will be 
provided separately to the sites, so that photography process can be standardized as much 
as possible. All the photographs will be downloaded by the site staff onto a specific 
PEPITES website with a restrictive access to the site staff members, the Sponsor 
members and Sponsor representatives. 
Photographic records will be made available to the DSMB members upon request. 
6.2.9
 Viaskin®Patch Adhesion 
To ensure that each Viaskin® patch adheres well on the subject’s skin for 24 hours and 
that occlusion of the condensation chamber is guaranteed over the 24 hours of 
application of each patch, the parents/guardians will be asked to take photographs and 
assess these parameters for 28 days between Month 3 and Month 6 (or up to Month 9 if 
necessary; whenever possible, these days of assessment should be as consecutive as 
possible). 
The scoring system for adhesion and occlusion of Viaskin® patches is indicated as 
follows: 
x
0=No lift off or detachment of the dressing edges and the occlusion chamber of 
the patch is intact.
x
1=Some edges of the dressing have lifted off the skin with no impact on the 
occlusion chamber of the patch which remains fully adherent to the skin. 
x
2=The occlusion chamber of the patch is partially or totally detached.
x
3=The patch has fallen off the skin.
During those 28 days of evaluable assessment, photos and assessment of patch adhesion 
must be done. Even on those days when the patch has deliberately been removed 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
73 of 142
09 Dec 2015
prematurely by the subject or parents/guardians, the photos and assessment should be 
made as recommended, even if the assessment might not be used in the analysis. That’s 
why the assessments should extend beyond 28 days to ensure that 28 days of usable 
evaluations of 24 hours of application are recorded. All information relative to the patch 
adhesion should be collected in the corresponding diary.  
Photographs and assessment of the adhesion of each patch will be made at 2 time points 
by the parents/guardians for 28 days:
x
Immediately after the application of a patch to assess that the patch was applied 
as recommended and stuck well to the skin (including the edges of the dressing); 
and
x
After 24 hours of application at time of removal of the patch. 
At the time of each patch removal, the subjects (parents/guardians) will also be asked:
x
To specify the suspected cause of adhesion issue (if any), 
x
To grade the easiness of removal of the patch  (very easy/ easy / difficult / very 
difficult),
x
To grade whether the removal of the patch was painful (very painful / painful / 
not painful), 
x
To specify whether the patch removal caused skin injury (yes / no).     
Of note, 24 hours is the recommended duration of daily application. However, a duration 
of daily application of 24 ± 4 hours will be allowed.
To guarantee the reliability of the adhesion scoring done by the subject’s 
parents/guardians, the Investigator will review the parents/guardians’ assessment of the
patch adhesion based on the photographs made by the parents/guardians during these 
28 days. 
If the parents/guardians did not or could not assess the patch adhesion with sufficient 
reliability according to the Investigator’s judgment and/or if the parents/guardians did not 
or could not take photos for a total of 28 days between Month 3 and Month 6, the 
Investigator can disqualify all or part of the data collected for the adhesion assessment 
and will  re-train the parents/guardians so that the assessment of the patch adhesion can 
be repeated between Month 6 and Month 9 either totally for 28 evaluable days or 
partially to compensate for the disqualified days of the first period of assessment. 
The assessment of adhesion of the Viaskin® patch will also be made at each site visit by 
site staff trained specifically for this purpose. The duration of application of the assessed 
Viaskin® patch must be noted, photographs must be taken and the assessment by the site 
staff will use the same scoring system as above. 
All the photographs will be downloaded by the site staff onto the PEPITES-specific 
dedicated website described in section 6.2.8.
6.3
Demographics and Baseline Characteristics
Demographics and baseline characteristics consist of those variables that are assessed 
only at screening/baseline.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
74 of 142
09 Dec 2015
6.3.1
Patient Demography 
Patient demography consists of: 
x
Age at screening Visit 1,
x
Race,
x
Sex. 
6.3.2
Disease History and Medical History
History and duration of peanut allergy with well-documented IgE-mediated symptoms 
after ingestion of peanut must be reported in the disease history form in the e-CRF. 
The documentation of the complete medical history will include history and duration of 
any other allergies and current medical conditions, any allergic reactions (other than 
peanut IgE-mediated symptoms) in the previous 12 months, past or present 
cardiovascular, respiratory (including asthma), gastrointestinal, renal, hepatic, 
neurological, endocrine, lymphatic, hematologic, immunologic, dermatological 
(including atopy), psychiatric, developmental, and genitourinary disorders, drug and 
surgical history and any other diseases or disorders.  
The disease and medical histories will be obtained by interviewing the subject’s 
parents/guardians or by inspecting her/his medical records.
For coding of disease/medical history, see Section 9.4.
6.3.3
Prior and Concomitant Medications 
Previous and concomitant medications will be documented as described in Section 5.8.
6.4
Exploratory Variables 
6.4.1
Immunological Markers 
Venous blood samples will be drawn to assess the following immunological markers: 
peanut-specific IgE and IgG4 at the visits specified in the Schedule of Procedures 
(Table 7). 
The following immunological markers will also be assessed at specific time points: IgE 
and IgG4 specific to peanut protein components, and IgE specific to cow’s milk, egg, 
house dust mites, and grass pollen. 
Analysis of samples will be conducted by 
 
and the results at any time point after baseline will be blinded until the data 
are unblinded at the study end. Further details of the procedures to be followed for 
sample collection, storage, and shipment will be documented in the Laboratory Manual.
6.4.2
Skin Prick Test
Peanut extract plus negative saline control and positive histamine control will be used for 
skin prick testing. All materials (SoluPrick® solutions and ancillary materials, CE 
marked) will be provided free of charge centrally to all sites by the Sponsor, including a 
detailed procedure for conducting the SPTs.
CCI
C
CI

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
75 of 142
09 Dec 2015
The subjects should wash out any antihistamines for the minimum period of time 
(specified in the table in APPENDIX 4) prior to performing the test. Briefly, a skin 
Duotip II® is pressed through a small drop of the commercial extract of peanut or 
positive and negative controls into the epidermis of the volar surface or back of the 
forearm. The area will be measured for the maximum wheal diameter after 15 minutes. A 
tracing should be obtained by using a fine ballpoint pen. The tracing will be performed at 
the demarcation line for the wheal as the skin drops back to flush. Scotch or a clear 
transport tape should be used to lift the tracing; the tape tracing should be placed on 
paper and filed as part of the subject’s source documentation. 
6.4.3
Food Allergy Quality of Life Questionnaire /Food Allergy Independent 
Measure
The FAQLQs are disease-specific health-related quality of life questionnaires for 
subjects with food allergy. They are considered reliable and valid instruments to measure 
the impact of food allergy on health-related quality of life (44). The FAIM questionnaires 
capture the subjects' expectation of something happening because of her/his food allergy 
(45). 
At screening and at Month 12, subjects  years of age and all parents/guardians will 
complete the FAQLQ/FAIM questionnaires. Children  years of age will complete the 
Child Forms of the questionnaires (FAQLQ-CF, FAIM-CF) while the parents/guardians, 
regardless of the age of their child, will complete the Parent Forms (FAQLQ-PF,
FAIM-PF). 
The template questionnaires are provided in APPENDIX 7. 
6.4.4
Accidental Consumption of Peanuts
Specific reactions triggered by accidental consumption of peanut and the conditions 
around that consumption will be collected. The related AEs will be classified and 
analyzed separately. Subjects (parents/guardians) will be asked to clarify whether any 
peanut consumption was accidental or not. 
6.4.5
Epigenetic analyses
Venous blood samples will be drawn to assess the epigenetic modifications induced by 
the EPIT treatment with Viaskin® Peanut on the promoter regions of the genes coding for 
several specific proteins. The tests will be managed centrally and the results at any time
point after baseline will be blinded until the data are unblinded at the study end. Detailed
procedures to be followed for sample collection, storage and shipment will be 
documented in a specific Manual provided to the sites.  
6.4.6
Genetic Screening
Samples of blood will be taken from volunteer subjects for genetic analysis of the 
possible mutations in the filaggrin gene. The tests will be conducted centrally. Detailed 
procedures to be followed for sample collection, storage and shipment will be 
documented in a specific Manual provided to the sites. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
76 of 142
09 Dec 2015
6.4.7
Scoring Atopic Dermatitis 
The SCORAD, a scoring index of atopic dermatitis developed by the European Task 
Force on Atopic Dermatitis (46) will be assessed as specified in the Schedule of 
Procedures (Table 7).
Sections A and B must be assessed and completed by the investigator, while section C is 
assessed by the subject/subject’s parents.
The SCORAD is provided in APPENDIX 8. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
77 of 142
09 Dec 2015
7
STUDY CONDUCT
7.1
Schedule of Procedures
The Schedule of Procedures is presented in Table 7.

Sponsor Name
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0  
81 of 142
09 Dec 2015
would then have to take place that same day.
2
Unscheduled Visit in case of AEs, need for treatment re-supply, etc. Procedures will be performed as deemed necessary by the investigator.
3
Except for those that depend on the results of the immunological markers testing (peanut-specific IgE) and on the outcome of the entry/screening
DBPCFC.
4
Including history of peanut allergy.
5
Including a complete skin examination, body weight and height. 
6
These examinations are to be done before the DBPCFC. Additionally, they can be repeated during the DBPCFC procedure on both days anytime if 
judged necessary by the Investigator.
7
Blood pressure, heart rate and respiratory rate. 
8
FEV1 will be measured in subjects 6 years of age and older.
9
Peanut-specific IgE, peanut-specific IgG4, peanut specific IgE and peanut specific IgG4 to Ara h 1, Ara h 2, Ara h 3, Ara h 8 and Ara h 9. IgE specific to 
cow’s milk, egg white, house dust mites, and grass pollen will be collected at Visit 1 and Visit 10 only and in case of an early termination visit. 
10
Laboratory tests performed centrally. Hematology: hemoglobin, hematocrit, platelets, red blood cells, white blood cells with differential cell count. 
Biochemistry: aspartate aminotransferase, alanine aminotransferase, total bilirubin, total protein, blood urea nitrogen, creatinine.
11
For both FAQLQ and FAIM, subjects  years of age will use the Child Form of the FAQLQ/FAIM. All parents/guardians will use the Parental Form for 
children. The specific forms of FAQLQ and FAIM will be completed in the countries where they are available in local languages.
12
Signing the consent for the filaggrin genetic analysis can be done any time after the subject is effectively randomized in the study. However, collection of 
blood is recommended only once at any of the following visits: Visit 7, 8 or 10.
13
Check the reaction of the skin on the back of the subject and grade the severity of the local skin reactions. At Visit 4, grading is to be done before patch 
application and 30 min, 1 h, 2 h and 3 h after patch application. 
14
The assessment of the patch adhesion to the skin will consist of a 28-day specific analysis to occur between Month 3 (Visit 7) and Month 6 (Visit 8). This 
assessment period can be extended up to Month 9 (Visit 9) in case it has not been completed or fully completed between Month 3 and Month 6.
15
The same treatment box dispensed at Visit 9 will be re-dispensed at Visit 10 (until Visit 11) after the compliance has been assessed.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
82 of 142
09 Dec 2015
7.2
Procedures by Visit
Visits should occur within the time windows indicated in the Schedule of Procedures
Table 7. All times should be recorded using the 24-hour clock (for example 23:20, not 
11:20 pm).
7.2.1
Visit 1, Screening (Day -42) 
The first screening Visit (Visit 1) will take place within 42 days prior to the start of the 
treatment period. Therefore, the duration of the screening period could be less than 
42 days.
The following assessments will be performed at this visit:
x
Written informed consent; 
x
Check inclusion/exclusion criteria, except for those criteria that depend on the 
results of the peanut-specific IgE assessment and on the outcome of the 
entry/screening DBPCFC; 
x
Disease/Medical history (see Section 6.3.2); 
x
Parental (father and/or mother) medical history of atopy (any allergies, asthma 
conditions, eczema/atopic dermatitis); 
x
Demographics (see Section 0);
x
Physical examination (including a complete skin examination; see Section 6.2.4); 
x
Vital signs (see Section 6.2.3);
x
Spirometry (FEV1) (see Section 6.2.5);
x
PEF (see Section 6.2.6);
x
SCORAD (see Section 6.4.7);
x
SPT (see Section 6.4.2);
x
Immunological markers (see Section 6.4.1);
x
Laboratory tests (see Section 6.2.2); if applicable, subjects with abnormal 
laboratory assessments due to a concomitant transient disease (flu, viral illness, 
etc.) can repeat their laboratory assessments or be rescheduled for laboratory 
assessment at the discretion of the Investigator;
x
Urine pregnancy test for female subjects of childbearing potential;
x
FAQLQ/FAIM (see Section 6.4.3);
x
Collect blood sample for epigenetic analyses (see Section 6.4.5); 
x
AEs recording (including volunteered or solicited AEs and AESI); 
x
Concomitant medications (see Section 5.8);
x
Schedule Visit 2. 
7.2.2
Visit 2, Screening (through Day -2) 
Visit 2 corresponds to the first day of the entry/screening DBPCFC. This visit can take 
place any time through Day -2, as soon as the peanut-specific IgE results for the subject 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
83 of 142
09 Dec 2015
are obtained by the site from the central laboratory. If the subject fulfills all inclusion 
criteria including the peanut-specific IgE value (>0.7 kU/L), then Visit 2 may proceed. 
The following assessments will be performed at this visit:
x
Physical examination (including a complete skin examination; to take place 
before DBPCFC; see Section 6.2.4);
x
Vital signs (to take place before DBPCFC; see Section 6.2.3);
x
PEF (to take place before DBPCFC; see Section 6.2.6);
x
Entry/screening DBPCFC (first day) (see Section 6.1.1) 
x
AEs recording (including volunteered or solicited AEs, AESIs, and recording of 
AEs/allergies in response to the DBPCFC); 
x
Concomitant medications (including any medications given to treat allergic 
symptoms; see Section 5.8);
x
Schedule Visit 3. 
Physical examinations, assessment of vital signs and PEF measurements can be repeated 
during the DBPCFC as deemed necessary by the Investigator.
The subject may be discharged after a minimum observation period of 3 hours after the
last dose of the challenge formula ingested. The observation period can be extended 
beyond 3 hours if deemed necessary by the Investigator. 
7.2.3
Visit 3, Screening (within 1 week of Visit 2 and through Day -1) 
Visit 3 corresponds to the second day of the entry/screening DBPCFC. It takes place 
within a week following Visit 2 (the first day of the entry/screening DBPCFC). Visit 3 
could take place 1 day prior to Visit 4. 
The following assessments will be performed at this visit:
x
Physical examination (including a complete skin examination; to take place 
before DBPCFC; see Section 6.2.4);
x
Vital signs (to take place before DBPCFC; see Section 6.2.3);
x
PEF (to take place before DBPCFC; see Section 6.2.6);
x
Entry/screening DBPCFC (second day) (see Section 6.1.1.3) 
x
AEs recording (including volunteered or solicited AEs, AESIs and recording of 
AEs/allergies in response to the DBPCFC);
x
Concomitant medications (including any medications given to treat allergic 
symptoms; see Section 5.8);
x
Schedule Visit 4. 
Physical examinations, assessment of vital signs and PEF measurements can be repeated 
during the DBPCFC as deemed necessary by the Investigator.
The subject may be discharged after a minimum observation period of 3 hours after the 
last dose of the challenge formula ingested. The observation period can be extended 
beyond 3 hours if deemed necessary by the Investigator. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
84 of 142
09 Dec 2015
7.2.4
Visit 4 (Day 1), First Day of Treatment
All screening assessments must be completed and subject eligibility must be checked 
before entry into the double-blind treatment period; thereafter, dates of all study visits 
will be scheduled relative to the date of Visit 4. Visit 4 will take place at a maximum of 
42 days after Visit 1 and might occur even closer to Visit 1 provided that Visit 2 and 
Visit 3 have been performed in between. Ideally, it will take place 1 day after Visit 3 and 
it may take place up to several weeks after Visit 3, respecting the maximum interval of 
42 days after Visit 1. Visit 4 may take place the same day as Visit 3 for those 
Investigators willing to combine the 2 visits, under the condition that all procedures of 
both visits and their specific durations are respected. 
The following assessments will be performed at this visit:
x
Physical examination (including a complete skin examination; see Section 6.2.4);
x
Vital signs (see Section 6.2.3);
x
PEF (see Section 6.2.6);
x
Confirm eligibility of subject and perform randomization;
x
AEs recording (including volunteered or solicited AEs and AESI);
x
Concomitant medications (see Section 5.8);
x
Dispense first box of study drug (instruct subject/parents/guardians on the proper 
application, timing and storage);
x
Apply the first Viaskin® patch to the subject and stick the tear-off part of the 
pouch label in the appropriate section of the subject diary. 
x
Keep under observation on-site for 3 hours after the patch has been applied;
x
Check skin reaction under patch and grade severity (see Table 6, Section 6.2.8); 
x
Without removing the patch, take a photograph of the site of application of the 
Viaskin® patch after the 3 hours of application, load it onto the PEPITES website 
(described in section 6.2.8) and keep it in the subject’s medical records or source 
documents;  
x
Patch adhesion Investigator’s assessment: Investigator assesses the adherence of 
the patch to the skin as well as the occlusion of the patch chamber just after first 
application and after 3 hours prior to discharge;
x
Dispense subject diary (instruct subject/parents/guardians on the use); see Section
6.2.7); 
x
Dispense the camera to the parents/guardians and instruct them when and how to 
use it; 
x
Dispense the subject safety leaflet and subject identification card;
x
Dispense an auto-injector of epinephrine and explain in detail the anaphylaxis 
emergency action plan to the subject/parents/guardians before discharge;
x
Dispense 1% hydrocortisone ointment; 
x
Schedule the Day 4 phone contact and Visit 5. 
After the first application of the Viaskin® patch at the study site, all subjects will be 
observed for 3 hours before being discharged with the patch still applied to the skin and 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
85 of 142
09 Dec 2015
the reactions under or around the patch will be checked and graded before discharge. The 
subject/parents/guardians will be instructed to remove the patch after a total of 6 hours of 
application, which is approximately 3 hours after discharge. 
7.2.5
Phone Contacts (Day 4±2 days and Day 22±2 days), Treatment Period
At Day 4 after the patch has been applied 6 hours daily for 3 days, and at Day 22 
(Week 3 of treatment), 1 week after the patch has been applied for 24 hours daily, 
specific phone contacts will be made to the parents/guardians to assess the safety of patch 
applications on the back. During the phone contacts, the site staff could ask to be 
provided with photos of the back of the subject to assess the local skin reactions. If 
required, the subjects may be seen earlier by the Investigator. 
The following assessments will be performed during the phone contact: 
x
AEs recording (including volunteered or solicited AEs and AESI);
x
Concomitant medications (see Section 5.8);
x
Check for any accidental peanut consumption (see Section 6.4.4); 
x
Check with the subject (parents/guardians) to ensure that the diary has been 
completed accurately and that the subject/parents/guardians is/are comfortable 
with using the diary; 
x
Remind of Visit 5 and Visit 6, respectively. 
7.2.6
Visit 5 (Day 8±3 days), Visit 6 (Month 1±3 days) and Visit 9 (Month 9±7 days), 
Treatment Period
The following assessments will be performed at these visits: 
x
Physical examination (including a complete skin examination; see Section 6.2.4);
x
Vital signs (see Section 6.2.3);
x
Spirometry (FEV1), only for Visit 9 (see Section 6.2.5); 
x
PEF (see Section 6.2.6);
x
AEs recording (including volunteered or solicited AEs and AESI);
x
Concomitant medications (see Section 5.8);
x
Check for any accidental peanut consumption (see Section 6.4.4); 
x
Check that the subject diary has been completed accurately and ensure that the 
subject/parents/guardians is/are comfortable with using the diary; 
x
Dispense subject diary (re-instruct subject/parents/guardians on the use, if 
necessary; see Section 6.2.7); 
x
Collect the treatment box dispensed at the previous visit, check the unused 
medication and assess medication compliance;
x
Dispense a new box of study drug (re-instruct subject/parents/guardians on the 
proper application, timing and storage, if necessary);
x
Patch adhesion Investigator’s assessment : with the patch still applied, the 
Investigator assesses the adherence of the patch to the skin as well as the 
occlusion of the patch chamber; 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
86 of 142
09 Dec 2015
x
Check skin reactions under or around the current patch (do not remove patch) and 
all other zones of application and grade severity of the skin reactions (see 
Table 6, Section 6.2.8); 
x
Take a photograph of the sites of application of the Viaskin® patch, load it onto
the PEPITES website (described in section 6.2.8) and keep it in the subject’s 
medical records or source documents;  
x
Review the use of the auto-injector of epinephrine and the anaphylaxis 
emergency action plan;  
x
Schedule next phone contact and Visit 6, Visit 7, and Visit 10 respectively. 
There is no requirement for subject observation before discharge at Visits 5, 6 and 9. 
7.2.7
Phone Contacts (Month 2±3 days, Month 4.5±7 days, Month 7.5±7 days), 
Treatment Period
The parents/guardians of the subject will be called to assess the subject’s condition since 
the last Visit.
The following assessments will be performed during the phone contact: 
x
AEs recording (including volunteered or solicited AEs and AESI);
x
Concomitant medications (see Section 5.8);
x
Check for any accidental or peanut consumption (see Section 6.4.4); 
x
Remind of Visit 7, Visit 8, and Visit 9 respectively.
7.2.8
Visit 7 (Month 3±7 days) and Visit 8 (Month 6±7 days), Treatment Period
The following assessments will be performed at these visits:
x
Physical examination (including a complete skin examination; see Section 6.2.4);
x
Vital signs (see Section 6.2.3);
x
Spirometry (FEV1) (see Section 6.2.5); 
x
PEF (see Section 6.2.6);
x
SCORAD (see Section 6.4.7);
x
SPT (see Section 6.4.2);
x
Immunological markers (see Section 6.4.1); 
x
Laboratory tests (see Section 6.2.2);
x
Written informed consent for filaggrin genetic screening (may be obtained at any 
visit after randomization, but must occur before blood sampling) 
x
Blood sampling for filaggrin genetic screening (after written informed consent 
has been obtained; only 1 sample is to be collected at Visit 7, 8 or 10; see 
Section 6.4.6);
x
Collect blood samples for epigenetic analyses (see Section 6.4.5); 
x
AEs recording (including volunteered or solicited AEs and AESI);
x
Concomitant medications (see Section 5.8);
x
Check for any accidental peanut consumption (see Section 6.4.4); 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
87 of 142
09 Dec 2015
x
Check that the subject diary has been completed accurately and ensure that the 
subject/parents/guardians is/are comfortable with using the diary;  
x
Dispense subject diary (re-instruct subject/parents/guardians on the use, if 
necessary; see Section 6.2.7); 
x
Collect the treatment box dispensed at the previous visit, check the unused 
medication and assess medication compliance;
x
Dispense a new box of study drug (re-instruct subject/parents/guardians on the 
proper application, timing and storage, if necessary); 
x
Patch adhesion Investigator’s assessment: with the patch still applied, the 
Investigator assesses the adherence of the patch to the skin as well as the 
occlusion of the patch chamber;
x
Check skin reactions under or around the current patch (do not remove patch) and 
all other zones of application and grade severity of the skin reactions (see 
Table 6, Section 6.2.8); 
x
Take a photograph of the sites of application of the Viaskin® patch, load it onto
the PEPITES website (described in section 6.2.8) and keep it in the subject’s 
medical records or source documents;  
x
Review the use of the auto-injector of epinephrine and the anaphylaxis 
emergency action plan; 
x
Schedule next phone contact and Visit 8 and Visit 9, respectively.
x
Patch adhesion Subject’s assessment: at Visit 7 (Month 3), the subject 
(parents/guardians) will be asked to assess the patch adhesion for 28 days 
between Visit 7 and Visit 8 (Month 6). The specific diary for assessing the patch 
adhesion should be dispensed and Investigators should instruct 
subject/parents/guardians on its use. The site staff will instruct the 
parents/guardians how to take the photographs and how to perform the 
assessment based on the grading system in Section 6.2.9.
The patch adhesion diary and all pictures taken will be collected by the site staff 
at Visit 8 (Month 6) (and up until Visit 9, if necessary). The Investigator will 
check whether the subject (parents/guardians) has provided all photographs and 
evaluations and will review the parents/guardians’ assessments based on the same 
photographs, to control and ensure that the parents’ assessments of the patch 
adhesion were satisfactory. 
There is no requirement for subject observation before discharge at Visits 7 and 8.  
7.2.9
Visit 10 (Month 12±7 days), Treatment Period
Visit 10 corresponds to the first day of the post-treatment DBPCFC.  
The following assessments will be performed at this visit: 
x
Physical examination (including a complete skin examination; to take place 
before DBPCFC; see Section 6.2.4);
x
Vital signs (to take place before DBPCFC; see Section 6.2.3);
x
Spirometry (FEV1) (see Section 6.2.5); 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
88 of 142
09 Dec 2015
x
PEF (to take place before DBPCFC; see Section 6.2.6);
x
SCORAD (see Section 6.4.7);
x
SPT (see Section 6.4.2);
x
Immunological markers (see Section 6.4.1); 
x
Laboratory tests (see Section 6.2.2);
x
FAQLQ/FAIM (see Section 6.4.3);
x
Written informed consent for filaggrin genetic screening, if not already done (this 
is the last visit with the possibility for signing this consent); 
x
Blood sampling for filaggrin genetic screening, if not already done at Visit 7 or 8;
see Section 6.4.6);
x
Urine pregnancy test for female subjects of childbearing potential;
x
Collect blood sample for epigenetic analyses (see Section 6.4.5); 
x
Post-treatment DBPCFC (first day) (see Section 6.1.1.4) 
x
AEs recording (including volunteered or solicited AEs, AESIs, and recording of 
AEs/allergies in response to the DBPCFC);
x
Concomitant medications (including any medications given to treat allergic 
symptoms) (see Section 5.8);
x
Check for any accidental peanut consumption (see Section 6.4.4); 
x
Check that the subject diary has been completed accurately and ensure that the 
subject/parents/guardians is/are comfortable with using the diary;  
x
Dispense subject diary (re-instruct subject/parents/guardians on the use, if 
necessary; see Section 6.2.7);
x
Collect the treatment box dispensed at the previous visit, check the unused 
medication and assess medication compliance;
x
Re-dispense the same treatment box to the subject for application until the 2nd day 
of the challenge (re-instruct subject/parents/guardians on the proper application, 
timing and storage, if necessary);
x
Patch adhesion Investigator’s assessment: with the patch still applied, the 
Investigator assesses the adherence of the patch to the skin as well as the 
occlusion of the patch chamber; 
x
Check skin reactions of all zones of application and grade the overall severity of 
the skin reactions (see Table 6, Section 6.2.8); 
x
Take a photograph of the sites of application of the Viaskin® patch, load it onto
the PEPITES website (described in section 6.2.8) and keep it in the subject’s 
medical records or source documents;  
x
Schedule Visit 11. 
Physical examinations, assessment of vital signs and PEF measurements can be repeated 
during the DBPCFC as deemed necessary by the Investigator. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
89 of 142
09 Dec 2015
The subject may be discharged after a minimum observation period of 3 hours after the 
last dose of the challenge formula is ingested. The observation period can be extended 
beyond 3 hours if deemed necessary by the Investigator. 
7.2.10 Visit 1 week after Visit 10), End of Treatment Period
Visit 11 corresponds to the end of the 12-month treatment period. Patch application ends 
at this visit. The patch worn by the subject when she/he arrives to this visit is removed 
and there will be no further patches applied beyond Visit 11.  
Visit 11 corresponds to the second day of the post-treatment DBPCFC after 12 months of 
treatment. It takes place within a week following the first day of the post-treatment 
DBPCFC. 
The following assessments will be performed at this visit: 
x
Physical examination (including a complete skin examination; to take place 
before DBPCFC; see Section 6.2.4);
x
Vital signs (to take place before DBPCFC; see Section 6.2.3);
x
PEF (to take place before DBPCFC; see Section 6.2.6);
x
Post-treatment DBPCFC (second day) (see Section 6.1.1) 
x
AEs recording (including volunteered or solicited AEs, AESIs, and recording of 
AEs/allergies in response to the DBPCFC);
x
Concomitant medications (including any medications given to treat allergic 
symptoms) (see Section 5.8);
x
Check for any accidental peanut consumption (see Section 6.4.4); 
x
Check that the subject diary has been completed accurately and ensure that the 
subject/parents/guardians is/are comfortable with using the diary;  
x
Dispense subject diary (re-instruct subjects/parents/guardians on the use, if 
necessary; see Section 6.2.7);
x
Collect the treatment box dispensed at the visit 10 (Month 12 visit), check the 
unused medication and assess medication compliance; 
x
Patch adhesion Investigator’s assessment: with the patch still applied, the 
Investigator assesses the adherence of the patch to the skin as well as the 
occlusion of the patch chamber; 
x
Check skin reactions of all zones of application and grade the overall severity of 
the skin reactions (see Table 6, Section 6.2.8); 
x
Take a photograph of the sites of application of the Viaskin® patch, load it onto
the PEPITES website (described in section 6.2.8) and keep it in the subject’s 
medical records or source documents;  
x
Schedule Visit 12. 
Physical examinations, assessment of vital signs and PEF measurements can be repeated 
during the DBPCFC as deemed necessary by the Investigator.
The subject may be discharged after a minimum observation period of 3 hours after the 
last dose of the challenge formula ingested. The observation period can be extended 
beyond 3 hours if deemed necessary by the Investigator. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
90 of 142
09 Dec 2015
7.2.11 Visit 12 (2 weeks after Visit 11), End of Study Period 
The following assessments will be performed at this visit: 
x
Physical examination (including a complete skin examination; see Section 6.2.4);
x
Vital signs (see Section 6.2.3);
x
AEs recording (including volunteered or solicited AEs and AESI);
x
Check for any accidental peanut consumption (see Section 6.4.4); 
x
Concomitant medications (see Section 5.8);
x
Check subject diary. 
7.2.12 Early Termination Visit
Subjects who discontinue early from the study should, if possible, have an Early 
Termination Visit. This visit should take place as soon as possible after the subject stops 
taking the study drug (see also Section 4.3). 
The following assessments will be performed at these visits:
x
Physical examination (including a complete skin examination; see Section 6.2.4);
x
Vital signs (see Section 6.2.3);
x
Spirometry (FEV1) (see Section 6.2.5); 
x
PEF (see Section 6.2.6);
x
SPT (see Section 6.4.2);
x
Pregnancy Test
x
Immunological markers (see Section 6.4.1); 
x
Laboratory tests (Section 6.2.2);
x
AEs recording (including volunteered or solicited AEs and AESI);
x
Concomitant medications (see Section 5.8);
x
Check for any accidental peanut consumption (see Section 6.4.4); 
x
Check subject diary;
x
Check unused medication and assess medication compliance;
x
Check skin reactions and grade severity (see Table 6, Section 6.2.8); 
x
Take a photograph of the sites of application of the Viaskin® patch and keep it in 
the subject’s medical records or source documents. 
7.2.13 Unscheduled Visit
Subjects may come to the site for visits outside of the scheduled visits in case of AEs, 
Viaskin® patch adhesion problems, etc.
The following assessments will be performed at these visits, at the discretion of the 
Investigator: 
x
Physical examination (including a complete skin examination; see Section 6.2.4);
x
Vital signs (see Section 6.2.3);
x
Spirometry (FEV1) (see Section 6.2.5); 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
91 of 142
09 Dec 2015
x
PEF (see Section 6.2.6);
x
Laboratory tests (Section 6.2.2);
x
AEs recording (including volunteered or solicited AEs and AESI); 
x
Concomitant medications (see Section 5.8);
x
Check for any accidental peanut consumption (see Section 6.4.4); 
x
Check subject diary; 
x
Dispense a new box of study drug (re-instruct subject/parents/guardians on the 
proper application, timing and storage, if necessary);
x
Check unused medication and assess medication compliance; 
x
Patch adhesion Investigator’s assessment: with the patch still applied, the 
Investigator assesses the adherence of the patch to the skin as well as the 
occlusion of the patch chamber;
x
Check skin reactions under or around the current patch (do not remove patch) and 
all other zones of application and grade severity of the skin reactions (see 
Table 6, Section 6.2.8); 
x
Take a photograph of the sites of application of the Viaskin® patch, load it onto
the PEPITES website (described in section 6.2.8) and keep it in the subject’s 
medical records or source documents. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
92 of 142
09 Dec 2015
8
STATISTICAL METHODS
The statistical considerations summarized in this section outline the plan for data analysis 
of this study.  
A separate detailed statistical analysis plan (SAP) providing detailed methods for the 
analyses outlined below will be prepared before first subject inclusion and finalized 
before unblinding.  
Any deviations from the planned analyses will be described and justified in the final 
integrated study report. 
8.1
Study Patients
8.1.1
Disposition of Patients
Subject disposition will be summarized for the Intent-to-treat (ITT) population overall 
and by screening ED stratum. The number and percentage of subjects randomized, 
subjects in each study population (Safety, ITT, Full analysis set (FAS), Per-protocol 
[PP]), and subjects who completed the double-blind period, who discontinued the 
double-blind period, and the primary reason for discontinuation from the double-blind 
period will be tabulated by treatment group and overall. 
An enrollment summary will be presented overall and by site, showing the first date of 
consent, and the last study visit exit date among enrolled subjects, duration (in days) 
which is calculated as last study visit exit date – first date of consent +1, number of 
subjects enrolled, randomized and completed. The number and percentage of subjects 
enrolled in total and by site will be summarized for each treatment group and overall.
8.1.2
Protocol Deviations 
Deviations from the protocol including violations of inclusion/exclusion criteria will be 
assessed as “minor” or “major” in cooperation with the Sponsor prior to unblinding. 
Major deviations from the protocol that impact the primary efficacy evaluation will lead 
to the exclusion of a subject from the PP population.  
8.1.3
Analysis Sets
All analysis populations will be identified and finalized in the SAP.
8.1.3.1
Safety Population 
The Safety population will be comprised of all subjects who are randomized and have 
received at least 1 dose of study drug. This population will be used to assess comparative 
safety information. In case the wrong study drug is dispensed, the subject will be 
analyzed according to the study drug received for the longest period of time. 
8.1.3.2
Intent-to-treat Population 
The ITT population will be comprised of all subjects who are randomized. This 
population will be used to assess comparative efficacy information. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
93 of 142
09 Dec 2015
8.1.3.3
Full analysis set 
The FAS will be comprised of all subjects who are randomized and have performed at 
least the peanut challenge of the second DBPCFC at Month 12. 
8.1.3.4
Per-protocol Population 
The PP population will include all subjects from the ITT population who do not have 
major deviations from the protocol that may affect the primary efficacy endpoint (for
instance, subjects who have not gone through the second DBPCFCs at Month 12, 
subjects with a global treatment compliance below 80%, etc.). The deviations to consider 
will be listed more exhaustively in the SAP. The PP population will be used to perform 
confirmatory analyses of the primary and secondary efficacy evaluations. 
8.2
General Considerations
8.2.1
Statistical Methods
The statistical analyses for the entire study as further outlined in the SAP will be 
included in the clinical study report (CSR) for this protocol. The SAP will give a detailed 
description of the summaries and analyses (primary and secondary) that will be 
performed and clearly describe when these analyses will take place. The SAP will be 
finalized shortly after the final protocol and well ahead of the database lock to preserve 
the integrity of the statistical analysis and study conclusions.
All pre-defined statistical analyses will be performed after the database is released for 
unblinding. Statistical analyses will be performed using SAS® Version 9.3 or higher 
(SAS Institute, Cary, NC, USA).
Categorical variables will be summarized using number of observations and percentages. 
The denominator for percentages will be the number of subjects in the population with 
data available unless otherwise stated. Continuous variables will be summarized using 
descriptive statistics (number of observations [n], mean, standard deviation, minimum, 
first quartile [Q1], median, third quartile [Q3], and maximum).
8.2.2
Analysis and Data Conventions
8.2.2.1
Definition of Baseline 
The baseline assessment will be the latest, valid pre-dose assessment available.
8.2.2.2
Visit Windows 
Assessments outside of protocol allowable windows will be taken into account in the 
analysis according to the visit in which the data are entered.
8.2.2.3
Unscheduled Assessments
Extra assessments (laboratory data or vital signs associated with non-protocol clinical 
visits or obtained in the course of investigating or managing AEs) will be included in 
listings, but not summaries. If more than 1 laboratory value is available for a given visit, 
the first valid observation will be used in summaries and all observations will be 
presented in listings. It is noted that invalid laboratory data may not be used (from 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
94 of 142
09 Dec 2015
hemolyzed samples, mishandled samples, quantity not sufficient, or other conditions that 
would render values invalid).  
8.2.2.4
Missing Data Conventions 
Every attempt must be made by the Investigator to provide complete data.  
Analyses of primary and secondary efficacy endpoints:
Analyses of primary and secondary efficacy endpoints will be based on the ITT 
population, with missing values imputed using last observation carried forward (LOCF) 
imputation (whereby the last value is considered as the value of threshold sensitivity at 
entry/screening DBPCFC). Because threshold sensitivity to peanut protein for all 
randomized subjects will be 300 mg (based on the exclusion criteria), subjects who 
discontinue prior to the post-treatment DBPCFC will be counted as non-responders in the 
efficacy analyses. 
In addition, primary and secondary efficacy analyses will be repeated on the FAS.  
Besides, the robustness of the primary and secondary efficacy analyses conclusions will 
be explored via sensitivity analyses on the PP population (thus excluding subjects who 
discontinue from the study prior to the post-treatment DBPCFC or those with a major 
protocol deviation that impacts the primary efficacy criteria). 
Lastly, sensitivity analyses of the primary efficacy endpoint will be conducted on the 
overall ITT population using multiple imputation and worst-case imputation (which 
means subjects from the Viaskin® Peanut group who discontinue prior to the 
post-treatment DBPCFC will be counted as non-responders and subjects from the 
placebo group who discontinue prior to the post-treatment DBPCFC will be counted as 
responders) instead of the LOCF imputation to assess the robustness of the primary 
efficacy analyses with regards to handling of missing data. 
Analyses of other efficacy, safety and exploratory criteria:
No imputation will be performed for other efficacy, safety and exploratory criteria
(observed data will be used). Partial or missing safety data will be imputed according to 
the most conservative approach. Adverse events with missing or incomplete onset date 
will be considered as TEAEs unless there is evidence that the event occurred prior to the 
treatment period. Treatment-emergent AEs with missing relationship to the study drug 
will be considered as drug-related and TEAEs with missing severity will be considered 
as severe. Actual values will be presented in listings. 
8.2.2.5
Pooling of Centers
Considering the expected small number of subjects to be randomized by center, the 
center effect will not be investigated. The region (Australia/Europe/North America) and 
the treatment-by-region factor might be integrated as factors in the model used for the 
analysis of the primary efficacy endpoint as well as treatment response analyses by ED 
stratum in sensitivity analyses. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
95 of 142
09 Dec 2015
8.3
Demographics, Disease and Medical Histories, Baseline Characteristics, and 
Concomitant Medications
Descriptive statistics will be produced for continuous demographic and baseline 
characteristics (including age, height, weight, BMI, FEV1, PEF, and peanut-specific IgE) 
for each treatment group, by screening ED stratum and overall. The number and percent 
of subjects in each group of the categorical demographic and baseline characteristics 
(including race, medical history, and SPT) will be tabulated by treatment group and 
screening ED stratum, and overall.  
Concomitant medications will be coded using the latest available version of the World 
Health Organization (WHO) Drug Dictionary. A summary of concomitant medications 
will be produced by preferred drug name and treatment group. All concomitant 
medications will be listed.
Medical history will be reported by SOC and PT and coded using the latest available 
version of the Medical Dictionary for Regulatory Activities (MedDRA) dictionary. 
Disease history will also be described.
All individual subject demographic and baseline characteristic data will be listed.
8.4
Treatment Compliance and Exposure
Treatment compliance (see Section 5.6) will be summarized for each treatment group by 
means of descriptive statistics (n, mean, SD, median, Q1, minimum, Q3, and maximum) 
and/or frequency tables (compliance < or 80%). 
The total number of days of patch application during the whole study will be presented 
overall and by treatment group. Besides, the exposure duration by subject will be 
summarized, quantitatively and by category, overall and by treatment group. Exposure 
duration will be calculated regardless of temporary interruptions, as follows: 
Date of last patch application – Date of first patch application + 1
The total dose of peanut protein received during the study (mg) will also be summarized 
overall and by treatment group. 
8.5
Efficacy Analyses 
8.5.1
Primary Efficacy Analysis
The primary efficacy endpoint in this study is the percentage of treatment responders in 
the active Viaskin® Peanut 250 μg group compared to the placebo group after 12 months 
of EPIT treatment.
8.5.1.1
Hypothesis to be tested
The null hypothesis is that the percentage of treatment responders in the active Viaskin®
Peanut 250 μg group is the same as that in the placebo treatment group (which means the 
parameter estimate associated to the treatment group is equal to zero).  

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
96 of 142
09 Dec 2015
8.5.1.2
Statistical Methods
The primary efficacy analysis will be performed on the ITT population (that is on all 
randomized subjects), using LOCF imputation (which means that subjects with missing 
DBPCFC value at Month 12 will be considered as non-responders). An exact logistic 
regression will be used to compare the percentage of treatment responders at Month 12 in 
the active Viaskin® Peanut 250 μg group versus the placebo group, adjusting for 
screening ED stratum and including the treatment group as fixed effect. A 2-sided, 1% 
significance level will be used to test the null hypothesis. The corresponding p-value as 
well as the number and percentage (95% confidence intervals [CIs]) of responders will 
be presented by treatment group. The difference between active and placebo response 
rates and the corresponding 95% CI will be presented. The clinical relevance of the 
treatment effect will be evaluated based on the lower bound of the 95% CI being higher 
or equal to 15%. This 15% difference is intended to exhibit a clear robustness of the 
treatment effect.
Relative risks of achieving response in the active group compared to the placebo group 
will be assessed using a log-binomial regression with the screening ED stratum and 
treatment group as covariates and will be presented together with associated 95% CI. 
The study will be considered positive, if the p-value from the exact logistic regression is 
significant (p<0.01) and the lower bound of the 95% CI of the difference between active 
treatment and placebo response rates is higher or equal to 15%.
8.5.1.3
Sensitivity Analyses
The above analysis will be repeated on the FAS and PP population. Sensitivity analyses 
will be conducted on the ITT population using multiple imputation and worst-case 
imputation instead of the LOCF imputation to assess the robustness of the primary 
efficacy analysis with regard to handling of missing data. In addition, a sensitivity 
analysis with the region (Australia/Europe/North America) and the interaction between 
region and treatment group as covariate will be performed.  
8.5.2
Secondary Efficacy Analyses
8.5.2.1
Percentage of treatment responders in each screening ED stratum  
The first secondary efficacy analysis is the comparison of the percentage of treatment 
responders at Month 12 in each screening ED stratum. Within each screening ED
stratum, the treatment group comparison is conducted on the ITT population at a 2-sided 
5% significance level, using LOCF imputation and the exact logistic model described in 
Section 8.5.1.2. The corresponding p-value as well as the number and percentage of 
responders (95% CI) will be presented by treatment group. The difference between active 
and placebo response rates and the corresponding 95% CI will be presented. The clinical 
relevance of the treatment effect in each screening ED stratum will be evaluated based on 
a lower bound of the 95% CI strictly higher than 0%. The relative risk of achieving a 
response in the active group compared to the placebo group within each screening ED 
stratum will be assessed using the log-binomial model described in Section 8.5.1.2 and 
will be presented together with the associated 95% CI. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
97 of 142
09 Dec 2015
The above analysis will be repeated on the FAS and PP population. Besides, a sensitivity 
analysis with the region (Australia/Europe/North America) and the interaction between 
region and treatment group as covariate will be performed.
8.5.2.2
Percentage of treatment responders in each age subgroup  
The comparison of the percentage of treatment responders at Month 12 in the following 
age subgroups will be presented: 4 to 5 years-old; 6 to 11 years-old. Within each age 
subgroup, the treatment group comparison is conducted on the ITT population at a 2-
sided 5% and 10% significance levels, using LOCF imputation and the exact logistic 
model described in Section 8.5.1.2. The corresponding p-value as well as the number and 
percentage of responders (95% CI) will be presented by treatment group. The difference 
between active and placebo response rates and the corresponding 95% CI will be 
presented. The relative risk of achieving a response in the active group compared to the 
placebo group within each subgroup will be assessed using the log-binomial model 
described in Section 8.5.1.2 and will be presented together with the associated 95% CI. 
The above analysis will be repeated on the FAS and PP population.  
8.5.2.3
Mean and Median Cumulative Reactive/Eliciting Doses 
The peanut protein cumulative reactive dose at Month 12 and the peanut protein ED at 
Month 12 will be summarized descriptively by treatment group (for the whole population 
and for each screening ED stratum), for the ITT population using LOCF imputation, as 
well as for the FAS and PP population. 
In addition, the peanut protein cumulative reactive dose and the ED in each treatment 
group at Month 12 will be compared using an analysis of covariance (ANCOVA) model. 
The ANCOVA model will include the treatment group, baseline value, screening ED
stratum and region (Australia/Europe/North America) as covariates. Results will be 
log-transformed if needed. The peanut protein cumulative reactive dose and the ED will 
be evaluated for the ITT population using LOCF imputation, as well as for the FAS and 
PP population, overall and for each screening ED stratum, at a 2-sided 5% significance 
level.
8.5.2.4
Responsive/Unresponsive Subjects, Subjects Passing DBPCFC 
The percentage of subjects responsive to a cumulative GRVH1,444 mg peanut protein at 
Month WKHSHUFHQWDJHRIVXEMHFWVXQUHVSRQVLYHWRDFXPXODWLYHGRVH444 mg 
peanut protein at Month 12, and the percentage of subjects passing the DBPCFC at 
Month 12 will be summarized descriptively by treatment group, for the whole population 
and for each screening ED stratum, for the ITT population using LOCF imputation, as 
well as for the FAS and PP population.  
,QDGGLWLRQWKHSHUFHQWDJHRIVXEMHFWVUHVSRQVLYHWRDFXPXODWLYHGRVH444 mg peanut 
protein at Month 12, the percentage of subjects unresponsive to a cumulative dose 
444 mg peanut protein at Month 12 and the percentage of subjects passing the 
challenge in each treatment group at Month 12 will be compared using an exact logistic 
regression (adjusting for screening ED stratum and including the treatment group as fixed 
effect) for the overall ITT population using LOCF imputation, as well as for the FAS and 
PP population, at a 2-sided 5% significance level.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
98 of 142
09 Dec 2015
8.5.3
Pre-defined Hierarchical Order for the Analysis of Efficacy Endpoints  
In order to handle the multiple comparisons versus placebo, the overall type-I error will 
be controlled by the use of a hierarchical inferential approach. Statistical significance of 
the primary efficacy criterion in the overall population at the 1% alpha level is required 
before drawing inferential conclusion about the first secondary efficacy criterion 
(percentage of treatment responders in Stratum 1). Statistical significance of the first
secondary efficacy endpoint at the 5% alpha level is required before drawing inferential 
conclusion about the next endpoint (percentage of treatment responders in Stratum 2).
Inferential conclusion about successive secondary efficacy endpoints require statistical 
significance at the 5% alpha level of the previous one. Specifically, the pre-defined 
hierarchical order is as summarized in Table 8.
Table 8: Pre-defined Hierarchical Order for Analysis of Efficacy Endpoints
Order
Efficacy endpoints (at 
Month 12)
Population
Missing data 
imputation 
method
Alpha
Method
1
Percentage of treatment 
responders
ITT
Overall
LOCF 
imputation
0.01
Exact logistic 
regression
2
Percentage of treatment 
responders
ITT Screening 
ED Stratum 1
LOCF 
imputation
0.05
Exact logistic 
regression
3
Percentage of treatment 
responders
ITT Screening 
ED Stratum 2
LOCF 
imputation
0.05
Exact logistic 
regression
4
Cumulative reactive dose
ITT
Overall
LOCF 
imputation
0.05
ANCOVA
5
Peanut protein ED
ITT
Overall
LOCF 
imputation
0.05
ANCOVA
6
Percentage of treatment 
responders
ITT Age 
subgroup 6 to 
11 years-old
LOCF 
imputation
0.10
Exact logistic 
regression
7
Percentage of treatment 
responders
ITT Age 
subgroup 4 to 5 
years-old
LOCF 
imputation
0.10
Exact logistic 
regression
8
Percentage of subjects 
responsive to a cumulative 
GRVH1,444 mg peanut 
protein
ITT
Overall
LOCF 
imputation
0.05
Exact logistic 
regression
9
Percentage of subjects 
unresponsive to a 
cumulative dose 
444 mg peanut protein
ITT
Overall
LOCF 
imputation
0.05
Exact logistic 
regression
10
Cumulative reactive dose
ITT Screening 
ED Stratum 1
LOCF 
imputation
0.05
ANCOVA
11
Peanut protein ED
ITT Screening 
ED Stratum 1
LOCF 
imputation
0.05
ANCOVA
12
Cumulative reactive dose
ITT Screening 
ED Stratum 2
LOCF 
imputation
0.05
ANCOVA
13
Peanut protein ED
ITT Screening 
ED Stratum 2
LOCF 
imputation
0.05
ANCOVA
14
Percentage of subjects 
passing the challenge
ITT
Overall
LOCF 
imputation
0.05
Exact logistic 
regression
Abbreviations: ANCOVA = Analysis of covariance; ED = Eliciting dose; ITT = Intent-to-treat; 
LOCF = Last observation carried forward.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
99 of 142
09 Dec 2015
8.5.4
Other Efficacy Analyses
No further adjustments will be made for the other efficacy endpoints for which p-values 
will be provided for descriptive purpose only. The following efficacy analyses will be 
performed using observed data (no imputation will be done).  
x
Peanut-specific IgE and IgG4 analysis over time: Peanut-specific IgE and IgG4 
levels at baseline and changes from baseline to Months 3, 6 and 12 will be 
summarized descriptively by treatment group on the whole ITT population and 
for each screening ED stratum, using observed data. Besides, the peanut-specific 
IgE and IgG4 results at Month 12 will be compared for the whole ITT population 
and for each screening ED stratum using an ANCOVA model on observed data. 
The ANCOVA model will include the treatment group, baseline value, screening 
ED stratum, and region (Australia/Europe/North America) as covariates. Results 
will be log-transformed if needed. 
x
Skin Prick Test analysis: The mean change from baseline at Months 3, 6 and 12 
in maximum average wheal diameter will be evaluated for each treatment group 
on the whole ITT population using observed data. The SPT results at Month 12 
will be compared for the whole ITT population using an ANCOVA model on 
observed data. The ANCOVA model will include the treatment group, baseline 
value, screening ED stratum, and region (Australia/Europe/North America) as 
covariates. Results will be log-transformed if needed.
A quality of life score from the FAQLQ/FAIM will be summarized at Month 12 and 
compared to baseline for both treatment groups for the overall ITT population, using 
observed data.
8.6
Safety Analyses 
Safety endpoints will be evaluated for the Safety population (all subjects who received at 
least 1 dose of study drug).
For all safety analyses, data will be summarized for Viaskin® Peanut 250 μg versus 
placebo during the 12 months of treatment.
8.6.1
Adverse Events
Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study 
drug, which occur during or after the initial Viaskin® patch application or any event 
already present that worsens in either severity or relationship to study drug following 
exposure to Viaskin® patches.
All AEs will be reported by SOC and PT as detailed in Section 9.4 and coded using the 
latest available version of the MedDRA dictionary.  
An overall summary of TEAEs will be provided showing the number and percentage of 
subjects in each treatment group with any TEAEs, any potentially drug-related TEAEs, 
any severe TEAEs, any severe potentially drug-related TEAEs, any serious TEAEs, any 
TEAEs leading to discontinuation, and any TEAEs leading to death. The number of 
events will also be presented. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
100 of 142
09 Dec 2015
The number of AEs as well as the number and percentage of subjects who experienced at 
least 1 AE will be summarized by SOC, PT and treatment group. The incidence of the 
following events will be summarized:
x
TEAEs (distinguished from symptoms/reactions elicited during the DBPCFCs): 
incidence, maximum severity and duration; 
x
Local skin tolerance at sites of Viaskin® patch application as assessed by the 
subjects (incidence, duration and severity) (see Section 8.6.6); 
x
Local skin tolerance at sites of Viaskin® patch application as assessed by the 
Investigator (severity) (see Section 8.6.7);
x
SAEs and serious TEAEs and relatedness; 
x
Potentially drug-related TEAEs;
x
Discontinuation due to TEAEs; 
x
AESI (including systemic allergic reactions considered related to Viaskin® Peanut 
and vesicles at patch application sites).
The safety parameters above will be analyzed in the overall Safety population, as well as 
for each of the age ranges 4 to 5 years, 6 to 8 years and 9 to 11 years, and for each of the 
screening ED strata. 
All AEs will be listed.
The reactions appearing during a DBPCFC (as they are expressly provoked) will be 
differentiated from those AEs occurring outside of the DBPCFC. Objective and 
subjective symptoms/reactions elicited during the DBPCFCs in the different treatment 
groups (see Section 6.1.1 for full details) will be summarized separately (see 
Section 8.6.8).
8.6.2
Laboratory Assessments
Descriptive statistics will be calculated for clinical laboratory tests (hematology and 
biochemistry) performed at Visit 1 (Day -42), Visit 7 (Month 3), Visit 8 (Month 6) and 
Visit 10 (Month 12). Categorical variables will be summarized by frequency and 
percentages of subjects in corresponding categories. 
Changes in laboratory data from baseline will also be presented.  
In addition, summaries of laboratory values categorized based on Common Toxicity 
Criteria for Adverse Events (CTCAE) grade will also be presented. 
Shift tables of test abnormalities will be generated to compare baseline values to the 
values collected at other time points.
Laboratory data will be analyzed overall and for the age ranges 4 to 5 years, 6 to 8 years 
and 9 to 11 years, as well as for each screening ED stratum and association with any age 
stratum will be presented.
All laboratory data will be listed. Listing of values that are out of normal range will be 
flagged in the data listings. 
8.6.3
Vital Signs
Observed vital sign values and changes from baseline will be descriptively summarized 
by visit and treatment group. All vital signs data will be listed.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
101 of 142
09 Dec 2015
The analysis of vital signs will focus on the incidence of clinically relevant 
abnormalities. The number of subjects evaluated and the number and percentage of 
subjects with clinically relevant post-baseline abnormalities at each visit will be 
presented. The criteria for clinically relevant post-baseline abnormalities are shown in 
Table 9. 
Table 9: Criteria to assess Clinically Relevant Abnormalities in Vital Signs
Vital Sign Criteria 
for Abnormalities
Criteria for Abnormalities
Pulse
>130 beats per minute or an increase from pre-dosing of >20 beats per minute, or
<60 beats per minute or a decrease from pre-dosing of >20 beats per minute
Systolic blood 
pressure
>130 mmHg or an increase from pre-dosing of >40 mmHg, or 
<70 mmHg or a decrease from pre-dosing of >30 mmHg
Diastolic blood 
pressure
>85 mmHg or an increase from pre-dosing of >30 mmHg, or
<45 mmHg or a decrease from pre-dosing of >20 mmHg
Vital signs will be analyzed overall and for the age ranges 4 to 5 years, 6 to 8 years and 
9 to 11 years, as well as for each screening ED stratum and association with any age 
stratum will be presented.
8.6.4
Physical Examination 
Physical examination data will be summarized by visit and treatment group and listed.  
Changes in physical examination data from baseline will be presented. Physical 
examination data will be analyzed overall and for the age ranges 4 to 5 years, 6 to 8 years 
and 9 to 11 years, as well as for each screening ED stratum and association with any age 
stratum will be presented.
Skin reactions observed during the physical examinations will also be reported and the 
corresponding data will be tabulated separately (see Section 8.6.7). 
8.6.5
Spirometry and Peak Expiratory Flow Results
Percent predicted values for FEV1 and PEF and changes from baseline will be 
descriptively summarized separately by visit and treatment group. All FEV1 and PEF 
data will be listed. Spirometry and PEF data will be analyzed overall and for the age 
ranges 4 to 5 years, 6 to 8 years and 9 to 11 years, as well as for each screening ED 
stratum and association with any age stratum will be presented.
8.6.6
Subject Diaries
Subject diary data will be summarized where appropriate and listed.
During the first 6 months, the number of days of itching, redness and swelling of 
Grade 1, 2, or 3 will be summarized separately by treatment group, age ranges 
(4 to 5 years, 6 to 8 years and 9 to 11 years), screening ED stratum, and overall. 
The most severe grades of itching, redness and swelling, documented in the diary, will 
also be summarized. The maximum grade of local reactions reported (itching, redness or 
swelling) during the first 6 months will also be tabulated.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
102 of 142
09 Dec 2015
8.6.7
Skin Reactions
Viaskin® patch site examination data will be summarized where appropriate and listed.  
Examination of the skin at the site of patch application will be graded by the 
Investigators on a scale of Grade 0 (negative) to Grade 4 (erythema, vesicles). 
Localization of the skin reaction (under the patch/beyond the patch) will also be 
collected. These results will be summarized using descriptive statistics and presented by 
visit and treatment group, regardless of the localization as well as for each type of 
localization. The worst grade reported will also be tabulated. The above descriptions will 
be presented for the overall Safety population as well as for the age ranges 4 to 5 years, 
6 to 8 years and 9 to 11 years and for each screening ED stratum.
8.6.8
Symptomatic Reactions During the DBPCFC
The incidence of objective and subjective symptoms/reactions elicited during the 
DBPCFCs will be summarized. Besides, a severity score based on the grades of objective 
symptoms elicited during the DBPCFCs will be described at baseline and at Month 12. 
The change in the severity score from baseline will also be presented.
8.7
Exploratory Analyses 
There will be no adjustments for multiplicity for any of the following exploratory 
analyses. 
The following exploratory analyses will be done: 
x
Analysis of IgE and IgG4 specific to peanut protein components: Descriptive 
analysis will be conducted for IgE and IgG4 specific to peanut protein 
components for the overall ITT population, using observed data. Comparison 
between treatment groups will be conducted using the ANCOVA model 
described above; 
x
Frequency of accidental consumptions, conditions around the accidental 
consumptions, estimated quantity consumed at each occurrence, and associated 
reactions and severity of reactions. These AEs will be classified and analyzed 
separately and specifically;
x
Risk-taking behaviors: frequency of deliberate consumption of peanut, conditions 
around the consumption, estimated quantity consumed at each occurrence and 
associated reactions with these consumptions. These AEs will be classified and 
analyzed separately and specifically for the overall ITT population, using 
observed data;  
x
Descriptive analyses of epigenetic modifications of some specific genes in both 
treatment groups for the overall ITT population, using observed data; 
x
Treatment-emergent AEs and local skin tolerance at sites of Viaskin® patch 
application will be described among subjects with mutations in the filaggrin gene 
versus subjects carrying the wild type gene;
x
Descriptive analysis will be conducted for each of the other allergen-specific IgE 
analyzed (cow’s milk, egg, house dust mites, grass pollen) and the change from 
baseline will be tabulated for the overall ITT population, using observed data; 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
103 of 142
09 Dec 2015
x
SCORAD change from baseline at Months 3, 6 and 12 will be presented for the 
overall ITT population using observed data. 
8.8
Patch adhesion 
A frequency table showing the number of patches evaluated by the subjects’ 
parents/guardians in their diaries and the proportion of patches for each adhesion score 
(see Section 6.2.9) will be presented, immediately after patch application and at time of 
patch removal.  
Percentage of patches assessed by the subjects’ parents/guardians and having an adhesion 
score equal to 2 (which means the occlusion chamber of the patch is partially or totally 
detached) or 3 (which means the patch has fallen off the skin) will be tabulated and the 
time to removal for those patches will be described. 
Patch adhesion will be considered as acceptable if more than 90% of the patches at time 
of target patch removal, i.e. at 24±4 hours, KDYHDQDGKHVLRQVFRUH as assessed by the 
subjects’ parents/guardians. 
Descriptive analysis will be conducted on the suspected causes of adhesion issues 
(scratching / swimming / sweating / other) and on the potential presence of skin 
injury(ies) caused by patch removal (yes / no), as assessed by the subjects 
(parents/guardians). Proportion of patches for each grade of patch removal easiness (very 
easy / easy / difficult / very difficult) and for each grade of pain at patch removal (very 
painful / painful / not painful), as assessed by the subjects (parents/guardians), will be 
tabulated.  
Finally, the proportion of patches for each adhesion score as assessed by the Investigator 
at each time point will be tabulated.
8.9
Interim Analyses
No interim analysis is planned for this study. 
8.10 Determination of Sample Size
The objective of this study is to assess the efficacy and safety of Viaskin® Peanut to 
induce desensitization to peanut in peanut-allergic children after a 12-month treatment 
period of EPIT. This will be evaluated by assessing the percentage of treatment 
responders in the active Viaskin® Peanut 250 μg group compared to the placebo group.  
The sample size is calculated based on the following assumptions: 
x
A 40% response rate for the active Viaskin® Peanut 250 μg group and 10% 
response rate for the placebo group in the overall population, with a 2-sided 
type-,HUURUUDWHĮVHWWR; 
x
A lower bound of the 95% CI of the difference between active treatment and 
SODFHERUHVSRQVHUDWHVLQWKHRYHUDOOpopulation and >0% in each stratum; 
x
A 60% response rate for the active Viaskin® Peanut 250 μg group and 10% 
response rate for the placebo group in Stratum 1, with a 2-sided type-,HUURUUDWHĮ
set to 5%; 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
104 of 142
09 Dec 2015
x
A 30% response rate for the active Viaskin® Peanut 250 μg group and 10% 
response rate for the placebo group in Stratum 2, with a 2-sided type-,HUURUUDWHĮ
set to 5% and a power (1-ȕVHWWR
x
The following expected distribution of the screening ED strata: 
- 1/3 of children having a screening ED from 1 mg to 10 mg;
- 2/3 of children having a screening ED from 30 mg to 300 mg.
x
A ratio 2:1 to maximize the number of subjects treated in the active Viaskin®
Peanut 250 μg group. 
Therefore, the sample size calculated for Stratum 2 is 185 subjects (approximately 
123 subjects in the active Viaskin® Peanut 250 μg group and 62 subjects in the placebo 
group. Hence, if 185 children with a screening ED from 30 mg to 300 mg are required in 
the study, then, according to the expected distribution of the screening ED strata, 
approximately 95 children having a screening ED from 1 mg to 10 mg should be 
randomized, resulting in a total of 280 subjects evaluable for the primary efficacy 
endpoint in the analysis.  
This number of subjects leads to a power of 99% in the overall population and in the 
Stratum 1.
This is summarized in Table 10.
Table 10: Summary of Sample Size Calculation
Population
alpha
Power
Sample size (N=N1+N2)
Expected Response Rate
Lower bound 
of the 95% CI
of the 
difference
Viaskin®
Peanut 
250 μg
Placebo
Total
Screening ED 
Stratum 1
5%
99%
N1=63
60%
N2=32
10%
N=95
>0%
Screening ED 
Stratum 2
5%
85% 
N1=123
30%
N2=62
10%
N=185
>0%
Overall population
1%
99%
N1=186
40%
N2=94
10%
N=280
15% 
Abbreviations: CI = Confidence interval; ED = Eliciting dose; N = Number of subjects.
To allow for a potential premature withdrawal rate of about 15%, the study will 
randomize a total of 330 subjects: 220 subjects will be randomized to receive Viaskin®
Peanut 250 μg and 110 subjects to placebo. Among the 330 subjects randomized, a
minimum of 20 subjects will be randomized for each of the following ages: 4 years, 
5 years and 11 years, respectively. Besides, a minimum number of 75 children of either 4 
or 5 years of age must be randomized.  
The distribution per ED stratum should lead to approximately 110 subjects with a 
screening ED from 1 mg to 10 mg and approximately 220 subjects with a screening ED 
from 30 mg to 300 mg, provided that the same distribution as obtained in the Phase IIb 
VIPES study is reproduced. If this expected distribution is not fully respected during the 
recruitment in the PEPITES study, a minimum of 50 subjects would need to be included 
in Stratum 1 in RUGHUWRJXDUDQWHHDSRZHURILQWKLVVWUDWXPDQGDWOHDVW

