Clinical Trials Register

Summary
EudraCT Number:	2020-005116-21
Sponsor's Protocol Code Number:	CER-FT011-SSc01
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:	2021-07-22
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

2020-005116-21

A.3

Full title of the trial

A phase II, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, of
oral FT011 in participants with diffuse systemic sclerosis

Estudio en fase II, aleatorizado, doble ciego y controlado con placebo de la farmacocinética, los efectos farmacodinámicos y la seguridad de FT011 por vía oral en participantes con esclerodermia difusa

A.3.1

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

FT011 for Scleroderma

FT011 para la esclerodermia

A.3.2

Name or abbreviated title of the trial where available

FT011 for scleroderma

FT011 para la esclerodermia

A.4.1

Sponsor's protocol code number

CER-FT011-SSc01

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04647890

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1259-3503

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	Certa Therapeutics Pty Ltd
B.1.3.4	Country	Australia
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	Certa Therapeutics Pty Ltd
B.4.2	Country	Australia
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dra. Carmen Pilar Simeon Aznar
B.5.2	Functional name of contact point	Coordinadora Nacional
B.5.3	Address:
B.5.3.1	Street Address	Passeig Vall d'Hebron, 119-129
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08035
B.5.3.4	Country	Spain
B.5.4	Telephone number	+349327462656265
B.5.6	E-mail	cpsimeon@vhebron.net

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	FT011 100 mg
D.3.2	Product code	FT011
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	None yet
D.3.9.1	CAS number	1001288-58-9
D.3.9.2	Current sponsor code	FT011
D.3.9.3	Other descriptive name	2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid
D.3.9.4	EV Substance Code	SUB222673
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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	FT011 200 mg
D.3.2	Product code	FT011
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	None yet
D.3.9.1	CAS number	1001288-58-9
D.3.9.2	Current sponsor code	FT011
D.3.9.3	Other descriptive name	2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid
D.3.9.4	EV Substance Code	SUB222673
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
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	Capsule
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

diffuse systemic sclerosis

Esclerosis sistémica difusa

E.1.1.1

Medical condition in easily understood language

Diffuse systemic sclerosis, commonly called scleroderma. Scleroderma is a rare autoimmune disease that causes thickening and hardening (fibrosis) of the skin and other organs.

ES difusa, comúnmente denominada esclerodermia. La esclerodermia es una enfermedad autoinmunitaria poco frecuente que provoca el engrosamiento y endurecimiento de la piel y otros órganos

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10012977
E.1.2	Term	Diffuse systemic sclerosis
E.1.2	System Organ Class	100000004859

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 assess the PK of oral FT011 in participants with diffuse SSc

Evaluar la FC de FT011 por vía oral en participantes con esclerosis sistémica (ES) difusa

E.2.2

Secondary objectives of the trial

To assess the safety and tolerability of oral FT011 compared to placebo in participants with diffuse SSc.

To evaluate the short-term efficacy of oral FT011 compared to placebo in improving disease activity in participants with diffuse SSc.

Evaluar la seguridad y tolerabilidad de FT011 por vía oral en comparación con placebo en participantes con ES difusa.

Evaluar la eficacia a corto plazo de FT011 por vía oral en comparación con placebo a la hora de mejorar la actividad de la enfermedad en los participantes con ES difusa.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Provide written informed consent prior to any study procedures and who agree to adhere to all
protocol requirements.
2. Aged 18 to 75 years inclusive at the time of consent.
3. Have a classification of systemic sclerosis, as defined by American College of Rheumatology (ACR)
and European League Against Rheumatism (EULAR) criteria with disease duration ≤5 years from
first non-Raynaud phenomenon manifestation.
4. Have a diagnosis of diffuse cutaneous SSc defined as systemic sclerosis with skin thickening on the
upper arms proximal to the elbows, on the upper legs proximal to the knees, or on the trunk.
5. Have skin thickening in a body area suitable for repeat biopsy.
6. Have a mRSS at Screening of ≥15 to ≤40.
7. FVC ≥50% of predicted at Screening.
8. If on azathioprine, mycophenolate mofetil, or hydroxychloroquine, have been on a stable dose for
at least 2 months prior to baseline.
9. Participants must agree to use contraception according to protocol section 5.4.4.

