Clinical Trials Register

Summary
EudraCT Number:	2020-005135-73
Sponsor's Protocol Code Number:	DC05DUO/2/20
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:	2021-02-09
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2020-005135-73

A.3

Full title of the trial

A Randomised, Double-blind, Two-arm, Parallel Groups, Multicentre Study to evaluate the efficacy and safety of a Fixed Dose Combination of Rupatadine and Montelukast vs. Rupatadine in adult patients with Seasonal Allergic Rhinitis with and without mild to moderate Bronchial Asthma

Un estudio multicéntrico, aleatorizado, doble ciego, de dos brazos, con grupos paralelos para evaluar la eficacia y seguridad de una combinación de dosis fija de rupatadina y montelukast frente a rupatadina en pacientes adultos con rinitis alérgica estacional con y sin asma bronquial leve a moderada

A.3.1

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

A clinical trial to evaluate the safety and the efficacy of a combination of Rupatadine and Montelukast compared to Rupatadine in patients with allergic rhinitis

Un ensayo clínico para evaluar la seguridad y la eficacia de la combinación de rupatadina y montelukast en comparación con solo rupatadina en pacientes con rinitis alérgica

A.3.2

Name or abbreviated title of the trial where available

DREAM-SAR

A.4.1

Sponsor's protocol code number

DC05DUO/2/20

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	Biohorm S.L
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	Biohorm S.L
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	Biohorm S.L
B.5.2	Functional name of contact point	Daniel Peris
B.5.3	Address:
B.5.3.1	Street Address	Av. Camí Reial, 51-57
B.5.3.2	Town/ city	Palau-solità i Plegamans
B.5.3.3	Post code	08184
B.5.3.4	Country	Spain
B.5.4	Telephone number	34937376690
B.5.5	Fax number	34938646606
B.5.6	E-mail	daniel.peris@noucor.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	Rupatadina Uriach 10 mg comprimidos EFG
D.2.1.1.2	Name of the Marketing Authorisation holder	Noucor Health S.A
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Rupatadine
D.3.4	Pharmaceutical form	Tablet
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	RUPATADINE
D.3.9.1	CAS number	158876-82-5
D.3.9.4	EV Substance Code	SUB10406MIG
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	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	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	SINGULAIR 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA
D.2.1.1.2	Name of the Marketing Authorisation holder	MERCK SHARP & DOHME DE ESPAÑA, S.A
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Montelukast
D.3.4	Pharmaceutical form	Tablet
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	Montelukast
D.3.9.1	CAS number	151767-02-1
D.3.9.3	Other descriptive name	MONTELUKAST
D.3.9.4	EV Substance Code	SUB09054MIG
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	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.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	Film-coated tablet
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

Seasonal allergic rhinitis with and without mild to moderate bronchial asthma

Rinitis alérgica estacional con y sin asma bronquial leve a moderada

E.1.1.1

Medical condition in easily understood language

Seasonal alergic rhinitis with or without asthma

Rinitis alérgica estacional con y sin asma

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

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	10001723
E.1.2	Term	Allergic rhinitis
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 demonstrate therapeutic superiority of the test FDC product (rupatadine and motelukast) over rupatadine monotherapy in seasonal allergic rhinitis patients with and without mild to moderate bronchial asthma inadequately controlled.

Demostrar la superioridad terapéutica del producto CDF de prueba (rupatadina y montelukast) sobre la monoterapia con rupatadina en pacientes con rinitis alérgica estacional con y sin asma bronquial leve a moderada no controlada adecuadamente.

E.2.2

Secondary objectives of the trial

To assess efficacy and safety parameters of the fix dose combination and to collect additional data that supports superiority in terms of efficacy versus monotherapy with rupatadine

Evaluar los otros parámetros de eficacia y seguridad de la CDF y recopilar datos adicionales que respalden la superioridad de la eficacia sobre la monoterapia con rupatadina.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Written informed consent in accordance with applicable regulatory requirements.
2. Male and female outpatients aged 18 or more with at least 1-year history of SAR inadequately controlled and in need of alternative treatments as per the treating physicians with or without mild to moderate allergic bronchial asthma.
3. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use methods of contraception (barrier methods and oral contraceptives) throughout the study visits.
4. Positive skin prick test (wheal ± 3 mm larger than the diluent control) to at least one seasonal allergen specific to their geographical location.
5. Evaluation of four nasal symptoms scores (T4NSS) measured as a reflective way (12 hours apart in morning and evening periods) at screening.
6. Adequate wash-out to baseline if patients are taking any of the some medications. Nasal corticosteroids are the unique medication allowed in this period.

Additional inclusion criteria for patients with asthma
1. History of asthma for at least 6 months before screening.
2. Adult patients with mild-to-moderate asthma partially controlled by beclomethasone dipropionate < or = 500 microg/d or equivalent according to GINA guidelines [(alone or in combination with long term beta2-adrenergic bronchodilators).

1) Consentimiento informado por escrito de acuerdo con los requisitos normativos aplicables.
2) Pacientes ambulatorios masculinos y femeninos mayores de 18 años con al menos 1 año de antecedentes de RAE no controlada adecuadamente y que necesitan tratamientos alternativos según los médicos tratantes con o sin asma bronquial alérgica leve a moderada.
3) Las pacientes de sexo femenino con capacidad de concebir y los pacientes masculinos fértiles sexualmente activos con una mujer con capacidad de concebir deben utilizar métodos anticonceptivos (métodos de barrera y anticonceptivos orales) durante las visitas del estudio.
4) Prueba de punción cutánea positiva (habón ± 3 mm más grande que el control del diluyente) para al menos un alérgeno estacional específico de su ubicación .
5) Evaluación de los cuatro síntomas nasales (T4NSS) medidos dos veces al día (con 12 horas de diferencia por la mañana y la noche) en el período de selección.
6) Periodo de reposo farmacológico adecuado hasta el inicio si los pacientes están tomando alguno de los siguientes medicamentos: corticosteroides sistémicos (28 días), ketotifeno (14 días), macrólidos (7 días), antifúngicos imidazólicos (7 días), anticolinérgicos (7 días), montelukast (7 días), cualquier fármaco antiH1 oral (7 días), antihistamínico tópico (nasal o gotas) (2 días), cualquier fármaco con actividad antihistamínica como fenotiazina o derivados (habituales en los remedios para el resfriado) (7 días), descongestivos intranasales/sistémicos o colirios (3 días). Los corticosteroides nasales son el único medicamento permitido en este periodo.

Criterios de inclusión adicionales para pacientes con asma
1) Antecedentes de asma durante 6 meses como mínimo antes de la selección.
2) Se inscribe a pacientes adultos con asma leve a moderada parcialmente controlada con dipropionato de beclometasona < o =500 microg/d o equivalente, solo o en combinación con broncodilatadores adrenérgicos beta2 a largo plazo.

E.4

Principal exclusion criteria

1. Active acute or chronic pulmonary disorder, acute sinus disease that have not resolved within 1 week (active hay fever and AR symptoms are allowed), and upper respiratory tract infection within 3 weeks, emergency department treatment of asthma within 1 month, and hospitalization for asthma within 3 months before the randomization visit.
2. Bronchial asthma patients who receive treatment with inhaled corticosteroids (ICS), alone or in combination with short and/or long term beta2-adrenergic bronchodilators, at dosage >500 microg beclomethasone dipropionate or equivalent (budesonide >400 microg/d, ciclesonide >160 microg/d, fluticasone >250 microg/d and mometasone >400 microg/d) within 2 weeks.
3. Daily treatment with montelukast within 7 days prior to randomization, cetirizine and bilastine (3 days), levocetirizine (2 days), loratadine, desloratadine, rupatadine and any other oral H1 antihistaminic not listed above (6 days), systemic corticosteroids (28 days), ketotifen (2 weeks), macrolides and imidazolic antifungals (7 days), anticholinergic drugs (7 days), topical antihistaminic drugs (e.g. nasal or drops) (2 days), drugs with
antihistamine properties (e. g. phenothiazine) (6 days), intranasal/systemic decongestants and eye drops (3 days).
4. Patients suffering from non-allergic rhinitis (e.g., vasomotor, infectious, or drug-induced rhinitis).
5. Patients who had undergone nasal surgery in the previous 6 months and patients with nasal polyps, significant deviation of the nasal septum, acute or chronic sinusitis.
6. Clinically relevant respiratory tract malformations.
7. Recent nasal biopsy (within 2 months).
8. Nasal trauma; nasal surgery; atrophic rhinitis; rhinitis medicamentosa (within 2 months).
9. Antibiotic use for acute conditions within 2 weeks prior to screening.
10. History of QT prolongation and/or torsade de pointes, including congenital long QT syndromes, history of cardiac arrhythmias.
11. Smokers who report consuming more than 10 cigarettes per day
12. History or presence of an immunodeficiency disorder.
13. Hypersensitivity to any beta-agonist, sympathomimetic drug, leukotriene antagonist.
14. Patients with a known history of HIV, hepatitis B or hepatitis C infection.
15. Any abnormal laboratory value of clinical relevance.
16. Pregnant or nursing mother.
17. Current evidence of any clinically significant disease of the hematopoietic, gastrointestinal, cardiovascular, pulmonary, or any other systems that might hinder the subject participation.
18. Abuse or dependency of alcohol, narcotics, opioids or any other addictive substances.
19. Patients that participated in any type of clinical study within the last month of the screening
date.
20. Unsuitability for enrollment otherwise as decided by the investigator.
21. The drug products contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take these drugs.
22. Patients who had received immunotherapy for less than 6 months (unless on a stable dose within the prior month, and none within 24 hours before any study visit) or any Central Nervous System (CNS) acting agents (including antidepressants, sedatives, anxiolytics, hypnotics, opioids or neuroleptics) at any time.

1) Trastorno pulmonar agudo o crónico activo, enfermedad sinusal aguda que no se ha resuelto en 1 semana (se permiten síntomas de fiebre del heno activa y RA) e infección de las vías respiratorias superiores 3 semanas antes, tratamiento del asma en el servicio de urgencias 1 mes antes y hospitalización por asma dentro de los 3 meses anteriores a la visita de aleatorización.
2) Pacientes con asma bronquial que reciben tratamiento con corticoesteroides inhalados (CEI), solo o en combinación con
broncodilatadores adrenérgicos beta2 a corto o largo plazo, en dosis > 500 microg de dipropionato de beclometasona o equivalente (budesonida >400 microg/d, ciclesonida >160 microg/d, fluticasona >250 microg/d and mometasona >400 μg/d) en un plazo de 2 semanas.
3) Tratamiento diario con montelukast en los 7 días anteriores a la aleatorización, cetirizina y bilastina (3 días), levocetirizina (2 días), loratadina, desloratadina, rupatadina y cualquier otro antihistamínico oral H1 (6 días), corticosteroides sistémicos (28 días), ketotifeno (2 semanas), macrólidos y antifúngicos imidazólicos (7 días), fármacos anticolinérgicos (7 días), fármacos con propiedades antihistamínicas (p. ej., fenotiazina) (6 días), antihistamínicos tópicos (2 días), descongestivos intranasales/sistémicos y colirios (3 días).
4) Pacientes que padecen rinitis no alérgica (p. ej., rinitis vasomotora, infecciosa o inducida por fármacos).
5) Pacientes sometidos a cirugía nasal en los 6 meses previos y pacientes con pólipos nasales, desviación significativa del tabique nasal, sinusitis aguda o crónica.
6) Malformaciones de las vías respiratorias clínicamente relevantes.
7) Biopsia nasal reciente (en un plazo de 2 meses).
8) Trauma nasal, cirugía nasal, rinitis atrófica, rinitis medicamentosa (en un plazo de 2 meses).
9) Uso de antibióticos para afecciones agudas dentro de las 2 semanas anteriores a la selección.
10) Antecedentes de prolongación del QT o torsade de pointes, incluidos síndromes de QT prolongado congénito, antecedentes de arritmias cardíacas.
11) Fumadores que reporten un consumo de más de 10 cigarros al día
12) Antecedentes o presencia de un trastorno de inmunodeficiencia.
13) Hipersensibilidad a cualquier agonista beta, fármaco simpaticomimético, antagonista de leucotrieno.
14) Pacientes con antecedentes conocidos de infección por el virus de la inmunodeficiencia humana (VIH), hepatitis B o hepatitis C.
15) Cualquier valor de laboratorio anormal de relevancia clínica.
16) Madre embarazada o lactante.
17) Evidencia actual de cualquier enfermedad clínicamente significativa de los sistemas hematopoyético, gastrointestinal, cardiovascular, pulmonar o cualquier otro sistema que pueda dificultar la participación del sujeto.
18) Abuso o dependencia del alcohol, narcóticos, opioides o cualquier otra sustancia adictiva.
19) Pacientes que han participado en cualquier tipo de estudio clínico en el mes anterior a la fecha de selección.
20) Cualquier otro tipo de no idoneidad para la inscripción según el criterio del investigador.
21) Los productos farmacéuticos contienen lactosa monohidrato. Los pacientes con problemas hereditarios poco frecuentes de intolerancia a la galactosa, deficiencia de lactasa o malabsorción de glucosa o galactosa no deben tomar estos medicamentos.
22) Pacientes que han recibido inmunoterapia durante menos de 6 meses (a menos que recibieran una dosis estable durante el mes
anterior y ninguna dentro de las 24 h previas a cualquier visita del estudio) o cualquier agente que actúe sobre el sistema nervioso central (incluidos antidepresivos, sedantes, ansiolíticos, hipnóticos, opioides o neurolépticos) en cualquier momento.

E.5 End points

E.5.1

Primary end point(s)

The main efficacy endpoint will be the change in the T4NSS on the 28 day of treatment (PDC reflective 12 hours symptoms, every day including the visit days with the investigator) compared with Day 0.

Cambio en la puntuación total de los síntomas nasales del paciente (T4NSS) el día 28 de tratamiento (el diario del paciente refleja los síntomas durante 12 horas, todos los días) en comparación con el día 0.

E.5.1.1

Timepoint(s) of evaluation of this end point

End of treatment (day 28)

Fin de tratamiento (día 28)

E.5.2

Secondary end point(s)

• Change in the total score of patient symptoms (T7SS) on the 28 day of treatment (reflective evaluation) compared with Day 0.
• Change in the total score of non-nasal patient symptoms (T3NNSS) on the 28 day of treatment (reflective evaluation) compared with Day 0.
• Change in the daily score for each symptom (DSS) on the 28 day of treatment (reflective evaluation) compared with Day 0.
• Mean value of the daily total score of symptoms (mTSS).
• Time to beginning of action (first week).
• Percentage of patients requiring rescue medication.
• Assessment of instantaneous overall effectiveness (both patient and investigator)
• Improvement in quality of life (Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ]) evaluated.
• Incidence of Adverse Events, Related Adverse Events and Serious Adverse Events
• Clinically relevant changes in the physical examination, vital signs, ECG or laboratory results

• Cambio en los síntomas totales (T7SS) el día 28 de tratamiento frente al día 0.
• Cambio en los síntomas totales no nasales (T3NNSS) el día 28 de tratamiento frente al día 0.
• Cambio en la puntuación diaria de cada síntoma el día 28 de tratamiento frente al día 0.
• Valor medio de la puntuación total diaria de síntomas.
• Tiempo hasta el inicio de la acción (primera semana).
• Porcentaje de pacientes que requieren medicación de rescate.
• Eficacia global instantánea (por paciente e investigador).
• Mejoría de la calidad de vida específica evaluada ante la RA (RQLQ).
• Incidencia de acontecimientos adversos, acontecimientos adversos relacionados y acontecimientos adversos graves.
• Descripción de cualquier cambio clínicamente relevante en la exploración física, las constantes vitales, el ECG y los resultados de laboratorio.

E.5.2.1

Timepoint(s) of evaluation of this end point

End of treatment (Day 28)

Fin de tratamiento (día 28)

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

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

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

E.8.6.2

Trial being conducted completely outside of the EEA

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 Patient Last Visit

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 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:

290

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

175

F.4.2

For a multinational trial

F.4.2.1

In the EEA

300

F.4.2.2

In the whole clinical trial

300

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)

Standard of care

Tratamiento estándard

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

2021-02-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-02-09

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials