Clinical Trials Register

Summary
EudraCT Number:	2016-003679-23
Sponsor's Protocol Code Number:	EPITOPE-V712-304
National Competent Authority:	Ireland - HPRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-10-01
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Ireland - HPRA

A.2

EudraCT number

2016-003679-23

A.3

Full title of the trial

A double-blind, placebo-controlled, randomized phase III trial to assess the safety and efficacy of Viaskin® Peanut in peanut-allergic young children 1-3 years of age (EPITOPE study)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A double-blind, placebo-controlled, randomized phase III trial to assess the safety and efficacy of Viaskin® Peanut in peanut-allergic young children 1-3 years of age (EPITOPE study)

A.3.2

Name or abbreviated title of the trial where available

EPITOPE

A.4.1

Sponsor's protocol code number

EPITOPE-V712-304

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/389/2020

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	DBV TECHNOLOGIES S.A.
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	DBV Technologies S.A.
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	DBV TECHNOLOGIES S.A.
B.5.2	Functional name of contact point	DBV TECHNOLOGIES S.A.
B.5.3	Address:
B.5.3.1	Street Address	177-181 avenue Pierre Brossolette
B.5.3.2	Town/ city	Montrouge
B.5.3.3	Post code	92120
B.5.3.4	Country	France
B.5.4	Telephone number	+33155 42 78 78
B.5.5	Fax number	+33172 36 49 71

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Viaskin® Peanut
D.3.2	Product code	DBV712
D.3.4	Pharmaceutical form	Cutaneous patch
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Peanut allergen extract
D.3.9.2	Current sponsor code	DBV712
D.3.9.3	Other descriptive name	DBV712
D.3.9.4	EV Substance Code	SUB180293
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	75.3 to 113.0
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Yes
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	Yes
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Cutaneous patch
D.8.4	Route of administration of the placebo	Cutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Peanut allergy

E.1.1.1

Medical condition in easily understood language

Peanut allergy

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10034202
E.1.2	Term	Peanut allergy
E.1.2	System Organ Class	100000004870

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The objective of this study is to verify the safety and local tolerance of
the 2 DBV712 doses of 100 and 250 μg and to assess the efficacy and
safety of DBV712 to induce desensitization to peanut in peanut-allergic
subjects 1 to 3 years of age after a 12-month treatment period by EPIT.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female from 1-3 years of age at Visit 1.
2. Physician-diagnosed peanut allergy or high suspicion of peanut allergy as assessed by the physician: child presenting signs, symptoms and a medical and/or a family history putting him/her at high risk of having a peanut allergy and/or history of presence of peanut-specific IgE and/or positive SPT.
3. Subject currently following a strict peanut-free diet.
4.Signed informed consent of parent(s)/guardian(s) of the children aged 1-3 years.
5. Peanut-specific immunoglobulin E (IgE) level (ImmunoCAP system) > 0.7 kU/L.
6. Positive peanut SPT with a largest wheal diameter ≥ 6 mm.
7. Positive DBPCFC to peanut, with symptoms meeting the challenge stopping criteria at an Eliciting Dose (ED) ≤300 mg peanut protein.
8. Parents/guardians and subjects willing to comply with all study requirements during their participation in the study.