1. Proporcionar el consentimiento informado por escrito antes de llevar a cabo cualquier procedimiento del estudio y quién acepta cumplir todos los requisitos del protocolo.
2. Edad entre 18 y 75 años, ambos inclusive, en el momento del consentimiento.
3. Tener una clasificación de la esclerosis sistémica, tal como se define en los criterios del Colegio Estadounidense de Reumatología (American College of Rheumatology, ACR) y la Liga Europea contra el Reumatismo (European League Against Rheumatism, EULAR), con una duración de la enfermedad de ≤5 años desde la primera manifestación del fenómeno no Raynaud.
4. Tener un diagnóstico de ES cutánea difusa definida como esclerosis sistémica con engrosamiento de la piel en la parte superior de los brazos próxima a los codos, en la parte superior de las piernas próxima a las rodillas o en el torso.
5. Tener un engrosamiento de la piel en una zona del cuerpo adecuada para la repetición de la biopsia.
6. Tener una puntuación en la escala mRSS de ≥15 a ≤40 en la selección.
7. CVF ≥50 % del valor previsto en la selección.
8. Si recibe azatioprina, micofenolato de mofetilo o hidroxicloroquina, haber recibido una dosis estable durante al menos 2 meses antes del inicio.
9. Los participantes deben aceptar el uso de anticonceptivos según se describe en el apartado 5.4.4 del protocolo.

E.4

Principal exclusion criteria

1. Pregnant or breast-feeding, or plan to become pregnant during the study.
2. Have received any IMP within 30 days or 5 half-lives prior to randomisation (4 months if the
previous drug was a new chemical entity), whichever is longer.
3. Have known or suspected contraindications to the IMP.
4. Have severe or unstable SSc or end-stage organ involvement as evidenced by:
a. On an organ transplantation list or has received an organ transplant including autologous
stem cell transplant.
b. Renal crisis within 1 year prior to Baseline.
5. Interstitial lung disease or pulmonary hypertension requiring constant oxygen therapy. This
excludes oxygen used to aid sleep or exercise.
6. Gastrointestinal dysmotility requiring total parenteral nutrition or requiring hospitalisation within
the 6 months prior to Baseline.
7. Concomitant inflammatory myositis, rheumatoid arthritis, or systemic lupus erythematosus when
definite classification criteria for those diseases are met (Bohan and Peter criteria for polymyositis
and dermatomyositis)
8. SSc-like illnesses related to exposures or ingestions
9. The use of the following drugs within the specified periods:
a. Methotrexate in the 2 weeks prior to Day 1
b. Other anti-fibrotic agents including D-penicillamine or tyrosine kinase inhibitors (nilotinib,
imatinib, dasatinib) in the month prior to Screening.
c. Biologic drugs such as tumour necrosing factor (TNF) inhibitors, tocilizumab, or Janus
kinase (JAK) inhibitors, in the 3 months prior to Screening.
d. Rituximab in the 6 months prior to Screening.
e. Cyclophosphamide oral or IV in the 3 months prior to Screening.
f. Oral prednisolone >10 mg per day or IV steroids in the month prior to Screening.
10. Have any malignancy not considered cured (except basal cell or squamous cell carcinoma of the
skin, or carcinoma in situ of the cervix); a subject is considered cured if there has been no evidence
of cancer recurrence for the 6 years prior to randomisation.
11. Have aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase
(GGT), lactate dehydrogenase (LDH), or bilirubin values above the upper limit of normal (ULN) at
Screening or Baseline, or evidence of hepatic disease as determined by any one of the following:
history of hepatic encephalopathy, history of oesophageal varices, or history of portacaval shunt.
12. Estimated glomerular filtration rate (eGFR) <60mL/min, urinary albumin/creatinine ratio <30mg/g.
13. Haemoglobin < 80 g/L, platelets < 90 x 109/L, or neutrophil count < 1.4 x 109/L
14. Other than SSc, have any other medical condition or significant co-morbidities, clinically relevant
social or psychiatric conditions, or any finding during Screening, which in the investigator’s opinion
may put the subject at risk or interfere with the study objectives.

