Clinical Trials Register

Summary
EudraCT Number:	2013-002283-25
Sponsor's Protocol Code Number:	EMR200575-001
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-11-06
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2013-002283-25

A.3

Full title of the trial

A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis

Estudio de fase II, multicéntrico, aleatorizado, de grupos paralelos, con enmascaramiento de los evaluadores para evaluar la eficacia, la seguridad y la tolerabilidad de las dosis de 0,5, 3, 10 y 20 mg del acetato de plovámero en comparación con Copaxone en pacientes con esclerosis múltiple remitente recidivante

A.3.1

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

A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis

Un estudio para evaluar la eficacia, seguridad y la tolerabilidad del acetato de plovámero en pacientes con esclerosis múltiple remitente recidivante.

A.3.2

Name or abbreviated title of the trial where available

Efficacy, safety, and tolerability of plovamer acetate

Eficacia, seguridad y la tolerabilidad del acetato de plovámero

A.4.1

Sponsor's protocol code number

EMR200575-001

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	Merck KGaA
B.1.3.4	Country	Germany
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	Merck KGaA
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	Merck KGaA
B.5.2	Functional name of contact point	Communication Centre merck KGaA
B.5.3	Address:
B.5.3.1	Street Address	Frankfurterstrasse 250
B.5.3.2	Town/ city	Darmstadt
B.5.3.3	Post code	64293
B.5.3.4	Country	Germany
B.5.4	Telephone number	496151725200
B.5.6	E-mail	service@merckgroup.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	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	Plovamer acetate
D.3.2	Product code	MSC2491529A
D.3.4	Pharmaceutical form	Solution for injection
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	--
D.3.9.2	Current sponsor code	MSC2491529A
D.3.9.3	Other descriptive name	Plovamer acetate
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	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	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	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	Plovamer acetate
D.3.2	Product code	MSC2491529A
D.3.4	Pharmaceutical form	Solution for injection
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	--
D.3.9.2	Current sponsor code	MSC2491529A
D.3.9.3	Other descriptive name	Plovamer acetate
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	6
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
D.IMP: 3
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	Plovamer acetate
D.3.2	Product code	MSC2491529A
D.3.4	Pharmaceutical form	Solution for injection
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	--
D.3.9.2	Current sponsor code	MSC2491529A
D.3.9.3	Other descriptive name	Plovamer acetate
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	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Comparator
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	Copaxone
D.2.1.2	Country which granted the Marketing Authorisation	Israel
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
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	Glatiramer acetate
D.3.9.1	CAS number	147245-92-9
D.3.9.3	Other descriptive name	GLATIRAMER ACETATE
D.3.9.4	EV Substance Code	SUB13971MIG
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	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Relapsing Remitting Multiple Sclerosis (RRMS)

Esclerosis múltiple remitente recidivante (EMRR)

E.1.1.1

Medical condition in easily understood language

Relapsing Remitting Multiple Sclerosis (RRMS)

Esclerosis múltiple remitente recidivante (EMRR)

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	PT
E.1.2	Classification code	10063399
E.1.2	Term	Relapsing-remitting multiple sclerosis
E.1.2	System Organ Class	10029205 - Nervous system 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

The primary objective of this trial is to evaluate the efficacy of plovamer acetate (0.5 mg, 3 mg, 10 mg and 20 mg) administered as weekly SC injection vs. Copaxone 20 mg administered as daily SC injection after 40 weeks of treatment on the mean number of T1 gadolinium (Gd)-enhancing lesions per patient and scan on brain MRI scans at Weeks 24, 28, 32, 36, and 40 in patients with RRMS.

El objetivo principal de este ensayo consiste en evaluar la eficacia del acetato de plovámero (0,5, 3, 10 y 20 mg) administrado en inyección SC semanal en comparación con Copaxone (20 mg) administrado en inyección SC diaria después de 40 semanas de tratamiento sobre el número medio de lesiones con captación de gadolinio (Gd) en T1 por paciente y estudio de imagen en las RM cerebrales realizadas en las semanas 24, 28, 32, 36 y 40 en pacientes con EMRR.

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of plovamer acetate (0.5 mg, 3 mg, 10 mg and 20 mg), administered as weekly SC injection vs. Copaxone 20 mg administered as daily SC injection after 40 weeks of treatment

Evaluar la eficacia del acetato de plovámero (0,5, 3, 10 y 20 mg) administrado en inyección SC semanal en comparación con Copaxone (20 mg) administrado en inyección SC diaria después de 40 semanas de tratamiento

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female, between the ages of 18 and 60 years.
2. Patient is able to learn and self-administer SC injections (a care-giver may be trained to inject the patient).
3. Patients must have a current diagnosis of RRMS (according to the 2010 McDonald MS diagnostic criteria).

Other protocol defined inclusion criteria could apply

1.Paciente de cualquier sexo con una edad comprendida entre los 18 y 60 años.
2.El paciente es capaz de aprender y administrarse inyecciones SC (puede formarse a un cuidador para que inyecte al paciente).
3. El paciente debe tener un diagnóstico presente de EMRR (con arreglo a los criterios diagnósticos de EM de McDonald de 2010).

