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M5049 在 DM 和 PM 参与者中的研究 (NEPTUNIA)

2026年8月17日 更新者：EMD Serono Research & Development Institute, Inc.

一项 IIa 期、随机、平行、双盲、安慰剂对照研究，以评估 Enpatoran 在接受标准治疗的皮肌炎和多发性肌炎参与者中的疗效和安全性 (NEPTUNIA)

本研究的目的是评估口服 M5049 在特发性炎症性肌病，特别是皮肌炎 (DM) 和多发性肌炎 (PM) 参与者中为期 24 周的疗效和安全性。

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

20

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 希腊
      • Athens、希腊
        • Hippokration Hospital - 2nd Department of Medicine and Laboratory
      • Athens、希腊
        • National and Kapodistrian University of Athens (Egnitio Hospital)
      • Larissa、希腊
        • University General Hospital of Larissa
  • 意大利
      • Catania、意大利
        • Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco Di Catania (Vittorio Emanuele) - Reumatologia
      • Catania、意大利
        • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
      • Florence、意大利
        • Azienda Usl Toscana Centro
      • Reggio Emilia、意大利
        • Arcispedale S. Maria Nuova
      • Rome、意大利
        • Fondazione Policlinico Universitario A. Gemelli-IRCCS, UCSC - Scienze Mediche e Chirurgiche
  • 捷克语
      • Prague、捷克语
        • Institute of Rheumatology - Rheumatology
  • 波兰
      • Warsaw、波兰
        • Instytut Reumatologii im. Eleonory Reicher - Department of Connective Tissue Diseases
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85028
        • Neuromuscular Research Center
      • Scottsdale、Arizona、美国、85251
        • HonorHealth Research Institute - Bob Bove Neuroscience Institute-Neuroscience Research
      • Scottsdale、Arizona、美国、85259
        • Mayo Clinic Scottsdale (6365)
    • Colorado
      • Aurora、Colorado、美国、80045
        • Barbara Davis Center
    • Florida
      • Orlando、Florida、美国、32819
        • HMD Research LLC
      • Pembroke Pines、Florida、美国、33026
        • Bolanos Clinical Research
    • Georgia
      • Augusta、Georgia、美国、30912
        • Augusta University-Rheumatology
    • Maryland
      • Baltimore、Maryland、美国、21224
        • Johns Hopkins University - Department of Medicine, Division of Rheumatology
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • University of Minnesota-Dermatology
    • Missouri
      • Kansas City、Missouri、美国、66103
        • University of Kansas Medical Center-Neuromuscular
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213
        • University of Pittsburgh
    • Texas
      • Austin、Texas、美国、78759
        • Austin Neuromuscular Center
      • Houston、Texas、美国、77030
        • Nerve and Muscle Center of Texas-Clinical research
  • 英国
      • Doncaster、英国
        • Doncaster Royal Infirmary (3466)
      • London、英国
        • Royal Free London NHS Foundation Trust
      • London、英国
        • University College London Hospitals NHS Foundation Trust- Neuromuscular Diseases
      • Salford、英国
        • Salford Royal Hospital, Barnes Clinical Research Facility
      • Wolverhampton、英国
        • Royal Wolverhampton Hospitals (6493)
  • 西班牙
      • A Coruña、西班牙
        • CHUAC - Complexo Hospitalario Universitario A Coruña - Rheumatology
      • Barcelona、西班牙
        • Hospital Vall d'hebrón
      • Madrid、西班牙
        • Hospital Universitario Ramon y Cajal, Madrid - Rheumatology Department

