Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Farmacocinética, seguridad y eficacia de nemolizumab en participantes con dermatitis atópica de moderada a grave

1 de junio de 2026 actualizado por: Galderma R&D

Un ensayo clínico multicéntrico, abierto y de un solo grupo para evaluar la farmacocinética, la seguridad y la eficacia de nemolizumab (CD14152) en sujetos pediátricos (de 2 a 11 años de edad) con dermatitis atópica de moderada a grave

El propósito de este estudio es evaluar la farmacocinética (FC), la eficacia y la seguridad de nemolizumab en participantes pediátricos con dermatitis atópica (DA) de moderada a grave.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

109

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

  • Dinamarca
      • Hellerup, Dinamarca, 2900
        • Galderma Investigational Site #6218
  • España
      • Esplugues de Llobregat, España, 0850
        • Galderma Investigational Site #5896
  • Estados Unidos
    • California
      • Fountain Valley, California, Estados Unidos, 92708-3701
        • Galderma Investigational Site #8636
      • San Diego, California, Estados Unidos, 92123-2746
        • Galderma Investigational Site #9937
      • Vista, California, Estados Unidos, 92083-6031
        • Galderma Investigational Site #9930
    • Florida
      • Coral Gables, Florida, Estados Unidos, 92083-6031
        • Galderma Investigational Site #9929
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46250-2041
        • Galderma Investigational Site #8142
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40217-1444
        • Galderma Investigational Site #8092
    • Michigan
      • Troy, Michigan, Estados Unidos, 48084-5260
        • Galderma Investigational Site #8155
      • West Bloomfield, Michigan, Estados Unidos, 48322
        • Galderma Investigational Site #8560
    • New York
      • Brooklyn, New York, Estados Unidos, 11203-2012
        • Galderma Investigational Site #8242
      • New York, New York, Estados Unidos, 10032-3729
        • Galderma Investigational Site #9938
    • Oklahoma
      • Norman, Oklahoma, Estados Unidos, 73069-6301
        • Galderma Investigational Site #8206
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19103-4708
        • Galderma Investigational Site #8255
    • Texas
      • Beaumont, Texas, Estados Unidos, 77706-3061
        • Galderma Investigational Site #9931
      • San Antonio, Texas, Estados Unidos, 78218-3128
        • Galderma Investigational Site #78218-3128
  • Hungría
      • Budapest, Hungría, 1036
        • Galderma Investigational Site #6147
      • Szeged, Hungría, 6720
        • Galderma Investigational Site #5531
  • Polonia
      • Lodz, Polonia, 90-265
        • Galderma Investigational Site #5570
      • Ostrowiec Świętokrzyski, Polonia, 27-400
        • Galderma Investigational Site #6237
      • Rzeszów, Polonia, 35-055
        • Galderma Investigational Site #5495
      • Warsaw, Polonia, 02-953
        • Galderma Investigational Site #6262
      • Wroclaw, Polonia, 51-685
        • Galderma Investigational Site #6261

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

2 años a 12 años (Niño)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • AD crónica documentada durante al menos 6 meses para participantes de 2 a 6 años y al menos 1 año para participantes de 7 a 11 años antes de la visita de selección y confirmada de acuerdo con los criterios de consenso de la Academia Estadounidense de Dermatología en el momento de la visita. visita de selección
  • Puntuación EASI >=16 en las visitas de selección y de referencia
  • Puntuación IGA >=3 en las visitas de selección y de referencia
  • Compromiso de AD >=10 % del BSA en las visitas de selección y de referencia
  • Puntaje pico (máximo) de PP NRS de al menos 4.0 en las visitas de selección y de referencia
  • Aceptar aplicar una crema hidratante durante todo el estudio desde la visita de selección todos los días, y generosamente según sea necesario; aceptar aplicar un corticosteroide tópico autorizado (TCS) desde la visita de selección y durante todo el estudio según lo determine el investigador
  • Participante y cuidador dispuestos y capaces de cumplir con todos los compromisos de tiempo y requisitos de procedimiento del protocolo del ensayo clínico
  • Podrían aplicarse otros criterios de inclusión definidos en el protocolo

Criterio de exclusión:

