Clinical Trials Register

Summary
EudraCT Number:	2015-004457-40
Sponsor's Protocol Code Number:	SL0023
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:	2016-08-05
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

2015-004457-40

A.3

Full title of the trial

A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS.

ESTUDIO MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE GRUPOS PARALELOS, DE RANGO DE DOSIS SEGUIDO DE UN PERÍODO DE OBSERVACIÓN PARA EVALUAR LA EFICACIA Y SEGURIDAD DE DAPIROLIZUMAB PEGOL EN SUJETOS CON LUPUS ERITEMATOSO SISTÉMICO DE MODERADO A SEVERAMENTE ACTIVO.

A.3.1

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

A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having
symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an
inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor
nor the patient will know which additional treatment is given.

Un ensayo clínico llevado a cabo en todo el mundo, en pacientes adultos con lupus eritematoso que actualmente tienen síntomas. A estos pacientes se les administra un medicamento (de 3 dosis diferentes) elegido al azar (como si se lanzara una moneda) o se les administra un medicamento inactivo, además de su medicación habitual para el lupus. El promotor, el médico y el paciente no conocerán el medicamento adicional que se administra.

A.4.1

Sponsor's protocol code number

SL0023

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	UCB Biopharma SPRL
B.1.3.4	Country	Belgium
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	UCB Biopharma SPRL
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	UCB BIOSCIENCES GmbH
B.5.2	Functional name of contact point	Clin Trial Reg & Results Disclosure
B.5.3	Address:
B.5.3.1	Street Address	Alfred-Nobel-Strasse 10
B.5.3.2	Town/ city	Monheim
B.5.3.3	Post code	40789
B.5.3.4	Country	Germany
B.5.4	Telephone number	0034917088600
B.5.5	Fax number	++492173481572
B.5.6	E-mail	clinicaltrials@ucb.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	Dapirolizumab pegol (DZP)
D.3.2	Product code	CDP7657
D.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dapirolizumab pegol
D.3.9.2	Current sponsor code	DZP
D.3.9.3	Other descriptive name	CDP7657
D.3.9.4	EV Substance Code	SUB30739
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	36
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	Dapirolizumab pegol (DZP)
D.3.2	Product code	CDP7657
D.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dapirolizumab pegol
D.3.9.2	Current sponsor code	DZP
D.3.9.3	Other descriptive name	CDP7657
D.3.9.4	EV Substance Code	SUB30739
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	144
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: 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	Dapirolizumab pegol (DZP)
D.3.2	Product code	CDP7657
D.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dapirolizumab pegol
D.3.9.2	Current sponsor code	DZP
D.3.9.3	Other descriptive name	CDP7657
D.3.9.4	EV Substance Code	SUB30739
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	270
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	Solvent for solution for infusion
D.8.4	Route of administration of the placebo	Intravenous 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 MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS.

Sujetos con lupus eritematoso sistémico entre moderado y severamente activo.

E.1.1.1

Medical condition in easily understood language

SYSTEMIC LUPUS ERYTHEMATOSUS.

Lupus eritematoso sistémico.

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	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10040967
E.1.2	Term	SLE
E.1.2	System Organ Class	100000004859

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 assess the dose-response for the efficacy of intravenous (iv) dapirolizumab pegol (DZP; 3 dose groups) at Week 24 in adult subjects with moderately to severely active SLE receiving stable standard of care treatment.

Evaluar la relación dosis-respuesta de la eficacia de la administración por vía intravenosa (iv) de dapirolizumab pegol (DZP; 3 grupos de dosis) en la semana 24 en sujetos adultos con LES entre moderado y severamente activo, que están recibiendo medicación estable de tratamiento de referencia.

E.2.2

Secondary objectives of the trial

•To assess the efficacy of the individual dose regimens of intravenous (iv) dapirolizumab pegol (DZP) at Week 24.
• To assess the safety and tolerability of intravenous (iv) dapirolizumab pegol (DZP).

- Evaluar la eficacia de los regímenes de dosis individuales de dapirolizumab pegol (DZP) por vía intravenosa (iv) en la semana 24.
- Evaluar la seguridad y tolerabilidad de dapirolizumab pegol (DZP) por vía intravenosa (iv).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Clinical diagnosis of SLE confirmed by the SLICC Classification Criteria for SLE .
2.The subject has at least 1 of the following:
Anti-dsDNA antibodies confirmed by the central laboratory
OR Low complement (ie, either low C3, or low C4, or both) confirmed by the central laboratory
OR ANA titer of >=1:80 confirmed by the central laboratory at in combination with at least 1 of the following:
1.Historical positivity for anti-dsDNA or 2.Positivity for anti-ENA confirmed by the central laboratory
3.The subject has moderate to severe SLE disease activity

1. LES diagnosticado por un médico y confirmado por los criterios de clasificación de SLICC para LES.
2. El sujeto tiene al menos 1 de los siguientes:
Anticuerpos anti-ADNdc confirmados por el laboratorio central
O BIEN Bajo complemento (es decir, bajo C3, bajo C4 o ambos) confirmado por el laboratorio central
O BIEN Valoración de ANA >= 1:80 confirmada por el laboratorio central en combinación con al menos 1 de los siguientes:
1.Positividad histórica para anti-ADNdc o bien 2.Positividad para anti-ENA confirmada por el laboratorio central. 3. El sujeto presenta una actividad entre moderada y severa de LES.

E.4

Principal exclusion criteria

1.Subject has a mixed connective tissue disease, scleroderma, and/or overlap syndromes of SLE.
2.Subjects with severe neuropsychiatric SLE or other neurological symptoms that in the opinion of the Investigator, would prevent the subject from completing protocol required procedures and assessments.
3.Subject has new or worsening Class III or IV lupus nephritis.
4.Subject has chronic kidney failure stage 3b.
5.Subject has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T cell deficiencies, or human T cell lymphotropic virus 1 infection at any time prior to or during the study.
6.Subject has clinically significant active or latent infection, for example, but not limited to, chronic viral hepatitis B or C.
7.Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB (LTB) infection are excluded.
8.Subjects who have received live/live attenuated vaccines within 6 weeks prior to the first study drug infusion (Visit 2) or who plan to receive these vaccines during the study or 12 weeks after the final dose of study drug .
9.Subjects with a history of thromboembolic events within 12 months of Screening.
10.Subject has used protocol defined prohibited medications.

1. Sujetos con una enfermedad mixta del tejido conectivo, escleroderma o síndromes solapados de LES.
2. Sujetos con LES neuropsiquiátrico grave u otros síntomas neurológicos que, en opinión del investigador, podrían impedir que completaran los procedimientos y evaluaciones requeridos por el protocolo.
3. Sujetos con nefritis lúpica de clase III o IV nueva o debida a un empeoramiento.
4. Sujetos con insuficiencia renal crónica de fase 3b.
5. Sujetos con evidencias de infección por el virus de inmunodeficiencia humana (VIH), agammaglobulinemia, deficiencia de células T o infección por el virus linfotrópico humano de células T de tipo 1 en cualquier momento anterior al estudio o durante el mismo.
6. Sujetos con una infección activa o latente clínicamente significativa, por ejemplo, aunque sin limitarse a ello, hepatitis B o C viral crónica.
7. Sujetos con infección por tuberculosis (TB) conocida, con alto riesgo de contraer la infección por TB o con una infección por TB latente (LTB) quedan excluidos.
8. Sujetos que hayan recibido vacunas vivas/vivas atenuadas en las 6 semanas anteriores a la primera infusión del fármaco del estudio (visita 2) o que planeen recibir estas vacunas durante el estudio o en las 12 semanas posteriores a la dosis final del fármaco del estudio.
9. Sujetos con antecedentes de episodios tromboembólicos en los 12 meses anteriores a la selección.
10. Sujetos que hayan usado los medicamentos prohibidos indicados en el protocolo.

E.5 End points

E.5.1

Primary end point(s)

•Percentage of subjects with BICLA response across 3 doses of dapirolizumab pegol (DZP) and placebo (PBO) at Week 24.

•Porcentaje de sujetos con respuesta de la BICLA de las 3 dosis de dapirolizumab pegol (DZP) y placebo (PBO) en la semana 24.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24.

Semana 24.

E.5.2

Secondary end point(s)

The percentage of subjects with BICLA response in the individual dose groups at Week 24.

El porcentaje de sujetos con respuesta de la BICLA de los regímenes de dosis individuales en la semana 24 .

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 24.

Semana 24.

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

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

Patient reported outcomes.

Resultados comunicados de los pacientes.

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

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

Bulgaria

Chile

Colombia

Germany

Hungary

Mexico

Peru

Poland

Romania

Russian Federation

Spain

Ukraine

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

The end of the study is defined as the date of the last visit of the last subject in the study.

El fin del ensayo se define como la fecha de la última visita del último paciente del ensayo.

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

E.8.9.2

In all countries concerned by the trial 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:

150

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

160

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

2016-10-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-09-30

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-11-15

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