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 根据 2017 ACR/EULAR 分类标准诊断可能或明确的 DM 或 PM，自身抗体状态呈阳性。 患有 PM 的参与者必须满足肌肉活检的分类标准。 允许符合分类标准的抗合成酶综合征 (ASyS) 参与者
  • 符合护理标准 (SoC) 的活动性疾病，必须在筛选前 6 个月内满足其中一项标准：肌肉活检中活动性肌炎的病理学证据；肌电图 (EMG) 活动性肌炎的证据；具有活动性肌炎证据的磁共振成像 (MRI)；或筛选时大于或等于（>=）4×正常上限（ULN）的任何肌酶；根据皮肤皮肌炎面积和严重程度指数-A (CDASI-A) 在筛选时 >= 7 的活动性 PM/DM 皮疹
  • 最低疾病严重程度定义为：中度至重度肌病，手动肌肉测试 - 8 (MMT-8) >= 80 且小于或等于 (= 2 厘米 (cm)；来自肌炎疾病活动评估的医师整体活动 (PGA)工具 (MDAAT) >= 2 cm；源自 MDAAT 的肌外活动评估 >= 2 cm；至少一种肌肉酶 > ULN 的 1.5 倍；健康评估问卷-残疾指数 (HAQ-DI) >= 0.25 或中度至重度皮疹和MMT-8 介于 137 和 = 14 之间且至少有 2 项以下 CSM 异常的轻度肌病：PtGA >= 2 cm；PGA 来自 MDAAT >= 2 cm；来自 MDAAT 的肌外活动评估 >= 2 cm；至少有一项肌肉酶 > ULN 的 1.5 倍；HAQ-DI >= 0.25
  • 稳定剂量的口服皮质类固醇 (CS) 和/或最多 1 种非皮质类固醇免疫抑制/免疫调节药物（甲氨蝶呤、6 巯基嘌呤、柳氮磺胺吡啶、霉酚酸酯或钠、硫唑嘌呤、来氟米特、环孢素、口服他克莫司）用于 DM 或 PM
  • 参与者的体重指数 (BMI) 在 18.5 至 35.0 千克每平方米 (kg/m^2)（含）范围内
  • 其他协议定义的纳入标准可以适用

排除标准：

  • 包涵体肌炎 (IBM)、恶性相关性肌炎（定义为癌症发生后 3 年内肌炎的诊断）、免疫介导坏死性肌病 (IMNM) 的初步诊断，活检特征为坏死性活检或 IMNM 具有阳性抗信号识别颗粒抗体 (SRP) 或抗 3-羟基-3-甲基戊二酰辅酶 A 还原酶 (HMGCR) 自身抗体。 具有抗转录中介因子 1 (TIF1) γ 抗体或新诊断（1 年内）抗 MDAT5 抗体的参与者应在第 1 天后的 12 个月内接受过充分的癌症筛查。充分的癌症筛查定义为最新根据国家指南进行适合年龄和性别的筛查
  • 青少年 DM 的初步诊断，或以前诊断为青少年 DM 的成人参与者
  • 研究者认为与炎性​​肌病相关的任何其他活动性并发结缔组织病。 诊断为并发结缔组织病的参与者的资格将由特发性炎症性肌病 (IIM) 专家委员会审查和批准
  • 严重间质性肺病定义为休息时需要补充氧气，或用力肺活量 (FVC)
  • 任何不受控制的疾病（例如[例如]，严重的呼吸系统疾病、心血管疾病、胃肠道疾病、神经系统疾病、精神疾病、血液疾病、代谢疾病[包括伴有促甲状腺激素 (TSH) 增加/减少的甲状腺炎]、肾病、肝病、内分泌/生殖器官疾病）其他比 DM/PM，研究者或申办者/指定人员认为构成参与研究的不适当风险或禁忌症，或可能干扰研究目标、行为或评估
  • 可以应用其他协议定义的排除标准

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：DBPC 时期：安慰剂
药品：安慰剂
参与者将口服与 M5049 匹配的安慰剂，每天两次，最多 24 周。
实验性的：Double-blind Placebo Controlled (DBPC) Period: M5049 dose
药品：M5049 dose
Participants will receive film-coated tablets of M5049 dose orally, twice daily up to 24 weeks.
其他名称：
  • 恩帕托兰
实验性的：Open Label Extension (OLE) Period: M5049 dose
药品：M5049 dose
Participants will receive film-coated tablets of M5049 dose orally, twice daily up to 24 weeks.
其他名称：
  • 恩帕托兰

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Double Blind Placebo Control Period (DBPC): American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) at Week 24
大体时间：At Week 24 (end of DBPC period)
The ACR/EULAR TIS was derived from evaluation of results from 6 Core Set Measures(CSMs) of myositis disease activity in participants with Dermatomyositis and Polymyositis.TIS was determined by summing scores for each CSM,based on improvement in absolute percent change which is calculated by subtracting the baseline value from the final value,dividing difference by the range, and then multiplying the result by100 and relative weight of each core set measure. The TIS scale ranges from 0 to 100 with thresholds for minimal [more than or equal to(>= 20)],moderate(>= 40) and major(>= 60)improvement in combined 6 CSM.The CSMs include,physician global activity visual analogue scale(VAS) score(0-10), patient global activity VAS score(0-10), manual muscle testing-8 score(0-150), health assessment questionnaire-disability index(0-3) along with checks for most abnormal muscle-associated enzymes and extra muscular activity assessment derived using myositis disease activity assessment tool(0-10).
At Week 24 (end of DBPC period)
DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
大体时间：Up to Week 26 (Safety follow up)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether considered related to the medicinal product or protocol-specified procedure. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious TEAEs and non-serious TEAEs. Adverse events of special interest (AESI) are serious or non-serious AEs that are of clinical interest and were closely followed.
Up to Week 26 (Safety follow up)
DBPC Period: Number of Participants With Clinically Meaningful Changes From Baseline in Laboratory Parameters
大体时间：Up to Week 26 (Safety follow up)
Laboratory parameters included hematology, biochemistry, urinalysis and reflex testing for HBV DNA. Number of participants with clinically meaningful changes from baseline in laboratory parameters were reported. Clinical meaningfulness was assessed by the investigator.
Up to Week 26 (Safety follow up)
DBPC Period: Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signs
大体时间：Up to Week 26 (Safety follow up)
Vital signs included body temperature, systolic and diastolic blood pressure, respiration rate, pulse rate, weight, height and body mass index. Number of participants with clinically meaningful changes from baseline in vital signs were reported. Clinical meaningfulness was assessed by the investigator.
Up to Week 26 (Safety follow up)
DBPC Period: Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECG) Parameters
大体时间：Up to Week 26 (Safety follow up)
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. Number of participants with clinically meaningful changes from baseline in ECG parameters were reported. Clinical meaningfulness was assessed by the investigator.
Up to Week 26 (Safety follow up)

次要结果测量

结果测量
措施说明
大体时间
DBPC Period: Number of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) Greater Than or Equal to (>=) 20, >= 40 and >= 60
大体时间：At Week 16 and Week 24
The ACR/EULAR TIS was derived from evaluation of results from 6 Core Set Measures(CSMs) of myositis disease activity in participants with Dermatomyositis and Polymyositis.TIS was determined by summing scores for each CSM,based on improvement in absolute percent change which is calculated by subtracting the baseline value from the final value,dividing difference by the range, and then multiplying the result by100 and relative weight of each core set measure. The TIS scale ranges from 0 to 100 with thresholds for minimal [more than or equal to(>= 20)],moderate(>=40) and major(>=60)improvement in combined 6 CSM.The CSMs include,physician global activity visual analogue scale(VAS) score(0-10), patient global activity VAS score(0-10), manual muscle testing-8 score(0-150), health assessment questionnaire-disability index(0-3) along with checks for most abnormal muscle-associated enzymes and extra muscular activity assessment derived using myositis disease activity assessment tool(0-10).
At Week 16 and Week 24
DBPC Period: Participant's Total Improvement Score (TIS)
大体时间：Week 4, 8, 12, 16, 20 and 24
The ACR/EULAR TIS was derived from evaluation of results from 6 Core Set Measures(CSMs) of myositis disease activity in participants with Dermatomyositis and Polymyositis.TIS was determined by summing scores for each CSM,based on improvement in absolute percent change which is calculated by subtracting the baseline value from the final value,dividing difference by the range, and then multiplying the result by100 and relative weight of each core set measure. The TIS scale ranges from 0 to 100 with thresholds for minimal [more than or equal to(>= 20)],moderate(>=40) and major(>=60)improvement in combined 6 CSM.The CSMs include,physician global activity visual analogue scale(VAS) score(0-10), patient global activity VAS score(0-10), manual muscle testing-8 score(0-150), health assessment questionnaire-disability index(0-3) along with checks for most abnormal muscle-associated enzymes and extra muscular activity assessment derived using myositis disease activity assessment tool(0-10).
Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Physician Global Activity (PGA) Scores From Myositis Disease Activity Assessment Tool (MDAAT)
大体时间：Baseline, Week 4, 8, 12, 16, 20 and 24
The Physician's Global Assessment of Disease Activity was an assessment of overall global disease activity by the physician that was taken from Myositis Disease Activity Assessment Tool (MDAAT). Physician rated participant's disease activity on a 0-10 centimeter (cm) visual analog scale (VAS). Extra-muscular activity ranged between 0 and 10, where, 0 cm = absent and 10 cm = maximum disease activity.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Patient Global Activity (PtGA) Visual Analog Scale (VAS) Score
大体时间：Baseline, Week 4, 8, 12, 16, 20 and 24
PtGA was the assessment of the severity of disease by the participant/participant's guardian, using a VAS from 0 mm (no evidence of disease activity) to 100 mm (extremely active or severe disease activity). Higher score indicated worse status.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Extra Muscular Global Assessment From Myositis Disease Activity Assessment Tool (MDAAT) Score
大体时间：Baseline, Week 4, 8, 12, 16, 20 and 24
MDAAT was a combined tool capturing physician's assessment of disease activity of various organ systems- constitutional, cutaneous, pulmonary, gastrointestinal, joints and cardiovascular, muscular using: Myositis Intention to Treat Activity Index (MITAX), a scale from 0("Not present in the last 4 weeks") to 4("New - in the last 4 weeks [compared to the previous 4 weeks]") and Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT), a 10 cm VAS assessing disease activity in the last 4 weeks of various organ systems from 0 cm("No evidence of disease activity") to 10 cm("Extremely active or severe disease activity"), disease activity being defined as potentially reversible pathology or physiology resulting from the myositis. Left end of line = no evidence of disease activity, midpoint of line = moderate disease activity, and right end of line = extreme or maximum disease activity. An assessment of extramuscular activity assessment was taken from MDAAT using a 10cm VAS scale.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Manual Muscle Testing-8 (MMT-8) Score
大体时间：Baseline, Week 4, 8, 12, 16, 20 and 24
MMT-8 was an International Myositis Assessment and Clinical Studies (IMACS) Core Set Measure used in the calculation of the IMACS Definition of Improvement (DOI) and ACR/EULAR TIS. It is a set of 8 designated muscles tested unilaterally (generally on right side) -which include 1 axial, 5 proximal (2 upper extremity, 3 lower extremity), and 2 distal muscles (1 upper, 1 lower extremity). Total score for unilateral testing ranges from 0 to 80, and bilateral testing ranges from 0 to 150 with normal strength represented by a higher score at or near the top of the scale. The total score for bilateral testing (item "MMT8 score (0 - 150)" from the MANUAL MUSCLE TESTING-8 (mmt8) form) is used in the derivation of the Total Improvement Score.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Health Assessment Questionnaire -Disability Index (HAQ-DI) Score
大体时间：Baseline, Week 4, 8, 12, 16, 20 and 24
HAQ-DI was an IMACS Core Set Measure used in the calculation of the IMACS DOI and ACR/EULAR TIS. It is a generic rather than a disease-specific instrument comprised of 8 sections (dressing, arising, eating, walking, hygiene, reach, grip, and activities), with 2 to 3 questions per section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8. Overall score ranges from 0-3.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Relative Change From Baseline in Most Abnormal Muscle-associated Enzyme
大体时间：Baseline, Week 4, 8, 12, 16, 20 and 24
For each participant, the most abnormal muscle-associated enzyme was defined as the baseline muscle-associated enzyme with the highest ratio of the observed value to the upper limit of the normal range (ULN) among creatinine kinase, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, and aldolase. The relative abnormality could be expressed as a percentage of ULN, calculated as (enzyme value divided by ULN) multiplied by 100.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Number of Participants Who Achieved International Myositis Assessment and Clinical Studies (IMACS) Response
大体时间：At Week 16 and 24
A participant was defined as an International Myositis Assessment and Clinical Studies (IMACS) Responder if 3 of any 6 IMACS Core Set Measures (CSMs) have been improved by more than equal to (>= 20) percent (%), with no more than 2 IMACS CSMs worse by >= 25%. The CSMs include, physician global activity visual analogue scale(VAS) score(0-10), patient global activity VAS score(0-10), manual muscle testing-8 score(0-150), health assessment questionnaire-disability index (0-3) along with checks for muscle-associated enzymes and extra muscular activity assessment derived using myositis disease activity assessment tool(0-10).
At Week 16 and 24
DBPC Period: Change From Baseline in Cutaneous Dermatomyositis Area and Severity Index-A (CDASI-A) and Cutaneous Dermatomyositis Area and Severity Index-D (CDASI-D) Subscale Score
大体时间：Baseline, Week 4, 8, 12, 16, 20 and 24
CDASI is a clinician-scored single page instrument that separately measures activity and damage in the skin of DM participants. CDASI has 3 activity measures (CDASI-A: erythema, scale, and erosion/ulceration) and 2 damage measures (CDASI-D: poikiloderma and calcinosis) which are assessed over 15 body areas. In addition, Gottron's papules on the hands, periungual changes and alopecia are evaluated separately both for activity and damage. Activity and Damage Subscale scores range from 0 to 100 and 0 to 32, respectively, where higher scores indicate greater disease severity.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Investigator's Global Assessment (IGA) Skin Activity Score
大体时间：Baseline, Week 4, 8, 12, 16, 20 and 24
The IGA skin activity is a five-point score that defines the level of disease severity based on overall lesion characteristics where 0 is "clear" and "4" is severe.
Baseline, Week 4, 8, 12, 16, 20 and 24
Open-label Extension (OLE) Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
大体时间：From start of OLE period (Week 1) up to safety follow up (Week 26)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether considered related to the medicinal product or protocol-specified procedure. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious TEAEs and non-serious TEAEs. Adverse events of special interest (AESI) are serious or non-serious AEs that are of clinical interest and were closely followed.
From start of OLE period (Week 1) up to safety follow up (Week 26)
OLE Period: Number of Participants With Clinically Meaningful Changes From Baseline in Laboratory Parameters
大体时间：From start of OLE period (Week 1) up to safety follow up (Week 26)
Laboratory parameters included hematology, biochemistry, urinalysis and reflex testing for HBV DNA. Number of participants with clinically meaningful changes from baseline in laboratory parameters were reported. Clinical meaningfulness was assessed by the investigator.
From start of OLE period (Week 1) up to safety follow up (Week 26)
OLE Period: Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signs
大体时间：From start of OLE period (Week 1) up to safety follow up (Week 26)
Vital signs included body temperature, systolic and diastolic blood pressure, respiration rate, pulse rate, weight, height and body mass index. Number of participants with clinically meaningful changes from baseline in vital signs were reported. Clinical meaningfulness was assessed by the investigator.
From start of OLE period (Week 1) up to safety follow up (Week 26)
OLE Period: Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECG) Parameters
大体时间：From start of OLE period (Week 1) up to safety follow up (Week 26)
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. Number of participants with clinically meaningful changes from baseline in ECG parameters were reported. Clinical meaningfulness was assessed by the investigator.
From start of OLE period (Week 1) up to safety follow up (Week 26)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

EMD Serono Research & Development Institute, Inc.

合作者

Merck KGaA, Darmstadt, Germany

调查人员

  • 研究主任：Medical Responsible、Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年1月19日

初级完成 (实际的)

2025年6月25日

研究完成 (实际的)

2025年6月25日

研究注册日期

首次提交

2022年12月6日

首先提交符合 QC 标准的

2022年12月6日

首次发布 (实际的)

2022年12月14日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MS200569_0041
  • 2022-501351-82-00 (其他标识符：EUCT number)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

我们致力于通过负责任地共享临床试验数据来增强公众健康。 在美国和欧盟批准新产品或批准产品的新适应症后，研究主办方和/或其附属公司将与以下各方共享研究方案、匿名患者数据和研究水平数据以及编辑后的临床研究报告根据要求，合格的科学和医学研究人员进行合法研究是必要的。 有关如何请求数据的更多信息，请访问我们的网站 bit.ly/IPD21

IPD 共享时间框架

在美国和欧盟批准新产品或批准产品的新适应症后六个月内

IPD 共享访问标准

合格的科学和医学研究人员可以索取数据。 此类请求必须以书面形式提交到公司的门户网站，并将根据研究人员的资格标准和研究计划的合法性进行内部审查。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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