  • Peso corporal inferior a 10 kilogramos (kg)
  • Niño bajo tutela: un niño que ha sido puesto bajo el control o protección de una agencia, organización, institución o entidad por los tribunales, el gobierno o un organismo gubernamental, actuando de acuerdo con los poderes que les confiere la ley o el reglamento.
  • Participantes con antecedentes médicos actuales de bronquitis crónica
  • Requiere terapia de rescate para AD durante el período de preinclusión o se espera que requiera terapia de rescate dentro de las 2 semanas posteriores a la visita inicial
  • Resultados serológicos positivos para el antígeno de superficie de la hepatitis B (HBsAg) o el anticuerpo central de la hepatitis B (HBcAb), el anticuerpo contra la hepatitis C (VHC) con una prueba confirmatoria positiva para el VHC (ejemplo, reacción en cadena de la polimerasa [PCR]) o el virus de la inmunodeficiencia humana (VIH) anticuerpos en la visita de selección
  • Antecedentes de enfermedad linfoproliferativa, hipersensibilidad (incluida la anafilaxia) a un producto de inmunoglobulina e intolerancia a los corticosteroides tópicos de potencia baja o media
  • Inmunosupresión conocida o sospechada
  • Participantes que no estén dispuestos a abstenerse de usar medicamentos prohibidos durante el ensayo clínico.
  • Podrían aplicarse otros criterios de exclusión definidos en el protocolo

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: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cohorte 2: participantes de 2 a 6 años
Los participantes de 2 a 6 años recibirán nemolizumab durante 52 semanas.
Droga: Nemolizumab
Los participantes recibirán una inyección subcutánea (SC) de 10, 20 o 30 miligramos (mg) de nemolizumab, cada 4 semanas (Q4W) durante 52 semanas con una dosis de carga de 20, 40 o 60 mg en el día 1 según el peso corporal.
Otros nombres:
  • CD14152
Droga: Nemolizumab
Los participantes recibirán una inyección SC de 5, 10 o 15 mg de nemolizumab, Q4W durante 52 semanas con una dosis de carga de 10, 20 o 30 mg en el día 1 según el peso corporal.
Otros nombres:
  • CD14152
Experimental: Cohorte 1.1: Participantes de 7 a 11 años
Los participantes de 7 a 11 años recibirán nemolizumab durante 52 semanas.
Droga: Nemolizumab
Los participantes recibirán una inyección subcutánea (SC) de 10, 20 o 30 miligramos (mg) de nemolizumab, cada 4 semanas (Q4W) durante 52 semanas con una dosis de carga de 20, 40 o 60 mg en el día 1 según el peso corporal.
Otros nombres:
  • CD14152
Droga: Nemolizumab
Los participantes recibirán una inyección SC de 5, 10 o 15 mg de nemolizumab, Q4W durante 52 semanas con una dosis de carga de 10, 20 o 30 mg en el día 1 según el peso corporal.
Otros nombres:
  • CD14152
Experimental: Cohorte 1: Participantes de 7 a 11 años
Los participantes de 7 a 11 años recibirán nemolizumab durante 52 semanas.
Droga: Nemolizumab
Los participantes recibirán una inyección subcutánea (SC) de 10, 20 o 30 miligramos (mg) de nemolizumab, cada 4 semanas (Q4W) durante 52 semanas con una dosis de carga de 20, 40 o 60 mg en el día 1 según el peso corporal.
Otros nombres:
  • CD14152
Droga: Nemolizumab
Los participantes recibirán una inyección SC de 5, 10 o 15 mg de nemolizumab, Q4W durante 52 semanas con una dosis de carga de 10, 20 o 30 mg en el día 1 según el peso corporal.
Otros nombres:
  • CD14152

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Nemolizumab Serum Concentrations
Periodo de tiempo: At Weeks 4, 8, 12, 16, 32 and 52
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
At Weeks 4, 8, 12, 16, 32 and 52
Apparent Total Body Clearance (Cl/F) of Nemolizumab
Periodo de tiempo: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
CL/F is apparent clearance of the drug from the serum, calculated as the drug dose divided area under the curve from time 0 extrapolated to infinite time [AUC (0-inf)]. Individual nemolizumab.
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Apparent Volume of Distribution (Vd/F) of Nemolizumab
Periodo de tiempo: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Vd/F was calculated as dose divided by lambda_z *AUC(0-inf).
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Absorption Rate Constant (Ka) of Nemolizumab
Periodo de tiempo: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Nemolizumab
Periodo de tiempo: Pre-dose at Weeks 4, 8, 12, and 16
Pre-dose at Weeks 4, 8, 12, and 16
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Nemolizumab
Periodo de tiempo: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Apparent Terminal Half-life (t1/2) of Nemolizumab
Periodo de tiempo: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), Adverse Events Leading to Discontinuation and Serious Adverse Events (SAEs)
Periodo de tiempo: Baseline through Week 52
AE defined as any untoward medical occurrence in clinical study participant administered a medicinal product which does not necessarily have causal relationship with this treatment. TEAEs defined as AEs occurring after first administration of study drug during the study. SAE was any untoward medical occurrence, in view of either Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was important medical event. AESI was noteworthy TEAE for study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. AEs Leading to study treatment withdrawal and AEs Leading to study withdrawal will also be reported.
Baseline through Week 52

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52
Periodo de tiempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in EASI Score
Periodo de tiempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Number of Participants Achieving 50 Percent (%), 75% or 90% Response From Baseline in EASI (EASI-50, EASI-75 and EASI-90)
Periodo de tiempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis. EASI-50, EASI-75 and EASI-90 responders will be the participants who achieved greater than or equal to (>=) 50%, >=75% and >=90% overall improvement in EASI score respectively from baseline to Week 52.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Number of Participants With Investigator's Global Assessment (IGA) Success Rate
Periodo de tiempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of AD. The Investigator reviewed the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe). Here, higher score indicates severe outcome. Success was defined as an IGA of 0 [Clear] or 1 [Almost clear] and a >=2-points improvement from baseline. Number of participants with IGA success rate was reported for this outcome measure.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Baseline in Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD)
Periodo de tiempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and reported as a percentage of all major body sections combined. The reported percentage of BSA was combined percentage of all major body sections.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score
Periodo de tiempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percent Change From Baseline in Weekly Average of PP NRS Score
Periodo de tiempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percentage of Participants With an Improvement of >= 4 From Baseline in Weekly Average of PP NRS
Periodo de tiempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in Weekly Average of Average Pruritus NRS Score
Periodo de tiempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percent Change From Baseline in Weekly Average of Average Pruritus NRS Score
Periodo de tiempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in Weekly Average of Sleep Disturbance NRS Score
Periodo de tiempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percent Change From Baseline in Weekly Average of Sleep Disturbance NRS Score
Periodo de tiempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percentage of Participants Receiving Any Rescue Therapy by Rescue Treatment
Periodo de tiempo: From Baseline up to Week 52
Percentage of participants receiving any rescue therapy by rescue treatment was reported.
From Baseline up to Week 52
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
Periodo de tiempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
SCORAD is a clinical tool for assessing the severity and the extent of AD signs and symptoms. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranged from 0 (absent disease) to 103 (severe disease), a higher score indicated severe disease.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) For Participants >=4 Years of Age
Periodo de tiempo: Baseline, Week 16 and Week 52
The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant rated each question ranging from 0 (not at all) to 3 (very much) and score ranged from 0 to 30. A higher total score indicated a poorer quality of life (QoL).
Baseline, Week 16 and Week 52
Change From Baseline in Infants' Dermatology Life Quality Index (iDLQI) Score For Participants Less Than (<) 4 Years of Age
Periodo de tiempo: Baseline, Week 16 and Week 52
The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant rated each question ranging from 0 (not at all) to 3 (very much) and score ranged from 0 to 30. A higher total score indicated a poorer QoL.
Baseline, Week 16 and Week 52
Change From Baseline in Patient-Oriented Eczema Measure (POEM)
Periodo de tiempo: Baseline, Week 16 and Week 52
The POEM is a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease). A high score indicated poor QOL.
Baseline, Week 16 and Week 52
Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in PP NRS
Periodo de tiempo: Baseline up to Week 52
The relationship between nemolizumab serum concentrations and changes in PP-NRS score was established using population point estimate of IC50, where IC50 is the concentration leading to half of the maximum drug-induced reduction (Imax) in PP NRS.
Baseline up to Week 52
PK/PD Relationship Between Nemolizumab Serum Concentration and Changes in EASI Score
Periodo de tiempo: Baseline up to Week 52
The relationship between nemolizumab serum concentrations and changes in EASI score was established using population point estimate of IC50. Where, IC50 is the concentration leading to half of the maximum drug-induced reduction (Imax) in EASI score.
Baseline up to Week 52
PK/PD Relationship Between Nemolizumab Serum Concentration and Changes in IGA Score
Periodo de tiempo: Baseline up to Week 52
The relationship between nemolizumab serum concentrations and changes in IGA score was established using the population point estimate of the slope parameter.
Baseline up to Week 52
Number of Participants With Positive Anti-Drug Antibody (ADA) for Nemolizumab
Periodo de tiempo: Baseline, Week 16 and Week 52
ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.
Baseline, Week 16 and Week 52

Colaboradores e Investigadores

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

Patrocinador

Galderma R&D

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)

24 de junio de 2021

Finalización primaria (Actual)

28 de abril de 2025

Finalización del estudio (Actual)

28 de abril de 2025

Fechas de registro del estudio

Enviado por primera vez

4 de junio de 2021

Primero enviado que cumplió con los criterios de control de calidad

4 de junio de 2021

Publicado por primera vez (Actual)

10 de junio de 2021

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 abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RD.06.SPR.118126

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. .

Suscribir