Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Dose-finding Study of YMI024 to Assess Efficacy, Safety, and Tolerability in Adults With Stable Coronary Artery Disease and Elevated hsCRP

14 de outubro de 2026 atualizado por: Novartis Pharmaceuticals

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study of YMI024 to Assess Efficacy in Reducing Inflammatory Markers, Safety, and Tolerability in Adults With Stable Coronary Artery Disease and Elevated hsCRP

The purpose of this Phase 2b study is to investigate the efficacy in reducing systemic inflammation, safety, tolerability, and dose response of five doses of YMI024, as compared to placebo in adult participants with stable coronary artery disease (CAD) and residual inflammatory risk defined by elevated high-sensitivity C-reactive protein (hsCRP) (≥2 mg/L)

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

Participants are randomized in a 1:1:1:1:1:1 ratio to one of the six arms, with stratification by comorbidity status at randomization: CAD-only, CAD+ (Heart Failure) HF, and CAD+Chronic Kidney Disease (CKD), and receive study medication on top of stable standard-of-care therapies. The study employs double-blinding, concealing treatment allocation from participants, Investigators, Sponsor, and study staff, with identical packaging and labelling, schedule of administration and appearance for all study drugs.

Tipo de estudo

Intervencional

Inscrição (Estimado)

180

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.

Contato de estudo

Estude backup de contato

  • Nome: Novartis Pharmaceuticals
  • Número de telefone: +41613241111

Locais de estudo

  • Alemanha
      • Berlin, Alemanha, 10787
        • Recrutamento
        • Novartis Investigative Site
      • Mannheim, Alemanha, 68165
        • Recrutamento
        • Novartis Investigative Site
      • Pirna, Alemanha, 01796
        • Recrutamento
        • Novartis Investigative Site
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Alemanha, 70376
        • Recrutamento
        • Novartis Investigative Site
    • Rhineland-Palatinate
      • Kaiserslautern, Rhineland-Palatinate, Alemanha, 67655
        • Recrutamento
        • Novartis Investigative Site
  • Austrália
    • South Australia
      • Adelaide, South Australia, Austrália, 5000
        • Recrutamento
        • Novartis Investigative Site
    • Victoria
      • Frankston, Victoria, Austrália, 3199
        • Recrutamento
        • Novartis Investigative Site
      • Melbourne, Victoria, Austrália, 8008
        • Recrutamento
        • Novartis Investigative Site
      • Mulgrave, Victoria, Austrália, 3170
        • Recrutamento
        • Novartis Investigative Site
  • Estados Unidos
    • Alabama
      • Fairhope, Alabama, Estados Unidos, 36532
        • Recrutamento
        • Eastern Shore Research Institute
        • Investigador principal:
          • Michael S Pursley
        • Contato:
      • Foley, Alabama, Estados Unidos, 36535
        • Recrutamento
        • G and L Research LLC
        • Investigador principal:
          • Nidal Morrar
        • Contato:
    • California
      • Los Angeles, California, Estados Unidos, 90035
        • Recrutamento
        • Biopharma Informatic LLC
        • Investigador principal:
          • Christian Assad-Kottner
        • Contato:
    • Florida
      • Coral Gables, Florida, Estados Unidos, 33134
    • Kansas
      • Wichita, Kansas, Estados Unidos, 67207
        • Recrutamento
        • Alliance for Multispecialty Research
        • Investigador principal:
          • Saifullah Nasir
        • Contato:
    • Maryland
      • Ft. Washington, Maryland, Estados Unidos, 20744
      • Oxon Hill, Maryland, Estados Unidos, 20745
        • Recrutamento
        • MD Medical Research
        • Investigador principal:
          • Stephen T Ong
        • Contato:
    • Texas
      • Amarillo, Texas, Estados Unidos, 79106
        • Recrutamento
        • Pharma Tex Research
        • Investigador principal:
          • David Brabham
        • Contato:
    • Virginia
      • Winchester, Virginia, Estados Unidos, 22601
        • Recrutamento
        • Selma Medical Associates
        • Contato:
        • Investigador principal:
          • Philip O Donnell
  • Japão
    • Aichi-ken
      • Kasugai, Aichi-ken, Japão, 4870016
        • Recrutamento
        • Novartis Investigative Site
    • Chiba
      • Matsudo, Chiba, Japão, 2702251
        • Recrutamento
        • Novartis Investigative Site
    • Kanagawa
      • Kamakura, Kanagawa, Japão, 2478533
        • Recrutamento
        • Novartis Investigative Site
    • Osaka
      • Matsubara, Osaka, Japão, 5800032
        • Recrutamento
        • Novartis Investigative Site
  • Reino Unido
      • London, Reino Unido, EC1A 7BE
        • Recrutamento
        • Novartis Investigative Site

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 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Signed informed consent must be obtained prior to any study specific procedures, and participant able to understand and comply with study requirements.

  2. Male and female participants aged between 18-80 years (inclusive) at Screening.

  3. Documented stable CAD as evidenced by presence of at least one of the following criteria:

    1. Documented history of spontaneous (Type 1) myocardial infarction (MI) of presumed atherosclerotic origin that occurred at least 30 days before the start of Screening. If a Pre-screening visit is conducted, the MI must have occurred at least 30 days before that visit.

      Diagnosis of the qualifying MI should be based on medical records and Investigator's judgment.

    2. Prior coronary revascularization (i.e. percutaneous coronary intervention (PCI) at least 30 days prior, or coronary artery bypass grafting (CABG), at least 6 months prior to Screening).

      • Any prior PCI must have occurred at least 30 days prior to the Screening Visit (or if conducted, prior to the Pre screening visit).
      • Any prior CABG must have occurred at least 6 months (i.e. 26 weeks) prior to the Screening (or if conducted, prior to the Pre-screening) Visit.

    3. Angiographic or CT-imaging (e.g., Multi Detector Computed Tomography/ Computed Tomography Angiography (MDCT/CTA)) evidence of coronary atherosclerosis: ≥50% stenosis in at least one major epicardial coronary artery.

    4. Coronary artery calcium (CAC) score of ≥300 AU by computed tomography.

    To ensure adequate representation of patients with clinically relevant comorbidities and to enable prespecified subgroup analyses, the trial will include participants with key comorbidities as follows:

    i. Moderate CKD Participants with moderate (Stage 3a/3b) kidney disease (CKD) defined as: Estimated Glomerular Filtration Rate (eGFR) ≥30 and ≤60 mL/min/1.73 m² (CKD EPI formula) at Screening.

    ii. Chronic HF

    Participants with a history of chronic heart failure (HF) defined as:

    • NYHA Class II-III symptoms of HF requiring ongoing treatment with diuretics (loop diuretics, thiazide diuretics, and/or mineralocorticoid receptor antagonists) for ≥30 days prior to Screening, AND
    • LVEF ≤40%, assessed by any standard modality (e.g., echocardiography, cardiac Magnetic Resonance Imaging (MRI), CT, MUGA, or ventricular angiography) on the most recent assessment within 12 months prior to Screening.

  4. Participants must have hsCRP levels ≥2 mg/L at two timepoints during Screening. Screening values must be separated by a minimum of 7 days. The initial hsCRP value must be a minimum of 30 days after a qualifying MI or after any PCI performed separately from the qualifying MI, or 6 months after CABG.

Note: Participants who choose to enter the optional Pre-screening period must have an hsCRP level, measured at a local laboratory, that is considered by the Investigator to be ≥2 mg/L. This Pre-screening hsCRP value (measured at the local laboratory) must be obtained at least 30 days after a qualifying MI or after any PCI performed separately from the qualifying MI, or 6 months after a CABG.

Irrespective of any Pre-screening hsCRP value, all participants must have two central laboratory hsCRP levels ≥2 mg/L at the two Screening visits to be eligible for randomization into the study.

Exclusion Criteria:

  1. Participants with recent major cardiovascular events or procedures, including:

    • myocardial infarction, unstable angina, or percutaneous coronary intervention within 30 days prior to Screening (or Pre-screening, if conducted), or
    • coronary artery bypass grafting or other cardiac surgery within 6 months prior to Screening (or Pre-screening, if conducted).

  2. Any major (cardiac or non-cardiac) surgical, interventional or endoscopic procedure (e.g: Percutaneous carotid intervention, carotid or peripheral arterial revascularization), or stroke, Transient ischemic attack (TIA), or acute limb ischemia within 12 weeks prior to Screening or Pre-screening, where applicable).

  3. Participants with a known systemic autoimmune or inflammatory disease (e.g., Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA)); clinically active diverticulitis or inflammatory bowel disease within 12 months prior to Screening; or a history of gastrointestinal perforation.

  4. Patients with suspected or proven immunocompromised state at Screening (e.g., clinical diagnosis of Human Immunodeficiency Virus (HIV) or on antiretroviral therapy, absolute neutrophil count ≤1000/mm3) or any other medical condition in the opinion of the Investigator places the patient at unacceptable risk by receiving immunomodulatory therapy.

  5. Known or suspected active infection, or chronic or recurrent infectious disease, including but not limited to:

    • Hepatitis B / Hepatitis C: Positive HBsAg, positive anti-HBc, positive anti-HBs, or positive anti-Hepatitis C Virus (HCV) at Screening.
    • Note: Participants positive for anti-HBs after HBV vaccination but negative for HBsAg and anti-HBc are eligible per local guidelines and Sponsor agreement.
    • Note: Participants positive for anti-HBc but negative for HBV Deoxyribonucleic Acid (DNA) receiving prophylactic HBV antiviral treatment (e.g., entecavir, lamivudine) are eligible per local guidelines and Sponsor agreement.
    • Note: Participants positive for anti-HCV but consistently negative for HCV RNA >6 months after HCV antiviral treatment are eligible per local guidelines and Sponsor agreement.
    • Tuberculosis (TB): Active or latent TB as indicated by a positive QuantiFERON® TB Gold Plus test or T-SPOT® TB test at Screening.
    • Any other known active or suspected active infection, or chronic infection, or history of ongoing, chronic, or major recurrent infectious disease.

  6. Participants with any of the following renal or hepatic abnormalities at Screening are excluded:

    1. Renal dysfunction with Estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73 m² (using CKD-EPI formula; s://.kidney.org/professionals/gfr_calculator).
    2. Evidence of hepatic disease as determined by any one of the following: Aspartate Aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) or Alanine Aminotransferase (ALT) (Serum Glutamic Pyruvic Transaminase (SGPT)) >3× ULN, or bilirubin >1.5 mg/dL at Screening (for patients with Gilbert's syndrome, total bilirubin <2× ULN is allowed).

  7. Current or prior history of severe heart failure of New York Heart Association (NYHA) Class IV.

Other protocol-defined inclusion/exclusion criteria may apply

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
Experimental: YMI024 Dose 1

Participants receive YMI024 Dose 1 in addition to standard-of-care therapies.
Medicamento: YMI024

YMI024 in different doses
Experimental: YMI024 Dose 2

Participants receive YMI024 Dose 2 in addition to standard-of-care therapies.
Medicamento: YMI024

YMI024 in different doses
Experimental: YMI024 Dose 3

Participants receive YMI024 Dose 3 in addition to standard-of-care therapies.
Medicamento: YMI024

YMI024 in different doses
Experimental: YMI024 Dose 4

Participants receive YMI024 Dose 4 in addition to standard-of-care therapies.
Medicamento: YMI024

YMI024 in different doses
Experimental: YMI024 Dose 5

Participants receive YMI024 Dose 5 in addition to standard-of-care therapies.
Medicamento: YMI024

YMI024 in different doses
Comparador de Placebo: Placebo

Participants receive a matching placebo in addition to standard-of-care therapies
Medicamento: Placebo

matching placebo

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in log-transformed IL-6
Prazo: Baseline and approximately 3 months

Change from baseline in log-transformed Interleukin-6 (IL-6) to evaluate the dose-response relationship using the Multiple Comparison Procedures (MCP) component of the Multiple Comparison Procedure-Modelling (MCP-Mod) methodology
Baseline and approximately 3 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in log-transformed IL-6
Prazo: Baseline and approximately 3 months

Change from baseline in log-transformed IL-6 to characterize the dose-response relationship for YMI024 in IL-6 using the model-based (Mod) component of the MCP-Mod methodology
Baseline and approximately 3 months
Change from baseline in log-transformed hsCRP
Prazo: Baseline and approximately 3 months

Change from baseline in log-transformed high-sensitivity C-reactive protein (hsCRP)
Baseline and approximately 3 months
Responder status - hsCRP <2 mg/L
Prazo: Approximately 3 months

Responder status (Yes/No), defined as hsCRP <2 mg/L
Approximately 3 months
Responder status - hsCRP <1 mg/L
Prazo: Approximately 3 months

Responder status (Yes/No), defined as hsCRP <1 mg/L
Approximately 3 months
Number of participants with adverse events
Prazo: Approximately 4 months

Number of participants with adverse events, including abnormal vital signs, ECGs, and laboratory assessments
Approximately 4 months

Colaboradores e Investigadores

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

Patrocinador

Novartis Pharmaceuticals

Investigadores

  • Diretor de estudo: Novartis Pharmaceuticals, Novartis Pharmaceuticals

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)

18 de setembro de 2026

Conclusão Primária (Estimado)

15 de agosto de 2027

Conclusão do estudo (Estimado)

15 de agosto de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

15 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de setembro de 2026

Primeira postagem (Real)

21 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CYMI024A12202
  • U1111-1339-3893 (Outro identificador: UTN number)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever