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Seguridad, tolerabilidad, farmacocinética, farmacodinamia y eficacia de SAR442501 en participantes pediátricos con acondroplasia (upreACH-2)

1 de junio de 2026 actualizado por: Sanofi

Un estudio de fase 2, abierto, multicéntrico, de cohorte secuencial de 2 etapas, de aumento de dosis para evaluar la seguridad, tolerabilidad, farmacocinética, farmacodinamia y eficacia del SAR442501 subcutáneo en participantes pediátricos con acondroplasia

Este es un estudio de fase 2, abierto y multicéntrico para evaluar la seguridad, tolerabilidad y eficacia de SAR442501 en niños desde el nacimiento hasta los 12 años con acondroplasia.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Hasta aproximadamente 275 semanas: 3 semanas de selección + 52 semanas de período de tratamiento primario + hasta aproximadamente 216 semanas de período de tratamiento extendido + 4 semanas de seguimiento.

Tipo de estudio

Intervencionista

Inscripción (Actual)

16

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Investigational Site Number : 0360001
  • Corea del Sur
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, Corea del Sur, 03080
        • Investigational Site Number : 4100001
      • Seoul, Seoul-teukbyeolsi, Corea del Sur, 06351
        • Investigational Site Number : 4100002
  • España
    • Basque Country
      • Vitoria-Gasteiz, Basque Country, España, 01008
        • Investigational Site Number : 7240002
    • Catalunya [Cataluña]
      • Esplugues de Llobregat, Catalunya [Cataluña], España, 08950
        • Investigational Site Number : 7240001
  • Italia
    • Lombardy
      • Milan, Lombardy, Italia, 20122
        • Investigational Site Number : 3800002
    • Roma
      • Rome, Roma, Italia, 00168
        • Investigational Site Number : 3800001
  • Porcelana
      • Shanghai, Porcelana, 200120
        • Investigational Site Number : 1560002
      • Wuhan, Porcelana, 430030
        • Investigational Site Number : 1560001

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Los participantes deben tener ACH con una mutación confirmada en el gen FGFR3.
  • Los participantes y/o padres o representantes legales deben estar dispuestos y ser capaces de realizar todos los procedimientos del estudio lo mejor que puedan.
  • Padres o representantes legales capaces de dar consentimiento informado firmado y participantes capaces de dar su consentimiento cuando corresponda.

Criterio de exclusión:

  • Tiene hipocondroplasia (o la mutación N540K) o una afección de baja estatura distinta de la ACH (p. ej., trisomía 21, pseudocondroplasia)
  • Los participantes han recibido cualquier dosis de medicamentos o producto en investigación, incluida la hormona del crecimiento humano, destinada a afectar la estatura o las proporciones corporales de los participantes dentro de los 6 meses posteriores a la inscripción (Semana 0/Día 1/Visita 2).
  • Tener antecedentes de cierre de la placa de crecimiento.
  • Fractura de hueso largo dentro de los 3 meses posteriores a la inscripción (Semana 0/Día 1/Visita 2)
  • Evidencia actual de trastorno/queratopatía corneal o retiniana.
  • Los participantes han tenido una intervención quirúrgica previa que afectó al agujero magno (solo etapa 2).
  • Hiperfosfatemia.

La información anterior no pretende contener todas las consideraciones relevantes para una posible participación en un ensayo clínico.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cohorte 1
Droga: SAR442501
Solución inyectable; Inyección subcutánea
Experimental: Cohorte 2
Droga: SAR442501
Solución inyectable; Inyección subcutánea
Experimental: Cohorte 3
Droga: SAR442501
Solución inyectable; Inyección subcutánea

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Stage 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Periodo de tiempo: From the first dose of study drug administration (Day 1) up to early termination of the study, approximately 58 weeks (Stage 1: SAR442501 Dose A) and 46 weeks (Stage 1: SAR442501 Dose B)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was defined as any untoward medical occurrence (whether considered to be related to study drug or not) that at any dose: resulted in death; or was life-threatening; or required inpatient hospitalization or prolongation of existing hospitalization; or resulted in persistent or significant disability/incapacity; or was a congenital anomaly/birth defect; or was an important medical event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. The TEAEs were defined as events that were newly reported or reported to worsen in severity after the start of study drug up to 5 days post last dose of the study drug.
From the first dose of study drug administration (Day 1) up to early termination of the study, approximately 58 weeks (Stage 1: SAR442501 Dose A) and 46 weeks (Stage 1: SAR442501 Dose B)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Stage 1: Change From Baseline to Weeks 26 and 52 in Growth Velocity Z-Score
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
Post-treatment annualized growth velocity (AGV) was calculated from height measurements collected during the study. AGV was calculated as: AGV (centimeter per year)= (Height at Date 2 - Height at Date 1) divided by interval length in days x 365.25, where interval length in days was calculated as (Date 2 - Date 1+1). Z scores were calculated using LMS methods (Box Cox power L, Median M and Variation S), where appropriate: If L≠ 0: Z= [(AGV/M)^L-1]/(LxS); If L= 0: Z= ln(AGV/M)/S. A Z score of 0 represents the mean AGV of the reference achondroplasia (ACH) population. For AGV Z scores in children with ACH: Higher Z scores represent better outcomes, meaning faster linear growth relative to age and sex matched reference populations. Lower Z scores represent worse outcomes, indicating slower growth compared to reference norms. Baseline value was defined as last available pre dose height measurement meeting statistical analysis plan specified time interval definitions.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Annualized Growth Velocity
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
The AGV was defined as follows: (Height at Date 2 - height at Date 1) divided by interval length in days x 365.25, where the interval length in days was calculated as (Date 2 - Date 1 +1) days. The post-treatment AGV was calculated from height measurements collected during the study. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Height Z-Score
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
Post-treatment AGV was calculated from height measurements collected during the study. AGV was calculated as: AGV (centimeter per year)= (Height at Date 2 - Height at Date 1) divided by interval length in days x 365.25, where interval length in days was calculated as (Date 2 - Date 1+1). Z scores were calculated using LMS methods (Box Cox power L, Median M and Variation S), where appropriate: If L≠ 0: Z= [(AGV/M)^L-1]/(LxS); If L= 0: Z= ln(AGV/M)/S. A Z score of 0 represents the mean AGV of the reference population (ACH). For AGV Z scores in children with ACH: Higher Z scores represent better outcomes, meaning faster linear growth relative to age and sex matched reference populations. Lower Z scores represent worse outcomes, indicating slower growth compared to reference norms. Baseline value was defined as last available pre dose height measurement meeting statistical analysis plan specified time interval definitions.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Upper to Lower Body Segment Ratio
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
The upper to lower body segment ratio was calculated by (standing height or total length - lower body segment length) divided by lower body segment length. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Upper to Lower Extremity Ratio
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
The upper to lower extremity ratio was calculated by (upper arm + forearm length) divided by (upper leg + lower leg length). The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Sitting to Standing Height Ratio
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
The sitting to standing height ratio was calculated by sitting height divided by standing height, or crown to rump length divided by total length. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Arm Span to Height Ratio
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
The arm span to height ratio was calculated by arm span divided by standing height, or arm span divided by total length. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Upper Arm to Forearm Length Ratio
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
The upper arm to forearm length ratio was calculated by upper arm length divided by forearm length. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Upper Leg to Lower Leg Ratio
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
The upper leg to lower leg length ratio was calculated by upper leg length divided by lower leg length. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Head Circumference to Height Ratio
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
The head circumference to height ratio was calculated by head circumference divided by standing height, or head circumference divided by total length. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 2: Change From Baseline to Week 52 in Brainstem, Skull, and Spine Morphometric and Volumetric Parameters
Periodo de tiempo: Baseline (Day 1) and Week 52
The magnetic resonance imaging was planned to be collected to measure foramen magnum and other brainstem, skull, and spine morphometric parameters in Stage 2 participants. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Week 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Social Score, Emotional Score, and School Functioning Score
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
The pediatric quality of life (PedsQL) Generic Core Scales assesses pediatric health related quality of life (HRQOL) across functioning domains. Items use a 5-point scale (0=Never to 4=Almost Always). Responses are reverse scored and linearly transformed to a 0-100 scale (0→100, 1→75, 2→50, 3→25, 4→0), where higher scores indicate better quality of life (fewer problems). Domain scores for Social, Emotional, and School Functioning are calculated from the transformed item scores. If more than 50% of items in a domain are missing, the domain score is not computed. If at least 50% are completed, the domain score equals the mean of the non missing transformed item scores. All domain scores range from 0 (almost always) to 100 (never), with higher scores indicate better HRQOL. Baseline was defined as the last available value prior to the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Psychosocial Health Summary Score, Physical Health Summary Score, and Total Score
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
The PedsQL core scale was a brief, standardized, generic instrument that was used to measure HRQOL in various pediatric conditions. Psychosocial health summary scores were the meaning of item scores in emotional, social, and school functioning scales; and Physical health summary scores were the meaning of item scores in physical scale. Total score was the mean of all the item scores in all scales. Psychosocial and physical health summary scores and total scores each ranged from 0 (almost always) to 100 (never). Higher scores indicate better HRQOL. For participants aged 5 to 7, only parents completed the questionnaire. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Mobility Score
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
The screening tool for everyday mobility and symptoms (STEMS) was completed by clinicians for participants 5 years of age and older. The STEMS captures mobility, use of mobility aides, and impact of pain and/or fatigue at the end of the day across 3 environments: home, school/work and community. Mobility aides were recorded using numeric 5-point rating scale, score ranged from 1 to 5, where 1= independent on all surfaces including stairs, 2= use of sticks, 3= use of crutches, 4= use of wheeled walking device, and 5= use of wheelchair or mobility scooter. Lower score indicated the better outcome. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Participants Reported Symptoms
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
The STEMS was completed by clinicians for participants 5 years of age and older. The STEMS captures mobility, use of mobility aides, and impact of pain and/or fatigue at the end of the day across 3 environments: home, school/work and community. Participant reported symptoms were recorded using letters where A= no pain or fatigue, B1= pain only, B2= fatigue and C= pain and fatigue. This was completed for each of the 3 environments resulting in 3 scores, whereby the numeric rating reflects the use of mobility aides and the letter reflects the symptoms. The baseline value was defined as the last available value before the first dose of study drug. Only participants with a Baseline response of "A" were included in the "A to A," "A to B1," and "A to missing" categories at each time point. Similarly, only participants with a Baseline response of "B1" were included in the "B1 to A" and "B1 to missing" categories at each time point.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in General Fatigue, Sleep/Rest Fatigue and Cognitive Fatigue Scores and Total Score
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
The PedsQL Multidimensional Fatigue Scale measures fatigue across 3 subscales:General Fatigue, Sleep/Rest Fatigue and Cognitive Fatigue. Items are rated on a 5 point scale (0=Never to 4=Almost Always). Responses are reverse scored and linearly transformed to a 0-100 scale (0→100, 1→75, 2→50, 3→25, 4→0), with higher scores indicate less fatigue and better functioning. Subscale scores are calculated as mean of transformed item scores within each subscale. A Total Score was calculated as mean of all transformed items across subscales. If more than 50% of items are missing within a subscale or across total scale, corresponding score is not computed. If at least 50% are completed, scores are calculated as mean of non missing transformed items. All scores range from 0 (no pain) to 100 (severe pain), with higher scores indicate less fatigue. Baseline was defined as last available value prior to first dose of study drug. For participants aged 5-7 years, only parent proxy report was completed.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Current Pain and Worst Pain Rating (PPQ) Score
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
The PedsQL PPQ assesses current pain and worst pain intensity in the last week using a visual analog scale as well as pain location using a body map. Current and worst pain were scored separately, and scoring was based on the line length to the nearest 0.5 centimeter (5 millimeter). The score ranged from 0 (no pain) to 100 (severe pain), where higher scores indicated greater levels of pain intensity. The PedsQL PPQ was only administered in participants ages 5 years of age and older using both self-report (ages 8 and older) and parent proxy report (ages 5 and older) forms in all countries. For participants aged 5 to 7, only parents completed the questionnaire. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 2: Change From Baseline to Week 52 in Achievement of Gross Motor, Fine Motor, Communication, and Feeding Milestones
Periodo de tiempo: Baseline (Day 1) and Week 52
For Stage 2 participants, achievement of developmental milestones was planned to be assessed using the ACH developmental recording form. This form allows developmental milestones to be recorded and was not a formalized screening tool or assessment. The form measures the domains of gross motor function, fine motor function, communication and feeding via participant reports to the Investigator. The form depicts the cumulative percentage distributions for children with ACH for each item as well as norms for reference based on the Denver II test, where available. Data collected via this form was planned to be evaluated descriptively to explore the age at which participants in this study achieve developmental milestones. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Week 52
Stage 1: Plasma Concentration of SAR442501
Periodo de tiempo: Pre-dose and 6, 24 and 72 hours post dose on Day 1; Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
Blood samples are collected to determine plasma concentration of SAR442501.
Pre-dose and 6, 24 and 72 hours post dose on Day 1; Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
Stage 1: Maximum Observed Plasma Concentration (Cmax) of SAR442501
Periodo de tiempo: Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
Blood samples are collected to determine Cmax of SAR442501. The Cmax of SAR442501 was calculated using non-compartmental method.
Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
Stage 1: Time to Reach the Maximum Concentration (Tmax) of SAR442501
Periodo de tiempo: Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
Blood samples are collected to determine tmax of SAR442501. The tmax of SAR442501 was calculated using non-compartmental method.
Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
Stage 1: Area Under the Concentration Versus Time Curve From Time 0 to 72 Hours After Study Drug Administration (AUC0-tau) of SAR442501
Periodo de tiempo: Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
Blood samples are collected to determine AUC0-tau of SAR442501. The AUC0-tau of SAR442501 was calculated using non-compartmental method.
Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
Stage 1: Minimum Plasma Concentration (Ctrough) of SAR442501
Periodo de tiempo: Pre-dose on Days 8, 29, 57, 92, 183, 274, 365 and 449
Blood samples are collected to determine Ctrough of SAR442501. The Ctrough of SAR442501 was calculated using non-compartmental method.
Pre-dose on Days 8, 29, 57, 92, 183, 274, 365 and 449
Stage 1: Change From Baseline to Week 26 in Collagen X Biomarker (CXM) Level
Periodo de tiempo: Baseline (Day 1) and Week 26
Serum samples were collected to assess the change in CXM level with study drug. The CXM was also named PRO-C10 because the biomarker assay used was aimed to target the recognition of the C terminus of the NC1 domain of type X collagen. The baseline value was defined as the last available value before the first dose of study drug. Change from baseline in CXM level has been reported.
Baseline (Day 1) and Week 26
Stage 1: Change From Baseline to Weeks 26 and 52 in Osteocalcin Level
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
Serum samples were collected to assess the change in osteocalcin level with study drug. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Bone-Specific Alkaline Phosphatase Level
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
Serum samples were collected to assess the change in bone-specific alkaline phosphatase level with study drug. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Procollagen Type 1 N-Terminal Propeptide (P1NP) Level
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
Serum samples were collected to assess the change in P1NP level with study drug. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Collagen-Type 1 C-Telopeptide (CTX) Level
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
Serum samples were collected to assess the change in CTX level with study drug. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Number of Participants With Anti-drug Antibodies (ADA) to SAR442501
Periodo de tiempo: From the first dose of study drug administration (Day 1) up to early termination of the study, approximately 58 weeks (Stage 1: SAR442501 Dose A) and 46 weeks (Stage 1: SAR442501 Dose B)
Serum samples were collected to assess the antibodies to SAR442501. Samples were screened and then confirmed for antibodies binding to SAR442501 and the titer of confirmed positive samples were reported. Positive ADA refers to pre-existing ADA at the pre-dose assessment on Day 1.
From the first dose of study drug administration (Day 1) up to early termination of the study, approximately 58 weeks (Stage 1: SAR442501 Dose A) and 46 weeks (Stage 1: SAR442501 Dose B)
Stage 2: Number of Participants With Change From Baseline to Weeks 26 and 52 in Neurological Examination Findings
Periodo de tiempo: Baseline (Day 1) and Weeks 26 and 52
A complete neurological examination included assessment of mental status, motor function and balance, sensory exam, newborn and infant reflexes, muscle stretch reflexes in the older children and evaluation of the cranial nerves. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Sanofi

Investigadores

  • Director de estudio: Clinical Sciences & Operations, Sanofi

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de octubre de 2023

Finalización primaria (Actual)

12 de febrero de 2025

Finalización del estudio (Actual)

12 de febrero de 2025

Fechas de registro del estudio

Enviado por primera vez

20 de septiembre de 2023

Primero enviado que cumplió con los criterios de control de calidad

28 de septiembre de 2023

Publicado por primera vez (Actual)

4 de octubre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • DRI16646
  • U1111-1280-5374 (Identificador de registro: ICTRP)
  • 2023-503677-37 (Identificador de registro: CTIS)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Los investigadores calificados pueden solicitar acceso a los datos a nivel del paciente y a los documentos del estudio relacionados, incluido el informe del estudio clínico, el protocolo del estudio con modificaciones, el formulario de informe de caso en blanco, el plan de análisis estadístico y las especificaciones del conjunto de datos. Los datos a nivel de paciente se anonimizarán y los documentos del estudio se redactarán para proteger la privacidad de los participantes del ensayo. Puede encontrar más detalles sobre los criterios de intercambio de datos de Sanofi, los estudios elegibles y el proceso para solicitar acceso en: https://vivli.org

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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