Clinical Trials Register

Summary
EudraCT Number:	2012-001840-23
Sponsor's Protocol Code Number:	CA209-038
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2019-07-12
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
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

Expand All Collapse All

A. Protocol Information

A.2

EudraCT number

2012-001840-23

A.3

Full title of the trial

An exploratory study of the biologic effects of Nivolumab and Ipilimumab Monotherapy and Nivolumab in Combination with Ipilimumab Treatment in Subjects with Advanced melanoma (Unresectable or metastatic)

Estudio exploratorio de los efectos biológicos del tratamiento con Nivolumab e Ipilimumab en monoterpia y Nivolumab en combinación con Ipilimumab en el tratamiento de sujetos con melanoma avanzado (irresecable o metastásico)

A.3.1

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

PH 1 Biomarker Study of nivolumab and ipilimumab and nivolumab in combination with ipilimumab in advanced melanoma

Estudio de biomarcadores PH 1 de nivolumab e ipilimumab y nivolumab en combinación con ipilimumab en sujetos con melanoma avanzado

A.3.2

Name or abbreviated title of the trial where available

PD-1

A.4.1

Sponsor's protocol code number

CA209-038

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01621490

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	Bristol-Myers Squibb International Corporation
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	Bristol-Myers Squibb International Corporation
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	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	GCT SU
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance - Avenue de Finlande, 8
B.5.3.2	Town/ city	Braine-l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.4	Telephone number	900 150 160
B.5.6	E-mail	clinical.trials@bms.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	NIVOLUMAB
D.3.2	Product code	BMS-936558
D.3.4	Pharmaceutical form	Solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Nivolumab
D.3.9.2	Current sponsor code	BMS-936558-01
D.3.9.3	Other descriptive name	Anti-PD-1 Human Monoclonal Antibody; MDX-1106
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	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	IPILIMUMAB
D.3.2	Product code	BMS-734016
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IPILIMUMAB
D.3.9.1	CAS number	477202-00-9
D.3.9.2	Current sponsor code	BMS734016
D.3.9.3	Other descriptive name	MDX010
D.3.9.4	EV Substance Code	SUB22577
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	5
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

Advanced or Metastatic Melanoma

Melanoma avanzado o metastásico

E.1.1.1

Medical condition in easily understood language

Advanced or Metastatic Melanoma

Melanoma avanzado o metastásico

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

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	10025671
E.1.2	Term	Malignant melanoma stage IV
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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	10025670
E.1.2	Term	Malignant melanoma stage III
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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	10053571
E.1.2	Term	Melanoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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 purpose of this study is to evaluate pharmacodynamic changes of nivolumab and nivolumab in combination with ipilimumab treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with advanced melanoma (unresectable or advanced)

El objetivo de este ensayo es evaluar los cambios farmacodinámicos de nivolumab, y nivolumab en combinación con ipilimumab a través de medidas de biomarcadores en sangre periférica y en cortes de biopsias tumorales de sujetos con melanoma avanzado (irresecable o metastásico).

E.2.2

Secondary objectives of the trial

Safety and Tolerability of BMS-936558 as measured by the incidence of adverse events (AEs), serious AEs, death, laboratory test abnormalities, and changes in vital signs;
Antitumor Activity of BMS-936558 as measured by the objective response rate, duration of response, and progression free survival;
Immunogenicity of BMS-936558 as measured by the frequency of subjects with at least one positive ADA assessment and the frequency of subjects who develop ADA after a negative baseline assessment;
Association between PD-L1 and clinical efficacy will be measured by PDL1 expression levels clinical activity (ORR, PFS)

-Seguridad y tolerabilidad de BMS-936558 medido por la incidencia de acontecimientos Adversos (AEs), acontecimientos Adversos Graves, muerte, anormalidades en las pruebas analíticas y cambios en los signos vitales
-Actividad antitumoral de BMS-936558, medida por la tasa de respuesta objetiva, la duración de la respuesta y supervivencia libre de progresión;
-La inmunogenicidad de BMS-936558, medido por la frecuencia de sujetos con al menos una evaluación positiva de ADA y la frecuencia de los sujetos que desarrollan ADA después de una evaluación inicial negativa;
-Asociación entre PD-L1 y la eficacia clínica se mide por los niveles de expresión PDL1 actividad clínica (ORR, SLP)

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 2.0, dated 23-MAY-2012).
The objective of this Amendment is to permit the collection and storage of blood samples
for use in future exploratory pharmacogenetic research. Bristol-Myers Squibb will use
DNA obtained from the blood sample and health information collected from the main
clinical trial, CA209038 to study the association between genetic variation and drug
response. Bristol-Myers Squibb may also use the DNA to study the causes and further
progression of melanoma. Samples from this study may also be used in conjunction with
pharmacogenetic research results from other clinical studies to accomplish this objective.

Enmienda 01 de muestra de sangre para Farmacogenética - específico por Hospital (versión 2.0, de fecha 23-MAY-2012).
El objetivo de esta enmienda es permitir la recogida y almacenamiento de muestras de sangre para su uso en futuras investigaciones de farmacogenética de exploración. Bristol-Myers Squibb utilizará ADN obtenido de la muestra de sangre y la información de salud procedentes del ensayo clínico, CA209-038 para estudiar la asociación entre la variación genética y la respuesta al medicamento. Bristol-Myers Squibb también utilizará el ADN para estudiar las causas y más sobre la progresión del melanoma. Las muestras de este estudio también se podrán usar en conjunción con los resultados de investigación de farmacogenética de otros estudios clínicos para lograr este objetivo

E.3

Principal inclusion criteria

Part 1:
- Men and women ? 18 years
- ECOG status = 0 to 1
- Subjects with unresectable Stage III or IV melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic melanoma
- Subject must have histologic or cytologic confirmation of advanced melanoma
- Subjects must have at least one measurable lesion at baseline by CT or MRI as per RECIST 1.1 criteria
- Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies.

Part 2, 3 and 4:
- Men and women > 16 years
- ECOG status = 0 to 1
- Subjects with unresectable Stage III or IV melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic melanoma
-subjects must never received anti-CTLA4 therapy
- Subjects must have histologic or cytologic confirmation of advanced melanoma
- Subjects must have at least two measurable lesions at baseline by CT or MRI as per RECIST 1.1 criteria
- Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies
-Subjects in Part 4 must have brain metastases

-Varones y mujeres ? 18 de años
-Los sujetos deben tener un estado functional del ECOG <=1
-Sujetos con melanoma irresecable que hayan recibido y hayan progresado o se hayan retirado con más de 3 regímenes de tratamiento previos o hayan rechazado terapia estándar para el tratamiento del melanoma metastásico.
-Los sujetos deben tener confirmación histológica o citológica de melanoma avanzado.
-Los sujetos deben tener al menos una lesion medible en el momento basal mediante TC o RM según los criterios RECIST 1.1
-Los sujetos deben tener al menos una localización tumoral que pueda biopsiarse con un riesgo clínico aceptable, a criterio del investigador y deben dar su consentimiento a las biopsias tumorales previas al tratamiento y durante el tratamiento
Parte 2, 3 y 4:
- Hombre y mujeres > 16 years
- ECOG status = 0 a 1
- Sujetos con melanoma irresecable o metastásico estadío III o IV que sean refractarios o intolerantes a o hayan rechazado el tratamiento estandar para el melanoma metastásico
-sujetos que no hayan recibido nunca tratamiento anti-CTLA4
- Los sujetos denen tener confirmación histológica o citologica de melanoma avanzado
- Los sujetos deben tener al menos dos lesiones medibles en el nivel basal mediante TC o RMI según los criterios RECIST 1.1
- Los sujetos deben tener al menos una localización tumoral que pueda biopsiarse con un riesgo aceptable y deben dar su conserntimiento a las biopsias previas y post-tratamiento
-Los Sujetos de la parte 4 deben tener metastasis cerebrales

E.4

Principal exclusion criteria

Part 1:
- Active or progressing brain metastases
- Other concomitant malignancies (with some exceptions per protocol)
- Active or history of autoimmune disease
- Positive test for H IV 1 &2 or known AIDS
- History of any hepatitis
- Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but
not limited to, anti-PO-1, anti-POL1, anti-PO-L2, anti-C0137, antiOX-40,and anti-C040 antibodies.
However, half the patients must have progressed on anti-CTLA4 monoclonal antibody therapy.

Part 2, 3 and 4:
- Active or progressing brain metastases (except for Part 4 subjects)
- Other concomitant malignancies (with some exceptions per protocol)
- Active or history of autoimmune disease
- Positive test for HIV 1&2 or known AIDS
- History of any hepatitis
- Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40,and anti-CD40 antibodies

Parte 1:
-Metástasis activas en el SNC (incluyendo pruebas de edema cerebral por TC o RM o progresión respecto a estudio de imagen anterior
-Otras enfermedades concomitantes
-Sujetos con enfermedad autoinmunitaria activa
-Resultados positivos para virus de la inmunodeficiencia humana (VIH 1 y 2) o síndrome de inmunodeficiencia adquirida (SIDA) conocido
-Antecedentes de cualquier hepatitis
-Los sujetos que han recibido tratamiento previo con terapias dirigidas a proteínas correguladoras de linfocitos T incluidas, entre otras anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40 en el contexto adyuvante o metastásico son inelegibles para participar en el estudio. Se permite la terapia previa con anticuerpos monoclonales anti-CTLA4
Parte 2, 3 y 4:
- Metastasis cerebrales activas o en progresión (excepto para los sujetos de la Parte 4)
- Otras enfermedaddes malignas concomitantes (con algunas excepciones por protocolo)
- Enfermedad autoinmune activa o historial de ella
- Resultados positivos para los tests de HIV 1&2 o DIDA conocido
- Antecedentes de cualquier hepatitis
- Sujetos que han recibido trtamiento previo con terpias dirtijidas a proteinas coreguladoras de linfocitos T incluidas, entre otras pero no limitadas a, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, y anticuerpos anti-CD40

E.5 End points

E.5.1

Primary end point(s)

Evidence of immunomodulatory effects of nivolumab and nivolumab in combination with ipilimumab as measured by changes from baseline in activated and memory T cells, interferon, interferon inducible factors, and C04 and CD8 T cell infiltration.

Evidencia de los efectos inmunomoduladores de nivolumab y nivolumab en combinación con ipilimumab, medida desde el inicio por la variación en las células T de memoria y activadas, interferón, factores inducidos por el interferón e infiltración de células T C04 y CD8

E.5.1.1

Timepoint(s) of evaluation of this end point

Part 1: From pre-dose day 1 and up to day 57
Part 2, 3 and 4 :From pre-dose Day 1 and up to Week 13

Parte 1: Desde el día 1 antes de la dosis hasta el día 57 (Ciclo 2 Día 1)
Parte 2, 3 y 4 : desde el día 1 antes de la dosis hasta la semana 13

E.5.2

Secondary end point(s)

Safety and tolerability of nivolumab, ipilimumab and nivolumab in combination with ipilimumab as measured by the incidence of adverse events (AEs), serious AEs, death, laboratory test abnormalities, and changes in vital signs;

Antitumor Activity of nivolumab, ipilimumab and nivolumab in combination with ipilimumab as measured by the objective response rate (ORR), duration of response, and progression free survival (PFS);

Immunogenicity of nivolumab, ipilimumab and nivolumab in combination with ipilimumab as measured by the frequency of baseline positive subjects and the frequency of ADA positive subjects

Association between PD-L1 and clinical efficacy will be measured by PDL1 expression levels clinical activity (ORR, PFS)

Seguridad y tolerabilidad de nivolumab , ipilimumab y nivolumab en combinación con ipilimumab medido por la incidencia de acontecimientos Adversos (AEs), acontecimientos Adversos Graves, muerte, anormalidades en las pruebas analíticas y cambios en los signos vitales
-Actividad antitumoral de nivolumab , ipilimumab y nivolumab en combinación con ipilimumab, medida por la tasa de respuesta objetiva, la duración de la respuesta y supervivencia libre de progresión;
-La inmunogenicidad de nivolumab , ipilimumab y nivolumab en combinación con ipilimumab, medida por la frecuencia de sujetos con al menos una evaluación positiva de ADA y la frecuencia de los sujetos que desarrollan ADA después de una evaluación inicial negativa;
-Asociación entre PD-L1 y la eficacia clínica se mide por los niveles de expresión PDL1 actividad clínica (ORR, SLP)

E.5.2.1

Timepoint(s) of evaluation of this end point

Adverse event-From screening up to 100 days after last dose of study drug. Lab abnormality every 2 or 3 weeks up to 100 days after last treatment

Efficacy-Approximately every 8 weeks until disease progression and in follow-up if no progression

Immunogenicity:
Part 1: Day 1, Day 15, Day 43 of cycle 1, Day 1 of cycle 2, Day 15 of cycle 3, every 16 weeks after cycle 3,up to 2 years and at Follow-up visits 1 (40-60days after last treatment and Follow-up visit 2 (101-120 days since last treatment)
Part 2, 3 and 4: Weeks 1, 3, 4, 7, 9, 10, 13, 25, 53 79, 95, and at Follow-up visits 1
PD-L1 expression:
Part 1: Pre-dose up to Day 1 (screening Day-7 to day 1 predose) and Day 29 of cycle 1
Part 2, 3 and 4: Pre-dose (screening Day -28 to Day 1 predose) and week 2 or week 4

A.Adverso desde screeening hasta 100 D desp. de la última dosis fármaco del estudio.
Analítica anormal de laboratorio cada 2 o 3 sem. hasta 100 D después del último tto.
Eficacia aprox. cada 8 semanas hasta progresión de la enfermedad y en seguimiento si no hay progresión.
Inmunogenicidad:
Parte 1: Día 1, 15, 43 del ciclo 1; D 1 del ciclo 2, D 15 del ciclo 3, cada 16 semanas después del ciclo 3, hasta 2 años y en las visitas de seguimiento 1( 40-60 d desp. del último tto. ) visita de seguimiento 2 (101-120 d desde el último tto.)
Parte 2,3, 4: sem.1, 3, 4, 7, 9, 10, 13, 25, 53 79, 95, y visita de seguim.1
PD-L1 expresión: Parte 1: pre dosis hasta D 1 (screening d7. a d 1 predosis ) y D 29 del ciclo 1.
Parte 2, 3 4: antes de dosis (screening D -28 a D 1 predosis) y sem.2 o 4

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

E.6.5

Efficacy

E.6.6

Pharmacokinetic

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

Basic Science: protocol designed to examine the basic mechanism of action (e.g.,physiology, biomechanics) of an intervention.

Ciencia básica: el protocolo diseñado para examinar el mecanismo básico de acción (por ejemplo, la fisiología, la biomecánica) de una intervención

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

to evaluate pharmacodynamic changes of nivolumab and niv + ipilimumab treatment on the biomarkers

Evaluar los cambios farmacodinámicos de nivolumab y nivolumab +a través de biomarcadores

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

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

Information not present in EudraCT

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

Will this trial be conducted at a single site globally?

Yes

E.8.4

Will this trial be conducted at multiple sites globally?

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

Netherlands

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

2 year overall survival assessment (by telephone contact) from first BMS-936558 dose for time remaining from the last follow up office visit.

Dos años de evaluación de la supervivencia global (por vía telefónica) de BMS-936558 desde la primera dosis y para el tiempo restante desde la última visita presencial de seguimiento

E.8.9 Initial estimate of the duration of the trial

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

119

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.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

200

F.5

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

None

G. Investigator Networks to be involved in the Trial

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	United States

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