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말초동맥질환 성인 참가자에서 Factor XI 억제를 통한 혈관 합병증 감소 (ROXI-PALISADE)

2026년 11월 3일 업데이트: Regeneron Pharmaceuticals

증상성 말초동맥질환 환자의 최근 하지 재관류술 후 REGN7508 및 REGN9933(제11인자 단일클론항체)의 효능과 안전성을 평가하기 위한 제3상 다기관 무작위 연구 마스터 프로토콜 (ROXI-PALISADE)

This study is researching 2 different experimental drugs called REGN7508 and REGN9933. The study is focused on people who have Peripheral Artery Disease (PAD), which means that the blood vessels in their arms and legs have become too narrow. People with PAD have a higher risk of getting blood clots after procedures like Lower Extremity Revascularization (LER), a procedure to improve blood flow in the legs and feet.

The aim of this study is to see how well REGN7508 and REGN9933 prevent life-threatening blood clots in participants with PAD who have recently had LER. The effects of REGN7508 and REGN9933, individually, will also be compared to rivaroxaban and a placebo.

The study is looking at several other research questions, including:

  • What side effects might happen from taking the study drugs and how do they compare to the side effects of rivaroxaban
  • How much study drug is in the blood at different times
  • Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)
  • If the study drugs affect the ability of the blood to clot normally

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

7050

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Alabama
      • Alexander City, Alabama, 미국, 35010
        • 모병
        • Lake Martin Medical and Vascular Center
      • Alexander City, Alabama, 미국, 35010
        • 모병
        • Advanced Cardiovascular
    • Arizona
      • Avondale, Arizona, 미국, 85392
        • 모병
        • Axsendo Clinical Research, Integrated Medical Services
    • Arkansas
      • Little Rock, Arkansas, 미국, 72205
        • 모병
        • Applied Research Center of Arkansas
    • California
      • Los Angeles, California, 미국, 90010
        • 모병
        • Angel City Research, Inc.
      • Oxnard, California, 미국, 93036
        • 모병
        • Pacific Cardiovascular and Vein Institute
      • West Hills, California, 미국, 91307
        • 모병
        • Interventional Cardiology Medical Group
    • Florida
      • Crystal River, Florida, 미국, 34429
        • 모병
        • Nature Coast Clinical Research - Cardiology
      • Jacksonville, Florida, 미국, 32209
        • 모병
        • University of Florida (UF) Health Jacksonville Clinical Center
      • Miami Lakes, Florida, 미국, 33014
        • 모병
        • Inpatient Research Clinic LLC
      • Panama City, Florida, 미국, 32405
        • 모병
        • Cardiovascular Institute of Northwest Florida, Main Office
      • Tampa, Florida, 미국, 33614
        • 모병
        • Tampa Cardiovascular Interventions and Research
    • Indiana
      • Fort Wayne, Indiana, 미국, 46804
        • 모병
        • Lutheran Medical Group LLC dba Lutheran Health Physicians
      • Hammond, Indiana, 미국, 46324
        • 모병
        • ASHA Clinical Research Munster, LLC
      • Munster, Indiana, 미국, 46321
        • 모병
        • Profound Research, Powers Health Medical Group
    • Louisiana
      • Shreveport, Louisiana, 미국, 71103
        • 모병
        • Cardiovascular Solutions
    • Mississippi
      • Petal, Mississippi, 미국, 39465
        • 모병
        • Rovia Clinical Research - Hattiesburg Clinic
    • New Jersey
      • Flemington, New Jersey, 미국, 08822
        • 모병
        • Advanced Heart and Vascular Institute of Hunterdon
    • New York
      • Valhalla, New York, 미국, 10595
        • 모병
        • Westchester Medical Center
    • North Carolina
      • Charlotte, North Carolina, 미국, 28207
        • 모병
        • Mecklenburg Heart Specialists Vascular Institute and Vein Center
      • Mooresville, North Carolina, 미국, 28117
        • 모병
        • Accellacare of Piedmont, Piedmont Healthcare
    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73102
        • 모병
        • Hightower Clinical
    • South Dakota
      • Rapid City, South Dakota, 미국, 57701
        • 모병
        • Monument Health Clinical Research
    • Tennessee
      • Jackson, Tennessee, 미국, 38301
        • 모병
        • Apex Research Foundation, LLC
      • Knoxville, Tennessee, 미국, 37934
        • 모병
        • Tennova TCMC
      • Tullahoma, Tennessee, 미국, 37388
        • 모병
        • Vanderbilt Heart and Vascular Tullahoma, Cardiology and Vascular Associates
    • Texas
      • Amarillo, Texas, 미국, 79106
        • 모병
        • PharmaTex Research
      • Cypress, Texas, 미국, 77429
        • 모병
        • Vital Heart and Vein
      • DeSoto, Texas, 미국, 75115
        • 모병
        • Epic Medical Research
      • Plano, Texas, 미국, 75093
        • 모병
        • Epic Medical Research-Plano
      • Doncaster, 영국, DN2 5LT
        • 모병
        • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
      • London, 영국, W6 8RF
        • 모병
        • Charing Cross Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Key Inclusion Criteria:

  1. Successful LER distal to the external iliac artery for ischemia due to atherosclerotic disease within 10 days prior to randomization as described in the protocol

  2. At least 1 of the following enrichment factors for major thrombotic vascular events:

    1. Bypass with prosthetic graft
    2. Endovascular treatment with stenting
    3. Target lesion length >15 cm
    4. History of LER or amputation for PAD prior to qualifying LER
    5. Type 2 diabetes mellitus requiring pharmacologic treatment
    6. Comorbid symptomatic coronary artery disease as described in the protocol
    7. Chronic kidney disease as described in the protocol
    8. Age ≥75 years

Key Exclusion Criteria:

  1. Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularization including known triple positive antiphospholipid syndrome
  2. Has known bleeding diathesis, platelet count <50,000/mm^3 or history of non-traumatic intracerebral hemorrhage, known cerebral amyloid angiopathy, or known unrepaired cerebrovascular malformations
  3. Has recent coronary revascularization as described in the protocol
  4. For Cohort 2 only: Has estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73m^2 within 14 days prior to randomization or on dialysis or expected to be started on dialysis within the next 12 weeks starting from randomization
  5. Has any other condition or therapy which would make the participant unsuitable for this study or not allow participation for the full planned study period
  6. Has allergy, hypersensitivity, or other contraindication to REGN7508, REGN9933, or rivaroxaban (Cohort 2 only) or their excipients

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 코호트 1

Administered per the protocol

Administered per the protocol

다른 이름들:
  • cenvacibart

Administered per the protocol

다른 이름들:
  • amrecibart
실험적: 코호트 2

Administered per the protocol

다른 이름들:
  • cenvacibart

Administered per the protocol

다른 이름들:
  • amrecibart

Administered per the protocol

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Time-to-first occurrence of a major thrombotic vascular event, consisting of Acute Limb Ischemia (ALI), major amputation (above the ankle) of vascular etiology, Myocardial Infarction (MI), ischemic stroke, or Cardiovascular (CV) death
기간: Approximately up to 42 months

Cohort 1

Approximately up to 42 months
Time-to-first occurrence of International Society of Thrombosis and Hemostasis (ISTH) major or Clinically Relevant Non-major (CRNM) bleeding
기간: Approximately up to 42 months

Cohort 1 and 2

Approximately up to 42 months

2차 결과 측정

결과 측정
측정값 설명
기간
Total (first and subsequent) occurrences of major thrombotic vascular events, consisting of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke, or CV death
기간: Approximately up to 42 months

Cohort 1 and 2

Approximately up to 42 months
Time-to-first occurrence of an expanded thrombotic vascular event, consisting of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke, CV death, unplanned index limb revascularization, or Venous Thromboembolism (VTE)
기간: Approximately up to 42 months

Cohort 1 and 2

Approximately up to 42 months
Time-to-first occurrence of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke or coronary death
기간: Approximately up to 42 months

Cohort 1

Approximately up to 42 months
Time-to-first occurrence of vascular hospitalization for a coronary cerebrovascular, or peripheral event of thrombotic nature
기간: Approximately up to 42 months

Cohort 1

Approximately up to 42 months
Time-to-first occurrence of ALI, major amputation of vascular etiology, MI, ischemic stroke, or all-cause mortality
기간: Approximately up to 42 months

Cohort 1

Approximately up to 42 months
Time-to-first occurrence of unplanned index limb revascularization for ischemia
기간: Approximately up to 42 months

Cohort 1

Approximately up to 42 months
Time-to-first occurrence of VTE
기간: Approximately up to 42 months

Cohort 1

Approximately up to 42 months
Time-to-all-cause mortality
기간: Approximately up to 42 months

Cohort 1

Approximately up to 42 months
Time-to-first occurrence of Major Adverse Limb Event (MALE)
기간: Approximately up to 42 months

Cohort 1

Approximately up to 42 months
Time-to-first occurrence of Major Adverse Cardiovascular Event (MACE)
기간: Approximately up to 42 months

Cohort 1

Approximately up to 42 months
Time-to-first occurrence of a major thrombotic vascular event or ISTH fatal/critical organ bleeding (net clinical benefit)
기간: Approximately up to 42 months

Cohort 1

Approximately up to 42 months
Time-to-first occurrence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding
기간: Approximately up to 42 months

Cohort 1 and 2

Approximately up to 42 months
Occurrence of Treatment-Emergent Adverse Event (TEAEs)
기간: Approximately up to 45 months

Cohort 1 and 2

Approximately up to 45 months
Severity of TEAEs
기간: Approximately up to 45 months

Cohort 1 and 2

Approximately up to 45 months
Occurrence of Anti-Drug Antibody (ADA) to REGN7508 over time
기간: Approximately up to 45 months

Cohort 1 and 2

Approximately up to 45 months
Magnitude of ADA to REGN7508 over time
기간: Approximately up to 45 months

Cohort 1 and 2

Approximately up to 45 months
Occurrence of ADA to REGN9933 over time
기간: Approximately up to 45 months

Cohort 1 and 2

Approximately up to 45 months
Magnitude of ADA to REGN9933 over time
기간: Approximately up to 45 months

Cohort 1 and 2

Approximately up to 45 months
Concentrations of REGN7508 over time
기간: Approximately up to 45 months

Cohort 1 and 2

Approximately up to 45 months
Concentrations of REGN9933 over time
기간: Approximately up to 45 months

Cohort 1 and 2

Approximately up to 45 months
Change from baseline in activated Partial Thromboplastin Time (aPTT) over time
기간: Approximately up to week 9

Cohort 1 and 2

Approximately up to week 9
Change from baseline in Prothrombin Time (PT)/International Normalization Ratio (INR) over time
기간: Approximately up to week 9

Cohort 1 and 2

Approximately up to week 9
Total (first and subsequent) occurrences of expanded thrombotic vascular events
기간: Approximately up to 42 months

Cohort 2

Approximately up to 42 months
Time-to-first occurrence of a major thrombotic vascular event
기간: Approximately up to 42 months

Cohort 2

Approximately up to 42 months
Total (first and subsequent) occurrences of ALI, major amputation (above the ankle) of vascular etiology, MI, all-cause stroke, or CV death
기간: Approximately up to 42 months

Cohort 2

Approximately up to 42 months
Total (first and subsequent) occurrences of ALI, major amputation (above the ankle) of vascular etiology, MI, all-cause stroke, CV death, unplanned index limb revascularization, or VTE
기간: Approximately up to 42 months

Cohort 2

Approximately up to 42 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 연구 책임자: Clinical Trial Management, Regeneron Pharmaceuticals

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 10일

기본 완료 (추정된)

2029년 8월 18일

연구 완료 (추정된)

2029년 11월 16일

연구 등록 날짜

최초 제출

2026년 1월 2일

QC 기준을 충족하는 최초 제출

2026년 1월 2일

처음 게시됨 (실제)

2026년 1월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 3일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • R9933-PAD-2394
  • 2025-522954-37-00 (씨티스)
  • 2025 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD 공유 기간

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD 공유 액세스 기준

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .