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Estudo de M5049 em participantes DM e PM (NEPTUNIA)

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

Um estudo de fase IIa, randomizado, paralelo, duplo-cego, controlado por placebo para avaliar a eficácia e a segurança do Enpatoran em participantes com dermatomiosite e polimiosite recebendo tratamento padrão (NEPTUNIA)

O objetivo deste estudo é avaliar a eficácia e a segurança do M5049 administrado por via oral em participantes com miopatias inflamatórias idiopáticas, especificamente dermatomiosite (DM) e polimiosite (PM) por 24 semanas.

Visão geral do estudo

Status

Rescindido

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

20

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Espanha
      • A Coruña, Espanha
        • CHUAC - Complexo Hospitalario Universitario A Coruña - Rheumatology
      • Barcelona, Espanha
        • Hospital Vall d'hebrón
      • Madrid, Espanha
        • 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
  • Grécia
      • Athens, Grécia
        • Hippokration Hospital - 2nd Department of Medicine and Laboratory
      • Athens, Grécia
        • National and Kapodistrian University of Athens (Egnitio Hospital)
      • Larissa, Grécia
        • University General Hospital of Larissa
  • Itália
      • Catania, Itália
        • Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco Di Catania (Vittorio Emanuele) - Reumatologia
      • Catania, Itália
        • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
      • Florence, Itália
        • Azienda Usl Toscana Centro
      • Reggio Emilia, Itália
        • Arcispedale S. Maria Nuova
      • Rome, Itália
        • Fondazione Policlinico Universitario A. Gemelli-IRCCS, UCSC - Scienze Mediche e Chirurgiche
  • Polônia
      • Warsaw, Polônia
        • 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)
  • Tcheca
      • Prague, Tcheca
        • Institute of Rheumatology - Rheumatology

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • Diagnóstico de DM ou PM provável ou definitivo de acordo com os critérios de classificação ACR/EULAR 2017, com status de autoanticorpo positivo. Participantes com PM devem preencher critérios de classificação com biópsia muscular. Os participantes da síndrome anti-sintetase (ASyS) que atendem aos critérios de classificação são permitidos
  • Doença ativa no padrão de atendimento (SoC), deve atender a um dos critérios dentro de 6 meses antes da triagem: evidência patológica de miosite ativa na biópsia muscular; Evidência de miosite ativa por Eletromiografia (EMG); Ressonância magnética (RM) com evidência de miosite ativa; ou qualquer enzima muscular maior ou igual a (>=) 4 × limite superior do normal (ULN) no momento da triagem; Erupção cutânea ativa de PM/DM de acordo com a área de dermatomiosite cutânea e índice de gravidade-A (CDASI-A) >= 7 no momento da triagem
  • Gravidade mínima da doença definida por: miopatia moderada a grave com teste muscular manual-8 (MMT-8) >= 80 e menor ou igual a (= 2 centímetros (cm); Atividade global do médico (PGA) derivada da avaliação da atividade da doença da miosite ferramenta (MDAAT) >= 2 cm; Avaliação de atividade extramuscular derivada de MDAAT >= 2 cm; Pelo menos uma enzima muscular > 1,5 vezes o LSN; índice de incapacidade do questionário de avaliação de saúde (HAQ-DI) >= 0,25 OU erupção cutânea moderada a grave e miopatia leve com MMT-8 entre 137 e = 14 E pelo menos 2 das seguintes anormalidades do CSM: PtGA >= 2 cm; PGA derivado de MDAAT >= 2 cm; Avaliação da atividade extramuscular derivada de MDAAT >= 2 cm; Pelo menos um enzima muscular > 1,5 vezes LSN; HAQ-DI >= 0,25
  • Doses estáveis ​​de corticosteroides orais (CS) e/ou máximo de 1 medicamento imunossupressor/imunomodulador não corticosteroide (metotrexato, 6 mercaptopurina, sulfassalazina, micofenolato de mofetil ou sódio, azatioprina, leflunomida, ciclosporina, tacrolimus oral) para DM ou PM
  • Os participantes têm um índice de massa corporal (IMC) dentro da faixa de 18,5 a 35,0 kg por metro quadrado (kg/m^2) (inclusive)
  • Outros critérios de inclusão definidos pelo protocolo podem ser aplicados

Critério de exclusão:

