Clinical Trials Register

Summary
EudraCT Number:	2021-004349-18
Sponsor's Protocol Code Number:	M-14789-41
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:	2022-04-27
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

2021-004349-18

A.3

Full title of the trial

A Phase 4, Multi-centre, Randomized, Evaluatorblinded, Active-controlled Study to Determine the Incidence of Squamous Cell Carcinoma and Evaluate the Long-term Safety of Tirbanibulin 10 mg/g Ointment and Diclofenac Sodium 3% Gel for the Treatment of Adult Patients with Actinic Keratosis on the Face or Scalp

Estudio de fase IV, multicéntrico, aleatorizado, enmascarado para el evaluador y comparativo con tratamiento activo para determinar la incidencia del carcinoma de células escamosas y evaluar la seguridad a largo plazo de la administración de tirbanibulina 10 mg/g pomada y diclofenaco sódico al 3 % gel para el tratamiento de pacientes adultos con queratosis actínica en la cara o el cuero cabelludo.

A.3.1

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

Long-term clinical safety study to evaluate the risk of actinic keratosis progressing to skin cancer following treatment of the face or scalp with tirbanibulin 10 mg/g ointment and in comparison to diclofenac 3% gel in adult patients. Tirbanibulin and diclofenac are used to treat adults with actinic keratosis on the face and scalp. Actinic keratosis is a precancerous, abnormal skin growth that develops after too much exposure to sunlight.

Estudio de seguridad clínica a largo plazo para evaluar el riesgo de que la queratosis actínica (QA) progrese a cáncer de piel tras el tratamiento en cara o cuero cabelludo con tirbanibulina 10 mg/g pomada comparado con diclofenaco 3% gel en pacientes adultos. La tirbanibulina y el diclofenaco se usan para tratar adultos con QA en cara y cuero cabelludo. La queratosis actínica es un crecimiento anormal y precanceroso de la piel que se desarrolla después de una exposición excesiva a la luz solar

A.4.1

Sponsor's protocol code number

M-14789-41

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	Almirall, S.A.
B.1.3.4	Country	Spain
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	Almirall, S.A.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Almirall, S.A.
B.5.2	Functional name of contact point	Internat. Clinical Trial Manager
B.5.3	Address:
B.5.3.1	Street Address	Ronda General Mitre 151
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08022
B.5.3.4	Country	Spain
B.5.6	E-mail	gco@almirall.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	Yes
D.2.1.1.1	Trade name	Klisyri 10 mg/g ointment
D.2.1.1.2	Name of the Marketing Authorisation holder	Almirall, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	Pharmaceutical form	Ointment
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tirbanibulin
D.3.9.2	Current sponsor code	KX2-391
D.3.9.4	EV Substance Code	SUB198081
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
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	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	Comparator
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	Yes
D.2.1.1.1	Trade name	Solaraze 3%, gel
D.2.1.1.2	Name of the Marketing Authorisation holder	Almirall S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Poland
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.3.4	Pharmaceutical form	Gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	n/a
D.3.9.2	Current sponsor code	n/a
D.3.9.3	Other descriptive name	DICLOFENAC SODIUM
D.3.9.4	EV Substance Code	SUB01674MIG
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	30
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Actinic Keratosis on the Face or Scalp

Queratosis actínica en la cara o el cuero cabelludo

E.1.1.1

Medical condition in easily understood language

Actinic keratosis is a precancerous, abnormal skin growth that develops after too much exposure to sunlight.

La queratosis actínica es un crecimiento anormal y precanceroso de la piel que se desarrolla después de una exposición excesiva a la luz solar.

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

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	10000614
E.1.2	Term	Actinic keratosis
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue 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 evaluate the incidence of biopsyconfirmed invasive SCC in the selected TF after administration of topical tirbanibulin 10 mg/g ointment or diclofenac sodium 3% gel over the 3-year study period.

Evaluar la incidencia de CCE
invasivo confirmado por biopsia en
el AT seleccionado tras la
administración tópica de
tirbanibulina 10 mg/g pomada o
diclofenaco sódico al 3 % gel
durante el periodo de estudio de
3 años

E.2.2

Secondary objectives of the trial

To evaluate the safety of topical tirbanibulin 10 mg/g ointment and diclofenac sodium 3% gel over the 3-year study period

Evaluar la seguridad de tirbanibulina
tópica 10 mg/g pomada y
diclofenaco sódico al 3 % gel
durante el periodo de estudio de 3
años.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female and ≥18 years old.
2. A TF on the face or scalp (excluding lips, eyelids, ears, and inside the nostrils), that:
• Is a contiguous area measuring 25 cm2,
• Contains 2 to 8 clinically typical, visible, and discrete AK lesions, and
• Has an overall clinical picture that is consistent with Olsen grade 1.
3. If a WOCBP, ie, fertile, defined as a female in the life period from menarche and until becoming post-menopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (with hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 3 months prior to Screening), she must:
• Have a negative urine pregnancy test using a highly sensitive method at screening and on Day 1 prior to treatment administration.
• Be using effective methods of birth control.
• Agree to have pregnancy tests while in the study and at the end of the study (according to the Schedule of Assessments in Table 1).
4. Patients should be willing to avoid sunlight or UV light exposure, including the use of tanning beds, to the face or scalp during the study.
5. Patients should have the ability to understand the purpose and risks of the study, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines.

1. Hombre o mujer y ≥18 años.
2. Un AT en la cara o el cuero cabelludo (excluyendo labios, párpados, orejas y dentro de las fosas nasales), que:
• Es un área contigua que mide 25 cm2,
• Contiene de 2 a 8 lesiones de QA clínicamente típicas, visibles y discretas, y
• Tiene un cuadro clínico general que es consistente con el grado 1 de Olsen
3. Si una MEF, es decir, fértil, definida como una mujer en el período de vida desde la menarquia y hasta la posmenopausia (sin menstruación durante 12 meses sin una causa médica alternativa) o permanentemente estéril (con histerectomía, salpingectomía bilateral u ovariectomía bilateral al menos 3 meses antes de la selección), debe:
• Tener una prueba de embarazo en orina negativa utilizando un método altamente sensible en la selección y en el Día 1 antes de la administración del tratamiento.
• Debe usar un método anticonceptivo eficaz.
• Estar de acuerdo en hacerse pruebas de embarazo mientras esté en el estudio y al final del estudio (de acuerdo con el Programa de Evaluaciones en la Tabla 1).
4. Los pacientes deben estar dispuestos a evitar la exposición a la luz solar o a la luz ultravioleta, incluido el uso de camas de bronceado, en la cara o el cuero cabelludo, durante el estudio.
5. Los pacientes deben tener la capacidad de comprender el propósito y los riesgos del estudio, la voluntad y la capacidad de cumplir con el protocolo y proporcionar un consentimiento informado por escrito de acuerdo con las pautas institucionales y regulatorias.

E.4

Principal exclusion criteria

1. The location of the TF is:
a) On any location other than the face or scalp.
b) Within 5 cm of an incompletely healed wound.
c) Within 10 cm of a suspected basal cell carcinoma (BCC) or other neoplasm.
d) On the lips, eyelids, ears, or inside the nostrils, periorbital, perioral, or the skin surrounding the nostrils.
2. Presence in the TF of:
a) Clinically atypical and/or rapidly changing AK lesions
b) Hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery onc2 previous occasions), and/or cutaneous horn.
c) Confluent AK lesions (ie, non-discrete lesions, as per inclusion criterion 2).
d) Persisting AK lesions at the screening visit following topical treatment with diclofenac sodium 3% gel.
3. History of any malignant skin tumour in the TF or history of skin tumour in any region of the body which has metastasized or in which metastasis within the study period is likely.
4. History of any malignant tumour with systemic antitumor treatment (including radiotherapy) within 12 weeks prior to the Screening Visit or systemic antitumor treatment is expected while on the study.
5. Immunocompromised patients, including patients with a history of chronic systemic lymphoma or chronic myeloid leukaemia, or organ transplant recipients.
6. Any other dermatological disease that causes difficulty with examination within the treatment area.
7. Anticipated need for inpatient hospitalization or inpatient surgery during the study.
8. Previous treatment with tirbanibulin 10 mg/g ointment in the selected TF.
9. Treatment with 5-fluorouracil, imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other topical treatments for AK within the TF or within 2 cm of the TF, within 8 weeks prior to the Screening Visit.
10. Use of the following therapies and/or medications within 4 weeks prior to the Screening Visit:
a) Treatment with cytotoxic drugs (eg, cyclophosphamide, vinblastine, chlorambucil, methotrexate)
b) Treatment with systemic medications that modulate and/or suppress the immune system (eg, cyclosporine, prednisone, methotrexate, alefacept, infliximab, interferons or interferon inducers)
c) Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene)
11. Use of the following therapies and/or medications within 2 weeks prior to the Screening
Visit:
a) Cosmetic or therapeutic procedures (eg, use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the TF or within a 2 cm margin of the selected TF.
b) Acid-containing therapeutic products (eg, salicylic acid or fruit acids, such as alpha and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the TF or within a 2 cm margin of the selected TF.
c) Topical steroids within the TF or within a 2 cm margin of the selected TF.
d) Artificial tanners within the TF or within a 5 cm margin of the selected TF.
12. History of sensitivity and/or allergy to any of the ingredients in the study medications to tirbanibulin, diclofenac, or nonsteroidal anti-inflammatory drugs (ie, NSAIDs).
13. A skin disease (eg, atopic dermatitis, psoriasis, eczema) or condition (eg, scarring, open wounds) that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the patient to unacceptable risk by study participation.
14. Significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the patient to unacceptable risk by study participation.
15. Females who are pregnant or nursing or who are intending to become pregnant
16. Participated in an investigational drug study during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, prior to screening
17. Patient who is an employee or a relative to an employee at the research site or Almirall

1. La ubicación del AT es:
a) En cualquier lugar que no sea la cara o el cuero cabelludo.
b) Unos 5 cm alrededor de una herida cicatrizada de forma incompleta.
c) Unos 10 cm alrededor de una sospecha de carcinoma de células basales (CBC) u otra neoplasia.
d) En los labios, párpados, oídos o dentro de las fosas nasales, periorbital, perioral o la piel que rodea las fosas nasales.
2. Presencia en el AT de:
a) Lesiones de QA clínicamente atípicas o que cambian rápidamente
b) Lesiones hiperqueratósicas o hipertróficas, enfermedad recalcitrante (recibió criocirugía en 2 ocasiones previas), o cuerno cutáneo.
c) Lesiones de QA confluentes (es decir, lesiones no discretas, según el criterio de inclusión 2).
d) Lesiones persistentes de QA en la visita de selección tras tratamiento tópico con diclofenaco sódico 3 % en gel.
3. Antecedentes de cualquier tumor maligno de piel en el AT o antecedentes de tumor de piel en cualquier región del cuerpo que haya hecho metástasis o en la que es probable que haya metástasis dentro del período de estudio.
4. Antecedentes de cualquier tumor maligno con tratamiento antitumoral sistémico (incluida la radioterapia) en las 12 semanas anteriores a la visita de selección, o se espera tratamiento antitumoral sistémico durante el estudio.
5. Pacientes inmunocomprometidos, incluidos pacientes con antecedentes de linfoma sistémico crónico o leucemia mieloide crónica, o receptores de trasplantes de órganos.
6. Cualquier otra enfermedad dermatológica que cause dificultad para el examen dentro del área de tratamiento.
7. Necesidad anticipada de hospitalización o cirugía como paciente hospitalizado durante el estudio.
8. Tratamiento previo con tirbanibulina 10 mg/g en pomada, en el AT seleccionado.
9. Tratamiento con 5-fluorouracilo, imiquimod, mebutato de ingenol, diclofenaco, terapia fotodinámica u otros tratamientos tópicos para QA dentro del AT o 2 cm alrededor del AT, en las 8 semanas anteriores a la visita de selección.
10. Uso de las siguientes terapias o medicamentos dentro de las 4 semanas anteriores a la visita de selección:
a) Tratamiento con fármacos citotóxicos (p. Ej., ciclofosfamida, vinblastina, clorambucilo, metotrexato)
b) Tratamiento con medicamentos sistémicos que modulan o suprimen el sistema inmunitario (p. Ej., ciclosporina, prednisona, metotrexato, alefacept, infliximab, interferones o inductores de interferones)
c) Uso de retinoides sistémicos (p. Ej., isotretinoína, acitretina, bexaroteno)
11. Uso de las siguientes terapias o medicamentos en las 2 semanas anteriores a la visita de selección:
a) Procedimientos cosméticos o terapéuticos (p. Ej., uso de nitrógeno líquido, escisión quirúrgica, curetaje, dermoabrasión, exfoliación química de profundidad media o mayor, rejuvenecimiento con láser) dentro del AT o dentro de un margen de 2 cm del AT seleccionado.
b) Productos terapéuticos que contienen ácido (p. Ej., ácido salicílico o ácidos de frutas, como alfa y beta-hidroxiácidos y ácidos glicólicos), retinoides tópicos o exfoliaciones químicas ligeras dentro del AT o dentro de un margen de 2 cm de la AT seleccionado.
c) Esteroides tópicos en el AT o en un margen de 2 cm del AT seleccionado.
d) Bronceadores artificiales dentro del AT o en un margen de 5 cm del AT seleccionado.
12. Antecedentes de sensibilidad o alergia a cualquiera de los ingredientes de los medicamentos del estudio como tirbanibulina, diclofenaco o antiinflamatorios no esteroideos (es decir, AINE).
13. Antecedentes o evidencia de enfermedad de la piel (dermatitis atópica, psoriasis, eczema) o afecciones (cicatrización, heridas abiertas) que no sean la indicación del estudio y que pueda interferir con la conducta o evaluaciones del estudio, o que exponga al sujeto a un riesgo inaceptable por la participación en el estudio.
14. Enfermedades o condiciones médicas significativas no controladas o inestables que, en opinión del investigador, expondrían al paciente a un riesgo inaceptable por la participación en el estudio.
15. Mujeres que están embarazadas o amamantando o que tienen la intención de quedar embarazadas.
16. Participó en un estudio de medicamentos en investigación durante el cual se administró un medicamento del estudio en investigación dentro de los 30 días o 5 semividas del producto en investigación, lo que sea más largo, antes de la selección.
17. Paciente que es empleado o familiar de los empleados del centro de investigación o Almirall.

