Clinical Trials Register

Summary
EudraCT Number:	2017-004702-17
Sponsor's Protocol Code Number:	COMB157G2102
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:	2018-09-17
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

2017-004702-17

A.3

Full title of the trial

A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients

Estudio multicéntrico, aleatorizado, abierto, de grupos paralelos y 12 semanas de duración para evaluar la bioequivalencia de ofatumumab 20 mg subcutáneo inyectado mediante jeringa precargada o autoinyector en pacientes adultos con esclerosis múltiple recurrente.

A.3.1

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

A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.

Un estudio abierto para evaluar la bioequivalencia de ofatumumab inyectado mediante jeringa precargada o autoinyector.

A.4.1

Sponsor's protocol code number

COMB157G2102

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 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	Trial Monitoring Organization (TMo)
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	+34 90 0353036
B.5.5	Fax number	+34 93 2479903
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	Yes
D.2.1.1.1	Trade name	Arzerra
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	ofatumumab
D.3.2	Product code	OMB157
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
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	OFATUMUMAB
D.3.9.1	CAS number	679818-59-8
D.3.9.4	EV Substance Code	SUB25221
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	50
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	No
D.IMP: 2
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	Arzerra
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	ofatumumab
D.3.2	Product code	OMB157
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	OFATUMUMAB
D.3.9.1	CAS number	679818-59-8
D.3.9.4	EV Substance Code	SUB25221
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	50
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	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

Multiple sclerosis

Esclerosis Múltiple

E.1.1.1

Medical condition in easily understood language

Multiple sclerosis

Esclerosis Múltiple

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	PT
E.1.2	Classification code	10048393
E.1.2	Term	Multiple sclerosis relapse
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

Demonstrate pharmacokinetic bioequivalence of 20 mg ofatumumab injected by prefilled syringe (PFS) or autoinjector (AI) devices

Demostrar la bioequivalencia farmacocinética de ofatumumab 20 mg inyectado mediante JP o AI.

E.2.2

Secondary objectives of the trial

Secondary objectives of the Core part:
1. To characterize the pharmacokinetics following subcutaneous administration of ofatumumab to either the abdominal region or the thigh
2. Assessment of immunogenicity
3. Asses the safety and tolorability of ofatumumab
See protocol for complete list of secondary objectives

Objetivos secundarios:
1. Caracterizar la farmacocinética tras la administración subcutánea de ofatumumab en la región abdominal o el muslo.
2. Evaluar la inmunogenicidad.
3. Evaluar la seguridad y tolerabilidad de ofatumumab.
Ver protocolo para el resto de objetivos secundarios

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

MS Patients eligible for inclusion in this study must fulfill all of the following criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Male or Female patients aged 18 to 55 years (inclusive) at screening.
3. Diagnosis of MS according to the 2010 Revised McDonald criteria
4. Relapsing MS: relapsing-remitting course (RRMS), or secondary progressive (SPMS) course with disease activity
5. Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive)
6. Documentation of at least: 1 relapse during the previous 1 year OR 2 relapses during the previous 2 years prior to Screening OR a positive Gd-enhancing MRI scan during the year prior to randomization. Note: Screening MRI scan may be used if no positive Gd enhancing scan exist from prior year.
7. Neurologically stable within 1 month prior to randomization

Los pacientes con EM elegibles para ser incluidos en este estudio deben cumplir todos los criterios siguientes:
1. El consentimiento informado por escrito se debe obtener antes de realizar cualquier evaluación.
2. Pacientes de ambos sexos entre 18 y 55 años de edad (ambos incluidos) en la selección.
3. Diagnóstico de EM según los criterios McDonald revisados de 2010
4. EM recurrente: evolución remitente-recurrente (EMRR) o ciclo progresivo secundario (EMPS) con actividad de la enfermedad
5. Estado de discapacidad en la selección con una puntuación EDSS de 0 a 5,5 (ambos incluidos).
6. Documentación de al menos: un brote durante el año anterior O dos brotes durante los dos años anteriores a la selección O un diagnóstico positivo mediante resonancia magnética (RM) con Gd durante el año previo a la aleatorización. Nota: Se puede realizar una RM en la selección si no existe un diagnóstico positivo mediante RM realzada con Gd durante el año anterior.
7. Neurológicamente estable durante el mes previo a la aleatorización.

E.4

Principal exclusion criteria

MS Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
1. Patients suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator
2. Patients with primary progressive MS (Polman et al. 2011) or SPMS without disease activity (Lublin et al. 2014)
3. Patients meeting criteria for neuromyelitis optica (Wingerchuk et al. 2006)
4. Disease duration of more than 10 years in patients with EDSS score of 2 or less
5. 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 hCG laboratory test.
6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 12 months after stopping of study medication. Highly effective contraception methods include:
•Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
•Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) total hysterectomy or tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
•Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject
•Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception
In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking investigational drug.
In case local regulations deviate from the contraception methods listed above, local regulations apply and will be described in the ICF
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
7. Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren’s syndrome, Crohn’s disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency)
8. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to test positive for HIV antibody at Screening
9. Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML
10. Patients at risk of developing or having reactivation of syphilis or tuberculosis (e.g. patients with known exposure to or history of syphilis or active or latent tuberculosis, even if previously treated). Testing for syphilis and tuberculosis will be done at Screening unless such testing has been performed in the past 6 months prior to Screening with documented negative result. For syphilis testing, it should be done per local clinical practice (e.g. by positive rapid plasma reagin (RPR)). For tuberculosis testing, QuantiFERON®-TB Gold test can be done locally or by the central lab to assess patient’s eligibility at Screening.
NOTE:
•Patients with an indeterminate QuantiFERON®-TB Gold test may be enrolled if the repeat QuantiFERON®-TB Gold test is negative prior to randomization.
•Patients with positive QuantiFERON®-TB Gold test are not eligible.

See protocol for complete list of exclusion criteria

Los pacientes con EM que cumplan alguno de los siguientes criterios no serán elegibles para ser incluidos en este estudio:
1. Pacientes con sospecha de no ser capaces o no estar dispuestos a cooperar o cumplir los requisitos del protocolo del estudio, en opinión del investigador.
2. Pacientes con EM primaria progresiva (Polman et al., 2011) o EMPS sin actividad de la enfermedad (Lublin et al., 2014).
3. Pacientes que cumplan los criterios de neuromielitis óptica (Wingerchuk et al., 2006).
4. Duración de la enfermedad superior a 10 años en pacientes con una puntuación EDSS igual o inferior a 2.
5. Mujeres embarazadas o en periodo de lactancia, donde embarazo se define como el estado de una mujer después de la concepción y hasta que finalice la gestación, confirmado por un resultado positivo en la analítica de hCG.
6. Mujer en edad fértil, definida como toda mujer fisiológicamente capaz de quedar embarazada, a menos que esté utilizando métodos anticonceptivos de elevada eficacia durante la administración y durante al menos 12 meses después de suspender la medicación del estudio.
Los métodos anticonceptivos altamente eficaces incluyen:
-Abstinencia total (cuando esté en consonancia con el estilo de vida habitual y preferente del sujeto, si está aceptado por la normativa local). La abstinencia periódica (p. ej., calendario, ovulación, métodos sintotérmicos o posovulación) y el coitus interruptus no son métodos anticonceptivos aceptables.
-Esterilización femenina (cuando se le haya realizado una ooforectomía bilateral con o sin histerectomía), histerectomía total o ligadura de trompas al menos 6 semanas antes de recibir el fármaco en investigación. Si solo se ha realizado ooforectomía, únicamente cuando se haya confirmado el estado reproductor de la mujer mediante la evaluación de seguimiento del nivel hormonal.
-Esterilización masculina al menos 6 meses antes de la selección. En el caso de las pacientes del estudio, el varón a quien se le haya realizado la vasectomía deberá ser su única pareja.
-Uso de métodos anticonceptivos hormonales orales (estrógeno y progesterona), inyectados o implantados, o implantación de un dispositivo intrauterino o sistema intrauterino u otros métodos anticonceptivos hormonales que tengan una eficacia comparable (tasa de fallo < 1 %), por ejemplo, anillo vaginal hormonal o anticonceptivo hormonal transdérmico. Las mujeres que tomen anticonceptivos orales deberán tomar la misma píldora durante un mínimo de 3 meses antes de recibir el fármaco del estudio.
Las mujeres se consideran postmenopáusicas y no en edad fértil si han pasado 12 meses de amenorrea natural (espontánea) con un perfil clínico adecuado (p. ej., edad apropiada, antecedentes de síntomas vasomotores) o se han sometido a ooforectomía bilateral (con o sin histerectomía), histerectomía total o ligadura de trompas al menos 6 semanas antes. En el caso de que solo se le haya practicado una ooforectomía, únicamente cuando se haya confirmado el estado reproductor de la mujer mediante una evaluación de seguimiento de los niveles hormonales, se considerará que no está en edad fértil.
7. Pacientes con una enfermedad activa crónica (o estable pero tratada con inmunoterapia) del sistema inmunitario que no sea EM (p. ej., artritis reumatoide, esclerodermia, síndrome de Sjögren, enfermedad de Crohn, colitis ulcerosa, etc.) o con un síndrome de inmunodeficiencia (inmunodeficiencia hereditaria o inmunodeficiencia provocada por fármacos).
8. Pacientes con infecciones bacterianas, víricas o fúngicas sistémicas activas, SIDA o resultado positivo en las pruebas de anticuerpos del VIH en la selección.
9. Pacientes con hallazgos neurológicos que coincidan con leucoencefalopatía multifocal progresiva (LMP), o LMP confirmada.
10. Los pacientes con riesgo de desarrollar o tener una reactivación de sífilis o tuberculosis (p. ej., pacientes con exposición conocida o antecedentes de sífilis, o tuberculosis activa o latente, incluso si se han tratado previamente). En la selección se realizarán las pruebas de la sífilis y la tuberculosis, a menos que dichas pruebas se hayan realizado en los 6 meses anteriores a la selección con un resultado negativo documentado. En las pruebas de la tuberculosis, la prueba QuantiFERON®-TB Gold se puede realizar de forma local o en el laboratorio central para evaluar la elegibilidad del paciente en la selección.
NOTA:
 los pacientes con un resultado indeterminado en la prueba QuantiFERON®-TB Gold se podrán incluir si la prueba QuantiFERON®-TB Gold repetida presenta un resultado negativo antes de la aleatorización.
 Los pacientes con un resultado positivo en la prueba QuantiFERON®-TB Gold no son elegibles.

Ver protocolo para el resto de criterios

E.5 End points

E.5.1

Primary end point(s)

AUC and Cmax calculated from data collected in the dosing interval after Week 8 dose administration in accordance with the assessment schedule.

AUC y Cmax calculados a partir de los datos recopilados en el intervalo de dosificación después de la administración de la dosis de la semana 8 de acuerdo con el calendario de evaluaciones.

E.5.1.1

Timepoint(s) of evaluation of this end point

At week 8 and 12.

En la semana 8 y 12

E.5.2

Secondary end point(s)

- AUC
- Cmax
- Proportion of patients with anti-ofatumumab antibodies
- Adverse events including injection related reaction, lab, vital signs, ECG, and eCSSRS

-AUC
-Cmax
-Proporción de pacientes con anticuerpos antiofatumumab.
-Acontecimientos adversos como reacciones relacionadasa con la inyección, pruebas analíticas, constantes vitales, ECG y eCSSRS

E.5.2.1

Timepoint(s) of evaluation of this end point

Up to 12 weeks

Hasta 12 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

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

Yes

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

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)

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

Yes

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

jeringas precargadas con ofatumumab

Ofatumumab prefilled syringe (PFS)

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

Austria

Bulgaria

Czech Republic

Estonia

Germany

Italy

Latvia

Lithuania

Poland

Russian Federation

Spain

United States

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

A patient will complete this study when the patient has completed the End of Study (EOS) visit.

Un paciente finalizará este estudio cuando haya completado la visita de fin de estudio (EOS).

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 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:

284

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

194

F.4.2.2

In the whole clinical trial

284

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)

Patients who complete the End of Study (EOS) visit on study drug, could enter the planned umbrella extension study. All patients who are prematurely withdrawn from the study will be provided with follow-up medical care or referred to appropriate ongoing care by investigators.
Patients who complete the EOS on study drug but do not enter the umbrella extension study or patients who prematurely discontinue study drug and complete their EOS visits will enter the Safety Follow-up.

Los pacientes que completen la EOS recibiendo el fármaco pueden entrar en el estudio paraguas de extensión. Todos los que se retiren prematuramente se les proporcionará asistencia médica de seguimiento o serán derivados para que reciban la asistencia adecuada.
Tanto los pacientes que completen la EOS recibiendo el fármaco y no entren en el estudio paraguas de extensión como los que discontinúen el fármaco del estudio prematuramente y completen sus EOS entrarán en el periodo de de seguridad.

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

2018-12-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-12-07

P. End of Trial
P.	End of Trial Status	Completed

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