Clinical Trials Register

Summary
EudraCT Number:	2019-003162-41
Sponsor's Protocol Code Number:	SGZ-2018-12012
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-08-10
Trial 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

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A. Protocol Information

A.1

Member State Concerned

Germany - PEI

A.2

EudraCT number

2019-003162-41

A.3

Full title of the trial

An investigator-initiated, multi-center, randomized, double-blind, placebo controlled study of Dupilumab to demonstrate efficacy in subjects with nummular eczema

A.3.1

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

An investigator-initiated, multi-center, randomized, double-blind, placebo controlled study of Dupilumab to demonstrate efficacy in subjects with nummular eczema

A.4.1

Sponsor's protocol code number

SGZ-2018-12012

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	Klinikum rechts der Isar, Technische Universität München
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Sanofi-Aventis Group Deutschland GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Technische Universität München, Department of Dermatology and Allergy
B.5.2	Functional name of contact point	Prof. Tilo Biedermann
B.5.3	Address:
B.5.3.1	Street Address	Biedersteiner Str. 29
B.5.3.2	Town/ city	München
B.5.3.3	Post code	80802
B.5.3.4	Country	Germany
B.5.4	Telephone number	00498941403170
B.5.5	Fax number	00498941403171
B.5.6	E-mail	tilo.biedermann@tum.de

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.2.1.1.1	Trade name	Dupixent
D.2.1.1.2	Name of the Marketing Authorisation holder	sanofi-aventis group
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.3.4	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.3.9.1	CAS number	1190264-60-8
D.3.9.2	Current sponsor code	SGZ-2018-12012
D.3.9.3	Other descriptive name	DUPILUMAB
D.3.9.4	EV Substance Code	SUB179171
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
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	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	Yes
D.3.11.13.1	Other medicinal product type	monoclonal antibody

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

Subjects with nummular eczema

Nummuläres Ekzem

E.1.1.1

Medical condition in easily understood language

Nummular eczema is an inflammatory skin disease with sharply defined rashes

Ein nummuläres Ekzem ist eine entzündliche Hauterkrankung, bei der sich scharf abgegrenzte Ausschläge bilden

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	10012431
E.1.2	Term	Dermatitis
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 in patients with nummular eczema.

E.2.2

Secondary objectives of the trial

To asses improvement (Decrease) of disease.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Clinically confirmed diagnosis of NE
2.Biopsy-proven, meaning histology consistent with eczema (including PAS-staining)
3.EASI score ≥ 10
4.History of continuous use of topical steroids for the last 8 weeks
5.Age 18-85 years of age, body weight ≥ 40 kg and ≤ 160 kg
6.Female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country at screening.
7.History of continuous use of at least mid-potency topical steroids for the last 8 weeks.
8.Age 18-85 years of age, body weight ≥ 40 kg and ≤ 160 kg.
9.Signed informed consent from patient.

E.4

Principal exclusion criteria

1)Permanent severe diseases, especially those affecting the immune system.
2)Pregnancy or breast feeding.
3)Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit, independent from of the cuntaneous dysbiosis found in NE.
4)Treatment with an investigational drug within 8 weeks before the baseline visit*.
5)Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.
6)Diagnosed active endoparasitic infections or at high risk of these infections.
7)Evidence of severe renal dysfunction defined as:
- eGFR < 30 ml/min/1,73 m2 (calculated using the cockroft gold formula) at screening (Visit 1)
8)Evidence of significant hepatic disease defined as:
At screening (Visit 1):
- Alkaline phosphatase >3x upper limit of normal (ULN) or alkaline phosphatase >2,5x ULN and total bilirubin > 2xULN
or
- Aspartate transaminase (AST, SGOT]) and alanine transaminase (ALT, SGPT]) > 2.5x upper limit of normal (ULN).
9)Patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits.
10)Inability or unwillingness to undergo repeated venipuncture (e.g., because of poor tolerability or lack of access to veins).
11)Inability or unwillingness to undergo repeated punch biopsies.
12)History of allergy to any component of the study medication.
13)Evidence of acute contact dermatitis at screening.
14)Evidence of Zink deficiency defined as Zink level < 20 µg/dL in serum.
15) History of important side effects of medium potency topical corticosteroids (eg, intolerance to treatment, hypersensitivity reactions*, significant skin atrophy, systemic effects), as assessed by the investigator or patient’s treating physician.
16.) ≥30% of the total lesional surface located on areas of thin skin that cannot be safely treated with medium potency TCS (eg, face, neck, intertriginous areas, genital areas, areas of skin atrophy) at baseline.
17.) Planned or anticipated use of any prohibited medications and procedures during study treatment.
18.) Known history of human immunodeficiency virus (HIV) infection.
19.) Established diagnosis of Hepatitis B viral infection at the time of screening.
20.) Established diagnosis of hepatitis C viral infection at the time of screening.
21.) History of past or current tuberculosis or other mycobacterial infection.
22.) Presence of skin comorbidities that may interfere with study assessments. This includes, but is not limited to, conditions like scabies, seborrheic dermatitis, Cutaneous T cell Lymphoma, Psoriasis, etc.
23.) Malignancy within 5 years of the screening visit excluding local cutaneous squamous cell
24.) Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study. Examples include, but are not limited to patients with short life expectancy, patients with major congenital malformations, patients with cardiovascular conditions (eg, major, clinically significant congenital cardiovascular abnormalities), severe renal conditions, hepato-biliary conditions (eg, Child-Pugh class B or C), active major autoimmune diseases (eg, lupus, inflammatory bowel disease etc.), other severe endocrinological, gastrointestinal, metabolic, pulmonary, neurological or lymphatic diseases. The specific justification for patients excluded under this criterion will be noted in study documents (chart notes, case report forms [CRF], etc).
25.) Any other medical or psychological condition including relevant laboratory abnormalities at screening that, in the opinion of the investigator, suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient as a result of his/her participation in this clinical trial, may make patient's participation unreliable, or may interfere with study assessments. The specific justification for patients excluded under this criterion will be noted in study documents (chart notes, CRF, etc).
26.) Planned major surgical procedure during the patient's participation in this study.
* Participation in a prior clinical trial is permitted, as long as adequate wash-out periods and exclusion criterion #4 are taken into consideration.

E.5 End points

E.5.1

Primary end point(s)

Percent change in EASI score from baseline to week 16

E.5.1.1

Timepoint(s) of evaluation of this end point

Change from baseline (visit 2) to week 16 (visit 10)

E.5.2

Secondary end point(s)

Number of Patients Achieving an Improvement (Decrease) in Physician Global Assessment (PGA) by two or more points at week 16 as compared to week 0 or achieving an absolute PGA of 0 or 1 at Week 16
Definition of the PGA 5-point scale:
Eczema Area and Severity Index (EASI) 50 score at week 16
Significant histological improvement at week 16
Change from Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16
Change from Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16
Change from Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) Score at Week 16
Safety of Dupilumab will be assessed by Evaluating Adverse Events (AEs)

E.5.2.1

Timepoint(s) of evaluation of this end point

Change from baseline (visit 2) to week 16 (visit 10)

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.6.2

Trial being conducted completely outside of the EEA

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.8.9.1

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

F.3.3.2

Women of child-bearing potential using contraception

Yes

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.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)

After the end of the study, regardless of whether the study end is according to the protocol or earlier, patient will continue their routine treatment.

Nach Ende der Studie können Patienten unabhängig davon, ob die Studie protokollgemäß oder vorzeitig beendet wurde, durch ihren behandelnden Arzt gemäß Routine, weiter behandelt werden.

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

2020-10-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-02-10

P. End of Trial
P.	End of Trial Status	Ongoing

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