  • Diagnóstico primário de miosite por corpos de inclusão (IBM), miosite associada a malignidade (definida como diagnóstico de miosite dentro de 3 anos de câncer), miopatia necrotizante imunomediada (IMNM) com uma biópsia caracterizada como biópsia necrosante ou IMNM com partícula de reconhecimento anti-sinal positiva anticorpo (SRP) ou autoanticorpos anti 3-hidroxi-3-metilglutaril-coenzima A redutase (HMGCR). Os participantes com anticorpo gama anti-fator intermediário de transcrição 1 (TIF1) ou anticorpo anti-MDAT5 recém-diagnosticado (dentro de 1 ano) devem ter feito triagem adequada para câncer dentro de 12 meses do Dia 1. Triagem adequada de câncer é definida como atualizada triagem apropriada para idade e sexo de acordo com as diretrizes nacionais
  • Diagnóstico primário de DM juvenil, ou participantes adultos previamente diagnosticados com DM juvenil
  • Qualquer outra doença concomitante ativa do tecido conjuntivo associada à miopatia inflamatória na opinião do investigador. A elegibilidade dos participantes com diagnóstico de doença(s) concomitante(s) do tecido conjuntivo será revisada e aprovada por um comitê de especialistas em miopatias inflamatórias idiopáticas (IIM).
  • Doença pulmonar intersticial grave definida como oxigênio suplementar necessário em repouso ou capacidade vital forçada (CVF) de
  • Qualquer doença não controlada (por exemplo [por exemplo], grave respiratória, cardiovascular, gastrointestinal, neurológica, psiquiátrica, hematológica, metabólica [incluindo tireoidite com aumento/diminuição do hormônio estimulador da tireoide (TSH)], doença renal, hepática, endócrina/do órgão reprodutivo) outra que DM/PM, que na opinião do Investigador ou Patrocinador/pessoa designada constitui um risco inapropriado ou contra-indicação para a participação no estudo ou que pode interferir nos objetivos, conduta ou avaliação do estudo
  • Outros critérios de exclusão definidos pelo protocolo podem ser aplicados

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Período DBPC: Placebo
Medicamento: Placebo
Os participantes receberão placebo combinado com M5049 por via oral, duas vezes ao dia até 24 semanas.
Experimental: Double-blind Placebo Controlled (DBPC) Period: M5049 dose
Medicamento: M5049 dose
Participants will receive film-coated tablets of M5049 dose orally, twice daily up to 24 weeks.
Outros nomes:
  • Enpatoran
Experimental: Open Label Extension (OLE) Period: M5049 dose
Medicamento: M5049 dose
Participants will receive film-coated tablets of M5049 dose orally, twice daily up to 24 weeks.
Outros nomes:
  • Enpatoran

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Double Blind Placebo Control Period (DBPC): American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) at Week 24
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

EMD Serono Research & Development Institute, Inc.

Colaboradores

Merck KGaA, Darmstadt, Germany

Investigadores

  • Diretor de estudo: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

19 de janeiro de 2023

Conclusão Primária (Real)

25 de junho de 2025

Conclusão do estudo (Real)

25 de junho de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

6 de dezembro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de dezembro de 2022

Primeira postagem (Real)

14 de dezembro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Estamos comprometidos em melhorar a saúde pública por meio do compartilhamento responsável de dados de ensaios clínicos. Após a aprovação de um novo produto ou uma nova indicação para um produto aprovado nos EUA e na União Europeia, o patrocinador do estudo e/ou suas empresas afiliadas compartilharão protocolos de estudo, dados anônimos de pacientes e dados de nível de estudo e relatórios de estudos clínicos redigidos com pesquisadores científicos e médicos qualificados, mediante solicitação, conforme necessário para a realização de pesquisas legítimas. Mais informações sobre como solicitar dados podem ser encontradas em nosso site bit.ly/IPD21

Prazo de Compartilhamento de IPD

Dentro de seis meses após a aprovação de um novo produto ou uma nova indicação para um produto aprovado nos Estados Unidos e na União Europeia

Critérios de acesso de compartilhamento IPD

Pesquisadores científicos e médicos qualificados podem solicitar os dados. Tais solicitações devem ser encaminhadas por escrito ao portal da empresa e serão analisadas internamente quanto aos critérios de qualificação dos pesquisadores e legitimidade da proposta de pesquisa.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • ANALYTIC_CODE
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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