Clinical Trials Register

Summary
EudraCT Number:	2020-003666-40
Sponsor's Protocol Code Number:	CLI-06001AA1-04
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:	2021-07-27
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

2020-003666-40

A.3

Full title of the trial

A 52-week, randomized, double-blind, placebo-controlled, parallel-group, study to evaluate the efficacy and safety of two doses of CHF6001 DPI add-on to maintenance triple therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis.

Estudio de 52 semanas, aleatorizado, con enmascaramiento doble, controlado con placebo, con grupos paralelos, para evaluar la eficacia y la seguridad de dos dosis de CHF6001 administradas con inhalador de polvo seco (DPI) como complemento a un tratamiento triple de mantenimiento de sujetos con enfermedad pulmonar obstructiva crónica (EPOC) y bronquitis crónica

A.3.1

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

The efficacy and the safety of two doses of CHF6001 for the treatment of Chronic Obstructive Pulmonary Disease (COPD).

La eficacia y la seguridad de dos dosis de CHF6001 para el tratamiento de la Enfermedad Pulmonar Obstructiva Crónica (EPOC).

A.3.2

Name or abbreviated title of the trial where available

PILASTER

A.4.1

Sponsor's protocol code number

CLI-06001AA1-04

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04636801

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	Chiesi Farmaceutici S.p.A.
B.1.3.4	Country	Italy
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	Chiesi Farmaceutici S.p.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Chiesi Farmaceutici S.p.A.
B.5.2	Functional name of contact point	CLINICAL PROJECT MANAGER
B.5.3	Address:
B.5.3.1	Street Address	Via Palermo 26/A
B.5.3.2	Town/ city	Parma
B.5.3.3	Post code	43122
B.5.3.4	Country	Italy
B.5.6	E-mail	clinicaltrials_info@chiesi.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	CHF6001 NEXThaler 400 μg/20 mg
D.3.2	Product code	CHF6001
D.3.4	Pharmaceutical form	Inhalation powder
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tanimilast
D.3.9.1	CAS number	1239278-59-1
D.3.9.2	Current sponsor code	CHF 6001
D.3.9.3	Other descriptive name	CHF 6001.00
D.3.9.4	EV Substance Code	SUB180242
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	400
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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	CHF6001 NEXThaler 800 μg/20 mg
D.3.2	Product code	CHF6001
D.3.4	Pharmaceutical form	Inhalation powder
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tanimilast
D.3.9.1	CAS number	1239278-59-1
D.3.9.2	Current sponsor code	CHF 6001
D.3.9.3	Other descriptive name	CHF 6001.00
D.3.9.4	EV Substance Code	SUB180242
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	800
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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	Inhalation powder
D.8.4	Route of administration of the placebo	Inhalation use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis

Enfermedad obstructiva pulmonar crónica (EPOC) y bronquitis crónica

E.1.1.1

Medical condition in easily understood language

Chronic Obstructive Pulmonary Disease (COPD)

Enfermedad obstructiva pulmonar crónica (EPOC)

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10010952
E.1.2	Term	COPD
E.1.2	System Organ Class	100000004855

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 evaluate the efficacy of two doses of CHF6001 add-on to maintenance triple therapy (ICS, LABA, LAMA) to reduce the rate of moderate and severe exacerbations after 52 weeks of treatment in comparison with maintenance triple therapy (i.e. placebo arm).

Evaluar la eficacia de dos dosis de CHF6001 como complemento a un tratamiento triple de mantenimiento (CI, LABA, LAMA) para reducir la frecuencia de exacerbaciones moderadas y graves tras 52 semanas de tratamiento, en comparación con el tratamiento triple de mantenimiento (es decir, el grupo de placebo).

E.2.2

Secondary objectives of the trial

To evaluate
- the efficacy of the two doses of CHF6001 add-on to maintenance triple therapy on health related quality of life after 52 weeks of
treatment (change in SGRQ total score).
-the efficacy of the two doses of CHF6001 add-on to maintenance triple therapy on lung function, health-related quality of life, severe exacerbations in the pooled analysis of CLI-06001AA1-04 and CLI-06001AA1-05 studies and other clinical outcome measures in comparison with maintenance triple therapy
-the safety and tolerability of the two doses of CHF6001

Evaluar:
- Lla eficacia de dos dosis de CHF6001 como complemento al tratamiento triple de mantenimiento en lo que respecta a la calidad de vida relacionada con la salud tras 52 semanas de tratamiento (cambio en la puntuación total de SGRQ).
- la eficacia de dos dosis de CHF6001 como complemento al tratamiento triple de mantenimiento en lo que respecta a la función pulmonar, la calidad de vida relacionada con la salud, las exacerbaciones graves en el análisis conjunto de los estudios de CLI-06001AA1-04 y CLI-06001AA1-05, y otros indicadores de resultados clínicos en comparación con el tratamiento triple de mantenimiento;
- la seguridad y tolerabilidad de las dos dosis de CHF6001.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Males and females aged ≥ 40 years with written informed consent obtained prior to any study-related procedure.
2.Females are eligible to enter the study if they are of
a.non-childbearing potential
or
b.childbearing potential, they must have a negative pregnancy test at screening and must agree to use one or more of the acceptable contraceptive measures.
3.Subjects with an established diagnosis of COPD with chronic bronchitis
4.Current smokers or ex-smokers who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years.
5.A post-bronchodilator FEV1 < 80% of the subject predicted normal value and a post-bronchodilator FEV1/FVC ratio < 0.7 after 400µg (4 puffs x 100µg) of salbutamol pMDI.
6.A documented history (e.g. medical record verification) of at least one moderate or severe COPD exacerbation in previous year.
7.Symptomatic subject at screening defined as having a CAT score ≥ 10.
8.Subjects on regular maintenance triple therapy (free or fixed combination of ICS, LABA, LAMA) according to GOLD 2020 recommendations, for at least 12 months prior to screening.
9.Subjects are willing and able to be trained to use correctly the DPI inhalers (NEXThaler®).
10.Subjects are willing and able to be trained to use correctly the electronic devices with COPD questionnaires, to understand and to perform required outcome measurements of the protocol (e.g. spirometry manoeuvres etc.) and ability to understand the risks involved.

1. Hombres y mujeres de ≥ 40 años de edad que hayan firmado un consentimiento informado previo a cualquier procedimiento relacionado con el estudio.
2. Las mujeres son aptas para participar en el estudio si
a. no presentan capacidad reproductiva
o
b. tienen capacidad reproductiva pero presentan una prueba de embarazo negativa al momento de la selección y aceptan utilizar una o más de las medidas anticonceptivas aceptadas.
3. Sujetos con un diagnóstico establecido de EPOC
4. Fumadores o exfumadores que hayan dejado de fumar al menos 6 meses antes de la visita de selección y que posean antecedentes de, al menos, 10 años-paquete.
5. Un VEF1 después de usar el broncodilatador inferior al 80 % del valor normal predicho para el sujeto y una relación VEF1/CVF menor de 0,7 después de 400 μg (4 inhalaciones de 100 μg) de salbutamol en inhalador de dosis medida presurizado (IDMp).
6. Antecedentes documentados (p. ej.: verificación de historia clínica) de, por lo menos, una exacerbación moderada o grave de la EPOC en el año anterior.
7. Se define al sujeto sintomático durante la selección como aquel que presente una puntuación de la evaluación CAT de > 10.
8. Sujetos que reciben tratamiento triple de mantenimiento regular (combinación con dosis fija o libre de CI, LABA, LAMA) según las recomendaciones del informe GOLD 2020 durante, por lo menos, 12 meses antes de la selección. La toma de los CI debe ser en una dosis aprobada para el tratamiento de la EPOC.
9. Los sujetos muestran disposición y capacidad para recibir formación sobre el uso correcto del DPI (NEXThaler).
10. Los sujetos muestran disposición y capacidad para recibir formación sobre el uso correcto de dispositivos electrónicos con cuestionarios sobre la EPOC, para comprender y llevar a cabo las medidas de resultados que indica el protocolo (p. ej., maniobras de espirometría, etc.), así como capacidad para comprender los riesgos asociados.

E.4

Principal exclusion criteria

1.Subjects with a diagnosis of current asthma.
2.Subjects with a moderate or severe COPD exacerbation 4 weeks prior to study entry and during run-in period.
3.Pregnant and lactating women.
4.Subjects requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
5.Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD
6.Subjects with COPD primarily emphysema phenotype as per investigator judgement and medical history records
7.Subjects with clinically significant respiratory disorders other than COPD.
8.Subjects with lung volume reduction surgery.
9.Subjects having lung cancer or a history of lung cancer or lung cancer resection in the past.
10.Subjects with active cancer or a history of cancer (other than the lung) with less than 5 years disease free survival time.
11.Subjects with a history of allergy or hypersensitivity to anticholinergics, β2-agonists, corticosteroids, PDE-4 inhibitors or any of the excipients contained in any of the formulations used in the trial or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the investigator’s opinion would contra-indicate study participation.
12.Subjects under Roflumilast treatment within 6 months before study entry
13.Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation or behaviour that might, according to the investigator judgement, place the subject at undue risk.
14.Subjects who have clinically significant cardiovascular condition.
15.An abnormal and clinically significant 12-lead ECG finding in relation to the subject’s medical history that results in active medical problem which may impact the safety of the subject according to investigator’s judgement.
16.Subjects with a significant neurological disease including transient ischemic attack (TIA), stroke, seizure disorder or behavioural disturbances that in investigator’s opinion, would place the subject at risk by participating to the study.
For complete list of exclusion criteria, please refer to the protocol.

1. Sujetos con diagnóstico de asma en la actualidad.
2. Sujetos que hayan presentado una exacerbación moderada o grave de la EPOC 4 semanas antes del acceso al estudio y durante el período de preinclusión.
3. Mujeres embarazadas y lactantes.
4. Sujetos que requieren terapia de oxígeno a largo plazo (por lo menos 12 horas diarias) como tratamiento de la hipoxemia crónica.
5. Sujetos que presenten una deficiencia de α1-antitripsina como la causa subyacente de la EPOC.
6. Sujetos que padezcan de EPOC principalmente fenotipo enfisema, según el criterio del investigador y la historia clínica.
7. Sujetos que presentan otros trastornos respiratorios de importancia clínica además de la EPOC.
8. Sujetos que hayan sido sometidos a una cirugía de reducción de volumen pulmonar.
9. Sujetos que sufran de cáncer de pulmón o tengan antecedentes previos de cáncer de pulmón o de extirpación de cáncer de pulmón.
10. Sujetos que tengan cáncer activo o que tengan antecedentes de cáncer (aparte del pulmonar) con una tasa de supervivencia sin enfermedad inferior a los cinco años.
11. Sujetos con antecedentes de alergias o hipersensibilidad a los anticolinérgicos, los agonistas β2, los corticoesteroides, los inhibidores de PDE-4 o cualquiera de los excipientes de una de las fórmulas utilizadas en el ensayo, o un trastorno médico que, según el criterio del investigador, desaconseje la participación en el estudio, como glaucoma de ángulo cerrado, hipertrofia prostática u obstrucción del cuello vesical.
12. Sujetos que reciban tratamiento con roflumilast en los 6 meses previos al acceso al estudio.
13. Sujetos que hayan recibido un diagnóstico de depresión, trastorno de ansiedad generalizada, pensamientos suicidas o comportamientos que, según el criterio del investigador, podrían ponerlo en un riesgo indebido.
14. Sujetos que presenten trastornos cardiovasculares de importancia.
15. Un hallazgo anómalo y de importancia clínica en el ECG de 12 derivaciones relacionado con la historia clínica del sujeto que sea signo de un problema médico activo que pueda afectar su seguridad, según el criterio del investigador.
16. Sujetos que padecen de enfermedades neurológicas considerables como un accidente isquémico transitorio (TIA, por sus siglas en inglés), accidente cerebrovascular, trastornos convulsivos o trastornos de conducta que, en la opinión del investigador, pondrían al sujeto en riesgo si participa del estudio.
Para obtener una lista completa de los criterios de exclusión, consulte el protocolo.

E.5 End points

E.5.1

Primary end point(s)

Annual rate of moderate and severe exacerbations over 52 weeks

Frecuencia anual de exacerbaciones moderadas y graves durante 52 semanas.

E.5.1.1

Timepoint(s) of evaluation of this end point

Over 52 weeks

Más de 52 semanas

E.5.2

Secondary end point(s)

•Change from baseline in SGRQ Total score at week 52
•Time to first moderate/severe exacerbation
•Annual rate of severe exacerbations
•Time to first severe exacerbation
•The number of on-treatment severe exacerbations
•Change from baseline in morning pre-dose of FEV1 at week 52
•Change from baseline in SGRQ Domain scores at week 52
•SGRQ response (i.e., change from baseline in SGRQ score ≥ -4) at week 52
•Change from baseline to last inter-visit period (week 40-52) in the average E-RS total and sub-scale scores
•E-RS response (i.e., change from baseline in E-RS total score ≤ -2) at week 52
•Change from baseline to last inter-visit period (week 40-52) in the percentage of days without intake of rescue medication and in the average daily use of rescue medication (number of puffs)
•Time to study medication discontinuation due to any reason
•Time to first moderate or severe exacerbation or study medication discontinuation due to any adverse events, lack of efficacy or death (composite endpoint) and time to its individual components (i.e. time to study medication discontinuation).

• Cambio en la semana 52 respecto de los valores iniciales en la puntuación total de SGRQ.
• Tiempo hasta la primera exacerbación moderada o grave.
• Frecuencia anual de las exacerbaciones graves.
• Tiempo hasta la primera exacerbación grave.
• Frecuencia de exacerbaciones que requieren antibióticos.
• Cambio en la semana 52 respecto de los valores iniciales en el valor de VEF1 matutino previo a la dosis en la semana 52.
• Cambio en la semana 52 respecto de los valores iniciales en las puntuaciones de dominios del SGRQ.
• Respuesta en el SGRQ (es decir, un cambio en relación con el inicio en la puntuación de SGRQ de ≥ -4) en la semana 52.
• Cambio desde el período inicial (período de preinclusión) hasta el último período entre visitas (semanas 40-52) en las puntuaciones de E-RS promedio totales y en las subescalas (disnea de RS, tos y esputo de RS, síntomas torácicos de RS).
• Respuesta en el E-RS (es decir, un cambio respecto de los valores iniciales en la puntuación de E-RS total de ≤ -2) en la semana 52.
• Cambio desde el período inicial (período de preinclusión) hasta el último período entre visitas (semana 40-52) en el porcentaje de días sin uso de medicamentos de rescate y del promedio de uso diario de medicamentos de rescate (número de inhalaciones/día).
• Tiempo hasta la interrupción del medicamento del estudio por cualquier motivo.
• Tiempo hasta la primera exacerbación moderada o grave, o la interrupción del medicamento del estudio (debido a cualquier acontecimiento adverso, falta de eficacia o la muerte [criterio de valoración compuesto]) y tiempo hasta sus componentes individuales (es decir, tiempo hasta la interrupción del medicamento del estudio y tiempo hasta la primera exacerbación moderada o grave, según lo descrito anteriormente).

E.5.2.1

Timepoint(s) of evaluation of this end point

Over 52 weeks

Más de 52 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

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

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

147

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

Chile

Israel

Mexico

New Zealand

Russian Federation

South Africa

Turkey

Ukraine

Austria

Bulgaria

France

Germany

Hungary

Italy

Netherlands

Poland

Slovakia

Spain

United Kingdom

Czechia

Argentina

Greece

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

UVUP

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:

1985

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

1000

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

1618

F.4.2.2

In the whole clinical trial

2985

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

2021-09-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-09-10

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

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