Summary
EudraCT Number:2022-000049-34
Sponsor's Protocol Code Number:ACT16753
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:2022-07-22
Trial results
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2022-000049-34
A.3Full title of the trial
A Phase 2 double blind, randomized, placebo controlled study evaluating the effect of SAR443820 on serum neurofilament levels in participants with multiple sclerosis, followed by an open label long-term extension period
Estudio en fase II, doble ciego, aleatorizado y controlado con placebo para evaluar el efecto de SAR443820 sobre los niveles séricos de neurofilamentos en participantes con esclerosis múltiple, seguido de un periodo de extensión a largo plazo abierto
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Phase 2 study of SAR443820 in participants with multiple sclerosis (MS)
A.4.1Sponsor's protocol code numberACT16753
A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1271-1257
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorSanofi-aventis recherche & développement
B.1.3.4CountryFrance
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportSanofi-Aventis recherche & développement
B.4.2CountryFrance
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationSanofi-Aventis, S.A
B.5.2Functional name of contact pointUnidad de Estudios Clínicos
B.5.3 Address:
B.5.3.1Street AddressC/ Josep Pla 2, 4ª planta
B.5.3.2Town/ cityBarcelona
B.5.3.3Post code08019
B.5.3.4CountrySpain
B.5.4Telephone number+3493485 94 00
B.5.6E-mail[email protected]
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameSAR443820
D.3.4Pharmaceutical form Film-coated tablet
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNSAR443820
D.3.9.1CAS number 2252271-93-3
D.3.9.2Current sponsor codeSAR443820
D.3.9.3Other descriptive nameRA15804589, C19061501-F, DNL788, DN2489, DN0002489
D.3.9.4EV Substance CodeSUB224044
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number20
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboFilm-coated tablet
D.8.4Route of administration of the placeboOral use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Multiple sclerosis
Esclerosis Múltiple
E.1.1.1Medical condition in easily understood language
Multiple sclerosis
Esclerosis Múltiple
E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.1
E.1.2Level PT
E.1.2Classification code 10028245
E.1.2Term Multiple sclerosis
E.1.2System Organ Class 10029205 - Nervous system disorders
E.1.3Condition being studied is a rare disease Yes
E.2 Objective of the trial
E.2.1Main objective of the trial
- Part A: To assess the effect of SAR443820 compared to placebo on serum neurofilament (sNfL)
- Part B: To assess long-term trends in durability of sNfL
- Parte A: Evaluar el efecto de SAR443820 en comparación con placebo sobre los niveles de neurofilamentos séricos (sNfL)
- Parte B: Evaluar las tendencias a largo plazo en la persistencia de los niveles de sNfL
E.2.2Secondary objectives of the trial
- Part A: To evaluate efficacy of SAR443820 compared to placebo on imaging and clinical endpoints
- Part A: To explore effect of SAR443820 compared to placebo on brain volume and chronic lesions
- Part A: To assess the safety and tolerability of SAR443820
- Part A: To assess pharmacokinetic (PK) of SAR443820
- Part B: To explore the effect of SAR443820 on brain volume and chronic lesions
- Part B: To assess the long-term safety and tolerability of SAR443820
- Part B: To evaluate long-term effect of SAR443820 on disease progression and activity assessed by other clinical and imaging measures on physical function and patient reported outcomes (PROs)
- Parte A: Evaluar la eficacia de SAR443820 en comparación con placebo en los criterios de valoración clínicos y de imagen
- Parte A: Explorar el efecto de SAR443820 en comparación con placebo sobre el volumen cerebral y las lesiones crónicas
- Parte A: Evaluar la seguridad y la tolerabilidad de SAR443820
- Parte A: Evaluar la farmacocinética (FC) de SAR443820
- Parte B: Explorar el efecto de SAR443820 sobre el volumen cerebral y las lesiones crónicas
- Parte B: Evaluar la seguridad y la tolerabilidad a largo plazo de SAR443820
- Parte B: Evaluar el efecto a largo plazo de SAR443820 sobre la progresión de la enfermedad y la actividad evaluadas mediante otras medidas clínicas y de imagen en la función física y en los resultados notificados por el paciente (RNP)
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
- Male or female, 18 to 60 years (inclusive) of age, at the time of signing the informed consent.
- Participants with diagnosis of RRMS, SPMS (relapsing or non-relapsing) or primary progressive subtype according to the 2017 revision of the McDonald diagnostic criteria (SPMS diagnostic criteria according to initial relapsing remitting disease course followed by progression with or without occasional relapses, minor remissions, and plateaus; progression denotes the continuous worsening of neurological impairment over at least 6 months).
- Participants with Expanded Disability Status Scale (EDSS) score of 2-6 inclusive at screening.
- Participants who in the opinion of the Investigator are stable on their disease-modifying therapy (DMT) (past 3 months), and do not require a change in multiple sclerosis (MS) treatment for the duration of Part A (through Week 48).
- Participants with body weight at least 45 kg and body mass index (BMI) at least 18.0 kg/m^2.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
-Participantes de entre 18 y 60 años (inclusive) en el momento de la firma del consentimiento informado.
-Participantes con un diagnóstico de EMRR, EMSP (recidivante o no recidivante) o un subtipo progresivo primario de acuerdo con la revisión de 2017 de los criterios de diagnóstico de McDonald (criterios de diagnóstico de la EMSP de acuerdo con un desarrollo inicial de la enfermedad remitente recidivante seguido de progresión con o sin recidivas ocasionales, remisiones menores y mesetas; la progresión denota el empeoramiento continuo del deterioro neurológico durante al menos 6 meses).
-Participantes con una puntuación de 2-6, inclusive, en la escala expandida del estado de discapacidad (EDSS) en la selección.
-Participantes que, en opinión del investigador, estén estables con su TME (últimos 3 meses) Y que no requieran un cambio en el tratamiento para la EM durante la parte A (hasta la semana 48).
-Participantes con un peso corporal ≥45 kg y un índice de masa corporal (IMC) ≥18,0 kg/m2.
E.4Principal exclusion criteria
Participants are excluded from the study if any of the following criteria apply:

Medical conditions
- Participants with a history of seizures or epilepsy (history of febrile seizure during childhood is allowed).
- Participants with known clinical relapse (acute or subacute episodes of new or increasing neurological dysfunction followed by full or partial recovery, in absence of fever or infection) within 8 weeks of study enrollment.
- Participants with neurological disease history other than MS, eg, head trauma within 3 months, cerebrovascular disease, and vascular dementia.
- Participants with a history of recent serious infection (eg, pneumonia,septicemia) within 4 weeks of screening; an infection requiring hospitalization or intravenous antibiotics, antivirals, or antifungals within 4 weeks of screening; or chronic bacterial infections (such as tuberculosis) deemed unacceptable, as per Investigator’s judgment.
- Participants who have significant cognitive impairment, psychiatric disease, other neurodegenerative disorders (eg, Parkinson disease or Alzheimer disease), substance abuse, or any other conditions that would make the
participants unsuitable for participating in the study or could interfere with assessment or completing the study in the opinion of the Investigator.
- Participants with a documented history of attempted suicide over the 24 weeks prior to the Screening Visit, presents with suicidal ideation of category 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS),or if in the Investigator's judgment, the participant is at risk for a suicide attempt.
- Participants with a history of unstable or severe cardiac, pulmonary, oncological, hepatic, or renal disease or another medically significant illness other than MS precluding their safe participation in this study.
- Participants who received a live vaccine within 14 days before the Screening Visit.
- Participants with a known history of allergy to any ingredients of SAR443820 (mannitol, lactose monohydrate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and microcrystalline cellulose).

Prior/concomitant therapy
- Participants with a current use of any medications that are moderate or strong inhibitors or strong inducers of cytochrome P450 3A4 (CYP3A4).
- Participants with a current use of any of the following medications/treatments: fampridine/dalfampridine, ofatumumab, fingolimod, cladribine, siponimod, ponesimod, ozanimod, alemtuzumab, mitoxantrone, ocrelizumab, natalizumab, or similar approved compounds but with different trade names and any unapproved treatments or therapies for MS. Any DMTs newly approved after July 2022 that are marketed at any time during the course of the double-blind study period. These medications are not allowed within 5 half-lives before the Screening Visit and for the duration of Part A.

Prior/concurrent clinical study experience
- Participants who have prior/concurrent clinical study enrollment, ie, the participant has taken other investigational drugs within 4 weeks or 5 halflives, whichever is longer, before the first Screening Visit; concurrent or recent participation in non-interventional studies may be permitted.

Diagnostic assessments
Participants with abnormal laboratory test(s) at the Screening Visit:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3.0 x upper limit of normal (ULN)
- Bilirubin more than 1.5 x ULN; unless the participant has documented Gilbert syndrome (isolated bilirubin more than 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%)
- Serum albumin less than 3.5 g/dL
- Estimated Glomerular filtration rate less than 60 mL/min/1.73 m^2 (Modification of Diet in Renal Disease [MDRD])
- Other abnormal laboratory values or electrocardiogram (ECG) changes that are deemed clinically significant as per Investigator’s judgment
Se excluirá del estudio a los participantes que cumplan cualquiera de los siguientes criterios:

Afecciones médicas

-Participantes con antecedentes de convulsiones o epilepsia (se permiten los antecedentes de convulsiones febriles durante la infancia).
-Participantes con recidiva clínica conocida (episodios agudos o subagudos de disfunción neurológica nueva o en aumento seguida de recuperación parcial o completa, en ausencia de fiebre o infección) en las 8 semanas previas a la inclusión en el estudio.
-Participantes con antecedentes de enfermedad neurológica distinta de la EM, p. ej., traumatismo craneal en los últimos 3 meses, enfermedad cerebrovascular y demencia vascular.
-Participantes con antecedentes de infección grave reciente (p. ej., neumonía, septicemia) en las 4 semanas anteriores a la selección; infección que requiera hospitalización o antibióticos intravenosos, antivíricos o antifúngicos en las 4 semanas anteriores a la selección; o infección bacteriana crónica (p. ej., tuberculosis) considerada inaceptable según el criterio del investigador.
-Participantes que tengan un deterioro cognitivo importante, enfermedad psiquiátrica, otros trastornos neurodegenerativos (p. ej., enfermedad de Parkinson o Alzheimer), abuso de sustancias o cualquier otra afección que hiciera que los participantes no fueran aptos para participar en el estudio o que, en opinión del investigador, pudiera interferir en la evaluación o la finalización del estudio.
-Participantes con antecedentes documentados de intento de suicidio en las 24 semanas anteriores a la visita de selección; que tengan pensamientos suicidas de categoría 4 o 5 en la escala Columbia para evaluar la seriedad de la ideación suicida (C-SSRS) o si, a juicio del investigador, corren el riesgo de intentar suicidarse.
-Participantes con antecedentes de enfermedad cardíaca, pulmonar, oncológica, hepática o renal, inestable o grave, u otra enfermedad importante desde el punto de vista médico, distinta de la EM que impida su participación segura en este estudio.
-Participantes que recibiesen una vacuna de virus vivos en los 14 días anteriores a la visita de selección.
-Participantes con antecedentes conocidos de alergia a cualquiera de los componentes de SAR443820 (manitol, lactosa monohidrato, glicolato sódico de almidón, dióxido de silicio coloidal, estearato de magnesio, hipromelosa, dióxido de titanio, polietilenglicol y celulosa microcristalina).

Tratamiento previo/concomitante

-Participantes que utilicen actualmente cualquier medicación con inhibidores moderados o potentes o inductores potentes del CYP3A4.
-Participantes que utilicen actualmente cualquiera de los siguientes medicamentos/tratamientos: fampridina/dalfampridina, ofatumumab, fingolimod, cladribina, siponimod, ponesimod, ozanimod, alemtuzumab, mitoxantrona, ocrelizumab, natalizumab o compuestos similares autorizados, pero con diferentes nombres comerciales y cualquier tratamiento o terapia no autorizado para la EM. Cualquier TME de reciente autorización (posterior a julio de 2022) que se comercialice en cualquier momento durante el transcurso del periodo de estudio doble ciego. Estos medicamentos no están permitidos en las 5 semividas anteriores a la visita de selección ni durante la parte A.

Experiencia en estudios clínicos previos/simultáneos

-Participantes que hayan sido incluidos en un estudio clínico previo/simultáneo, es decir, que hayan recibido otros fármacos en investigación en las 4 semanas o 5 semividas anteriores a la primera visita de selección, lo que suponga más tiempo; se permite la participación simultánea o reciente en estudios de observación.
Evaluaciones diagnósticas
-Participantes con resultados anómalos en las pruebas de laboratorio en la visita de selección:
-Alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) >3,0 × el límite superior del valor normal (LSN).
-Bilirrubina >1,5 × LSN; a menos que el participante tenga síndrome de Gilbert documentado (un valor de bilirrubina aislada >1,5 × LSN es aceptable si se fracciona la bilirrubina y la bilirrubina directa es <35 %).
-Albúmina sérica <3,5 g/dl.
-Tasa de filtración glomerular estimada <60 ml/min/1,73 m2 (modificación de la dieta en la enfermedad renal, MDRD).
-Otros valores analíticos anómalos o cambios en el electrocardiograma (ECG) que se consideren clínicamente significativos a criterio del investigador.
E.5 End points
E.5.1Primary end point(s)
1)Part A: Week 48 sNfL levels relative to baseline
2)Part B: Week 96 sNfL levels relative to baseline
1)Parte A: Niveles de sNfL en la semana 48 con respecto al valor inicial
2)Parte B: Niveles de sNfL en la semana 96 con respecto al valor inicial
E.5.1.1Timepoint(s) of evaluation of this end point
1)2)From baseline (Week 0) to Week 48
E.5.2Secondary end point(s)
1)Part A: Cumulative number of new gadolinium (Gd)-enhancing T1 hyperintense lesions as detected by magnetic resonance imaging (MRI)
2)Part A: Cumulative number of new and/or enlarging T2 hyperintense lesions as detected by MRI
3)Part A: Time to onset of 12 weeks confirmed disability progression (CDP) from baseline as assessed by the Expanded Disability Status Scale (EDSS) score
4)Part A: Time to onset of sustained 20% increase in 9-Hole Peg Test (9-HPT) confirmed over at least 12 weeks
5)Part A: Time to onset of sustained 20% increase in timed 25-foot walk test (T25-FW) confirmed over at least 12 weeks
6)Part A: Change from baseline in EDSS Plus
7)Part A: Annualized relapse rate (ARR) of RMS population (relapsing SPMS and RRMS)
8)Part A: Percent change from baseline in brain volume loss (BVL) as detected by brain MRI
9)Part A: Change from baseline in the volume, number, and intensity (T1) of slowly expanding lesions (SELs), and normalized T1 intensity in lesions
10)Part A: Change from baseline in the total number and volume of non-enhancing lesions
11)Part A: Change from baseline in the number of phase rim lesions (PRL) (subset of centers with 3T capacity, 25% of participants)
12)Part A and Part B: Incidence of adverse event(AE), serious adverse event (SAE), treatment emergent adverse event (TEAE), potentially clinically significant abnormality (PCSA) in laboratory tests, electrocardiogram (ECG) and vital signs
13)Part A: Plasma concentration of SAR443820
14)Part B: Percent change from baseline in BVL as detected by brain MRI
15)Part B: Change from baseline in volume, number and intensity (T1) in SEL and normalized T1 intensity in lesions
16)Part B: Change from baseline in the total number and volume of non-enhancing lesions
17)Part B: Change from baseline in the number of PRLs (same participants/centers from Part A with 3T capacity, 25% of participants)
18)Part B: Cumulative number of new Gd enhancing lesions as detected by T1-weighted MRI
19)Part B: number of new or enlarging T2- hyperintense lesions on MRI
20)Part B: ARR of RMS population (relapsing SPMS and RRMS)
21)Part B: Time to onset of composite CDP (CCDP), confirmed over at least 12 weeks (3-month CCDP), by the EDSS Plus composite(EDSS score increase, OR 20% increase in the T25-FW test, OR 20% increase in the 9-HPT)
22)Part B: Time to onset of 12 weeks CDP as assessed by the EDSS score
23)Part B: Time to onset of sustained 20% increase in 9-HPT confirmed over at least 12 weeks
24)Part B: Time to onset of sustained 20% increase T25-FW test confirmed over at least 12 weeks
25)Part B: Change from baseline in EDSS Plus
26)Part B: Change in Multiple Sclerosis Impact Scale -29 version 2 (MSIS-29v2m) physical and psychological domains scoring
27)Part B: Change in Multiple Sclerosis Walking Scale 12 items (MSWS-12m)
1) Parte A: Número acumulado de lesiones hiperintensas en T1 nuevas realzadas con gadolinio (Gd) detectadas por RM
2) Parte A: Número acumulado de lesiones hiperintensas en T2 nuevas y/o en aumento detectadas por RM
3) Parte A: Tiempo hasta el inicio de la progresión confirmada de la discapacidad (PCD) a las 12 semanas con respecto al momento inicial evaluada con la puntuación de la escala expandida del estado de discapacidad (EDSS)
4) Parte A: Tiempo hasta el inicio de un aumento mantenido del 20 % en la prueba de clavijas de 9 orificios (9-HPT) confirmado durante al menos 12 semanas
5) Parte A: Tiempo hasta el inicio de un aumento mantenido del 20 % en la prueba de marcha de 25 pies (8 metros) (T25-FW) confirmado durante al menos 12 semanas
6) Parte A: Cambio con respecto al momento inicial en la escala EDSS Plus
7) Parte A: Tasa de recidiva anual (TRA) de la población con EMR (EMSP recidivante y EMRR)
8) Parte A: Cambio porcentual con respecto al momento inicial en la pérdida de volumen cerebral (PVC) detectada mediante RM cerebral
9) Parte A: Cambio con respecto al momento inicial en el volumen, el número y la intensidad (T1) de las lesiones de evolución lenta (LEL) y en la intensidad T1 normalizada de las lesiones
10) Parte A: Cambio con respecto al momento inicial en el número total y el volumen de las lesiones no realzadas
11) Parte A: Cambio con respecto al momento inicial en el número de lesiones con borde de la fase (PRL) (subconjunto de centros con capacidad para realizar RM de 3T; el 25 % de los participantes)
12) Parte A: Incidencia de AA, AAG, AADT, ACPI en las pruebas de laboratorio
13) Parte A: Concentración plasmática de SAR443820
14) Parte B: Cambio porcentual con respecto al momento inicial en la PVC detectada mediante RM cerebral
15) Parte B: Cambio con respecto al momento inicial en el volumen, el número y la intensidad (T1) de las lesiones LEL y la intensidad en T1 normalizada de las lesiones
16) Parte B: Cambio con respecto al momento inicial en el número total y el volumen de lesiones no realzadas
17) Parte B: Cambio con respecto al momento inicial en el número de PRLs (mismos participantes/centros de la parte A con capacidad para realizar RM de 3T; el 25 % de los participantes)
18) Parte B: Número acumulado de lesiones nuevas realzadas con Gd detectadas por RM ponderada en T1
19) Parte B: Número de lesiones hiperintensas en T2 nuevas o en aumento en la RM
20) Parte B: Tasa de recidiva anual (TRA) de la población con EMR (EMSP recidivante y EMRR)
21) Parte B: Tiempo hasta el inicio de la PCD compuesta (PCDC), confirmada durante al menos 12 semanas (PCDC de 3 meses), por la EDSS Plus compuesta (aumento de la puntuación de la EDSS O aumento del 20 % en la prueba T25-FW O un aumento del 20 % en la 9-HPT)
22) Parte B: Tiempo hasta el inicio de la PCD a las 12 semanas evaluada con la puntuación de la EDSS
23) Parte B: Tiempo hasta el inicio de un aumento mantenido del 20 % en la 9-HPT confirmado durante al menos 12 semanas
24) Parte B: Tiempo hasta el inicio de un aumento mantenido del 20 % en la prueba T25-FW confirmado durante al menos 12 semanas
25) Parte B: Cambio con respecto al momento inicial en la escala EDSS Plus
26) Cambio en la puntuación de los dominios físico y psicológico de la escala MSIS-29v2m
27) Cambio en la escala MSWS-12m
E.5.2.1Timepoint(s) of evaluation of this end point
1)Baseline (Week 0) to Week 48
2)Baseline (Week 0) to Week 48
3)Up to Week 48
4)Up to Week 48
5)Up to Week 48
6)From baseline (Week 0) to Week 48
7)Up to Week 48
8)From baseline (Week 0) to Weeks 48
9)From baseline (Week 0) to Weeks 12, 24, 36 and 48
10)From baseline (Week 0) to Weeks 12, 24, 36 and 48
11)From baseline (Week 0) to Weeks 12, 24, 36 and 48
12)Up to Week 96
13)Up to Week 36
14)From baseline (Week 0) to Week 96
15)From baseline (Week 0) to Weeks 96
16)From baseline (Week 0) to Weeks 96
17)From baseline (Week 0) to Weeks 96
18)Week 48 to Week 96
19)Week 48 to Week 96
20)Up to Week 96
21)Up to Week 96
22)Up to Week 96
23)Up to Week 96
24)Up to Week 96
25)From baseline (Week 0) to Week 96
26)From baseline (Week 0) to Week 96
27)From baseline (Week 0) to Week 96
1.Momento inicial (semana 0) a semana 48
2.Momento inicial (semana 0) a semana 48
3.Hasta semana 48
4.Hasta semana 48
5.Hasta semana 48
6.Desde semana 0 a semana 48
7.Hasta semana 48
8.Desde semana 0 a semana 48
9.Desde semana 0 a semanas 12,24,36 y 48
10.Desde semana 0 a semanas 12,24,36 y 48
11.Desde semana 0 a semanas 12,24,36 y 48
12.Hasta semana 96
13.Hasta semana 36
14.Desde semana 0 a semana 96
15.Desde semana 0 a semana 96
16.Desde semana 0 a semana 96
17.Desde semana 0 a semana 96
18.Semana 48 a semana 96
19.Semana 48 a semana 96
20.Hasta semana 96
21.Hasta semana 96
22.Hasta semana 96
23.Hasta semana 96
24.Hasta semana 96
25.Desde semana 0 a semana 96
26.Desde semana 0 a semana 96
27.Desde semana 0 a semana 96
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Yes
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial2
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned6
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA39
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
Belgium
Canada
China
Czechia
France
Germany
Italy
Poland
Spain
United States
E.8.7Trial 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
La última visita del último paciente
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years2
E.8.9.1In the Member State concerned months11
E.8.9.1In the Member State concerned days9
E.8.9.2In all countries concerned by the trial years2
E.8.9.2In all countries concerned by the trial months11
E.8.9.2In all countries concerned by the trial days9
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 280
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state19
F.4.2 For a multinational trial
F.4.2.1In the EEA 200
F.4.2.2In the whole clinical trial 280
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
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2022-07-21
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2022-06-28
P. End of Trial
P.End of Trial StatusOngoing