E.4

Principal exclusion criteria

1. Peanut allergic subjects presenting a medical history of severe
anaphylaxis to peanut will be excluded for this study. Severe
anaphylaxis is defined by the Grade 3 of the Anaphylaxis Staging System(Appendix 4), including:
• Severe hypoxia, persistent hypotension or more than 20% drop in
blood pressure, neurological compromise, or
• Cyanosis or SpO2 ≤ 92% at any stage, confusion, cardiovascular
collapse, loss of consciousness, bradychardia, cardiac arrest.
2. Severe reaction during the entry/screening DBPCFC, defined as any of the following:
•Need for intubation
•Hypotension persisting after epinephrine administration
•Need for three doses or more of systemic epinephrine.
3. Subject with reactions to the placebo formula during the screening
DBPCFC(with reactions deemed to stopping the challenge).
4. Subjects who fail to complete the entry food challenge due to any
reason including clear aversion to the food formula matrix,
5. Subject with any clinically significant abnormality identified at the
time of screening such as major infantile infectious diseases (pox,
measles) which in the judgment of the Investigator can preclude safe
participation or strict compliance to the protocol procedures. Subjects
can be considered for the study after recovery from these diseases.
6. Viral upper respiratory infection or gastroenteritis or any severe
disease within 7 days of food challenge (challenge must be rescheduled
at least after 7 days upon recovery).
7. Hypersensitivity to any of the Viaskin® patch components (except to
peanut protein), including the adhesive film.
8. Hypersensitivity to any component of the food challenge formula
(except to peanut protein) or a known history of apple allergy.
9. Inability to discontinue short-acting antihistamines or long-acting
antihistamines for the minimum wash-out periods required (depending
on half-lives and specified in APPENDIX 3) prior to the skin prick testing
or the food challenges.
10. Diagnosis of asthma that fulfills any of the following criteria:
• Uncontrolled asthma (as per Global Initiative for Asthma [GINA] latest
guidelines; see APPENDIX 8)
• Asthma requiring controller treatment step 3 or higher (as per GINA
latest guidelines: either moderate [double low dose] of inhaled
corticosteroid, or association of inhaled corticosteroid with leukotriene
receptor antagonist [see APPENDIX 8]. Long acting beta agonists are not recommended below 5 years)
• History of 2 or more systemic corticoid courses within the 3 previous
months prior to Visit 1 or 1 systemic corticoid course within the 4 weeks
prior to Visit 1 for treating a diagnosed asthma.
• Prior intubation/mechanical ventilation for asthma within one year
prior to Visit 1. Asthmatic subjects with the following treatment options are eligible:
− No controller treatment (GINA Step 1),
− Controller treatment monotherapy (GINA Step 2):
o with daily or short-term course (intermittent) low dose inhaled
corticosteroid,
o or with leukotriene receptor antagonist.
11. Presence of more than 3 episodes of wheezing in the past year (each lasting more than 10 consecutive days, apart from colds) or presence of respiratory symptoms (wheezing, cough, heavy breathing) between these episodes, and/or other respiratory symptoms suggesting either undiagnosed asthma or asthma not controlled by asthma treatment (as per GINA latest guidelines, see APPENDIX 8).
12. Generalized dermatologic disease (e.g. severe atopic dermatitis,
uncontrolled generalized eczema, ichthyosis vulgaris) extending widely
on the skin and especially on the back with no intact zones to apply the
Viaskin® patches.
13. Diagnosis of mast cell disorders including mastocytosis or urticaria
pigmentosa as well as hereditary or idiopathic angioedema;
14. Prior history of any immunotherapy to any food (e.g. oral
immunotherapy, sublingual immunotherapy, specific oral tolerance
induction). Subjects who received a prior oral immunotherapy of less
than 1 month-duration which ended at least 3 months before Visit 1 are
eligible for inclusion.
15. Subject receiving or planning to receive any immunotherapy
(aeroallergens, venoms, anti-infective) during their participation in the study. These immunotherapies must be discontinued at the time of Visit 1.
16. Symptomatic seasonal allergies that may interfere with the conduct
of a DBPCFC. These subjects could be screened at a time when such
allergies are asymptomatic (for example outside of the culprit season);
17. Subject receiving β-blocking agents, angiotensin-converting enzyme
inhibitors, angiotensin-receptor blockers, calcium channel blockers or
tricyclic antidepressant therapy.
18. Subject who received anti-tumor necrosis factor drugs or anti-IgE
drugs (such as omalizumab), any biologic immunomodulatory therapy,
cyclosporine or other immunosuppressive drugs within one year prior to
Visit 1 or during screening period. Topical calcineurin inhibitors are
permitted.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is the difference between the percentage of treatment responders in the active selected DBV712 group (250μg) compared to the placebo group. A subject is defined as a treatment responder if:
• The initial Eliciting Dose (ED) was >10 mg peanut protein and the ED is ≥1,000 mg peanut protein at the post-treatment DBPCFC at Month 12; or
• The initial ED was ≤10 mg peanut protein and the ED is ≥300 mg peanut protein at the post-treatment DBPCFC at Month 12.

E.5.1.1

Timepoint(s) of evaluation of this end point

Refer to Section 6.1 of the protocol.

E.5.2

Secondary end point(s)

• Change from baseline to Month 12 in Cumulative Reactive Dose (CRD)
in the selected active DBV712 group (250μg) versus the placebo group;
• Change from baseline to Month 12 in ED in the selected active DBV712 group (250μg) versus the placebo group;

E.5.2.1

Timepoint(s) of evaluation of this end point

Refer to Section 6.1 of the protocol.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Canada

France

Germany

Ireland

Netherlands

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

400

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

320

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

400

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-11-30

Ethics Committee Opinion of the trial application

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-04-27

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials