Clinical Trials Register

Summary
EudraCT Number:	2016-001163-37
Sponsor's Protocol Code Number:	CNTO1959PSA3001
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:	2017-06-21
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2016-001163-37

A.3

Full title of the trial

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects with Active Psoriatic Arthritis including those Previously Treated with Biologic Anti-TNFα Agent(s)

Ensayo clínico multicéntrico en fase 3, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de guselkumab administrado por vía subcutánea en pacientes con artritis psoriásica activa, incluidos pacientes previamente tratados con agentes biológicos anti-TNFα.

A.3.1

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

A Phase 3 Study of Guselkumab in Subjects with Active Psoriatic Arthritis

Ensayo clínico en fase 3 de Guselkumab en pacientes con Artritis Psoriásica activa.

A.3.2

Name or abbreviated title of the trial where available

Discover-1

A.4.1

Sponsor's protocol code number

CNTO1959PSA3001

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	Janssen-Cilag International N.V.
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	Janssen Research & Development, LLC
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Janssen-Cilag S.A
B.5.2	Functional name of contact point	Global Clinical Operations Spain
B.5.3	Address:
B.5.3.1	Street Address	Paseo de las Doce Estrellas, 5-7
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28042
B.5.3.4	Country	Spain
B.5.4	Telephone number	+3491722 8100
B.5.5	Fax number	+3491722 8628
B.5.6	E-mail	agonza45@its.jnj.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	Guselkumab
D.3.2	Product code	CNTO1959
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	Guselkumab
D.3.9.2	Current sponsor code	CNTO1959
D.3.9.3	Other descriptive name	GUSELKUMAB
D.3.9.4	EV Substance Code	SUB179789
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	100
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	Yes
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	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

Active Psoriatic Arthritis

Artritis Psoriásica Activa

E.1.1.1

Medical condition in easily understood language

Active Psoriatic Arthritis

Artritis Psoriásica Activa

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10037160
E.1.2	Term	Psoriatic arthritis
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

The primary objective of this study is to evaluate the efficacy of guselkumab treatment in subjects with active PsA by assessing the reduction in signs and symptoms of PsA.

El objetivo principal de este estudio es evaluar la eficacia del tratamiento con guselkumab en pacientes con artritis psoriásica (APs) activa valorando la reducción de signos y síntomas de APs.

E.2.2

Secondary objectives of the trial

- Efficacy in improving psoriatic skin lesions
- Improvement in physical function
- Efficacy in improving general and disease specific health-related quality of life and patient-reported health outcomes
- Safety
- Pharmacokinetics, PD, and immunogenicity

- Eficacia para mejorar las lesiones cutáneas psoriásicas.
- Mejoría de la funcionalidad física.
- Eficacia para mejorar la calidad de vida relacionada con la salud general y específica de la enfermedad y los resultados de salud comunicados por los pacientes.
- Seguridad.
- Farmacocinética, farmacodinámica e inmunogenicidad.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Be a man or a woman at least 18 years of age
2. Have a diagnosis of PsA for at least 6 months before the first administration of study agent and meet ClASsification criteria for Psoriatic ARthritis at screening
3. Have active PsA as defined by:
a. At least 3 swollen joints and at least 3 tender joints at screening and at baseline
-AND-
b. C-reactive protein (CRP) ≥0.3 mg/dL at screening from the central laboratory.
4. Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
5. Have active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis.
6. Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID therapy.
- Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3 months or evidence of intolerance.
- Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 4 months or evidence of intolerance.
- NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance.
7. Subjects may have been previously treated with up to 2 anti-TNFα agents , and must document the reason for discontinuation
a. Lack of benefit to an anti-TNFα therapy, as assessed by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy and/or at least a 14 week dosage regimen of infliximab. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity.
b. Intolerance to an anti-TNFα biologic therapy, as assessed by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab.
c. If no intolerance or lack of benefit, the reason for discontinuation must be documented.
8. If currently using non-biologic DMARDs subjects should have started treatment at least 3 months and the dose must be stable for at least 4 weeks before first administration of study agent and should have no serious toxic side effects attributable to the non-biologic DMARD. If currently not using a MTX, SSZ, or HCQ, must have not received for at least 4 weeks before first administration of study agent.
If currently not using LEF, must not have received for at least 12 weeks before first administration of study agent.
a) If using MTX, the route of administration and dose must be stable and the dose must be ≤25 mg/week.
b) If receiving SSZ, the dose must be ≤ 3g/day.
c) If receiving HCQ, the dose must be ≤400 mg/day.
d) If receiving LEF, the dose must be ≤20 mg/day.
9. If currently using NSAIDs or other analgesics for PsA, subjects must be on a stable dose for at least 2 weeks before first administration of study agent. If currently not using NSAIDs or other analgesics for PsA, must not have received NSAIDs or other analgesics for PsA within 2 weeks before first administration of study agent.
10. If currently using oral corticosteroids for PSA, subjects must be on a stable dose equivalent to ≤10 mg of prednisone/day for at least 2 weeks before first administration of study agent.
If currently not using oral corticosteroids, the subject must not have received oral corticosteroids within 2 weeks before first administration of study agent

For a complete overview of the inclusion criteria please refer to protocol section 4.1. (pages 45-49)

1. Ser varón o mujer mayor de 18 años.
2. Haber sido diagnosticado de APs al menos 6 meses antes de la primera administración del fármaco de estudio y cumplir con los Criterios de Clasificación para Artritis Psoriásica (CASPAR) en la selección.
3. Presentar APs activa de acuerdo con la siguiente deficinión:
a. Al menos 3 articulaciones inflamadas y al menos 3 articulaciones dolorosas en la selección y en la visita basal.
-Y-
b. Niveles de proteína C reactiva (CRP) ≥0.3 mg/dL en los resultados de laboratorio central en la selección.
4. Presentar al menos 1 de los subtipos de APs: implicación de las articulaciones interfalangicas distales, artiritis poliarticular con ausencia de nódulos reumatoides, artritis mutilante, artritis periférica asimétrica o espondilitis con artritis periférica.
5. Presentar placas activas de psoriasis, con al menos una placa de ≥2cm de diámetro o cambios en las uñas consistentes con psoriasis o historia documentada de psoriasis en placas.
6. Presentar APs activa a pesar de terapia previa con DMARDs no-biológicos, apremilast y/o AINEs.
- La terapia con DMARDs no-biológicos se define como tomar DMARDs no-biológicos durante al menos 3 meses o evidencia de intolerancia.
- La terapia con apremilast se define como tomar apremilast a la dosis marcada aprobada en el país dónde se esté llevando a cabo el estudio durante al menos 4 meses o evidencia de intolerancia.
- la terapia con AINEs se define como tomar AINEs durante al menos 4 semanas o evidencia de intolerancia.
7. Los sujetos puede haber recibido anteriormente tratamiento con agentes anti-TNFα, la razón por la que se interrumpió dicha terapia debe estar documentada.
a. Falta de beneficio a la terapia anti-TNFα, valorada por el médico que le trata, después de al menos 12 semanas de terapia con etanercept, adalimumab, golimumab, o certolizumab pegol y/o al menos 14 semanas de régimen de dosificación con infliximab. La falta de beneficio documentada puede incluir la inadecuada mejora de recuento de articulationes, función física o actividad de la enfermedad.
b. Intolerancia a la terapia con anti-TNFα biológicos, valorada por el médico que le trata, a etanercept, adalimumab, golimumab, certolizumab pegol, o infliximab.
c. Si no ha presentado intolerancia o falta de beneficio, el motivo de la discontinuación debe estar documentado.
8. Si está recibiendo DMARDs no-biológicos, debe haber estado tratándose al menos 3 meses y a dosis estable al menos durante 4 semanas antes de la primera administración del fármaco del estudio y no deben presentar efectos secundarios serios tóxicos atribuibles a los DMARDs no-biológicos. Si actualmente no recibe MTX, SSZ o HCQ, no debe haberlos recibido durante al menos 4 semanas antes de la primera administración del fármaco del estudio.
Si actualmente no recibe LEF, no debe haberlo recibido al menos durante las 12 semanas previas a la primera administración del fármaco del estudio.
a. Si toma MTX, la ruta de administración y la dosis debe mantenerse estable y a ≤25 mg/semana.
b. Si recibe SSZ, la dosis debe ser ≤ 3g/día.
c. Si recibe HCQ la dosis debe ser ≤400 mg/día.
d. Si recibe LEF, la dosis debe ser ≤20 mg/día.
9. Si actualmente está tomando AINEs u otros analgésicos para la APs, la dosis debe mantenerse estable durante al menos 2 semanas antes de la primera administración de fármaco de estudio. Si actualmente no está tomando AINEs u otros analgésicos para APs, no debe haber recibido AINEs u otros analgésicos para APs durante las 2 semanas previas a la primera administración de fármaco del estudio.
10. Si actualmente está tomando coricosteroides orales para APs, debe mantenerse a una dosis estable equivalente a prednisona ≤10 mg/día durante al menos dos semanas antes de la primera administración del fármaco del estudio.
Si actualmente no está tomando corticosteroides orales, el paciente no debe haber recibido corticosteroides orales dentro de las 2 semanas previas a la primera administración del fármaco del estudio.
Para consultar los criterios de inclusión adicionales, por favor consulte la sección 4.1 de protocolo (páginas 45-49).

E.4

Principal exclusion criteria

1. Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to RA, axial spondyloarthritis, systemic lupus erythematosus, or
Lyme disease.
2. Has ever received more than 2 anti-TNFα agents.
3. Has received an anti-TNF agent within the following timeframes:
a. Has received infliximab or golimumab within 8 weeks before the first administration of study agent.
b. Has received golimumab SC, adalimumab or certolizumab pegol within 6 weeks before the first administration of study agent.
c. Has received etanercept within 4 weeks before the first administration of study agent.
4. Has previously been treated with guselkumab.
5. Has previously received any biologic treatment (other than anti-TNFα agents), including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment.
6. Has previously received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, or any other Janus kinase inhibitor.
7. Has previously received any systemic immunosuppressants
8. Has received non-biologic DMARDs including, but not limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first administration of study agent.
9. Is currently receiving 2 or more non-biologic DMARDs at baseline.
10. Has received apremilast within 4 weeks prior to the first administration of study agent.

For a complete overview of the exclusion criteria please refer to protocol section 4.2. (pages 49-52)

1. Presentar otra enfermedad inflamatoria que pueda dar lugar a confusión en las evaluaciones o beneficios de la terapia con guselkumab incluyendo, pero no solamente, AR, espondiloartritis axial, lupus eritematoso sistémico o enfermedad de Lyme.
2. Haber recibido más de 2 agentes anti-TNFα.
3. Haber recibido un agente anti-TNFα dentro de los siguientes periodos de tiempo:
a. Haber recibido infliximab o golimumab durante las 8 semanas previas a la primera administración de fármaco del estudio.
b. Haber recibido golimumab SC, adalimumab o certolizumab pegol durante las 6 semanas previas a la primera administración de fármaco del estudio.
c. Haber recibido etanercept durante las 4 semanas previas a la primera administración de fármaco del estudio.
4. Haber recibido previamente tratamiento con guselkumab.
5. Haber recibido previamente algún tratamiento biológico (que no sea un agente anti-TNFα) incluyendo, pero no limitado a, ustekinumab, abatacept, secukinumab, tildrakinumab, ixekinumab, brodalumab, risakizumab u otros tratamientos biológicos en investigación.
6. Haber recibido previamente tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib o algún otro inhibidor de la kinasa Janus.
7. Haber recibido algún inmunosupresor sistémico.
8 Haber recibido DMARDs no-biológicos incluyendo, pero no limitado a, cloroquina, preparaciones de oro, y penicilamina durante las 4 semanas previas a la primera administración de fármaco del estudio.
9. Estar recibiendo actualmente 2 o más DMARDs no-biológicos en el momento basal.
10. Haber recibido apremilast durante las 4 semanas previas a la primera administración de fármaco del estudio.
Para una visión completa de los criterios de exclusión, refiérase al apartado 4.2. del protocolo (páginas 49-52).

