Clinical Trials Register

Summary
EudraCT Number:	2020-004033-20
Sponsor's Protocol Code Number:	ARGX-113-2005
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-09
Trial 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

2020-004033-20

A.3

Full title of the trial

A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

Ensayo en fase III, multicéntrico, sin enmascaramiento y a largo plazo para evaluar la seguridad y la eficacia de efgartigimod (ARGX-113) PH20 subcutáneo en pacientes adultos con trombocitopenia inmunitaria primaria

A.3.1

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

Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

Estudio para evaluar la seguridad y la eficacia de efgartigimod (ARGX-113) PH20 subcutáneo en pacientes adultos con trombocitopenia inmunitaria primaria

A.3.2

Name or abbreviated title of the trial where available

ADVANCE SC+

A.4.1

Sponsor's protocol code number

ARGX-113-2005

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	argenx BV
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	argenx BV
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	argenx BV
B.5.2	Functional name of contact point	Regulatory
B.5.3	Address:
B.5.3.1	Street Address	Industriepark Zwijnaarde 7
B.5.3.2	Town/ city	Zwijnaarde
B.5.3.3	Post code	B-9052
B.5.3.4	Country	Belgium
B.5.4	Telephone number	+32 9 310 3400
B.5.6	E-mail	regulatory@argenx.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	Yes
D.2.5.1	Orphan drug designation number	EU/3/19/2230
D.3 Description of the IMP
D.3.1	Product name	efgartigimod PH20 SC
D.3.4	Pharmaceutical form	Solution for injection
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	efgartigimod alfa
D.3.9.1	CAS number	1821402-21-4
D.3.9.2	Current sponsor code	ARGX-113
D.3.9.4	EV Substance Code	SUB198780
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	180
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Primary immune thrombocytopenia (ITP)

Trombocitopenia inmunitaria
primaria (ITP)

E.1.1.1

Medical condition in easily understood language

Disorder that can lead to easy or excessive bruising and bleeding due to low levels of the cells that help blood clot

Trastorno que puede causar facilidad para sufrir hematomas y hemorragias o una cantidad excesiva debido a una baja concentración de las células que contribuyen a la coagulación de la sangre

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.0
E.1.2	Level	LLT
E.1.2	Classification code	10083843
E.1.2	Term	Primary immune thrombocytopenia
E.1.2	System Organ Class	100000004851

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the safety and tolerability of efgartigimod PH20 SC in adult patients with primary ITP

Evaluar la seguridad y la tolerabilidad de efgartigimod PH20 s.c. en pacientes adultos con TPI primaria

E.2.2

Secondary objectives of the trial

First 52-week treatment period only
• To evaluate the efficacy of efgartigimod PH20 SC on overall platelet count response
• To evaluate the use of rescue treatment and reduction in concurrent ITP therapy while receiving treatment with efgartigimod PH20 SC
• To evaluate the incidence and severity of bleeding events while receiving treatment with efgartigimod PH20 SC
• To assess the PK of efgartigimod PH20 SC
• To evaluate the effects of efgartigimod PH20 SC treatment on quality-of-life (QoL) measures and patient-reported outcomes (PRO)
• To assess the PD effects of efgartigimod PH20 SC
• To evaluate the feasibility of self-administration of efgartigimod PH20 SC

First 52-week treatment period and additional 52-week treatment periods
• To assess the immunogenicity of efgartigimod and/or rHuPH20

Solo el primer periodo de tratamiento de 52 semanas
• Evaluar la eficacia de efgartigimod PH20 s.c. en la respuesta global del número de plaquetas
• Evaluar el uso del tratamiento de rescate y la disminución del tratamiento simultáneo de la TPI mientras se recibe el tratamiento con efgartigimod PH20 s.c.
• Evaluar la incidencia y la gravedad de los acontecimientos hemorrágicos mientras se recibe el tratamiento con efgartigimod PH20 s.c.
• Evaluar la FC de efgartigimod PH20 s.c.
• Evaluar los efectos del tratamiento con efgartigimod PH20 s.c. en los parámetros de la calidad de vida (CdV) y los resultados percibidos por el paciente (RPP)
• Evaluar los efectos de la FD de efgartigimod PH20 s.c.
• Evaluar la viabilidad de la autoadministración de efgartigimod PH20 s.c.
Primer periodo de tratamiento de 52 semanas y periodos de tratamiento adicionales de 52 semanas
• Evaluar la inmunogenia de efgartigimod y/o rHuPH20

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Participants are eligible to be included in the trial only if all of the following criteria apply:
1. Ability to understand the requirements of the trial and provide written informed consent (including consent for the use and disclosure of research-related health information), willing and able to comply with the trial protocol procedures (including attending the required trial visits).
2. Participants enrolled in the ARGX-113-2004 trial who completed the 24-week trial period. Note: If a participant has had an SAE during the ARGX-113-2004 trial, his/her eligibility should be evaluated by the investigator and the sponsor’s trial physician. The decision of enrolling the participant will be evaluated case by case.
3. Women of childbearing potential:
• As defined in Woman of Childbearing Potential in the protocol, women of childbearing potential must have a negative urine pregnancy test at baseline before trial medication can be administered
• Must be on a stable regimen for at least 1 month of a highly effective or acceptable method of contraception (see Female Contraception in the protocol) during the trial and for 90 days after the last administration of efgartigimod PH20 SC
4. Non-sterilized male participants who are sexually active with a female partner of childbearing potential must use an acceptable method of contraception, ie, a condom (see Male Contraception in the protocol) from signing the informed consent form (ICF) until the end of the trial. Male participants are not allowed to donate sperm from signing the ICF until the end of the trial.
In addition to the above criteria, for participants who want to continue receiving efgartigimod during an additional 52-week treatment period (only applicable in case efgartigimod is not yet commercially available for patients with primary ITP or available through another patient program for patients with primary ITP):
5. Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits).
6. Participant has completed a 52-week treatment period.

Los pacientes se considerarán idóneos para participar en el ensayo únicamente si cumplen todos los criterios que se detallan a continuación:
1. Capacidad para comprender los requisitos del ensayo y proporcionar el consentimiento informado por escrito (incluido el consentimiento para el uso y la divulgación de información médica asociada con la investigación), estar dispuesto y ser capaz de seguir los procedimientos del protocolo del ensayo (incluida la asistencia a las visitas del ensayo requeridas).
2. Participantes incluidos en el ensayo ARGX-113-2004 que han completado el periodo del ensayo de 24 semanas. Nota: Si un participante ha sufrido un AAG durante el ensayo ARGX-113-2004, el investigador y el médico del ensayo del promotor evaluarán su idoneidad. La decisión de incluir al participante se tomará de manera individual en cada caso.
3. Mujeres en edad fértil:
• Tal como se define en «Mujeres en edad fértil» del protocolo, estas mujeres deben dar negativo en la prueba de embarazo en orina en el momento basal antes de que se les pueda administrar el fármaco del ensayo
• Deben seguir una pauta estable durante al menos 1 mes de un método anticonceptivo muy eficaz o aceptable (consulte «Métodos anticonceptivos femeninos muy eficaces» en el protocolo) durante el ensayo y durante 90 días posteriores a la última administración de efgartigimod PH20 s.c.
4. Los varones no esterilizados que participen en el estudio y sean sexualmente activos, cuya pareja femenina esté en edad fértil, deben utilizar un método anticonceptivo aceptable, por ejemplo, un preservativo (consulte «Anticonceptivos masculinos» en el protocolo) desde el momento en que firmen el formulario de consentimiento informado (FCI) hasta el final del ensayo. Los varones participantes no pueden donar esperma desde la firma del FCI hasta el final del ensayo.
Además de los criterios anteriores, en el caso de los participantes que deseen seguir recibiendo efgartigimod durante un periodo de tratamiento adicional de 52 semanas (solo aplicable en caso de que el efgartigimod todavía no esté comercialmente disponible para los pacientes con TPI primaria o esté disponible a través de otro programa para pacientes destinado a pacientes con TPI primaria):
5. Capacidad para comprender los requisitos del periodo de tratamiento adicional de 52 semanas del ensayo, proporcionar el consentimiento informado por escrito (incluido el consentimiento para el uso y la divulgación de información médica asociada con la investigación) y cumplir con los procedimientos del protocolo del ensayo (incluidas las visitas del ensayo requeridas).
6. Haber completado un periodo de tratamiento de 52 semanas.

E.4

Principal exclusion criteria

Participants are eligible to be included in the trial only if none of the following criteria apply:
1. Introduction or continuation of nonpermitted medications during the ARGX-113-2004 trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusion proteins, or live/live-attenuated vaccines)
2. Use of any other investigational drug or participation in any other investigational trial
3. Known hypersensitivity reaction to efgartigimod PH20 SC or any of its excipients
4. Pregnant or lactating females and those who intend to become pregnant during the trial or within 90 days after last dose of efgartigimod PH20 SC

Los pacientes se considerarán idóneos para participar en el ensayo únicamente si no cumplen ninguno de los criterios que se detallan a continuación:
1. La introducción o la continuación de medicamentos que no estén permitidos durante el ensayo ARGX-113-2004 (como el tratamiento anti-CD20, romiplostim, anticuerpos monoclonales, proteínas de fusión Fc o vacunas con microbios vivos o atenuadas)
2. El uso de cualquier otro fármaco en investigación o participación en algún otro ensayo de investigación
3. Reacción de hipersensibilidad conocida al efgartigimod PH20 s.c. o a cualquiera de sus excipientes
4. Mujeres gestantes o en período de lactancia y aquellas que piensan quedarse embarazadas durante el ensayo o durante los 90 días siguientes a la última dosis de efgartigimod PH20 s.c.

E.5 End points

E.5.1

Primary end point(s)

1. Incidence, frequency, and severity of adverse events (AEs), AEs of special interest (AESIs), and serious AEs (SAEs)
2. Vital signs, electrocardiogram (ECG), and laboratory safety evaluations

Incidencia, frecuencia e intensidad de los acontecimientos adversos (AA), los AA de especial interés (AAEI) y los AA graves (AAG)
2. Evaluaciones de las constantes vitales, el electrocardiograma (ECG) y las pruebas analíticas de seguridad

E.5.1.1

Timepoint(s) of evaluation of this end point

1. At all visits
2. At planned visits per schedule of assessment

1. En todas las visitas
2. En visitas programadas de acuerdo con el calendario de evaluaciones

E.5.2

Secondary end point(s)

First 52-week treatment period only
1. Extent of disease control defined as the percentage of weeks in the trial with platelet counts of ≥50×10^9/L
2. Proportion of patients with overall platelet count response defined as achieving a platelet count of ≥50×10^9/L on at least 4 occasions at any time during the 52-week treatment period
3. Mean change from baseline in platelet count at each visit
4. For patients rolling over from the ARGX-113-2004 trial with a platelet count of <30×10^9/L: time to response defined as the time to achieve 2 consecutive platelet counts of ≥50×10^9/L
5. The percentage of weeks in the trial with platelet counts of ≥30×10^9/L and ≥20×10^9/L above baseline
6. In patients with a baseline platelet count of <15×10^9/L in the current trial (ARGX-113-2005), the percentage of weeks in the trial with platelet counts of ≥30×10^9/L and ≥20×10^9/L above baseline
7. In patients with the first exposure to efgartigimod PH20 SC, the proportion of patients who achieve a sustained platelet response defined as achieving platelet counts of ≥50×10^9/L for at least 4 of the 6 visits between week 19 and week 24
8. In patients with the first exposure to efgartigimod PH20 SC, the proportion of patients achieving platelet counts of ≥50×10^9/L for at least 6 of the 8 visits between week 17 and week 24
9. Proportion of patients for whom dose and/or frequency of concurrent ITP therapies have been reduced compared to baseline
10. Rate of receipt of rescue therapy (rescue per patient per month)
11. Incidence and severity of the World Health Organization (WHO)-classified bleeding events
12. Serum efgartigimod concentration observed predose (Ctrough)
13. Change from baseline in PRO (Functional Assessment of Chronic Illness Therapy Fatigue Scale [FACIT-fatigue], Functional Assessment of Cancer Therapy questionnaire-Th6 [FACT-Th6]) and QoL (Short Form-36 [SF-36]) at planned visits
14. Pharmacodynamics markers: total IgG
15. Number and percentage of patients who performed self-administration at home over time
16. Number and percentage of caregivers who administered the injection to the patient at home over time
17. Number of training visits needed for the participant or caregiver to be competent to start administering efgartigimod PH20 SC
18. Number and percentage of self- or caregiver-supported administrations at home

First 52-week treatment period and additional 52-week treatment periods
19. Incidence and prevalence of antibodies to efgartigimod
20. Titers of antibodies to efgartigimod
21 Presence of neutralizing antibodies (NAb) against efgartigimod

Solo el primer periodo de tratamiento de 52 semanas

1. Alcance del control de la enfermedad, que se define como el porcentaje de semanas durante el ensayo con un número de plaquetas ≥50 × 109/l
2. Proporción de pacientes con una respuesta global del número de plaquetas, que se define como alcanzar un número de plaquetas ≥50 × 109/l en al menos 4 ocasiones en cualquier momento durante el periodo de tratamiento de 52 semanas
3. Media del cambio en el número de plaquetas desde el momento basal en cualquier visita
4. En el caso de los pacientes procedentes del ensayo ARGX-113-2004 con un número de plaquetas <30 × 109/l, el tiempo de respuesta, que se define como alcanzar dos números de plaquetas consecutivos ≥50 × 109/l
5. El porcentaje de semanas durante el ensayo con un número de plaquetas ≥30 × 109/l y ≥20 × 109/l por encima del valor basal
6. En el caso de pacientes con un número basal de plaquetas <15 × 109/l en el ensayo actual (ARGX-113-2005), el porcentaje de semanas durante el ensayo con un número de plaquetas ≥30 × 109/l y ≥20 × 109/l por encima del valor basal
7. En el caso de pacientes que se exponen por primera vez a efgartigimod PH20 s.c., la proporción de pacientes que consiguen mantener la respuesta de plaquetas, que se define como alcanzar un número de plaquetas ≥50 × 109/l durante al menos 4 de las 6 visitas entre la semana 19 y la semana 24
8. En el caso de pacientes que se exponen por primera vez a efgartigimod PH20 s.c., la proporción de pacientes que consiguen un número de plaquetas ≥50 × 109/l durante al menos 6 de las 8 visitas entre la semana 17 y la semana 24
9. Proporción de pacientes para los que se ha disminuido la dosis o la frecuencia de los tratamientos simultáneos para la TPI en comparación con el momento basal
10. Tasa de administración de tratamiento de rescate (rescate por paciente por mes)
11. Incidencia y gravedad de los acontecimientos hemorrágicos según la clasificación de la Organización Mundial de la Salud (OMS)
12. La concentración sérica de efgartigimod observada antes de la dosis (Cmín)
13. Cambio en los RPP desde el momento basal (la escala de evaluación funcional de terapia de enfermedades crónicas para el cansancio [FACIT-fatiga], el cuestionario de evaluación funcional de la terapia antineoplásica Th6 [Fact-Th6]) y la CdV (formulario abreviado-36 [SF-36]) en las visitas programadas
14. Marcadores farmacodinámicos: IgG total
15. Número y porcentaje de pacientes que se autoadministran en el domicilio a lo largo del tiempo
16. Número y porcentaje de cuidadores que administran la inyección al paciente en el domicilio a lo largo del tiempo
17. Número de visitas de formación necesarias para que el participante o el cuidador adquirieran la suficiente competencia para comenzar a administrar efgartigimod PH20 s.c.
18. Número y porcentaje de administraciones realizadas en el domicilio por el paciente o con ayuda del cuidador

Primer periodo de tratamiento de 52 semanas y periodos de tratamiento adicionales de 52 semanas
19. Incidencia y prevalencia de los anticuerpos frente a efgartigimod
20. Valores de los anticuerpos frente a efgartigimod
21 Presencia de anticuerpos neutralizantes (AcN) frente a efgartigimod

E.5.2.1

Timepoint(s) of evaluation of this end point

1,2 At any time during the 52-week treatment period
3. At each visit
4, 5, 6 At planned visits per schedule of assessment
7. Between week 19 and week 24
8. Between week 17 and week 24
9,10,11,12, 13, 14 At planned visits per schedule of assessment
15, 16, 17, 18 Throughout the treatment period
19, 20, 21 At planned visits per schedule of assessments

1, 2 En cualquier momento durante el periodo de tratamiento de 52 semanas
3. En cada visita
4, 5, 6 En visitas programadas de acuerdo con el calendario de evaluaciones
7. Entre la semana 19 y la semana 24
8. Entre la semana 17 y la semana 24
9, 10, 11, 12, 13, 14 En visitas programadas de acuerdo con el calendario de evaluaciones
15, 16, 17, 18 Durante todo el periodo de tratamiento
19, 20, 21 En visitas programadas de acuerdo con el calendario de evaluaciones

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

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

Immunogenicity

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

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

Chile

China

Colombia

Georgia

Israel

Japan

Jordan

Korea, Republic of

Mexico

New Zealand

Peru

Russian Federation

Serbia

South Africa

Taiwan

Thailand

Tunisia

Turkey

United States

Bulgaria

Denmark

France

Germany

Greece

Ireland

Italy

Latvia

Norway

Poland

Portugal

Romania

Spain

United Kingdom

Argentina

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

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:

136

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

156

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

After a participant has completed the trial, has withdrawn/discontinued early, or has completed the 2 follow-up visits, usual treatment will be administered if required, in accordance with the trial site’s standard of care and generally accepted medical practice depending on the participant’s individual needs.

Cuando un participante haya finalizado el ensayo, haya abandonado o se haya retirado anticipadamente o haya completado las 2 visitas de seguimiento, se le administrará el tratamiento habitual si es necesario, de conformidad con las normas asistenciales del centro y la práctica médica generalmente aceptada, en función de las necesidades concretas de dicho participante.

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

2021-08-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-06-28

P. End of Trial
P.	End of Trial Status	Ongoing

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