Clinical Trials Register

Summary
EudraCT Number:	2013-002758-62
Sponsor's Protocol Code Number:	EMR700461-024
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2014-07-21
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

Spain - AEMPS

A.2

EudraCT number

2013-002758-62

A.3

Full title of the trial

A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II)

Ensayo de extensión, a largo plazo, multicéntrico y de fase IIb para evaluar la seguridad y tolerabilidad de atacicept en sujetos con lupus eritematoso sistémico (LES) que han completado el protocolo EMR-700461-023 (ADDRESS II)

A.3.1

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

Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II)

Ensayo a largo plazo para evaluar la seguridad y tolerabilidad de atacicept en sujetos con lupus ertematoso sistémico (LES) que han completado el protocolo EMR-700461-023 (ADDRESS II)

A.4.1

Sponsor's protocol code number

EMR700461-024

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 Center
B.5.3	Address:
B.5.3.1	Street Address	Frankfurter Strasse 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	Atacicept
D.3.4	Pharmaceutical form	Solution for infusion 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	Atacicept
D.3.9.3	Other descriptive name	ATACICEPT
D.3.9.4	EV Substance Code	SUB30888
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	75
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	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	Atacicept
D.3.4	Pharmaceutical form	Solution for infusion 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	Atacicept
D.3.9.3	Other descriptive name	ATACICEPT
D.3.9.4	EV Substance Code	SUB30888
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	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Systemic Lupus Erythematosus (SLE)

Lupus Eritematoso Sistémico (LES)

E.1.1.1

Medical condition in easily understood language

Systemic Lupus Erythematosus (SLE)

Lupus Eritematoso Sistémico (LES)

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	PT
E.1.2	Classification code	10042945
E.1.2	Term	Systemic lupus erythematosus
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective 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

Determine the long-term safety and tolerability of atacicept in SLE subjects.

Determinar la seguridad y la tolerabilidad a largo plazo de atacicept en pacientes de LES.

E.2.2

Secondary objectives of the trial

1. Evaluate the effect of atacicept on changes in disease activity over time.
2. Evaluate the effect of atacicept in reducing corticosteroid (CS) usage.
3. Evaluate the immunogenicity, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of atacicept.
4. Evaluate the effect of atacicept on patient-reported outcomes (PROs).
5. Identify potential associations of genetic variations and gene.

1. Evaluar el efecto de atacicept en los cambios en la actividad de la enfermedad con el tiempo.
2. Evaluar el efecto de atacicept en la reducción del uso de CS.
3. Evaluar los perfiles de inmunogenicidad, FC y FD de atacicept.
4. Evaluar el efecto de atacicept en los resultados notificados por el paciente (PRO).
5. Identificar posibles asociaciones entre las variaciones genéticas y la expresión génica con la respuesta a atacicept, su eficacia y seguridad.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Pharmacokinetic study; Objective see E.2.2

Estudio farmacocinético; ver objetivo E.2.2

E.3

Principal inclusion criteria

- Subjects who have completed the 24-week treatment period of trial EMR-700461-023 (ADDRESS II core trial).
- Women of childbearing potential (WOCBP) who have a negative pregnancy test
- Other protocol defined inclusion criteria may apply

- Los pacientes han completado el periodo de tratamiento de 24 semanas del ensayo EMR-700461-023 (ensayo central ADDRESS II).
-Las mujeres en edad fértil (MEF) que tengan un resultado negativo de test de embarazo
- Otros criterios de inclusión descritos en el protocolo pueden aplicar

E.4

Principal exclusion criteria

- Active neurological symptoms of SLE that are deemed severe or progressive
- Diagnosis of any demyelinating disease, such as, but not restricted to, MS or optic neuritis
- Pregnancy
- Other protocol defined exclusion criteria may apply

- Síntomas neurológicos activos del LES que se consideren graves o progresivos
- Diagnóstico de alguna enfermedad desmielinizante como, entre otras, EM o neuritis óptica.
- Embarazo
- Otros criterios de exclusión descritos en el protocolo pueden aplicar

E.5 End points

E.5.1

Primary end point(s)

- Number of subjects reporting at least one SAE during the treatment period.
- Number of subjects prematurely discontinuing the treatment due to AE.

- Número de pacientes que informan de al menos un AAG durante el periodo de tratamiento.

- Número de pacientes que interrumpen de forma prematura el tratamiento debido a un AA.

E.5.1.1

Timepoint(s) of evaluation of this end point

Continuous throughout treatment period up to week 96

Continuo durante todo el período de tratamiento hasta la semana 96

E.5.2

Secondary end point(s)

- Change from Baseline in SLICC/ACR Damage Index organ damage scores at Week 96
- Change from Baseline in disease activity as measured by BILAG at Week 96
- Change from Baseline in disease activity as measured by SLEDAI-2K at Week 96
- Change from Baseline in disease activity as measured by SRI-50 at Week 96
- Change from Baseline in disease activity as measured by PGA at Week 96
- Change from Baseline in SRI (a disease activity composite index) response at Week 96
- Change from Baseline in BICLA (a disease activity composite index) response at Week 96
- Change from Baseline in prednisone-equivalent CS dose at Week 96
- Change from Baseline in SF-36 at Week 96
- Change from Baseline in LupusQoL at Week 96
- Change from Baseline in PGIC at Week 96
- Change from Baseline in EQ-5D at Week 96
- Change from Baseline in FACIT-Fatigue at Week 96
- Number of subjects with AEs
- C-SSRS score

- Cambios a lo largo del tiempo en las puntuaciones de daño de los órganos de los índices SLICC/ACR
- Cambios a lo largo del tiempo en la actividad de la enfermedad medida mediante BILAG
- Cambios a lo largo del tiempo en la actividad de la enfermedad medida mediante SLEDAI-2K
- Cambios a lo largo del tiempo en la actividad de la enfermedad medida mediante SRI-50
- Cambios a lo largo del tiempo en la actividad de la enfermedad medida mediante PGA
- Cambios a lo largo del tiempo en el índice SRI (un índice compuesto de actividad de la enfermedad)
- Cambios a lo largo del tiempo en el BICLA (un índice compuesto de actividad de la enfermedad)
- El cambio a lo largo del tiempo en la dosis CS de equivalente de prednisona
- Cambios a lo largo del tiempo en la CdV medidos por: SF-36.
- Cambios a lo largo del tiempo en la CdV medidos por: LupusQoL
- Cambios a lo largo del tiempo en la CdV medidos por:PGIC
- Cambios a lo largo del tiempo en la CdV medidos por: EQ-5D
- Cambios a lo largo del tiempo en la CdV medidos por: FACITCansancio
- Número de pacientes con acontecimientos adversos
- Puntuación C-SSRS

E.5.2.1

Timepoint(s) of evaluation of this end point

96 weeks (See E.5.2)

96 semanas (ver punto E.5.2)

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Biomarker and Health resource utilization

Biomarcadores y la utilización de recursos de la salud

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

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

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

Argentina

Brazil

Bulgaria

Chile

Czech Republic

Germany

Italy

Korea, Republic of

Mexico

Peru

Philippines

Poland

Russian Federation

South Africa

Spain

Ukraine

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

When final database lock occurs (according to protocol)

Cuando el final del cierre de la base de datos tenga lugar (de acuerdo con el protocolo)

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:

202

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

213

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 a subject has completed the trial through the safety FU period, or has withdrawn early, standard treatment should be administered, if required, in accordance with the trial site?s SoC and generally accepted medical practice, and depending on the subject?s individual medical needs.

Después que un paciente haya completado el ensayo y el periodo de segumiento de seguirdad, o haya terminado tempranamente, tratamiento estandard debería ser administrado, si es requerido, de acuerdo con los centros y generalmente aceptado por práctica médica y dependiendo de las necesidades médicas de los pacientes.

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

2014-07-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-04-07

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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