Clinical Trials Register

Summary
EudraCT Number:	2020-002601-26
Sponsor's Protocol Code Number:	EFC16823
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2024-02-11
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
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2020-002601-26

A.3

Full title of the trial

A randomized, double-blind, placebo-controlled, multi-center, parallel-group study to evaluate the efficacy, safety and pharmacokinetics of dupilumab compared to placebo in Japanese patients with atopic dermatitis aged 6 months to <18 years whose disease is not adequately controlled with existing therapies

A.3.1

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

Dupilumab in Japanese patients with atopic dermatitis

A.4.1

Sponsor's protocol code number

EFC16823

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04678882

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Sanofi K.K
B.1.3.4	Country	Japan
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	Sanofi K.K
B.4.2	Country	Japan
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	sanofi
B.5.2	Functional name of contact point	-
B.5.3	Address:
B.5.3.1	Street Address	-
B.5.3.2	Town/ city	-
B.5.3.3	Post code	-
B.5.3.4	Country	United States
B.5.4	Telephone number	----
B.5.5	Fax number	----
B.5.6	E-mail	contactus@sanofi.com

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	Yes
D.2.1.1.1	Trade name	dupixent
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Winthrop Industrie
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	dupixent
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dupilumab
D.3.9.2	Current sponsor code	SAR231893
D.3.9.4	EV Substance Code	SUB179171
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
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	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
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.IMP: 2
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	Yes
D.2.1.1.1	Trade name	dupixent
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Winthrop Industrie
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	dupixent
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dupilumab
D.3.9.2	Current sponsor code	SAR231893
D.3.9.4	EV Substance Code	SUB179171
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
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	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
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	Solution for injection in pre-filled syringe
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

atopic dermatitis

E.1.1.1

Medical condition in easily understood language

atopic dermatitis

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10012438
E.1.2	Term	Dermatitis atopic
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS)

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of dupilumab administered concomitantly with TCS.
To assess the safety of dupilumab over 16 weeks of treatment when administered concomitantly with TCS in participants.
To assess immunogenicity as determined by the incidence, titer, and clinical impact of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time in pediatric patients with atopic dermatitis (AD) (aged ≥6 months to <18 years old)
To assess the concentration of dupilumab in serum following administration concomitantly with TCS.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Japanese and ≥6 months to <18 years of age, at the time of signing the informed consent and/or assent.
Diagnosis of atopic dermatitis (AD) at screening visit.
(Investigator's Global Assessment) IGA ≥ 3 at screening and baseline visits.
(Eczema Area and Severity Index) EASI ≥16 at screening and baseline visits.
Baseline peak pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity ≥4 for participants ≥12 to <18 years of age.
Baseline worst itch NRS or worst scratch/itch NRS weekly average score for maximum itch or scratch/itch intensity ≥4 for participants ≥6 months to <12 years of age.
Body surface area (BSA) of AD involvement >10% at screening and baseline visits.
With documented recent history of inadequate response to topical AD medication(s).
Participant or parents/caregiver or legal guardians, must be able to understand and complete study-related questionnaires.
Body weight ≥5 kg at baseline.

E.4

Principal exclusion criteria

Active chronic or acute infection within 2 weeks before the baseline visit or during the screening period.
Known or suspected immunodeficiency, including history of invasive opportunistic infections
Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB.
Known history of human immunodeficiency virus (HIV)-1 and HIV-2 infection or HIV seropositivity at the screening
Participants with any of the following result at the screening:
• Positive (or indeterminate) Hepatitis B surface antigen (HBs Ag) or,
• Positive hepatitis B core antibody (HBc Ab) confirmed by positive hepatitis B virus (HBV) DNA or,
• Positive hepatitis C antibody (HCV Ab) confirmed by positive hepatitis C virus (HCV) RNA.
Presence of skin comorbidities that may interfere with study assessments
History of malignancy within 5 years before the baseline visit
History of systemic hypersensitivity or anaphylaxis to dupilumab or any other biologic therapy.
Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection.
Severe concomitant illness(es)
Participant with any other medical or psychological condition
Having used any of immunosuppressive/immunomodulating drugs and phototherapy within 4 weeks before the screening visit.
History of important side effects to medium potency TCS
Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit.
Either intravenous immunoglobulin therapy and/or plasmapheresis within 30 days prior to screening visit.
Planned or anticipated use of any prohibited medications and procedures during screening and study treatment period.

E.5 End points

E.5.1

Primary end point(s)

Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% improvement from baseline EASI)

E.5.1.1

Timepoint(s) of evaluation of this end point

At Week 16

E.5.2

Secondary end point(s)

1/ Percent change in EASI score
2/ Percent change in weekly average of daily worst itch numerical rating scale (NRS) for participants aged ≥6 years to <12 years old
3/ Proportion of participants with Investigator’s Global Assessment (IGA) 0 or 1
4/ Percent change in weekly average of daily worst peak pruritus NRS for participants aged ≥12 years to <18 years old
5/ Percent change in weekly average of daily worst scratch/itch NRS for participants aged ≥6 months to <6 years old
6/ Percent change for intensity of pruritus
7/ Proportion of participants with EASI-50 (≥50% improvement from baseline)
8/ Proportion of participants with EASI-90 (≥90% improvement from baseline)
9/ Change in percent body surface area (BSA) affected by atopic dermatitis (AD)
10/ Change in Children's Dermatology Life Quality Index (CDLQI) (≥4 years)
11/ Change in Infants' Dermatitis Quality of Life Index (IDQOL) (<4 years
12/ Change in Patient Oriented Eczema Measure (POEM)
13/ Change in weekly average of daily worst peak pruritus NRS for participants aged ≥12 years to <18 years old
14/ Change in weekly average of daily worst itch NRS for participants aged ≥6 years to <12 years old
15/ Change in weekly average of daily worst scratch/itch NRS for participants aged ≥6 months to <6 years old
16/ Incidence of Adverse Event
17/ Incidence of Skin-infection TEAE
18/ Incidence of Adverse Event during open-label extension
19/ Incident of Treatment- emergent anti-drug antibody (ADA)
20/ Titer of ADA
21/ Ctrough of functional dupilumab

E.5.2.1

Timepoint(s) of evaluation of this end point

1, 2, 4 to 6, 9 to 17: From baseline to week 16
3, 7, 8: At Week 16
18: From week16 to week 172
19-20: Weeks 16, 28, 32, 68, 92, 116, 140 and 164
21: Weeks 4, 12, 16, 24, 28, 32, 52, 68, 92, 116, 140 and 164

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

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

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

Japan

E.8.7

Trial has a data monitoring committee

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.8.9.2

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:

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:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

Yes

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

children

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

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

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	Japan

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