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

14 de octubre de 2026 actualizado 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)

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

180

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Novartis Pharmaceuticals
  • Número de teléfono: +41613241111

Ubicaciones de estudio

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

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 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

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
Experimental: YMI024 Dose 1

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

YMI024 in different doses
Experimental: YMI024 Dose 2

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

YMI024 in different doses
Experimental: YMI024 Dose 3

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

YMI024 in different doses
Experimental: YMI024 Dose 4

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

YMI024 in different doses
Experimental: YMI024 Dose 5

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

YMI024 in different doses
Comparador de placebos: Placebo

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

matching placebo

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in log-transformed IL-6
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in log-transformed IL-6
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Approximately 3 months

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

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

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

Colaboradores e Investigadores

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

Patrocinador

Novartis Pharmaceuticals

Investigadores

  • Director de estudio: Novartis Pharmaceuticals, Novartis Pharmaceuticals

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)

18 de septiembre de 2026

Finalización primaria (Estimado)

15 de agosto de 2027

Finalización del estudio (Estimado)

15 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

15 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de septiembre de 2026

Publicado por primera vez (Actual)

21 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de octubre de 2026

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

14 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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

Información sobre medicamentos y dispositivos, documentos del estudio

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

Sí

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

No

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

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