Otros criterios de inclusión definidos en el protocolo pueden aplicar.

E.4

Principal exclusion criteria

Patients are not eligible for this trial if they fulfill any of the following exclusion criteria:
1. Any MS categorized as primary progressive, secondary progressive and progressive relapsing.
2. Any relapse of MS within 30 days of the Baseline Visit 2.
3. Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for MRI.
4. Systemic glucocorticoid therapy within 30 days of Baseline Visit 2. Any requirement for continuous systemic glucocorticoid administration during the trial period. (Note: Treatment with interferons such as Avonex®, Rebif®, or Betaseron® will be allowed until the baseline visit, as no wash-out period is needed.)
5. Contraindication to Copaxone use.

Other protocol defined exclusion criteria could apply

Un paciente no podrá participar en este ensayo en caso de cumplir cualquiera de los criterios de exclusión siguientes:
1.EM clasificada como progresiva primaria, progresiva secundaria o recidivante progresiva.
2.Cualquier recaída de la EM en los 30 días previos a la visita 2 basal.
3.Alergia al manitol, acetato de plovámero, Copaxone (acetato de glatirámero) o contraste de Gd para RM.
4.Tratamiento con glucocorticoides sistémicos en los 30 días previos a la visita 2 basal. Necesidad de administración continua de glucocorticoides sistémicos durante el período del ensayo. (Nota: Se permitirá el tratamiento con interferones, como Avonex®, Rebif® o Betaseron®, hasta la visita basal, ya que no se precisa período de lavado.)
5. Contraindicaciones para el uso del Capaxone.

Otros criterios de inclusión definidos en el protocolo pueden aplicar.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the mean number of T1 Gd-enhancing lesions per patient per scan measured over 5 monthly visits (Weeks 24, 28, 32, 36 and 40).

La variable principal es el número medio de todas las lesiones con captación de Gd en T1 por paciente y estudio de imagen a partir de las 5 RM seriadas realizadas en las semanas 24, 28, 32, 36 y 40.

E.5.1.1

Timepoint(s) of evaluation of this end point

40 weeks

40 semanas

E.5.2

Secondary end point(s)

Mean Annualized Relapse Rate.
· Percentage of patients remaining relapse-free at
Week 40.
· Mean number of new T1 Gd-enhancing lesions per
patient and scan from 5 serial MRI scans performed on
Weeks 24, 28, 32, 36, and 40.
· Mean number of new or enlarging T2 lesions per patient and scan from 5 serial MRIs performed on Weeks 24, 28, 32, 36, and 40.
· Mean number of new, unenhancing T1 lesions (black holes) per patient and scan on MRI scans from 5 serial MRIs performed on Weeks 24, 28, 32, 36, and 40.
· Mean change in volume of T1 Gd-enhancing lesions per patient baseline vs. mean of 5 serial MRI scans performed on Weeks 24, 28, 32, 36, and 40.
· Mean change per patient in volume of T2 Gd-enhancing lesions baseline vs. last MRI scan performed between Weeks 24 and 40.
· Time to first relapse.
· Mean change in brain volume per patient baseline vs. last MRI performed between Weeks 24 and 40.

?TAR media en la semana 40.
?Porcentaje de pacientes que permanezcan sin recaídas en la semana 40.
?Número medio de lesiones nuevas con captación de Gd en T1 por paciente y estudio de imagen a partir de las 5 RM seriadas realizadas en las semanas 24, 28, 32, 36 y 40.
?Número medio de lesiones nuevas o con aumento de tamaño en T2 por paciente y estudio de imagen a partir de las 5 RM seriadas realizadas en las semanas 24, 28, 32, 36 y 40.
?Número medio de lesiones nuevas sin captación de Gd en T1 (agujeros negros) por paciente y estudio de imagen a partir de las 5 RM seriadas realizadas en las semanas 24, 28, 32, 36 y 40.
?Variación media por paciente del volumen de lesiones con captación de Gd en T1 entre el momento basal y la media de 5 RM seriadas realizadas en las semanas 24, 28, 32, 36 y 40.
?Variación media por paciente del volumen de lesiones con captación de Gd en T2 entre el momento basal y la última RM realizada entre las semanas 24 y 40.
?Tiempo hasta la primera recaída.
?Variación media por paciente del volumen encefálico entre el momento basal y la última RM realizada entre las semanas 24 y 40.

E.5.2.1

Timepoint(s) of evaluation of this end point

40 weeks

40 semanas

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

Yes

E.6.13.1

Other scope of the trial description

Tolerability

Tolerabilidad

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

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Enmascaramiento del evaluador

Rater blinded

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

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

Serbia

Bulgaria

Colombia

Croatia

Czech Republic

Finland

Greece

Hungary

Italy

Spain

Mexico

Poland

South Africa

Turkey

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

Última visita del último paciente

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

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:

550

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

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.4.2

For a multinational trial

F.4.2.1

In the EEA

335

F.4.2.2

In the whole clinical trial

550

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

Ninguno.

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

2014-01-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-12-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-03-03

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