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
105 of 142
09 Dec 2015
220 subjects would need to be included in Stratum 2 in order to guarantee a power of 
85% in this stratum.
From experience, the screen failure rate could be up to 30%; hence, up to 470 peanut 
allergic subjects might need to be screened.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
106 of 142
09 Dec 2015
9
ETHICAL, LEGAL, AND ADMINISTRATIVE ASPECTS
9.1
Data Quality Assurance 
The Sponsor or Sponsor’s designee will conduct a site visit or a site phone contact to 
verify the qualifications of each Investigator, inspect the site facilities, and inform the
Investigator of responsibilities and the procedures for ensuring adequate and correct 
documentation. 
The Investigator is required to prepare and maintain adequate and accurate case histories 
designed to record all observations and other data pertinent to the study for each study 
participant. All information recorded in the e-CRF for this study must be consistent with 
the subjects’ source documentation (that is medical records).
9.1.1
Database Management and Quality Control 
All data generated by the site personnel will be captured electronically at each study 
center using e-CRFs. Data from external sources (such as laboratory data) will be 
imported into the database. Once the e-CRF clinical data have been submitted to the 
central server at the independent data center, corrections to the data fields will be 
captured in an audit trail. The reason for change, the name of the person who performed 
the change, together with the time and date will be logged to provide an audit trail.  
If additional corrections are needed, the responsible monitor or data manager or the 
Sponsor will raise a query in the Electronic Data Capture (EDC) application. The 
appropriate staff at the study site will answer queries sent to the Investigator. The name 
of the staff member responding to the query, and time and date stamp will be captured to 
provide an audit trail. Once all source data verification is complete and all queries are 
closed, the monitor will freeze the e-CRF page. 
The specific procedures to be used for data entry and query resolution using the EDC 
system/e-CRF will be provided to study sites in a training manual. In addition, site 
personnel will receive training on the EDC system/e-CRF. 
9.2
Case Report Forms and Source Documentation
All data obtained during this study should be entered in the e-CRFs promptly. All source 
documents from which e-CRF entries are derived should be placed in the subject’s 
medical records. Measurements for which source documents are usually available 
include laboratory assessments, spirometry, PEF and immunological markers.  
Data that will be entered directly into the e-CRF (those for which there is no prior written 
or electronic record of data) are considered to be source data.
The original e-CRF entries for each subject may be checked against source documents at 
the study site by PAREXEL’s site monitor. 
After review by PAREXEL’s site monitor, completed e-CRF entries will be uploaded 
and forwarded to PAREXEL. Instances of missing or uninterpretable data will be 
discussed with the Investigator for resolution.  
The specific procedures to be used for data entry and query resolution using the e-CRF
will be provided to study sites in a training manual. In addition, site personnel will 
receive training on the e-CRF.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
107 of 142
09 Dec 2015
9.2.1
Data Collection  
The Investigators (and appropriately authorized staff) will be given access to an online 
webbased EDC system which is 21 CFR Part 11 compliant. This system is specifically 
designed for the collection of the clinical data in electronic format. Access and rights to 
the EDC system will be carefully controlled and configured according to each 
individual’s role throughout the study. In general, only the Investigator and authorized 
staff will be able to enter data and make corrections in the e-CRFs.
The e-CRF should be completed for each subject for whom the study-specific ICF was 
obtained and should reflect the latest observations on the subject participating in the 
study. Therefore, the e-CRFs are to be completed as soon as possible during or 
immediately after the subject’s visit or assessment. The Investigator must verify that all 
data entries in the e-CRF are accurate and correct. If some assessments cannot be done, 
or if certain information is unavailable, not applicable or unknown, the Investigator 
should indicate this in the e-CRF.  
Computerized data-check programs and manual checks will identify any clinical data 
discrepancies for resolution. Corresponding queries will be loaded into the system and 
the site will be informed about new issues to be resolved on-line. All discrepancies will 
be solved online directly by the Investigator or by authorized staff. Off-line edit checks 
will be done to examine relationships over time and across panels to facilitate quality 
data.  
After completion, the Investigator will be required to electronically sign off the clinical 
data. 
Information concerning study drug dispensation to the subject will be tracked in the e-
CRF.
9.3
Access to Source Data
9.3.1
Routine Monitoring
During the study, a PAREXEL site monitor will make site visits to review protocol 
compliance, compare e-CRF entries and individual subject’s medical records, assess drug 
accountability, and ensure that the study is being conducted according to ethical and
pertinent regulatory requirements. The e-CRF entries will be verified with source 
documentation. The review of medical records will be performed in a manner to ensure 
that subject confidentiality is maintained.
Checking of the e-CRF entries for completeness and clarity, and cross-checking with 
source documents, will be required to monitor the progress of the study. Direct access to 
source data will be required for the monitoring activities. 
9.3.2
Inspections and Auditing Procedures 
The Sponsor or its representative may conduct audits at the investigative sites including, 
but not limited to, drug supply, presence of required documents, the informed consent 
process, and comparison of e-CRFs with source documents. All medical records 
(progress notes) must be available for audit. The Investigator agrees to participate in
audits conducted at a convenient time in a reasonable manner.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
108 of 142
09 Dec 2015
Moreover, Regulatory Authorities of certain countries, IRBs and IECs may wish to carry 
out such source data checks and/or on-site audit inspections. Direct access to source data 
will be required for these inspections and audits; they will be carried out giving due 
consideration to data protection and medical confidentiality. The Investigator assures 
PAREXEL and the Sponsor of the necessary support at all times.
The purpose of an audit is to assess whether ethics, regulatory and quality requirements 
are fulfilled.
9.4
Data Processing
All data will be entered by site personnel into the e-CRF (as detailed in Section 9.2.1).
The data-review and data-handling document, to be developed during the initiation phase 
of the study, will include specifications for consistency and plausibility checks on data 
and will also include data-handling rules for obvious data errors. Query/correction sheets 
for unresolved queries will be sent to the study monitors for resolution with the 
Investigator. The database will be updated on the basis of signed corrections.  
Previous and concomitant medications will be coded using the WHO Drug Reference 
List, which employs the Anatomical Therapeutical Chemical (ATC) classification 
system. Disease and Medical histories/current medical conditions and AEs will be coded 
using the MedDRA terminology. 
Previous and concomitant diseases as well as AEs will be coded with MedDRA.
The versions of the coding dictionaries will be provided in the CSR. 
9.5
Archiving Study Records
All data derived from the study will remain the property of the Sponsor. Records must be 
retained in accordance with the current ICH Guidelines on Good Clinical Practice (GCP).
All essential study documents including records of subjects, source documents, e-CRFs
and study drug inventory must be kept in a study-specific file.
US Food and Drug Administration (FDA) regulations (21 Code of Federal Regulations 
[CFR] 312.62[c]) require that records and documents pertaining to the conduct of this 
study and the distribution of investigational drug, including e-CRFs, consent forms, 
laboratory test results, and medical inventory records, must be retained by the Principal 
Investigator for 2 years after marketing application approval. If no application is filed, 
these records must be kept 2 years after the investigation is discontinued and the US 
FDA and the applicable national and local health authorities are notified. The Sponsor or 
their representative will notify the Principal Investigator of these events.
The Investigator will not dispose of any records relevant to this study without written 
permission from the Sponsor, and will provide the Sponsor the opportunity to collect 
such records. The Investigator shall notify the Sponsor in writing of their intent to 
destroy all such material. The Sponsor shall have 30 days to respond to the Investigator’s 
notice, and the Sponsor shall have a further opportunity to retain such materials at the 
Sponsor’s expense. 
The Investigator shall take responsibility for maintaining adequate and accurate hard 
copy source documents of all observations and data generated during this study. Such 
documentation is subject to inspection by the Sponsor, its representatives and Regulatory 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
109 of 142
09 Dec 2015
Authorities. If an Investigator moves, withdraws from an investigation or retires the 
responsibility for maintaining the records may be transferred to another person who will 
accept responsibility. Notice of transfer must be made to and agreed by the Sponsor. 
9.6
Good Clinical Practice
The procedures set out in this study protocol are designed to ensure that the Sponsor and 
Investigator abide by the principles of the ICH-GCP Guidelines, and of the Declaration 
of Helsinki (APPENDIX 1). The study also will be carried out in keeping with local legal 
requirements.  
9.7
Informed Consent
The Investigator is responsible for and will obtain a signed ICF from each subject’s 
parents/guardians, before each subject is admitted to the study, in accordance with the 
ICH-GCP Guidelines, the Declaration of Helsinki, and applicable regulatory 
requirements.
This consent form must be dated and retained by the Investigator as part of the study 
records. The Investigator will not undertake any investigation specifically required only 
for the clinical study until valid consent has been obtained. The terms of the consent and 
when it was obtained must be documented in the subject’s medical records and the e-
CRF.
Subjects/parents/guardians will be informed of the nature of the study, its aim, its 
possible risks and restrictions, its duration, and the compensation that they might receive. 
The protocol will be explained during a meeting prior to study enrollment, and each 
subject/parents/guardians must be informed that participation in the study is voluntary 
and that the subject may withdraw from the study at any time. The parents/guardians 
should read the ICF before signing and dating it and a copy of the signed document 
should be given to the parents/guardians. No subject can enter the study before informed 
consent has been obtained from her/his parents/guardians. Subjects 7 to 11 years of age
will sign an assent form specific to their ages, wherever that is required by local country 
laws. The parents/guardians of all subjects regardless of age must sign the ICF.  
The explicit wish of a minor, who is capable of forming an opinion and assessing the 
study information, to refuse participation in or to be withdrawn from the study at any 
time will be respected by the Investigator.
If a protocol amendment is required, the ICF may need to be revised to reflect the 
changes to the protocol. If the consent form is revised, it must be reviewed and approved 
by the appropriate IEC/IRB, and signed by the parents/guardians of all subjects
subsequently enrolled in the study as well as those currently enrolled in the study. 
The Investigator should inform the subject’s primary physician about participation in the 
clinical study wherever required.
A specific written informed consent for the screening of mutations in the filaggrin gene 
and for evaluating the epigenetic modifications on some specific genes will also be 
prepared, submitted and approved by the IRBs/IECs, and has to be signed by the 
subject’s parents/guardians before the blood samples are drawn. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
110 of 142
09 Dec 2015
9.8
Protocol Approval and Amendment
Before the start of the study, the study protocol and/or other relevant documents will be 
reviewed and approved by the IEC/IRB/Regulatory Authorities, in accordance with local 
legal requirements. The Sponsor must ensure that all ethical and legal requirements have 
been met before the first subject is enrolled in the study. 
This protocol is to be followed exactly. Any change to the protocol must be handled as a 
protocol amendment. Any potential amendment must be approved by the Sponsor. A 
written amendment must be submitted to the appropriate Regulatory Authorities and to 
the IRB/IECs assuming this responsibility. The Investigator must await IRB/IEC 
approval of protocol amendments before implementing the changes, except where 
necessary to eliminate apparent immediate hazard to subjects. In these cases, the 
IRB/IEC must be notified within 5 days of the change. 
All amendments to the protocol must be approved in writing by both the appropriate 
Regulatory Authorities and the IRB/IEC, except for administrative amendments, which 
require notification but not written approval. Once approved, the protocol amendment 
will be distributed to all recipients of the original protocol, with instructions to append 
the amendment to the protocol. If, in the judgment of the local IRB/IEC, the Investigator 
and/or Sponsor, the protocol amendment alters the study design, procedures and/or 
increases the potential risk to the subject, the currently approved written ICF will require 
modifications. The modified ICF must also be reviewed and approved by the Sponsor, 
appropriate Regulatory Authorities, and the IRB/IEC. In such cases, repeat informed 
consent must be obtained from the enrolled subjects’ parents/guardians before 
participation continues. 
9.9
Data and Safety Monitoring Board 
A DSMB composed of experts in food allergy and in the methodology of clinical studies 
will be established in due time for the first data review. This DSMB will be independent 
of the Sponsor and will review safety data from the study at specified intervals during the 
study and on an ad hoc basis as deemed necessary by the DSMB Chair person or when 
conveyed by the Sponsor. A specific DSMB meeting will be held when the first 
15 subjects 4 to 5 years of age have been randomized and treated for at least 4 weeks 
(that is, have completed the Month 1 visit). This is to assess very early in the study that 
safety of Viaskin® Peanut in these younger patients is acceptable.  
The DSMB members will review blinded data, but may have access to unblinded data as 
deemed necessary during the closed review meetings. During these review meetings, the 
DSMB will assess whether the nature, frequency, and severity of the AEs associated with 
the study treatment warrant any recommendations or corrective actions in the best 
interest of the subjects.
The roles, responsibilities, constitution, and operations of the DSMB will be described in 
the DSMB Charter, which will be reviewed and signed by each member before the first 
subject is randomized and treated. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
111 of 142
09 Dec 2015
9.10 Duration of the Study
For an individual subject, the maximum duration of study participation will be up to
61 weeks (including up to 6 weeks for screening, 12 months of treatment and up to 
3 weeks for follow-up). The planned study duration is 24 months. The study will close 
when all subjects have completed the Final Follow-up visit. 
9.11 Premature Termination of the Study
If the Investigator, the Sponsor, or the Medical Monitor becomes aware of conditions or 
events that suggest a possible hazard to subjects if the study continues, the study may be 
terminated after appropriate consultation between the relevant parties. The study may 
also be terminated early at the Sponsor’s discretion in the absence of such a finding. 
Conditions that may warrant termination include, but are not limited to:
x
The discovery of an unexpected, significant, or unacceptable risk to the subjects
enrolled in the study; 
x
Failure to enroll subjects at an acceptable rate;
x
A decision on the part of the Sponsor to suspend or discontinue development of 
the drug; 
x
A decision from the Regulatory Authorities to suspend or discontinue the study. 
In terminating the study, the Sponsor, PAREXEL and the Investigator will ensure that 
adequate consideration is given to the protection of the subjects’ interests.
9.12 Confidentiality
All information obtained during the conduct of the study with respect to the subject’s 
state of health will be regarded as confidential. For disclosure of any such information, 
an agreement will be obtained in writing. The Investigator must ensure that each 
subject’s anonymity is maintained. On e-CRFs and other documents submitted to the 
Sponsor or PAREXEL, subjects must not be identified by name. Instead, subjects will 
only be known by the unique subject screening number allocated to them in order to 
ensure confidentiality on all study documentation. Subjects will retain this unique 
number throughout the study. The Investigator will keep a separate log of these codes. 
In order to comply with government regulatory guidelines and to ensure subject safety, it 
may be necessary for the Sponsor and its representative, the PAREXEL personnel, the 
IEC/IRB, or Regulatory Authority to review subjects’ medical records as they relate to 
this study. Only the subject’s unique number in the e-CRFs will identify her/him, but 
their full names may be made known to a Regulatory Authority or other authorized 
government or health care officials, if necessary, and to personnel designated by the 
Sponsor. 
Documents that are not for submission to the Sponsor or to PAREXEL (for example
consent forms) will be maintained by the Investigator in strict confidence, except to the 
extent necessary to allow monitoring by the Sponsor and PAREXEL, and auditing by 
regulatory authorities. No documents identifying subjects by name will leave the 
investigative site and subject identity will remain confidential in all publications related 
to the study. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
112 of 142
09 Dec 2015
9.13 Contractual and Financial Details 
The Investigator (and/or, as appropriate, the hospital administrative representative) and 
the Sponsor will sign a clinical study agreement prior to the start of the study, outlining 
overall Sponsor and Investigator responsibilities in relation to the study. The contract 
should describe whether costs for pharmacy, laboratory and other protocol-required 
services are being paid directly or indirectly.
Financial Disclosure Statements will need to be completed, as requested by FDA CFR 21 
part 54.  
9.14 Liability and Insurance
The Sponsor will take out reasonable third-party liability insurance cover in accordance 
with all local legal requirements. The civil liability of the Investigator, the persons 
instructed by her/him and the hospital, practice, or institute in which they are employed 
and the liability of the Sponsor with respect to financial loss due to personal injury and 
other damage that may arise as a result of the carrying out of this study are governed by 
the applicable law.
Deviations from the study protocol, especially the prescription of a dose other than that 
scheduled in the study protocol, other modes of administration, other indications, and 
longer treatment periods, are not permitted and shall not be covered by the statutory 
subject insurance scheme.
The Sponsor will arrange for subjects participating in this study to be insured against 
financial loss due to personal injury caused by the pharmaceutical products being tested 
or by medical steps taken in the course of the study.  
9.15 Publication Policy
By signing the study protocol, the Investigator agrees with the use of results of the study 
for the purposes of national and international registration, publication and information for 
medical and pharmaceutical professionals. If necessary, Regulatory Authorities will be 
notified of the Investigator's name, address, qualifications and extent of involvement. 
An Investigator shall not publish any data (poster, abstract, paper, etc.) without having 
consulted with the Sponsor in advance and having received a written approval for such a 
publication. Details are provided in a separate document.
9.16 Study Center File Management
The Investigator is responsible for assuring that the Study Center File is maintained. The 
Study Center File will contain, but will not be limited to, the information listed below:
1. IB; 
2. Current, signed version of the protocol and any previous versions of the protocol; 
3. Protocol amendments (if applicable); 
4. Operations Manual (if applicable);
5. Current ICF (blank) and any previous versions of the ICF; 
6. Curricula Vitae of Investigator(s) and sub-investigator(s) and photocopy of their 
respective license(s) where required by law; Original US FDA Form 1572 (for all 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
113 of 142
09 Dec 2015
studies conducted under US Investigational New Drug [IND] regulations), signed by 
all Principal Investigators. The names of any sub-investigators must appear on this 
form. Investigators must also complete all regulatory documentation as required the 
ICH GCP and by local or national regulations; 
7. Documentation of IRB/IEC approval of the protocol, the ICF, any protocol 
amendments, and any ICF revisions; 
8. All correspondence between the Investigator, IRB/IEC, and the Sponsor/ PAREXEL
relating to study conduct; 
9. Laboratory Manual and certification(s);
10. Monitoring log; 
11. Study drug accountability forms; 
12. Signature list of all staff completing e-CRFs; 
13. Signature list of all staff completing drug accountability summaries; and
14. Delegation log.
9.17 Clinical Study Report
A final CSR will be prepared according to the ICH E3 guideline on Structure and 
Contents of CSRs. A final CSR will be prepared regardless of whether the study is 
completed or prematurely terminated. The Sponsor will provide each Investigator with a 
copy of the final report or synopsis for retention.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
114 of 142
09 Dec 2015
10 REFERENCE LIST
1 Bock SA, Muñoz-Furlong A, Sampson HA. Further fatalities caused by anaphylactic reactions to food, 
2001-2006. J Allergy Clin Immunol. 2007;119(4):1016-8.
2 Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy 
Clin Immunol. 2001;107(1):191-3.
3 Sicherer SH, Muñoz-Furlong A, Godbold JH, Sampson HA. US prevalence of self-reported peanut, tree 
nut, and sesame allergy: 11-year follow-up. J Allergy Clin Immunol. 2010;125(6):1322-6.
4 Sicherer SH, Muñoz-Furlong A, Sampson HA. Prevalence of peanut and tree nut allergy in the United 
States determined by means of a random digit dial telephone survey: a 5-year follow-up study. J 
Allergy Clin Immunol. 2003;112(6):1203-7.
5 Grundy J, Matthews S, Bateman B, Dean T, Arshad SH. Rising prevalence of allergy to peanut in 
children: Data from 2 sequential cohorts. J Allergy Clin Immunol. 2002;110(5):784-9.
6 Peters RL, Allen KJ, Dharmage SC, Koplin JJ, Dang T, Tilbrook KP, et al.; HealthNuts study. Natural 
history of peanut allergy and predictors of resolution in the first 4 years of life: A population-based 
assessment. J Allergy Clin Immunol. 2015;135(5):1257-1266.
7 Ho MH, Wong WH, Heine RG, Hosking CS, Hill DJ, Allen KJ. Early clinical predictors of remission of 
peanut allergy in children. J Allergy Clin Immunol. 2008;121(3):731-6.
8 Fleischer DM, Conover-Walker MK, Christie L, Burks AW, Wood RA. The natural progression of 
peanut allergy: Resolution and the possibility of recurrence. J Allergy Clin Immunol. 
2003;112(1):183-9.
9 Hourihane JO, Roberts SA, Warner JO. Resolution of peanut allergy: case-control study. BMJ 
1998;316(7140):1271-1275. 
10 Du Toit G, Roberts G, Sayre PH, Bahnson HT, Radulovic S, Santos AF, et al; LEAP Study Team. 
Randomized trial of peanut consumption in infants at risk for peanut allergy. N Engl J Med. 
2015;372(9):803-13.
11 Eigenmann PA, Beyer K, Wesley Burks A, Lack G, Liacouras CA, Hourihane JO, et al. New visions for 
food allergy: an iPAC summary and future trends. Pediatr Allergy Immunol. 2008;Suppl 19:26-39.
12 Sampson HA. Food allergy--accurately identifying clinical reactivity. Allergy. 2005;60 Suppl 79:19-24.
13 Sampson HA, Muñoz-Furlong A, Campbell RL, Adkinson NF Jr, Bock SA, Branum A, et al. Second 
symposium on the definition and management of anaphylaxis: summary report—second National 
Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. 
Ann Emerg Med. 2006;47(4):373-80.
14 Burks AW. Peanut allergy. Lancet. 2008;371(9623):1538-46.
15 Eigenmann PA. Mechanisms of food allergy. Pediatr Allergy Immunol. 2009;20(1):5-11.
16 Otsu K, Dreskin SC. Peanut allergy: an evolving clinical challenge. Discov Med. 2011;12(65):319-28.
17 Sicherer SH, Furlong TJ, Muñoz-Furlong A, Burks AW, Sampson HA. A voluntary registry for peanut 
and tree nut allergy: characteristics of the first 5149 registrants. J Allergy Clin Immunol. 
2001;108(1):128-32.
18 Kemp SF, Lockey RF, Simons FE; World Allergy Organization ad hoc Committee on Epinephrine in 
Anaphylaxis. Epinephrine: the drug of choice for anaphylaxis-a statement of the world allergy 
organization. World Allergy Organ J. 2008;1(7 Suppl):S18-26.
19 Leung DY, Sampson HA, Yunginger JW, Burks AW Jr, Schneider LC, Wortel CH, et al.; Avon 
Longitudinal Study of Parents and Children Study Team. Effect of anti-IgE therapy in patients with 
peanut allergy. N Engl J Med. 2003;348(11):986-93.
20 Sampson HA, Leung DY, Burks AW, Lack G, Bahna SL, Jones SM, et al. A phase II, randomized, 
double̻blind, parallel̻group, placebo̻controlled oral food challenge trial of Xolair (omalizumab) 
in peanut allergy. J Allergy Clin Immunol. 2011;127(5):1309-10.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
115 of 142
09 Dec 2015
21 Jones SM, Burks AW, Dupont C. State of the art on food allergen immunotherapy: oral, sublingual, and 
epicutaneous. J Allergy Clin Immunol. 2014;133(2):318-23.
22 Leung DY. Food allergy: are we getting closer to a cure? J Allergy Clin Immunol. 2011;127(3):555-7.
23 Anagnostou K, Islam S, King Y, Foley L, Pasea L, Bond S, et al. Assessing the efficacy of oral 
immunotherapy for the desensitisation of peanut allergy in children (STOP II): a phase 2 
randomised controlled trial. Lancet. 2014;383(9925):1297-304.
24 Kim EH, Bird JA, Kulis M, Laubach S, Pons L, Shreffler W, et al. Sublingual immunotherapy for 
peanut allergy: clinical and immunologic evidence of desensitization. J Allergy Clin Immunol. 
2011;127(3):640-6.e1.
25 Varshney P, Jones SM, Scurlock AM, Perry TT, Kemper A, Steele P, et al. A randomized controlled 
study of peanut oral immunotherapy: clinical desensitization and modulation of the allergic 
response. J Allergy Clin Immunol. 2011;127(3):654-60.
26 Jones SM, Pons L, Roberts JL, Scurlock AM, Perry TT, Kulis M, et al. Clinical efficacy and immune 
regulation with peanut oral immunotherapy. J Allergy Clin Immunol. 2009;124(2):292-300.
27 Blumchen K, Ulbricht H, Staden U, Dobberstein K, Beschorner J, de Oliveira LC, et al. Oral peanut 
immunotherapy in children with peanut anaphylaxis. J Allergy Clin Immunol. 2010;126(1):83-
91.e1.
28 Vickery BP, Scurlock AM, Steele P, Kamilaris J, Hiegel AM, Carlisle SK, et al. Early and Persistent 
Gastrointestinal Side Effects Predict Withdrawal from Peanut Oral Immunotherapy (OIT). J Allergy 
Clin Immunol. 2011;127(2):AB26.
29 Wasserman RL, Factor JM, Baker JW, Mansfield LE, Katz Y, Hague AR, et al. Oral immunotherapy 
for peanut allergy: multipractice experience with epinephrine-treated reactions. J Allergy Clin 
Immunol Pract. 2014;2(1):91-6.
30 Wasserman RL, Sugerman RW, Mireku-Akomeah N, Gallucci AR, Pence DM, Long NA. Peanut Oral 
Immunotherapy (OIT) of Food Allergy (FA) Carries a Significant Risk of Eosinophilic Esophagitis 
(EoE). J Allergy Clin Immunol. 2011;127(2):AB28.
31 Hsieh FH. Oral food immunotherapy and iatrogenic eosinophilic esophagitis: an acceptable level of 
risk? Ann Allergy Asthma Immunol. 2014;113(6):581-2.
32 Lucendo AJ, Arias A, Tenias JM. Relation between eosinophilic esophagitis and oral immunotherapy 
for food allergy: a systematic review with meta-analysis. Ann Allergy Asthma Immunol. 
2014;113(6):624-9.
33 Investigator’s Brochure. DBV712. Edition Number 7, 18 Aug 2015. 
34 International Conference on Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. General Considerations for 
Clinical Trials – E8. Version dated 17 July 1997. Available from www.ich.org. 
35 Niggemann B, Beyer K. Diagnosis of food allergy in children: toward a standardization of food 
challenge. J Pediatr Gastroenterol Nutr. 2007;45(4):399-404.
36 Kulis M, Vickery BP, Burks AW. Pioneering immunotherapy for food allergy: clinical outcomes and 
modulation of the immune response. Immunol Res. 2011;49(1-3):216-26.
37 Taylor SL, Moneret-Vautrin DA, Crevel RW, Sheffield D, Morisset M, Dumont P, et al. Threshold dose 
for peanut: Risk characterization based upon diagnostic oral challenge of a series of 286 
peanut-allergic individuals. Food Chem Toxicol. 2010;48(3):814-9.
38 Kim EH, Bird JA, Kulis M, Laubach S, Pons L, Shreffler W, et al. Sublingual immunotherapy for 
peanut allergy: clinical and immunologic evidence of desensitization. J Allergy Clin Immunol. 
2011;127(3):640-6.
39 Beydon N, Davis SD, Lombardi E, Allen JL, Arets HG, Aurora P, et al; American Thoracic 
Society/European Respiratory Society Working Group on Infant and Young Children Pulmonary 
Function Testing. An official American Thoracic Society/European Respiratory Society statement: 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
116 of 142
09 Dec 2015
pulmonary function testing in preschool children. Am J Respir Crit Care Med. 
2007;175(12):1304-45.
40 National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program Expert 
Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Bethesda, MD: National 
Institutes of Health; 2007.
41 Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. Available from 
www.ginasthma.org. Date last updated: April 2015.
42 Sampson HA, Muñoz-Furlong A, Campbell RL, Adkinson NF Jr, Bock SA, Branum A, et al. Second 
symposium on the definition and management of anaphylaxis: summary report—Second National 
Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J 
Allergy Clin Immunol. 2006;117(2):391-7.
43 Turjanmaa K, Darsow U, Niggemann B, Rancé F, Vanto T, Werfel T. EAACI/GA2LEN position paper: 
present status of the atopy patch test. Allergy. 2006;61(12):1377-84.
44 Flokstra-de Blok, B.M.J. Food Allergy Quality of Life Questionnaires (FAQLQ). In: Encyclopedia of 
Quality of Life and Well-Being Research. Michalos, A.C. (Editor). 2014, 2319-22.
45 van der Velde JL, Flokstra-de Blok BM, Vlieg-Boerstra BJ, Oude Elberink JN, DunnGalvin A, 
Hourihane JO, et al. Development, validity and reliability of the food allergy independent measure 
(FAIM). Allergy. 2010;65(5):630-5.
46 Kunz B, Oranje AP, Labreze L, Staldor JF, Ring J, Taieb A. Clinical validation and guidelines for the 
SCORAD Index: Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology 
1997;195(1):10-9.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
117 of 142
09 Dec 2015
APPENDICES
APPENDIX 1: Declaration of Helsinki 
APPENDIX 2: Dosages of Inhaled Corticosteroids 
APPENDIX 3: Activity of Corticosteroids 
APPENDIX 4: Wash-out periods of Short-acting and Long-acting Antihistamines based 
on Terminal Elimination Half-Lives
APPENDIX 5: Anaphylaxis Staging System
APPENDIX 6: Oral Food Challenge Symptom Score Sheet for the PEPITES Study
APPENDIX 7: FAQLQ/FAIM Questionnaires
APPENDIX 8: SCORAD

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
118 of 142
09 Dec 2015
APPENDIX 1 
Declaration of Helsinki

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
119 of 142
09 Dec 2015
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI 
Ethical Principles for Medical Research Involving Human Subjects
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the:
29th WMA General Assembly, Tokyo, Japan, October 1975
35th WMA General Assembly, Venice, Italy, October 1983
41st WMA General Assembly, Hong Kong, September 1989
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996
52nd WMA General Assembly, Edinburgh, Scotland, October 2000  
53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added)
55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added)
59th WMA General Assembly, Seoul, Republic of Korea, October 2008
64th WMA General Assembly, Fortaleza, Brazil, October 2013
Preamble
1.
The World Medical Association (WMA) has developed the Declaration of Helsinki as a 
statement of ethical principles for medical research involving human subjects, including research 
on identifiable human material and data. 
The Declaration is intended to be read as a whole and each of its constituent paragraphs 
should be applied with consideration of all other relevant paragraphs. 
2.
Consistent with the mandate of the WMA, the Declaration is addressed primarily to 
physicians. The WMA encourages others who are involved in medical research involving human 
subjects to adopt these principles.  
General Principles
3. 
The Declaration of Geneva of the WMA binds the physician with the words, “The health 
of my patient will be my first consideration,” and the International Code of Medical Ethics 
declares that, “A physician shall act in the patient's best interest when providing medical care.”
4. 
It is the duty of the physician to promote and safeguard the health, well-being and rights 
of patients, including those who are involved in medical research. The physician's knowledge and 
conscience are dedicated to the fulfilment of this duty.
5.
Medical progress is based on research that ultimately must include studies involving 
human subjects. 
6. 
The primary purpose of medical research involving human subjects is to understand the 
causes, development and effects of diseases and improve preventive, diagnostic and therapeutic 
interventions (methods, procedures and treatments). Even the best proven interventions must be 
evaluated continually through research for their safety, effectiveness, efficiency, accessibility and 
quality. 
7.
Medical research is subject to ethical standards that promote and ensure respect for all 
human subjects and protect their health and rights. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
120 of 142
09 Dec 2015
8.
While the primary purpose of medical research is to generate new knowledge, this goal 
can never take precedence over the rights and interests of individual research subjects.
9. 
It is the duty of physicians who are involved in medical research to protect the life, 
health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal 
information of research subjects. The responsibility for the protection of research subjects must 
always rest with the physician or other health care professionals and never with the research 
subjects, even though they have given consent. 
10.
Physicians must consider the ethical, legal and regulatory norms and standards for 
research involving human subjects in their own countries as well as applicable international 
norms and standards. No national or international ethical, legal or regulatory requirement should 
reduce or eliminate any of the protections for research subjects set forth in this Declaration. 
11.
Medical research should be conducted in a manner that minimises possible harm to the 
environment. 
12. 
Medical research involving human subjects must be conducted only by individuals with 
the appropriate ethics and scientific education, training and qualifications. Research on patients or 
healthy volunteers requires the supervision of a competent and appropriately qualified physician 
or other health care professional. 
13. 
Groups that are underrepresented in medical research should be provided appropriate 
access to participation in research.
14. 
Physicians who combine medical research with medical care should involve their patients 
in research only to the extent that this is justified by its potential preventive, diagnostic or 
therapeutic value and if the physician has good reason to believe that participation in the research 
study will not adversely affect the health of the patients who serve as research subjects.
15. 
Appropriate compensation and treatment for subjects who are harmed as a result of 
participating in research must be ensured. 
Risks, Burdens and Benefits
16.
In medical practice and in medical research, most interventions involve risks and 
burdens. 
Medical research involving human subjects may only be conducted if the importance of 
the objective outweighs the risks and burdens to the research subjects. 
17.
All medical research involving human subjects must be preceded by careful assessment 
of predictable risks and burdens to the individuals and groups involved in the research in 
comparison with foreseeable benefits to them and to other individuals or groups affected by the 
condition under investigation.
Measures to minimise the risks must be implemented. The risks must be continuously 
monitored, assessed and documented by the researcher.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
121 of 142
09 Dec 2015
18. 
Physicians may not be involved in a research study involving human subjects unless they 
are confident that the risks have been adequately assessed and can be satisfactorily managed.
When the risks are found to outweigh the potential benefits or when there is conclusive 
proof of definitive outcomes, physicians must assess whether to continue, modify or immediately 
stop the study.
Vulnerable Groups and Individuals
19. 
Some groups and individuals are particularly vulnerable and may have an increased 
likelihood of being wronged or of incurring additional harm. 
All vulnerable groups and individuals should receive specifically considered protection. 
20.
Medical research with a vulnerable group is only justified if the research is responsive to 
the health needs or priorities of this group and the research cannot be carried out in a non-
vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or 
interventions that result from the research.
Scientific Requirements and Research Protocols  
21. 
Medical research involving human subjects must conform to generally accepted scientific 
principles, be based on a thorough knowledge of the scientific literature, other relevant sources of 
information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of 
animals used for research must be respected.
22. 
The design and performance of each research study involving human subjects must be 
clearly described and justified in a research protocol.
The protocol should contain a statement of the ethical considerations involved and should 
indicate how the principles in this Declaration have been addressed. The protocol should include 
information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, 
incentives for subjects and information regarding provisions for treating and/or compensating 
subjects who are harmed as a consequence of participation in the research study.
In clinical trials, the protocol must also describe appropriate arrangements for post-trial 
provisions. 
Research Ethics Committees
23.
The research protocol must be submitted for consideration, comment, guidance and 
approval to the concerned research ethics committee before the study begins. This committee 
must be transparent in its functioning, must be independent of the researcher, the sponsor and any 
other undue influence and must be duly qualified. It must take into consideration the laws and 
regulations of the country or countries in which the research is to be performed as well as 
applicable international norms and standards but these must not be allowed to reduce or eliminate 
any of the protections for research subjects set forth in this Declaration.  

