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Estudio de M5049 en participantes de DM y PM (NEPTUNIA)

17 de agosto de 2026 actualizado por: EMD Serono Research & Development Institute, Inc.

Estudio de fase IIa, aleatorizado, paralelo, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de Enpatoran en participantes con dermatomiositis y polimiositis que reciben atención estándar (NEPTUNIA)

El propósito de este estudio es evaluar la eficacia y seguridad de M5049 administrado por vía oral en pacientes con miopatías inflamatorias idiopáticas, específicamente dermatomiositis (DM) y polimiositis (PM) durante 24 semanas.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

20

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

  • Chequia
      • Prague, Chequia
        • Institute of Rheumatology - Rheumatology
  • España
      • A Coruña, España
        • CHUAC - Complexo Hospitalario Universitario A Coruña - Rheumatology
      • Barcelona, España
        • Hospital Vall d'Hebron
      • Madrid, España
        • Hospital Universitario Ramon y Cajal, Madrid - Rheumatology Department
  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85028
        • Neuromuscular Research Center
      • Scottsdale, Arizona, Estados Unidos, 85251
        • HonorHealth Research Institute - Bob Bove Neuroscience Institute-Neuroscience Research
      • Scottsdale, Arizona, Estados Unidos, 85259
        • Mayo Clinic Scottsdale (6365)
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Barbara Davis Center
    • Florida
      • Orlando, Florida, Estados Unidos, 32819
        • HMD Research LLC
      • Pembroke Pines, Florida, Estados Unidos, 33026
        • Bolanos Clinical Research
    • Georgia
      • Augusta, Georgia, Estados Unidos, 30912
        • Augusta University-Rheumatology
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21224
        • Johns Hopkins University - Department of Medicine, Division of Rheumatology
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • University of Minnesota-Dermatology
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 66103
        • University of Kansas Medical Center-Neuromuscular
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • University of Pittsburgh
    • Texas
      • Austin, Texas, Estados Unidos, 78759
        • Austin Neuromuscular Center
      • Houston, Texas, Estados Unidos, 77030
        • Nerve and Muscle Center of Texas-Clinical research
  • Grecia
      • Athens, Grecia
        • Hippokration Hospital - 2nd Department of Medicine and Laboratory
      • Athens, Grecia
        • National and Kapodistrian University of Athens (Egnitio Hospital)
      • Larissa, Grecia
        • University General Hospital of Larissa
  • Italia
      • Catania, Italia
        • Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco Di Catania (Vittorio Emanuele) - Reumatologia
      • Catania, Italia
        • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
      • Florence, Italia
        • Azienda Usl Toscana Centro
      • Reggio Emilia, Italia
        • Arcispedale S. Maria Nuova
      • Rome, Italia
        • Fondazione Policlinico Universitario A. Gemelli-IRCCS, UCSC - Scienze Mediche e Chirurgiche
  • Polonia
      • Warsaw, Polonia
        • Instytut Reumatologii im. Eleonory Reicher - Department of Connective Tissue Diseases
  • Reino Unido
      • Doncaster, Reino Unido
        • Doncaster Royal Infirmary (3466)
      • London, Reino Unido
        • Royal Free London NHS Foundation Trust
      • London, Reino Unido
        • University College London Hospitals NHS Foundation Trust- Neuromuscular Diseases
      • Salford, Reino Unido
        • Salford Royal Hospital, Barnes Clinical Research Facility
      • Wolverhampton, Reino Unido
        • Royal Wolverhampton Hospitals (6493)

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

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Diagnóstico de DM o PM probable o definitiva según los criterios de clasificación ACR/EULAR 2017, con estado de autoanticuerpos positivo. Los participantes con PM deben cumplir criterios de clasificación con biopsia muscular. Se permiten participantes con síndrome anti-sintetasa (ASyS) que cumplan con los criterios de clasificación
  • Enfermedad activa en el estándar de atención (SoC), debe cumplir con uno de los criterios dentro de los 6 meses anteriores a la detección: Evidencia patológica de miositis activa en biopsia muscular; Evidencia de miositis activa por Electromiografía (EMG); Resonancia magnética nuclear (RMN) con evidencia de miositis activa; o cualquier enzima muscular mayor o igual a (>=) 4 × límite superior normal (LSN) en el momento de la selección; Erupción cutánea PM/DM activa según el área de dermatomiositis cutánea y el índice de gravedad A (CDASI-A) >= 7 en el momento de la selección
  • Gravedad mínima de la enfermedad definida por: miopatía de moderada a grave con prueba muscular manual-8 (MMT-8) >= 80 y menor o igual a (= 2 centímetros (cm); actividad global del médico (PGA) derivada de la evaluación de la actividad de la enfermedad de miositis (MDAAT) >= 2 cm; Evaluación de actividad extramuscular derivada de MDAAT >= 2 cm; Al menos una enzima muscular > 1,5 veces el ULN; Cuestionario de evaluación de la salud-índice de discapacidad (HAQ-DI) >= 0,25 O sarpullido de moderado a grave y miopatía leve con MMT-8 entre 137 y = 14 Y al menos 2 de las siguientes anomalías del CSM: PtGA >= 2 cm; PGA derivada de MDAAT >= 2 cm; Evaluación de actividad extramuscular derivada de MDAAT >= 2 cm; Al menos una enzima muscular > 1,5 veces ULN, HAQ-DI >= 0,25
  • Dosis estables de corticosteroides orales (CS) y/o máximo de 1 medicamento inmunosupresor/inmunomodulador no corticosteroides (metotrexato, 6 mercaptopurina, sulfasalazina, micofenolato mofetilo o sodio, azatioprina, leflunomida, ciclosporina, tacrolimus oral) para DM o PM
  • Los participantes tienen un índice de masa corporal (IMC) dentro del rango de 18,5 a 35,0 kilogramos por metro cuadrado (kg/m^2) (incluido)
  • Podrían aplicarse otros criterios de inclusión definidos en el protocolo

Criterio de exclusión:

  • Diagnóstico primario de miositis por cuerpos de inclusión (IBM), miositis asociada a malignidad (definida como diagnóstico de miositis dentro de los 3 años posteriores al cáncer), miopatía necrotizante inmunomediada (IMNM) con una biopsia caracterizada como biopsia necrotizante o IMNM con partículas de reconocimiento anti-señal positivas (SRP) o autoanticuerpos anti 3-hidroxi-3-metilglutaril-coenzima A reductasa (HMGCR). Los participantes con anticuerpo gamma anti-factor intermediario de transcripción 1 (TIF1) o anticuerpo anti MDAT5 recientemente diagnosticado (dentro de 1 año) deben haber tenido una prueba de detección adecuada para el cáncer dentro de los 12 meses posteriores al Día 1. La prueba de detección adecuada del cáncer se define como actualizada. Cribado apropiado para la edad y el sexo según las directrices nacionales
  • Diagnóstico primario de DM juvenil, o participantes adultos previamente diagnosticados con DM juvenil
  • Cualquier otra enfermedad concurrente activa del tejido conectivo asociada con miopatía inflamatoria en opinión del investigador. Un comité de expertos en miopatías inflamatorias idiopáticas (IIM, por sus siglas en inglés) revisará y aprobará la elegibilidad de los participantes con diagnóstico de enfermedad(es) concurrente(s) del tejido conectivo
  • Enfermedad pulmonar intersticial grave definida como oxígeno suplementario requerido en reposo o capacidad vital forzada (FVC) de
  • Cualquier enfermedad no controlada (por ejemplo [p. ej.], enfermedad grave respiratoria, cardiovascular, gastrointestinal, neurológica, psiquiátrica, hematológica, metabólica [incluida la tiroiditis con aumento/disminución de la hormona estimulante de la tiroides (TSH)], enfermedad renal, hepática, endocrina/de órganos reproductivos) otra que DM/PM, que en opinión del investigador o del patrocinador/designado constituya un riesgo inapropiado o una contraindicación para la participación en el estudio o que pueda interferir con los objetivos, la realización o la evaluación del estudio
  • 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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Período DBPC: Placebo
Droga: Placebo
Los participantes recibirán un placebo equivalente a M5049 por vía oral, dos veces al día hasta 24 semanas.
Experimental: Double-blind Placebo Controlled (DBPC) Period: M5049 dose
Droga: M5049 dose
Participants will receive film-coated tablets of M5049 dose orally, twice daily up to 24 weeks.
Otros nombres:
  • Enpatoran
Experimental: Open Label Extension (OLE) Period: M5049 dose
Droga: M5049 dose
Participants will receive film-coated tablets of M5049 dose orally, twice daily up to 24 weeks.
Otros nombres:
  • Enpatoran

