Clinical Trials Register

Summary
EudraCT Number:	2013-003086-34
Sponsor's Protocol Code Number:	CAIN457A3301
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:	2013-12-05
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

2013-003086-34

A.3

Full title of the trial

A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis.

Estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo, de 52 semanas de duración, para demostrar la eficacia de secukinumab subcutáneo, según la evaluación del Índice de gravedad y área de la psoriasis pustulosa palmoplantar (ppPASI) a las 16 semanas de tratamiento, comparado con placebo, y para evaluar su seguridad, tolerabilidad y eficacia a largo plazo en
pacientes con psoriasis pustulosa palmoplantar crónica de moderada a grave.

A.3.1

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

Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis.

Estudio de eficacia, tolerabilidad y seguridad de Secukinumab en pacientes con Psoriasis pustulosa palmoplantar crónica de moderada a grave.

A.4.1

Sponsor's protocol code number

CAIN457A3301

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	Novartis Farmacéutica, S.A.
B.1.3.4	Country	Spain
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	Novartis Pharma Services AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Farmacéutica S.A.
B.5.2	Functional name of contact point	Departamento Médico (HOR-MK)
B.5.3	Address:
B.5.3.1	Street Address	Gran Vía de Les Corts Catalanes, 764
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08013
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034900353036
B.5.5	Fax number	0034392479903
B.5.6	E-mail	eecc.novartis@novartis.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	Secukinumab
D.3.2	Product code	AIN457
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	Secukinumab
D.3.9.1	CAS number	1229022-83-6
D.3.9.3	Other descriptive name	SECUKINUMAB
D.3.9.4	EV Substance Code	SUB33242
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	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Suspension 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

Moderate to severe chronic palmoplantar pustular psoriasis.

Psoriasis pustulosa palmoplantar crónica de moderada a grave.

E.1.1.1

Medical condition in easily understood language

In palmoplantar pustular psoriasis the palms and soles are affected by the appearance of the pustules which is preceded by the reddening of skin.

En la psoriasis pustulosa palmoplantar, las palmas y las plantas se ven afectados por la aparición de pústulas que son antecedidas por el enrojecimiento de la piel.

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10037575
E.1.2	Term	Pustular psoriasis
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10037158
E.1.2	Term	Psoriasis palm & soles
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 demonstrate the superiority of secukinumab 150 mg s.c. and/or 300 mg s.c. in patients with moderate to severe chronic palmoplantar pustular psoriasis at Week 16 with respect to the palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate (ppPASI 75) compared to placebo.

Demostrar la superioridad de secukinumab 150 mg s.c. y/o 300 mg s.c. en pacientes con psoriasis pustulosa palmoplantar crónica de moderada a grave en la semana 16 en lo que respecta a la tasa de respuesta 75 del Índice de gravedad y área de la psoriasis pustulosa palmoplantar (ppPASI 75), en comparación con placebo.

E.2.2

Secondary objectives of the trial

1- To demonstrate the superiority of secukinumab 150 mg s.c. and/or 300 mg s.c. in patients with moderate to severe chronic palmoplantar pustular psoriasis at Week 16 with respect to the mean change from Baseline of palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI), compared to placebo.
2- To evaluate the time courses of the mean ppPASI response rates until Week 16 (secukinumab 150 mg s.c. and 300 mg s.c compared to placebo), and over time until week 52.
3- To evaluate the clinical safety and tolerability of secukinumab treatment regimens as assessed by vital signs, clinical laboratory variables, electrocardiograms (ECGs), and adverse events monitoring

1- Demostrar la superioridad de secukinumab 150 mg s.c. y/o 300 mg s.c. en pacientes con psoriasis pustulosa palmoplantar crónica de moderada a grave en la semana 16 en lo que respecta al cambio medio con respecto al periodo basal en el Índice de gravedad y área de la
psoriasis pustulosa palmoplantar (ppPASI), en comparación con placebo.
2- Evaluar la evolución de las tasas de respuesta medias del ppPASI hasta la semana 16 (secukinumab 150 mg s.c. y 300 mg s.c en comparación con placebo), y a lo largo del tiempo hasta la semana 52.
3- Evaluar la tolerabilidad y seguridad clínica de las pautas de tratamiento de secukinumab en función de la valoración de las constantes vitales, las variables analíticas clínicas, los electrocardiogramas (ECG) y la monitorización de acontecimientos adversos.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients must be able to understand and communicate with the
investigator and comply with the requirements of the study (including administration of s.c. injections at home) and must give a written, signed and dated informed consent, before any study-related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
2. Men or women ? 18 years of age at time of screening
3. Palmoplantar pustular psoriasis for at least 6 months before
randomization; the medical history should confirm the presence of
pustules in the last six months if not present at the time of screening
4. Moderate to severe palmoplantar pustular psoriasis as defined at
Baseline by:
? ppPASI score of ? 12 and
? DLQI ? 10
5. Candidate for systemic therapy, defined as having palmoplantar
pustular psoriasis inadequately controlled by:
? Topical treatment and/or
? Phototherapy, and/or
? Previous systemic therapy

1. Los pacientes deberán ser capaces de entender al investigador y comunicarse con él, y de cumplir los requisitos del estudio (incluida la administración de inyecciones subcutáneas en el domicilio), y deben entregar un consentimiento informado por escrito, firmado y fechado, antes de que se realice cualquier actividad relacionada con el estudio. Cuando resulte pertinente, un representante legal también firmará el consentimiento informado del estudio de acuerdo con las leyes y normativas locales.
2. Varones o mujeres ? 18 años de edad en el momento de la selección
3. Psoriasis pustulosa palmoplantar durante al menos los 6 meses anteriores a la aleatorización; la historia clínica debe confirmar la presencia de pústulas en los últimos seis meses si no las hay en el momento de la selección
4. Psoriasis pustulosa palmoplantar de moderada a grave en el periodo basal definida por:
· Puntuación ppPASI ? 12 y
· DLQI ? 10
5. Candidato para tratamiento sistémico, definido como paciente con psoriasis pustulosa palmoplantar controlada de forma inadecuada mediante:
· Tratamiento tópico y/o
· Fototerapia y/o
· Tratamiento sistémico previo

E.4

Principal exclusion criteria

1. Forms of psoriasis other than chronic plaque psoriasis and palmoplantar pustular psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis)
2. Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis on the hands and/or feet
3. Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study
4. Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to (Table 5-2).
5. Previous exposure to any biologic drug directly targeting IL-17A or IL- 17RA Receptor (e.g., secukinumab, ixekizumab, or brodalumab)
6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
7. Women of child-bearing potential, unless they are using effective methods of contraception during the study and for 16 weeks after study treatment discontinuation
8. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
9. Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer.
10. Underlying condition (including, but not limited to metabolic,
hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy
11. Screening total WBC count <2.500/?l, or thrombocytes <100.000/?l, or neutrophils <1.500/?l, or hemoglobin <8.5 g/dl
12. Chest X-ray, computerized tomography (CT scan), or MRI with evidence of ongoing infectious or malignant process, obtained within 12 weeks prior to randomization, and evaluated by a qualified physician
13. Active systemic infections during the last two weeks (exception: common cold) prior to randomization or any infection that reoccurs on a regular basis
14. History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test (QFT) at screening. Patients with a positive or indeterminate QFT test may participate in the study if full tuberculosis work up (according to local practice/guidelines) completed within 12 weeks prior to randomization and establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines prior to randomization
15. Past medical history record of HIV, hepatitis B or hepatitis C prior to randomization
16. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of reoccurrence in the past 12 weeks prior to randomization; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed)
17. Inability or unwillingness to undergo repeated venipuncture (e.g., because of poor tolerability or lack of access to veins)
18. Current severe progressive or uncontrolled disease which in the judgment of the clinical investigator renders the patient unsuitable for the trial or puts the patient at increased risk (e.g., myocardial infarction within 26 weeks prior to randomization)
19. History of hypersensitivity to constituents of the study treatment and/or patients who are allergic to rubber or latex; (the needle covers on the single-use pre-filled syringe (PFS) for secukinumab and placebo contain dry natural rubber)
20. History or evidence of ongoing alcohol or drug abuse, within the last six months before randomization
21. Plans for administration of live vaccines during the study period or 6 weeks prior to randomization
22. Patients who are not able and not willing to self-administer secukinumab PFS injections or who have no trained caregiver available to administer these injections.