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
122 of 142
09 Dec 2015
The committee must have the right to monitor ongoing studies. The researcher must 
provide monitoring information to the committee, especially information about any serious 
adverse events. No amendment to the protocol may be made without consideration and approval 
by the committee. After the end of the study, the researchers must submit a final report to the 
committee containing a summary of the study’s findings and conclusions.  
Privacy and Confidentiality  
24.
Every precaution must be taken to protect the privacy of research subjects and the 
confidentiality of their personal information.
Informed Consent  
25.
Participation by individuals capable of giving informed consent as subjects in medical 
research must be voluntary. Although it may be appropriate to consult family members or 
community leaders, no individual capable of giving informed consent may be enrolled in a 
research study unless he or she freely agrees.
26.
In medical research involving human subjects capable of giving informed consent, each 
potential subject must be adequately informed of the aims, methods, sources of funding, any 
possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits 
and potential risks of the study and the discomfort it may entail, post-study provisions and any 
other relevant aspects of the study. The potential subject must be informed of the right to refuse to 
participate in the study or to withdraw consent to participate at any time without reprisal. Special 
attention should be given to the specific information needs of individual potential subjects as well 
as to the methods used to deliver the information.
After ensuring that the potential subject has understood the information, the physician or 
another appropriately qualified individual must then seek the potential subject’s freely-given 
informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-
written consent must be formally documented and witnessed.     
All medical research subjects should be given the option of being informed about the 
general outcome and results of the study.
27. 
When seeking informed consent for participation in a research study the physician must 
be particularly cautious if the potential subject is in a dependent relationship with the physician or 
may consent under duress. In such situations the informed consent must be sought by an 
appropriately qualified individual who is completely independent of this relationship. 
28.
For a potential research subject who is incapable of giving informed consent, the 
physician must seek informed consent from the legally authorised representative. These 
individuals must not be included in a research study that has no likelihood of benefit for them 
unless it is intended to promote the health of the group represented by the potential subject, the 
research cannot instead be performed with persons capable of providing informed consent, and 
the research entails only minimal risk and minimal burden. 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
123 of 142
09 Dec 2015
29.
When a potential research subject who is deemed incapable of giving informed consent is 
able to give assent to decisions about participation in research, the physician must seek that assent 
in addition to the consent of the legally authorised representative. The potential subject’s dissent 
should be respected.
30.
Research involving subjects who are physically or mentally incapable of giving consent, 
for example, unconscious patients, may be done only if the physical or mental condition that 
prevents giving informed consent is a necessary characteristic of the research  group. In such 
circumstances the physician must seek informed consent from the legally authorised 
representative. If no such representative is available and if the research cannot be delayed, the 
study may proceed without informed consent provided that the specific reasons for involving 
subjects with a condition that renders them unable to give informed consent have been stated in 
the research protocol and the study has been approved by a research ethics committee. Consent to 
remain in the research must be obtained as soon as possible from the subject or a legally 
authorised representative.
31. 
The physician must fully inform the patient which aspects of their care are related to the 
research. The refusal of a patient to participate in a study or the patient’s decision to withdraw 
from the study must never adversely affect the patient-physician relationship. 
32. 
For medical research using identifiable human material or data, such as research on 
material or data contained in biobanks or similar repositories, physicians must seek informed 
consent for its collection, storage and/or reuse. There may be exceptional situations where 
consent would be impossible or impracticable to obtain for such research. In such situations the 
research may be done only after consideration and approval of a research ethics committee. 
Use of Placebo
33.
The benefits, risks, burdens and effectiveness of a new intervention must be tested 
against those of the best proven intervention(s), except in the following circumstances:
Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; 
or 
Where for compelling and scientifically sound methodological reasons the use of any 
intervention less effective than the best proven one, the use of placebo, or no intervention is 
necessary to determine the efficacy or safety of an intervention 
and the patients who receive any intervention less effective than the best proven one, 
placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as 
a result of not receiving the best proven intervention.  
Extreme care must be taken to avoid abuse of this option.
Post-Trial Provisions
34.
In advance of a clinical trial, sponsors, researchers and host country governments should 
make provisions for post-trial access for all participants who still need an intervention identified 

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
124 of 142
09 Dec 2015
as beneficial in the trial. This information must also be disclosed to participants during the 
informed consent process.
Research Registration and Publication and Dissemination of Results
35. 
Every research study involving human subjects must be registered in a publicly 
accessible database before recruitment of the first subject.
36.
Researchers, authors, sponsors, editors and publishers all have ethical obligations with 
regard to the publication and dissemination of the results of research. Researchers have a duty to 
make publicly available the results of their research on human subjects and are accountable for 
the completeness and accuracy of their reports. All parties should adhere to accepted guidelines 
for ethical reporting. Negative and inconclusive as well as positive results must be published or 
otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of 
interest must be declared in the publication. Reports of research not in accordance with the 
principles of this Declaration should not be accepted for publication. 
Unproven Interventions in Clinical Practice
37. 
In the treatment of an individual patient, where proven interventions do not exist or other 
known interventions have been ineffective, the physician, after seeking expert advice, with 
informed consent from the patient or a legally authorised representative, may use an unproven 
intervention if in the physician's judgement it offers hope of saving life, re-establishing health or 
alleviating suffering. This intervention should subsequently be made the object of research, 
designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, 
where appropriate, made publicly available.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
127 of 142
09 Dec 2015
APPENDIX 3 
Activity of Corticosteroids
CORTICOSTEROID
ACTIVITY
RELATIVE POTENCY
EQUIVALENT DOSE 
(MG)
Dexamethasone
Long-acting
25
0.75
Prednisone
Intermediate-acting
4
5.0
Methylprednisolone
Intermediate -acting
5
4.0
Hydrocortisone
Short-acting
1.0
20.0
Information from Drug facts and comparisons. St Louis: Facts and Comparisons, 1997:122-23.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
129 of 142
09 Dec 2015
APPENDIX 5
Anaphylaxis Staging System
Anaphylaxis is a generalized allergic reaction that is rapid in onset and may progress to 
death (42).

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
130 of 142
09 Dec 2015
APPENDIX 6
Oral Food Challenge Symptom Score Sheet for the PEPITES Study
(Displayed by Categories I to V) 
I. SKIN
A. Erythematous Rash- % area involved (see diagram below): ______________________
B. Pruritus
0 = Absent
1 = Mild: occasional scratching
2 = Moderate: scratching continuously for >2 minutes at a time
3 = Severe: hard continuous scratching excoriations
C. Urticaria/Angioedema
0 = Absent
1 = Mild: <3 hives, or mild lip edema
2 = Moderate: <10 hives but >3, or significant lip or face edema
3 = Severe: generalized involvement
D. Rash
0 = Absent
1 = Mild: few areas of faint erythema
2 = Moderate: areas of erythema (>20% and <50%), macular and raised rash  
3 = Severe: generalized marked erythema (>50%), extensive raised lesions (>25%)
Head 
 
4.5%
Neck 
 
1%
Anterior trunk
18%
Posterior trunk
18%
Leg 
 
18%
Arm 
 
9%
II. UPPER RESPIRATORY
A. Sneezing/Itching
0 = Absent
1 = Mild: rare bursts
2 = Moderate: bursts <10, intermittent rubbing of nose / eyes / external ear canals
3 = Severe: continuous rubbing of nose / eyes, periocular swelling and/or long
bursts of sneezing
B. Nasal Congestion
0 = Absent
1 = Mild: some hindrance to breathing

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
131 of 142
09 Dec 2015
2 = Moderate: nostrils feel blocked, breathing through mouth most of time
3 = Severe: nostrils occluded
C. Rhinorrhea
0 = Absent
1 = Mild: occasional sniffling
2 = Moderate: frequent sniffling, requires tissues
3 = Severe: nose runs freely despite sniffling and tissues
D. Laryngeal
0 = Absent
1 = Mild: throat clearing, occasional cough
2 = Moderate: hoarseness, frequent dry cough
3 = Severe: inspiratory stridor
III. LOWER RESPIRATORY
A. Wheezing
0 = Absent
1 = Mild: expiratory wheezing to auscultation
2 = Moderate: dyspnea, inspiratory and expiratory wheezing
3 = Severe: dyspnea, use of accessory muscles, audible wheezing
IV. GASTROINTESTINAL
A. Subjective Complaints
0 = Absent
1 = Mild: itchy mouth/throat, c/o nausea, abdominal pain, no change in activity
2 = Moderate: frequent c/o nausea or abdominal pain, decreased activity
3 = Severe: patient in bed; crying, notably distressed 
B. Objective Complaints
0 = Absent
1 = Mild: 1 episode of emesis or diarrhea
2 = Moderate: 2-3 episodes of emesis or diarrhea or 1 of each
3 = Severe: >3 episodes of emesis or diarrhea or 2 of each
V. CARDIOVASCULAR/NEUROLOGIC
0 = Normal: heart rate or BP for age/baseline
1 = Mild: color change, subjective response (weak, dizzy), or tachycardia, mental status change, mild 
hypotension (weak rapid pulse and/or 10-20% drop in blood pressure from baseline)
2 = Moderate: drop in blood pressure >20% from baseline, significant change in mental status, light-
headedness, feeling of “pending doom”
3 = Severe: cardiovascular collapse, signs of impaired circulation, unconsciousness, bradycardia,
cardiac arrest.

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
132 of 142
09 Dec 2015
APPENDIX 7
FAQLQ/FAIM Questionnaires

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
133 of 142
09 Dec 2015

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
134 of 142
09 Dec 2015

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
135 of 142
09 Dec 2015

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
136 of 142
09 Dec 2015

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
137 of 142
09 Dec 2015

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
138 of 142
09 Dec 2015

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
139 of 142
09 Dec 2015

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
140 of 142
09 Dec 2015

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
141 of 142
09 Dec 2015

DBV Technologies
Clinical Study Protocol
PEPITES 
 
CONFIDENTIAL
Protocol Version 2.0 
142 of 142
09 Dec 2015
APPENDIX 8 
SCORAD
Source: Kunz B, Oranje AP, Labrèze L, Stalder JF, Ring J, Taïeb A. Clinical validation and guidelines for 
the SCORAD index: consensus report of the European Task Force on Atopic Dermatitis. Dermatology. 
1997;195(1):10-9.