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Double Blind Placebo Control Period (DBPC): American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) at Week 24
Periodo de tiempo: At Week 24 (end of DBPC period)
The ACR/EULAR TIS was derived from evaluation of results from 6 Core Set Measures(CSMs) of myositis disease activity in participants with Dermatomyositis and Polymyositis.TIS was determined by summing scores for each CSM,based on improvement in absolute percent change which is calculated by subtracting the baseline value from the final value,dividing difference by the range, and then multiplying the result by100 and relative weight of each core set measure. The TIS scale ranges from 0 to 100 with thresholds for minimal [more than or equal to(>= 20)],moderate(>= 40) and major(>= 60)improvement in combined 6 CSM.The CSMs include,physician global activity visual analogue scale(VAS) score(0-10), patient global activity VAS score(0-10), manual muscle testing-8 score(0-150), health assessment questionnaire-disability index(0-3) along with checks for most abnormal muscle-associated enzymes and extra muscular activity assessment derived using myositis disease activity assessment tool(0-10).
At Week 24 (end of DBPC period)
DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
Periodo de tiempo: Up to Week 26 (Safety follow up)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether considered related to the medicinal product or protocol-specified procedure. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious TEAEs and non-serious TEAEs. Adverse events of special interest (AESI) are serious or non-serious AEs that are of clinical interest and were closely followed.
Up to Week 26 (Safety follow up)
DBPC Period: Number of Participants With Clinically Meaningful Changes From Baseline in Laboratory Parameters
Periodo de tiempo: Up to Week 26 (Safety follow up)
Laboratory parameters included hematology, biochemistry, urinalysis and reflex testing for HBV DNA. Number of participants with clinically meaningful changes from baseline in laboratory parameters were reported. Clinical meaningfulness was assessed by the investigator.
Up to Week 26 (Safety follow up)
DBPC Period: Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signs
Periodo de tiempo: Up to Week 26 (Safety follow up)
Vital signs included body temperature, systolic and diastolic blood pressure, respiration rate, pulse rate, weight, height and body mass index. Number of participants with clinically meaningful changes from baseline in vital signs were reported. Clinical meaningfulness was assessed by the investigator.
Up to Week 26 (Safety follow up)
DBPC Period: Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECG) Parameters
Periodo de tiempo: Up to Week 26 (Safety follow up)
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. Number of participants with clinically meaningful changes from baseline in ECG parameters were reported. Clinical meaningfulness was assessed by the investigator.
Up to Week 26 (Safety follow up)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
DBPC Period: Number of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) Greater Than or Equal to (>=) 20, >= 40 and >= 60
Periodo de tiempo: At Week 16 and Week 24
The ACR/EULAR TIS was derived from evaluation of results from 6 Core Set Measures(CSMs) of myositis disease activity in participants with Dermatomyositis and Polymyositis.TIS was determined by summing scores for each CSM,based on improvement in absolute percent change which is calculated by subtracting the baseline value from the final value,dividing difference by the range, and then multiplying the result by100 and relative weight of each core set measure. The TIS scale ranges from 0 to 100 with thresholds for minimal [more than or equal to(>= 20)],moderate(>=40) and major(>=60)improvement in combined 6 CSM.The CSMs include,physician global activity visual analogue scale(VAS) score(0-10), patient global activity VAS score(0-10), manual muscle testing-8 score(0-150), health assessment questionnaire-disability index(0-3) along with checks for most abnormal muscle-associated enzymes and extra muscular activity assessment derived using myositis disease activity assessment tool(0-10).
At Week 16 and Week 24
DBPC Period: Participant's Total Improvement Score (TIS)
Periodo de tiempo: Week 4, 8, 12, 16, 20 and 24
The ACR/EULAR TIS was derived from evaluation of results from 6 Core Set Measures(CSMs) of myositis disease activity in participants with Dermatomyositis and Polymyositis.TIS was determined by summing scores for each CSM,based on improvement in absolute percent change which is calculated by subtracting the baseline value from the final value,dividing difference by the range, and then multiplying the result by100 and relative weight of each core set measure. The TIS scale ranges from 0 to 100 with thresholds for minimal [more than or equal to(>= 20)],moderate(>=40) and major(>=60)improvement in combined 6 CSM.The CSMs include,physician global activity visual analogue scale(VAS) score(0-10), patient global activity VAS score(0-10), manual muscle testing-8 score(0-150), health assessment questionnaire-disability index(0-3) along with checks for most abnormal muscle-associated enzymes and extra muscular activity assessment derived using myositis disease activity assessment tool(0-10).
Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Physician Global Activity (PGA) Scores From Myositis Disease Activity Assessment Tool (MDAAT)
Periodo de tiempo: Baseline, Week 4, 8, 12, 16, 20 and 24
The Physician's Global Assessment of Disease Activity was an assessment of overall global disease activity by the physician that was taken from Myositis Disease Activity Assessment Tool (MDAAT). Physician rated participant's disease activity on a 0-10 centimeter (cm) visual analog scale (VAS). Extra-muscular activity ranged between 0 and 10, where, 0 cm = absent and 10 cm = maximum disease activity.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Patient Global Activity (PtGA) Visual Analog Scale (VAS) Score
Periodo de tiempo: Baseline, Week 4, 8, 12, 16, 20 and 24
PtGA was the assessment of the severity of disease by the participant/participant's guardian, using a VAS from 0 mm (no evidence of disease activity) to 100 mm (extremely active or severe disease activity). Higher score indicated worse status.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Extra Muscular Global Assessment From Myositis Disease Activity Assessment Tool (MDAAT) Score
Periodo de tiempo: Baseline, Week 4, 8, 12, 16, 20 and 24
