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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

2026年10月14日 更新者：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)

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

180

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前：Novartis Pharmaceuticals
  • 電話番号：+41613241111

研究場所

  • アメリカ
    • Alabama
      • Fairhope、Alabama、アメリカ、36532
        • 募集
        • Eastern Shore Research Institute
        • 主任研究者：
          • Michael S Pursley
        • コンタクト：
      • Foley、Alabama、アメリカ、36535
        • 募集
        • G and L Research LLC
        • 主任研究者：
          • Nidal Morrar
        • コンタクト：
    • California
      • Los Angeles、California、アメリカ、90035
        • 募集
        • Biopharma Informatic LLC
        • 主任研究者：
          • Christian Assad-Kottner
        • コンタクト：
    • Florida
      • Coral Gables、Florida、アメリカ、33134
    • Kansas
      • Wichita、Kansas、アメリカ、67207
        • 募集
        • Alliance for Multispecialty Research
        • 主任研究者：
          • Saifullah Nasir
        • コンタクト：
    • Maryland
      • Ft. Washington、Maryland、アメリカ、20744
      • Oxon Hill、Maryland、アメリカ、20745
    • Texas
      • Amarillo、Texas、アメリカ、79106
        • 募集
        • Pharma Tex Research
        • 主任研究者：
          • David Brabham
        • コンタクト：
    • Virginia
      • Winchester、Virginia、アメリカ、22601
        • 募集
        • Selma Medical Associates
        • コンタクト：
        • 主任研究者：
          • Philip O Donnell
  • イギリス
      • London、イギリス、EC1A 7BE
        • 募集
        • Novartis Investigative Site
  • オーストラリア
    • South Australia
      • Adelaide、South Australia、オーストラリア、5000
        • 募集
        • Novartis Investigative Site
    • Victoria
      • Frankston、Victoria、オーストラリア、3199
        • 募集
        • Novartis Investigative Site
      • Melbourne、Victoria、オーストラリア、8008
        • 募集
        • Novartis Investigative Site
      • Mulgrave、Victoria、オーストラリア、3170
        • 募集
        • Novartis Investigative Site
  • ドイツ
      • Berlin、ドイツ、10787
        • 募集
        • Novartis Investigative Site
      • Mannheim、ドイツ、68165
        • 募集
        • Novartis Investigative Site
      • Pirna、ドイツ、01796
        • 募集
        • Novartis Investigative Site
    • Baden-Wurttemberg
      • Stuttgart、Baden-Wurttemberg、ドイツ、70376
        • 募集
        • Novartis Investigative Site
    • Rhineland-Palatinate
      • Kaiserslautern、Rhineland-Palatinate、ドイツ、67655
        • 募集
        • Novartis Investigative Site
  • 日本
    • Aichi-ken
      • Kasugai、Aichi-ken、日本、4870016
        • 募集
        • Novartis Investigative Site
    • Chiba
      • Matsudo、Chiba、日本、2702251
        • 募集
        • Novartis Investigative Site
    • Kanagawa
      • Kamakura、Kanagawa、日本、2478533
        • 募集
        • Novartis Investigative Site
    • Osaka
      • Matsubara、Osaka、日本、5800032
        • 募集
        • Novartis Investigative Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～80年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：YMI024 Dose 1

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

YMI024 in different doses
実験的：YMI024 Dose 2

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

YMI024 in different doses
実験的：YMI024 Dose 3

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

YMI024 in different doses
実験的：YMI024 Dose 4

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

YMI024 in different doses
実験的：YMI024 Dose 5

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

YMI024 in different doses
プラセボコンパレーター：Placebo

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

matching placebo

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline in log-transformed IL-6
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline in log-transformed IL-6
時間枠：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
時間枠：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
時間枠：Approximately 3 months

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

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

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Novartis Pharmaceuticals

捜査官

  • スタディディレクター：Novartis Pharmaceuticals、Novartis Pharmaceuticals

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年9月18日

一次修了 (推定)

2027年8月15日

研究の完了 (推定)

2027年8月15日

試験登録日

最初に提出

2026年9月15日

QC基準を満たした最初の提出物

2026年9月15日

最初の投稿 (実際)

2026年9月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月15日

QC基準を満たした最後の更新が送信されました

2026年10月14日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CYMI024A12202
  • U1111-1339-3893 (その他の識別子：UTN number)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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