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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 oktober 2026 bijgewerkt door: 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)

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

180

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Novartis Pharmaceuticals
  • Telefoonnummer: +41613241111

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: YMI024 Dose 1

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

YMI024 in different doses
Experimenteel: YMI024 Dose 2

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

YMI024 in different doses
Experimenteel: YMI024 Dose 3

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

YMI024 in different doses
Experimenteel: YMI024 Dose 4

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

YMI024 in different doses
Experimenteel: YMI024 Dose 5

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

YMI024 in different doses
Placebo-vergelijker: Placebo

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

matching placebo

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in log-transformed IL-6
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in log-transformed IL-6
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Approximately 3 months

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

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

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Novartis Pharmaceuticals

Onderzoekers

  • Studie directeur: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 september 2026

Primaire voltooiing (Geschat)

15 augustus 2027

Studie voltooiing (Geschat)

15 augustus 2027

Studieregistratiedata

Eerst ingediend

15 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

15 september 2026

Eerst geplaatst (Werkelijk)

21 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

14 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CYMI024A12202
  • U1111-1339-3893 (Andere identificatie: UTN number)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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