MDAAT was a combined tool capturing physician's assessment of disease activity of various organ systems- constitutional, cutaneous, pulmonary, gastrointestinal, joints and cardiovascular, muscular using: Myositis Intention to Treat Activity Index (MITAX), a scale from 0("Not present in the last 4 weeks") to 4("New - in the last 4 weeks [compared to the previous 4 weeks]") and Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT), a 10 cm VAS assessing disease activity in the last 4 weeks of various organ systems from 0 cm("No evidence of disease activity") to 10 cm("Extremely active or severe disease activity"), disease activity being defined as potentially reversible pathology or physiology resulting from the myositis. Left end of line = no evidence of disease activity, midpoint of line = moderate disease activity, and right end of line = extreme or maximum disease activity. An assessment of extramuscular activity assessment was taken from MDAAT using a 10cm VAS scale.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Manual Muscle Testing-8 (MMT-8) Score
Periodo de tiempo: Baseline, Week 4, 8, 12, 16, 20 and 24
MMT-8 was an International Myositis Assessment and Clinical Studies (IMACS) Core Set Measure used in the calculation of the IMACS Definition of Improvement (DOI) and ACR/EULAR TIS. It is a set of 8 designated muscles tested unilaterally (generally on right side) -which include 1 axial, 5 proximal (2 upper extremity, 3 lower extremity), and 2 distal muscles (1 upper, 1 lower extremity). Total score for unilateral testing ranges from 0 to 80, and bilateral testing ranges from 0 to 150 with normal strength represented by a higher score at or near the top of the scale. The total score for bilateral testing (item "MMT8 score (0 - 150)" from the MANUAL MUSCLE TESTING-8 (mmt8) form) is used in the derivation of the Total Improvement Score.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Health Assessment Questionnaire -Disability Index (HAQ-DI) Score
Periodo de tiempo: Baseline, Week 4, 8, 12, 16, 20 and 24
HAQ-DI was an IMACS Core Set Measure used in the calculation of the IMACS DOI and ACR/EULAR TIS. It is a generic rather than a disease-specific instrument comprised of 8 sections (dressing, arising, eating, walking, hygiene, reach, grip, and activities), with 2 to 3 questions per section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8. Overall score ranges from 0-3.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Relative Change From Baseline in Most Abnormal Muscle-associated Enzyme
Periodo de tiempo: Baseline, Week 4, 8, 12, 16, 20 and 24
For each participant, the most abnormal muscle-associated enzyme was defined as the baseline muscle-associated enzyme with the highest ratio of the observed value to the upper limit of the normal range (ULN) among creatinine kinase, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, and aldolase. The relative abnormality could be expressed as a percentage of ULN, calculated as (enzyme value divided by ULN) multiplied by 100.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Number of Participants Who Achieved International Myositis Assessment and Clinical Studies (IMACS) Response
Periodo de tiempo: At Week 16 and 24
A participant was defined as an International Myositis Assessment and Clinical Studies (IMACS) Responder if 3 of any 6 IMACS Core Set Measures (CSMs) have been improved by more than equal to (>= 20) percent (%), with no more than 2 IMACS CSMs worse by >= 25%. The CSMs include, physician global activity visual analogue scale(VAS) score(0-10), patient global activity VAS score(0-10), manual muscle testing-8 score(0-150), health assessment questionnaire-disability index (0-3) along with checks for muscle-associated enzymes and extra muscular activity assessment derived using myositis disease activity assessment tool(0-10).
At Week 16 and 24
DBPC Period: Change From Baseline in Cutaneous Dermatomyositis Area and Severity Index-A (CDASI-A) and Cutaneous Dermatomyositis Area and Severity Index-D (CDASI-D) Subscale Score
Periodo de tiempo: Baseline, Week 4, 8, 12, 16, 20 and 24
CDASI is a clinician-scored single page instrument that separately measures activity and damage in the skin of DM participants. CDASI has 3 activity measures (CDASI-A: erythema, scale, and erosion/ulceration) and 2 damage measures (CDASI-D: poikiloderma and calcinosis) which are assessed over 15 body areas. In addition, Gottron's papules on the hands, periungual changes and alopecia are evaluated separately both for activity and damage. Activity and Damage Subscale scores range from 0 to 100 and 0 to 32, respectively, where higher scores indicate greater disease severity.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Investigator's Global Assessment (IGA) Skin Activity Score
Periodo de tiempo: Baseline, Week 4, 8, 12, 16, 20 and 24
The IGA skin activity is a five-point score that defines the level of disease severity based on overall lesion characteristics where 0 is "clear" and "4" is severe.
Baseline, Week 4, 8, 12, 16, 20 and 24
Open-label Extension (OLE) Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
Periodo de tiempo: From start of OLE period (Week 1) up to safety follow up (Week 26)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether considered related to the medicinal product or protocol-specified procedure. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious TEAEs and non-serious TEAEs. Adverse events of special interest (AESI) are serious or non-serious AEs that are of clinical interest and were closely followed.
From start of OLE period (Week 1) up to safety follow up (Week 26)
OLE Period: Number of Participants With Clinically Meaningful Changes From Baseline in Laboratory Parameters
Periodo de tiempo: From start of OLE period (Week 1) up to safety follow up (Week 26)
Laboratory parameters included hematology, biochemistry, urinalysis and reflex testing for HBV DNA. Number of participants with clinically meaningful changes from baseline in laboratory parameters were reported. Clinical meaningfulness was assessed by the investigator.
From start of OLE period (Week 1) up to safety follow up (Week 26)
OLE Period: Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signs
Periodo de tiempo: From start of OLE period (Week 1) up to safety follow up (Week 26)
Vital signs included body temperature, systolic and diastolic blood pressure, respiration rate, pulse rate, weight, height and body mass index. Number of participants with clinically meaningful changes from baseline in vital signs were reported. Clinical meaningfulness was assessed by the investigator.
From start of OLE period (Week 1) up to safety follow up (Week 26)
OLE Period: Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECG) Parameters
Periodo de tiempo: From start of OLE period (Week 1) up to safety follow up (Week 26)
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. Number of participants with clinically meaningful changes from baseline in ECG parameters were reported. Clinical meaningfulness was assessed by the investigator.
From start of OLE period (Week 1) up to safety follow up (Week 26)

Colaboradores e Investigadores

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

Patrocinador

EMD Serono Research & Development Institute, Inc.

Colaboradores

Merck KGaA, Darmstadt, Germany

Investigadores

  • Director de estudio: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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)

19 de enero de 2023

Finalización primaria (Actual)

25 de junio de 2025

Finalización del estudio (Actual)

25 de junio de 2025

Fechas de registro del estudio

Enviado por primera vez

6 de diciembre de 2022

Primero enviado que cumplió con los criterios de control de calidad

6 de diciembre de 2022

Publicado por primera vez (Actual)

14 de diciembre de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de septiembre de 2026

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

17 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • MS200569_0041
  • 2022-501351-82-00 (Otro identificador: EUCT number)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Estamos comprometidos a mejorar la salud pública mediante el intercambio responsable de datos de ensayos clínicos. Tras la aprobación de un nuevo producto o una nueva indicación para un producto aprobado tanto en los EE. UU. como en la Unión Europea, el patrocinador del estudio y/o sus empresas afiliadas compartirán los protocolos del estudio, los datos anónimos del paciente y los datos del nivel del estudio, y los informes del estudio clínico redactados con investigadores científicos y médicos calificados, previa solicitud, según sea necesario para realizar investigaciones legítimas. Puede encontrar más información sobre cómo solicitar datos en nuestro sitio web bit.ly/IPD21

Marco de tiempo para compartir IPD

Dentro de los seis meses posteriores a la aprobación de un nuevo producto o una nueva indicación para un producto aprobado tanto en los Estados Unidos como en la Unión Europea

Criterios de acceso compartido de IPD

Investigadores científicos y médicos calificados pueden solicitar los datos. Dichas solicitudes deberán presentarse por escrito al portal de la empresa y serán revisadas internamente en cuanto a los criterios de calificación de los investigadores y la legitimidad de la propuesta de investigación.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CÓDIGO_ANALÍTICO
  • RSC

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

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