1. Tipos de psoriasis distintos de la psoriasis en placas crónica y la psoriasis pustulosa palmoplantar (por ejemplo, eritrodermia psoriásica, psoriasis guttata o psoriasis pustulosa generalizada).
2. Psoriasis inducida por fármacos (por ejemplo, de nueva aparición o exacerbación actual causada por betabloqueantes, antagonistas del calcio, o litio) o antecedentes de dermatitis de contacto confirmada en manos y/o pies.
3. Pacientes no dispuestos a limitar la exposición a la luz UV (por ejemplo, tomar baños de sol y/o usar productos bronceadores) durante el transcurso del estudio.
4. Uso concomitante de tratamientos para la psoriasis prohibidos (por ejemplo, corticosteroides tópicos o sistémicos, tratamiento con luz UV). Deben respetarse los periodos de lavado detallados en el protocolo.
5. Exposición previa a cualquier fármaco biológico que actúe directamente sobre la IL-17A o el receptor IL-17RA (por ejemplo, secukinumab, ixekizumab o brodalumab).
6. Mujeres embarazadas o en periodo de lactancia, definiéndose el embarazo como el estado de la mujer después de la concepción y hasta el fin de la gestación, confirmado por un resultado positivo en las pruebas analíticas de gonadotropina coriónica humana (hCG).
7. Las mujeres en edad fértil, definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, a menos que utilicen métodos anticonceptivos eficaces durante la administración del tratamiento del estudio y durante las 16 semanas posteriores a la
suspensión del tratamiento del estudio.
8. Patologías inflamatorias activas en curso, aparte de psoriasis, que podría falsear la evaluación del efecto beneficioso del tratamiento con secukinumab.
9. Uso de cualquier otro fármaco en investigación en las 4 semanas previas al inicio del fármaco del estudio o en un periodo de 5 semividas del tratamiento en investigación, lo que sea más largo.
10. Trastornos subyacentes (incluidos trastornos metabólicos, hematológicos, renales, etc) que, en opinión del investigador, inmunodepriman significativamente al
paciente y/o supongan un riesgo inaceptable para el paciente por recibir un tratamiento inmunomodulador.
11. Análisis con una cifra total de leucocitos < 2500/?l, o plaquetas < 100 000/?l, o neutrófilos < 1500/?l, o hemoglobina < 8,5 g/dl.
12. Radiografía de tórax, tomografía computarizada (TC) o resonancia magnética (RM) con signos de proceso canceroso o infeccioso en curso, obtenidas en las 12 semanas previas a la aleatorización, y evaluadas por un médico cualificado.
13. Infecciones sistémicas activas en las dos últimas semanas (excepción: resfriado común) previas a la aleatorización o cualquier tipo de infección que reaparezca de forma periódica.
14. Antecedentes de una patología infecciosa crónica o recurrente en curso, o signos de infección por tuberculosis definida por un resultado positivo en la prueba de QuantiFERON TB-Gold (QFT) en la selección. Los pacientes con un resultado positivo o indeterminado en la prueba QFT pueden participar en el ensayo si el estudio diagnóstico completo de tuberculosis finalizó en las 12 semanas anteriores a la aleatorización y establece de forma concluyente que el paciente no presenta signos de tuberculosis activa. Si se confirma la presencia de tuberculosis latente, el tratamiento debe haberse iniciado y mantenido de acuerdo con las guías locales antes de la aleatorización.
15. Registro de antecedentes médicos de VIH, hepatitis B o C antes de la aleatorización.
16. Antecedentes de enfermedad linfoproliferativa o presencia de algún tipo de neoplasia maligna diagnosticada o antecedentes de neoplasia maligna en los últimos 5 años (excepto carcinoma basocelular o queratosis actínica que hayan sido tratados y no presenten signos de recurrencia en las 12 semanas previas a la aleatorización; carcinoma in situ de cuello uterino o pólipos cancerosos no invasivos en el colon que se hayan extirpado).
17. Incapacidad o rechazo a someterse a venopunción repetida
18. Enfermedad actual grave progresiva o no controlada que, a juicio del investigador clínico, hace que el paciente no sea apto para el ensayo o pone al paciente en un mayor riesgo (por ejemplo, infarto de miocardio en las 26 semanas anteriores a la aleatorización).
19. Antecedentes de hipersensibilidad a los componentes del tratamiento del estudio y/o pacientes con alergia a la goma o el látex (la cubierta de la aguja de las jeringas precargadas (PFS) de un solo uso para secukinumab y placebo contiene caucho natural seco).
20. Antecedentes o indicios de alcoholismo o abuso de drogas en curso, en los 6 meses anteriores a la aleatorización.
21. Intención de administrar vacunas atenuadas durante el período del estudio o durante las 6 semanas previas la aleatorización.
22. Pacientes que no sean capaces de autoadministrarse las inyecciones con jeringas precargadas de secukinumab, o no estén dispuestos a hacerlo, o que no tengan un cuidador formado disponible para administrar estas inyecciones.

E.5 End points

E.5.1

Primary end point(s)

Palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate.

Tasa de respuesta 75 del Índice de gravedad y área de la psoriasis pustulosa palmoplantar.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 16.

Semana 16.

E.5.2

Secondary end point(s)

1/ mean change from Baseline of palmoplantar pustulosis Psoriasis Area
and Severity Index (ppPASI)
2/ mean ppPASI response rates

1 / Cambio medio con respecto al periodo basal en el Índice de gravedad y área de la psoriasis pustulosa palmoplantar (ppPASI)
2 / Tasa de respuesta media del ppPASI

E.5.2.1

Timepoint(s) of evaluation of this end point

1/ week 16
2/ week 16 & over time till week 52

1/ Semana 16
2/ Semana 16 & a lo largo del tiempo hasta la semana 52.

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

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

Gene Expression.

Expresión génica.

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

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

Belgium

France

Germany

Italy

Austria

Poland

Russian Federation

Spain

Sweden

United Kingdom

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

Ultima 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:

189

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

195

F.4.2.2

In the whole clinical trial

210

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)

When subject leaves the study the investigator will discuss the different medications or possible alternatives that are available to treat the subject's psoriasis.

Cuando el paciente abandona el estudio, el investigador discutirá los las diferentes medicaciones o las posibles alternativas que están disponibles para el tratamiento de la psoriasis del paciente.

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

2013-12-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-11-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-05-31

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Clinical trials