1. Estar embarazada o en período de lactancia o tener pensado quedarse embarazada durante el estudio.
2. Haber recibido algún PEI en los 30 días o las 5 semividas anteriores a la aleatorización (4 meses si
el fármaco anterior era una nueva entidad química), lo que dure más.
3. Tener contraindicaciones conocidas o posibles al PEI.
4. Tener ES grave o inestable o afectación de los órganos en fase terminal que se manifiesta de la siguiente manera:
a. Estar en una lista de trasplante de órganos o haber recibido un trasplante de órgano, incluido un autotrasplante
de células madre.
b. Tener una crisis renal en el plazo de 1 año antes del inicio.
5. Enfermedad pulmonar intersticial o hipertensión pulmonar que requiera oxigenoterapia constante. Sin
contar con el oxígeno utilizado para facilitar el sueño o el ejercicio.
6. Dismotilidad gastrointestinal que requiera nutrición parenteral total o que haya requerido hospitalización en el plazo de los 6 meses anteriores al inicio.
7. Miositis inflamatoria concomitante, artritis reumatoide o lupus eritematoso sistémico cuando se cumplan los criterios de clasificación definidos para esas enfermedades (criterios de Bohan y Peter para la polimiositis y dermatomiositis).
8. Enfermedades parecidas a la ES relacionadas con la exposición o la ingesta
9. El uso de los siguientes fármacos en los períodos especificados:
a. Metotrexato en las 2 semanas anteriores al día 1
b. Otros antifibróticos como la D-penicilamina o los inhibidores de la tirosina cinasa (nilotinib,
imatinib, dasatinib) en el mes previo a la selección.
c. Fármacos biológicos, como inhibidores del factor de necrosis tumoral (tumour necrosing factor, TNF), tocilizumab o inhibidores de las janocinasas
(Janus kinase, JAK), en los 3 meses previos a la selección.
d. Rituximab en los 6 meses previos a la selección.
e. Ciclofosfamida por vía oral o i.v. en los 3 meses previos a la selección.
f. >10 mg al día de prednisolona por vía oral o esteroides por vía i.v. en el mes previo a la selección.
10. Tener cualquier neoplasia maligna que no se considere curada (excepto carcinoma basocelular o carcinoma epidermoide de la piel o carcinoma del cuello uterino in situ). Se considera que un sujeto está curado si no ha habido indicios de recaída del cáncer en los 6 años previos a la aleatorización.
11. Presentar valores de aspartato aminotransferasa (AST), alanina aminotrasferasa (ALT), gamma-glutamil transferasa (GGT), lactato deshidrogenasa (LDH) o bilirrubina por encima del límite superior de la normalidad (LSN) en la selección o el inicio, o signos de enfermedad hepática según lo determinado por cualquiera de los siguientes: antecedentes de encefalopatía hepática, antecedentes de varices esofágicas o antecedentes de derivación portocava.
12. Tasa de filtración glomerular estimada (TFGe) <60 ml/min, cociente de albúmina/creatinina en orina <30 mg/g.
13. Hemoglobina <80 g/l, plaquetas <90 x 109/l o recuento de neutrófilos <1,4 x 109/l
14. Aparte de la ES, tiene cualquier otra afección médica o comorbilidad significativa, afecciones sociales o psiquiátricas clínicamente relevantes, o cualquier hallazgo durante la selección que, en opinión del investigador, pueda poner en riesgo al sujeto o interferir con los objetivos del estudio.

E.5 End points

E.5.1

Primary end point(s)

• FT011 cmax, tmax, and AUC in plasma after a single dose and after 12-weeks of treatment.
• Measurement of steady state FT011 levels in plasma.

Additional calculations may be performed, and metabolites may also be measured.

• cmáx, tmáx y ABC de FT011 en plasma después de una dosis única y después de 12 semanas de tratamiento.
• Medición de los niveles de FT011 en situación de equilibrio en plasma.

Se podrán hacer cálculos adicionales y es posible que también se midan los metabolitos.

E.5.1.1

Timepoint(s) of evaluation of this end point

FT011 cmax, tmax, and AUC in plasma after a single dose on day 1 and after last dose at week 12.
Steady state concentrations will be at the 1, 2, and 3 month pre-dose timepoints.

Cmáx, tmáx y ABC de FT011 en plasma después una dosis única el día 1 y después de la última dosis en la semana 12.
Las concentraciones en situación de equilibrio serán en los puntos temporales de 1, 2 y 3 meses antes de la dosis.

E.5.2

Secondary end point(s)

Safety will be assessed by:
• Treatment emergent adverse events from first dose of study drug to End of Study.
• Physical examination.
• Vital signs (blood pressure, heart rate, respiratory rate, and temperature).
• 12-lead ECG.
• Safety laboratory results (haematology, biochemistry, coagulation, and urinalysis).
• Use of concomitant medications.

Efficacy Endpoints
• Change in mRSS from Baseline at each visit.
• Change in percent predicted FVC from Baseline to Week 4, Week 8, and Week 12.
• Change in HAQ-DI Score from Baseline to Week 4, Week 8, and Week 12.
• Change in Patient Global Assessment Score from Baseline to Week 4, Week 8, and Week 12.
• Change in Physician Global Assessment Score from Baseline to Week 4, Week 8, and Week 12.
• The proportion of patients showing an improvement (defined as ACR Composite Response Index
in Diffuse Cutaneous Systemic Sclerosis (CRISS) score predicted probability of ≥0.60) at Week 12.
• Change in the Scleroderma Clinical Trials Consortium Damage Index (SCTC-DI) score from Baseline
to Week 12.
• Change in the 5-D Itch Scale from Baseline to Week 12.

La seguridad se evaluará mediante:
• Acontecimientos adversos surgidos durante el tratamiento desde la primera dosis del fármaco del estudio hasta el final del estudio.
• Exploración física.
• Constantes vitales (presión arterial, frecuencia cardíaca, frecuencia respiratoria y temperatura).
• ECG de 12 derivaciones.
• Resultados analíticos de seguridad (hematología, bioquímica, coagulación y análisis de orina).
• Uso de medicación concomitante.

Criterios de valoración de la eficacia
• Cambio en la puntuación en la escala mRSS con respecto al inicio en cada visita.
• Cambios en el porcentaje previsto de CVF desde el inicio hasta la semana 4, semana 8 y semana 12.
• Cambio en la puntuación del HAQ-DI desde el inicio hasta la semana 4, la semana 8 y la semana 12.
• Cambio en la puntuación de la evaluación global del paciente desde el inicio hasta la semana 4, semana 8 y semana 12.
• Cambio en la puntuación de la evaluación global por parte del médico desde el inicio hasta la semana 4, semana 8 y semana 12.
• La proporción de pacientes que muestran una mejoría (definida como una probabilidad prevista ≥0,60 en la puntuación en el índice de respuesta compuesta para la esclerosis sistémica (CRISS) cutánea difusa del ACR) en la semana 12.
• Cambio en la puntuación del índice de daño del Consorcio de ensayos clínicos sobre la esclerodermia (Scleroderma Clinical Trials Consortium Damage Index, SCTC-DI) desde el inicio hasta la semana 12.
• Cambios en la escala de prurito de 5 dimensiones (5-D) desde el inicio hasta la semana 12.

E.5.2.1

Timepoint(s) of evaluation of this end point

Timepoints are described in the endpoints in E.5.2

Los puntos temporales se describen en los criterios de valoración de E.5.2.

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

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

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

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

Australia

Russian Federation

Ukraine

Netherlands

Poland

Spain

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

The end of the trial is defined as the last protocol-specified data available from the last participant in the study.

El final del ensayo se define como los últimos datos disponibles especificados en el protocolo procedentes del último participante en el estudio.

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:

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

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

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-07-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-07-14

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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