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients with histologically confirmed invasive SCC in the TF over the 3-year study period.

Proporción de pacientes con SCC invasivo confirmado histológicamente en el AT durante el período de estudio de 3 años.

E.5.1.1

Timepoint(s) of evaluation of this end point

Please refer to E.5.1

Consulte E.5.1

E.5.2

Secondary end point(s)

• AEs and SAEs over 3 years
• Proportion of patients with any other skin cancer (other than SCC) in the TF over the 3-year study period.
• Time to occurrence of invasive SCC from baseline in the TF.
• Proportion of patients requiring rescue treatment after 1 treatment course.
• Proportion of patients requiring rescue treatment at any time during the study.
• Proportion of patients with no lesions after treatment of the first recurrence with tirbanibulin during the first 52 weeks.
• Other safety assessments (vital signs, PE) over 3 years

• AE y SAE durante 3 años
• Proporción de pacientes con cualquier otro cáncer de piel (que no sea SCC) en el AT durante el período de estudio de 3 años.
• Tiempo hasta la aparición de SCC invasivo desde el inicio en el AT.
• Proporción de pacientes que requieren tratamiento de rescate después de 1 curso de tratamiento.
• Proporción de pacientes que requieren tratamiento de rescate en cualquier momento durante el estudio.
• Proporción de pacientes sin lesiones tras el tratamiento de la primera recurrencia con tirbanibulin durante las primeras 52 semanas.
• Otras evaluaciones de seguridad (signos vitales, PE) durante 3 años

E.5.2.1

Timepoint(s) of evaluation of this end point

Please refer to E.5.2

Consulte 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

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

incidence

Incidencia

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

referencia IMP Diclofenaco sódico 3% gel

reference IMP Diclofenac sodium 3% gel

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

Yes

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

France

Germany

Italy

Poland

United Kingdom

Spain

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

last visit of the last patient (LVLP)

Última visita del último paciente (LVLP)

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

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:

190

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

350

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

108

F.4.2

For a multinational trial

F.4.2.1

In the EEA

540

F.4.2.2

In the whole clinical trial

540

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

2022-07-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-07-12

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

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Orphan Designation Number:
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