E.5 End points

E.5.1

Primary end point(s)

The proportion of subjects who achieve an ACR 20 response at Week 24

Proporción de pacientes que logran una respuesta del American College of Rheumatology (ACR) 20 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)

1. Change from baseline in HAQ-DI score at Week 24.
2. Proportion of subjects who achieve an ACR 50 response at Week 24.
3. Proportion of subjects with a psoriasis response of an Investigator Global Assessment at Week 24 among subjects with ≥3% body surface area psoriatic involvement and an IGA score of ≥2 at baseline.
4. Proportion of subjects who achieve an ACR 20 response at Week 16.
5. Change from baseline in DAS28 at Week 24.
6. Proportion of subjects who achieve an ACR 70 response at Week 24.
7. Proportion of subjects who achieve an ACR 50 response at Week 16.
8. Change from baseline in 36-item short form health survey (SF-36) Physical Component Summary at Week 24.
9. Proportion of subjects with resolution of enthesitis at Week 24 among the subjects with enthesitis at baseline.
10. Change from baseline in enthesitis score at Week 24 among the subjects with enthesitis at baseline.
11. Change from baseline in SF-36 Mental Component Summary at Week 24.
12. Proportion of subjects with resolution of dactylitis at Week 24 among the subjects with dactylitis at baseline.
13. Change from baseline in dactylitis scores at Week 24 among the subjects with dactylitis at baseline.

For additional secondary endpoints please refer to the protocol, section 2.1

1. Variación con respecto al momento basal de la puntuación en el cuestionario de evaluación de la salud-índice de discapacidad (HAQ-DI) en la semana 24.
2. Proporción de pacientes que logran una respuesta ACR 50 en la semana 24.
3. Proporción de pacientes que logran una respuesta de la psoriasis según la evaluación global por el investigador (IGA) (es decir, una puntuación IGA de la psoriasis de 0 [remisión completa] o 1 [mínima] Y una reducción de ≥ 2 grados respecto al valor basal) en la semana 24 entre los pacientes con BSA ≥ 3 % y una puntuación IGA ≥ 2 (leve) en el momento basal.
4. Proporción de pacientes que logran una respuesta ACR 20 en la semana 16.
5. Variación con respecto al momento basal en la DAS28 (proteína C reactiva [CRP]) en la semana 24.
6. Proporción de pacientes que logran una respuesta ACR 70 en la semana 24.
7. Proporción de pacientes que logran una respuesta ACR 50 en la semana 16.
8. Variación con respecto al momento basal en el resumen de componentes físicos (PCS) del cuestionario de salud abreviado de 36 preguntas (SF-36) en la semana 24.
9. Proporción de pacientes con resolución de la entesitis en la semana 24, en relación al total de pacientes que presentaban entesitis en el momento basal.
10. Variación con respecto al momento basal de la puntuación de la entesitis (basado en el índice de entesitis de Leeds [LEI]) en la semana 24, en relación al total de pacientes que presentaban entesitis en el momento basal.
11. Variación con respecto al momento basal del resumen de componentes mentales (MCS) del SF-36 en la semana 24.
12. Proporción de pacientes con resolución de la dactilitis en la semana 24, en relación al total de pacientes que presentaban dactilitis en el momento basal.
13. Variación con respecto al momento basal de la puntuación de la dactilitis en la semana 24, en relación al total de pacientes que presentaban dactilitis en el momento basal.

Para ver los criterios de valoración secundarios adicionales, refiérase a la sección 2.1 del protocolo.

E.5.2.1

Timepoint(s) of evaluation of this end point

1 - 3, 5 - 6, 8 - 13: Week 24
4, 7: Week 16

1-3, 5-6, 8-13: Semana 24
4, 7: Semana 16

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

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

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)

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

E.8.1.6

Cross over

Yes

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

Australia

Canada

Czech Republic

Germany

Hungary

Korea, Republic of

Malaysia

Poland

Russian Federation

Spain

Taiwan

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

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

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:

288

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

250

F.4.2.2

In the whole clinical trial

360

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)

There are no plans for additional treatment or care after the subject ends (or has ended) participation in the trial.

No está planeado el tratamiento adicional o cuidado después de que el paciente finalice (o haya finalizado) la participación en el ensayo.

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

2017-08-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-06-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-11-14

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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