Clinical Trials Register

Summary
EudraCT Number:	2019-004647-74
Sponsor's Protocol Code Number:	LPS15834
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:	2020-05-15
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

2019-004647-74

A.3

Full title of the trial

Randomized, double blind, placebo controlled study to evaluate the effect of dupilumab on airway inflammation through assessments of lung function, mucus plugging and other lung imaging parameters in patients with asthma

Estudio aleatorizado, doble ciego, controlado con placebo para evaluar el efecto de dupilumab en la inflamación de las vías respiratorias a través de evaluaciones de la función pulmonar, taponamiento mucoso y otros parámetros de imagen pulmonar en pacientes con asma

A.3.1

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

The effect of dupilumab on lung function and related changes in airway volumes detectable by functional respiratory imaging in patients with moderate-severe asthma

El efecto del dupilumab en la función pulmonar y los cambios relacionados en los volúmenes de las vías respiratorias detectables mediante imágenes respiratorias funcionales en pacientes con asma moderada-severa.

A.3.2

Name or abbreviated title of the trial where available

VESTIGE

A.4.1

Sponsor's protocol code number

LPS15834

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1238-4679

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	Sanofi-Aventis Groupe
B.1.3.4	Country	France
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	Sanofi-Aventis Groupe
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	sanofi-aventis, s.a.
B.5.2	Functional name of contact point	Unidad de Estudios Clínicos
B.5.3	Address:
B.5.3.1	Street Address	c/ Josep Pla 2, 4ª planta
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08019
B.5.3.4	Country	Spain
B.5.4	Telephone number	3493485 94 00
B.5.6	E-mail	es-unidadestudiosclinicos@sanofi.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	Dupilumab
D.3.2	Product code	SAR231893
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	Dupilumab
D.3.9.2	Current sponsor code	SAR231893
D.3.9.3	Other descriptive name	REGN668
D.3.9.4	EV Substance Code	SUB88511
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	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	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

Asthma

Asma

E.1.1.1

Medical condition in easily understood language

Asthma

Asma

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

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	10003553
E.1.2	Term	Asthma
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the effect of dupilumab on lung function and related changes in airway volumes detectable by functional respiratory imaging

Evaluar el efecto del dupilumab en la función pulmonar y los cambios relacionados en los volúmenes de las vías respiratorias detectables mediante imágenes respiratorias funcionales.

E.2.2

Secondary objectives of the trial

To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation, airway resistance, airway wall thickness, ventilation defects and mucus plugging derived from high-resolution computed tomography (HRCT) scans, patient-reported outcomes, FeNO and spirometry.
To evaluate safety of dupilumab

Evaluar el efecto del dupilumab en la semana 24 en la broncodinamia, hiperinsuflación, resistencia de las vías respiratorias, grosor de la pared de las vías respiratorias, defectos de ventilación y taponamiento mucoso derivados de exploraciones por tomografía computarizada de alta resolución (TCAR), resultados notificados por el paciente, FeNO y espirometría.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-18 to 70 years of age inclusive with the diagnosis of asthma based on Global Strategy for Asthma Management and Prevention (GINA) 2019 at the time of signing the informed consent
-History of ≥1 exacerbation (s) in the previous year
-Uncontrolled moderate to severe asthma (ACQ-5 ≥1.5) at V1 and V2, prior to randomization
-Pre-bronchodilator FEV1 ≤80% of predicted normal at V1 and V2, prior to randomization
-Exhibit bronchodilator reversibility (≥12% and 200 mL improvement in FEV1 post SABA administration) during screening, prior to randomization
-Blood eosinophil ≥300 cells /µL and FeNO ≥25 ppb during screening, prior to randomization
-Existing treatment with medium to high dose ICS in combination with a second controller (e.g. LABA, LTRA) ± a third controller. The dose regimen should be stable ≥1 month prior V1 and during screening.

- 18 a 70 años inclusive, con diagnóstico de asma basado en la Estrategia Global para el Manejo y Prevención del Asma (GINA) 2019 (1) en el momento de firmar el consentimiento informado.
- Antecedentes de ≥ 1 exacerbación(es) en el año anterior
- Asma de moderada a grave no controlada (ACQ-5 ≥ 1,5) en la V1 y en la V2, antes de la aleatorización.
- VEF1 previo al broncodilatador ≤ 80 % de lo normal previsto en la V1 y en la V2, antes de la aleatorización.
- Muestra reversibilidad del broncodilatador (≥ 12 % y 200 mL de mejora en el VEF1 tras la administración de ABAC) durante la selección, antes de la aleatorización.
- Eosinófilos en sangre ≥ 300 células /μL y FeNO ≥ 25 ppb durante la selección, antes de la aleatorización.
- Tratamiento existente con CEI de dosis media a alta en combinación con un segundo controlador (por ejemplo, ABAP, ARLT) ± un tercer controlador. La posología debe ser estable ≥ 1 mes antes de la V1 y durante la selección.

E.4

Principal exclusion criteria

-Current smoker (cigarette or e-cigarette) or cessation of smoking within 1 year prior randomization
-Previous smoker with a smoking history >10 pack-years
-Known hypersensitivity to dupilumab or any of its excipients
-Asthma exacerbation during the screening, prior to randomization
-Current acute bronchospasm or status asthmaticus
-Diagnosed pulmonary (other than asthma) or systemic disease associated with elevated peripheral eosinophil counts
-History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome, etc)
- Active tuberculosis, latent untreated tuberculosis or a history of incompletely treated tuberculosis or non-tuberculous mycobacterial infection unless it is well documented by a specialist that the patient has been adequately treated and the treatment with a biologic agent can be initiated, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing would only be performed on a country by country basis according to the routine clinical practice and the local guidelines, if required by regulatory authorities or ethics committees.
-History of or current evidence of clinically significant disease in any non-respiratory system (e.g. cardiovascular, nervous system, gastrointestinal, endocrinological, rheumatological, dermatological), which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study
-Current evidence of clinically significant oncological disease, which in the opinion of the investigator may interfere with the objectives of the study or put the subject at undue risk
-Participants with any of the following results at Visit (V) 1:
-Positive (or indeterminate) hepatitis B surface antigen (HBs Ag) or
-Positive Hepatitis B IgM core antibody (IgM HBc Ab) or
-Positive total hepatitis B core antibody (total HBc Ab) confirmed by positive HBV DNA or
-Positive hepatitis C antibody (HCV Ab) confirmed by positive HCV RNA
-History of human immunodeficiency virus (HIV) infection or positive HIV serology at V 1
-Any biologic therapy (including experimental treatments and dupilumab) or any other biologic therapy/immunosuppressant within 3 months prior to V1
-Treatment with live (attenuated) vaccine within 12 weeks before V1
-Chronic treatment with oral corticosteroids (OCS) for more than 2 weeks before V1
-Enrolled in other ongoing studies regardless of the investigational product
-Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to V1
-Suspected or high risk of parasitic infection (helminthic infection), unless clinical and (if necessary) laboratory assessments have ruled out active infection prior to randomization
-Females who are lactating, breastfeeding, or who are pregnant
-Individuals accommodated in an institution because of regulatory or legal order; prisoners or subjects who are legally institutionalized
-Patients are dependent on the Sponsor or Investigator (in conjunction with Section 1.61 of the ICH GCP Ordinance E6)
-Patients are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals
-Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
-Any country-related specific regulation that would prevent the subject from entering the study

- Fumador actual (cigarrillos o cigarrillos electrónicos) o cese del hábito de fumar en el año previo a la aleatorización.
- Fumador previo con antecedentes de tabaquismo de > 10 paquetes-año.
- Hipersensibilidad conocida a dupilumab o a cualquiera de sus excipientes.
- Exacerbación del asma durante la selección, antes de la aleatorización.
- Broncoespasmo agudo o estado asmático actuales.
- Enfermedad pulmonar diagnosticada (aparte del asma) o enfermedad sistémica asociada con recuentos elevados de eosinófilos en sangre periférica.
- Antecedentes o evidencia clínica de EPOC, incluido el síndrome de superposición asma–EPOC (ACOS) o cualquier otra enfermedad pulmonar significativa (por ejemplo, fibrosis pulmonar, sarcoidosis, enfermedad pulmonar intersticial, hipertensión pulmonar, bronquiectasia, síndrome de Churg-Straus).
- Tuberculosis activa, tuberculosis latente no tratada o antecedentes de tuberculosis tratada de forma incompleta o infección micobacteriana no tuberculosa, a menos que esté bien documentado por un especialista que el paciente ha sido tratado adecuadamente y puede iniciar el tratamiento con un fármaco biológico, según el criterio médico del investigador y/o especialista en enfermedades infecciosas. La prueba de tuberculosis solo se realizaría según cada país de acuerdo con la práctica clínica habitual y las directrices locales, si así lo requieren las autoridades reguladoras o los comités de ética.
- Antecedentes o evidencia actual de enfermedad clínicamente significativa en cualquier sistema no respiratorio (por ejemplo, cardiovascular, sistema nervioso, gastrointestinal, endocrinológico, reumatológico, dermatológico), que, a juicio del investigador, podría interferir con el estudio o requerir un tratamiento que podría interferir con el estudio.
- Evidencia actual de enfermedad oncológica clínicamente significativa que, a juicio del investigador, podría interferir con los objetivos del estudio o poner al sujeto en riesgo indebido.
- Pacientes que tengan cualquiera de los siguientes resultados en la V1:
• Resultado positivo (o indeterminado) en la prueba de detección del anticuerpo del antígeno de superficie del virus de la hepatitis B (HBsAg) o
• Resultado positivo en la prueba de detección del anticuerpo contra el antígeno central del virus de la hepatitis B (Ac anti-HBcAg) o
• Resultado positivo en la prueba Ac anti-HBcAg totales confirmado por un resultado positivo de ADN del VHB o
• Resultado positivo en la prueba de detección de anticuerpos contra el virus de la hepatitis C (Ac anti-HCV) confirmado por un resultado positivo en la prueba de ARN del VHC.
- Antecedentes de infección por el virus de la inmunodeficiencia humana (VIH) o prueba serológica para VIH en la V1.
- Cualquier terapia biológica (incluyendo tratamientos experimentales y dupilumab) o cualquier otra terapia biológica/inmunodepresora en los 3 meses anteriores a la V1.
- Tratamiento con vacuna de virus vivos (atenuados) en las 12 semanas anteriores a la V1.
- Tratamiento crónico con corticoesteroides orales (CEO) durante más de 2 semanas antes de la V1.
- Participar en otros estudios que estén en curso independientemente del producto en investigación.
- Tratamiento con un medicamento en investigación en las 8 semanas o 5 semividas anteriores a la V1 (si se conoce), prevaleciendo la que sea más prolongada.
- Sospecha o alto riesgo de infección parasitaria (infección helmíntica), a menos que las evaluaciones clínicas y (si es necesario) analíticas hayan descartado una infección activa antes de la aleatorización.
- Mujeres en período de lactancia o embarazadas.
- Individuos ingresados en instituciones por mandato judicial o legal, presos o sujetos en instituciones estatales.
- Pacientes que dependen del promotor o del investigador (junto con la sección 1.61 de la Ordenanza E6 de BPC del ICH).
- Pacientes que son empleados del centro del estudio clínico o cualquier otra persona que intervenga de manera directa en la realización del estudio o que sean familiares directos de dichas personas.
- El paciente presenta sensibilidad a alguno de los tratamientos del estudio o a los elementos de los mismos o bien tiene alergia a un fármaco u otro tipo de alergia que, en opinión del investigador, desaconsejen la participación en el estudio.
- Cualquier normativa específica del país que impida que el sujeto participe en el estudio.

E.5 End points

E.5.1

Primary end point(s)

1/ Change from baseline to Week 24 in pre-bronchodilator FEV1
2/ Percent change from baseline to Week 24 in regional airway volumes corrected for lung volume ([s]iVaw) at total lung capacity (TLC)

1/ Cambio en el VEF1 previo al broncodilatador desde el inicio hasta la semana 24
2/ Porcentaje de cambio desde el inicio hasta la semana 24 en los volúmenes regionales de las vías respiratorias corregidos para el volumen pulmonar ([s]iVaw) a la capacidad pulmonar total (CPT)

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline to Week 24

Desde el inicio hasta la semana 24

E.5.2

Secondary end point(s)

1/ Percent change from baseline to Week 24 in regional airway volumes corrected for lung volume ([s]iVaw) at functional residual capacity (FRC)
2/ Percent change from baseline to Week 24 in regional airway resistance corrected for lung volume ([s]iRaw) at TLC
3/ Percent change from baseline to Week 24 in regional airway resistance corrected for lung volume ([s]iRaw) at FRC
4/ Change from baseline to Week 24 in lobar volumes (iVlobes) at TLC
5/ Change from baseline to Week 24 in image-based ventilation/perfusion (iV/Q) at TLC
6/ Change from baseline to Week 24 in HRCT-based internal airflow distribution (IAD)
7/ Change from baseline to Week 24 in FeNO
8/ Achievement of FeNO <25 parts per billion (ppb) at Week 24
9/ Change from baseline to Week 24 in post-bronchodilator FEV1
10/ Change from baseline to Week 24 in ACQ-7
11/ Incidence of treatment emergent adverse events (TEAE) and serious adverse events (SAE) including clinically significant changes in vital signs and laboratory abnormalities
12/ Incidence of adverse events of special interest (AESI

1/ Porcentaje de cambio desde el inicio hasta la semana 24 en los volúmenes regionales de las vías respiratorias corregidos para el volumen pulmonar ([s]iVaw) a la capacidad funcional residual (CFR)
2/ Porcentaje de cambio desde el inicio hasta la semana 24 en la resistencia regional de las vías respiratorias corregida para el volumen pulmonar ([s]iRaw) a la CPT
3/ Porcentaje de cambio desde el inicio hasta la semana 24 en la resistencia regional de las vías respiratorias corregida para el volumen pulmonar ([s]iRaw) a la CFR
4/ Cambio desde el inicio hasta la semana 24 en los volúmenes lobulares (iVlobes) a la CPT
5/ Cambio desde el inicio hasta la semana 24 en la ventilación/perfusión basado en imágenes (iV/Q) a la CPT
6/ Cambio desde el inicio hasta la semana 24 en la distribución del flujo de aire interno (DFAI) basado en una TCAR
7/ Cambio en la FeNO desde el inicio hasta la semana 24
8/ Logro de la FeNO < 25 partes por mil millones (ppb) en la semana 24
9/ Cambio en el VEF1 desde el inicio hasta la semana 24 después del uso de broncodilatador
10/ Cambio en el ACQ-7 desde el inicio hasta la semana 24
11/ Incidencia de acontecimientos adversos derivados del tratamiento (AADT) y acontecimientos adversos graves (AAG), incluidos cambios clínicamente significativos en las constantes vitales y las anomalías de laboratorio
12/ Incidencia de los acontecimientos adversos de interés especial (AAIE)

E.5.2.1

Timepoint(s) of evaluation of this end point

1 a 7, 9 y 10 : Baseline to Week 24
8 : Week 24
11/12 : Baseline up to Week 36

1 a 7, 9 y 10 : Baseline to Week 24
8 : Week 24
11/12 : Desde el inicio hasta la semana 36

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Exploratory

Exploratorio

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Saudi Arabia

Taiwan

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

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 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:

340

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

224

F.4.2.2

In the whole clinical trial

340

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

Ninguno

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

2020-05-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-16

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

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